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Aandeel Pharming Group AEX:PHARM.NL, NL0010391025

Laatste koersSettlement koers (eur) 0,900 26 apr 2024 17:35
Verschil +0,019 (+2,16%) Dagrange 0,883 - 0,903
Volume 3.641.122 Gem. (3M) 6,8M

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Janssen&Janssen 18 juni 2021 14:02
   Janssen&Janssen

Lid sinds: 27 jun 2020

Laatste bezoek: 27 apr 2024

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Ontvangen: 9421

Gegeven: 2037

   Aantal posts: 4.275
Investor Relations Assistant Full-time Leiden

Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for an Investor Relations Assistant for our Leiden office.

About the role:

As an Investor Relations Assistant you are responsible for facilitating the day-to-day activities of the department. This includes administrative duties, arranging events and collaborating with the team to ensure continuity in external corporate messaging. Working within the disciplines of external and internal communications, PR and in conjunction with the Marketing department to oversee the use of key messages in all IR communication outside Pharming following the established corporate communication strategy.

Areas of responsibilities:

Coordinating day to day project activities including preparation of documentation and upkeep of processes
Organize materials in line with the existing corporate identity, facilitating the production of IR communication materials and the maintenance there of
Maintain the corporate website, reviewing on a regular basis and revise content, structure, and applying design changes in line with the corporate strategy
Organization and preparation of various IR communication activities, from logistics to execution
Secondary contact person for relevant external and internal sources involved in the execution of IR communication projects

Required skills and qualifications in order to be successful in this role:

Strong communication skills (in Dutch and English)
Integrity
Organizational sensitivity
ability to prioritize and work with deadlines

Knowledge:
HBO/Bachelor degree in Communication or similar

Experience:
2 years of experience in communication related roles preferably in the pharma/bio-tech industry

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Janssen&Janssen 22 juni 2021 18:39
   Janssen&Janssen

Lid sinds: 27 jun 2020

Laatste bezoek: 27 apr 2024

   Aanbevelingen

Ontvangen: 9421

Gegeven: 2037

   Aantal posts: 4.275
Quality Assurance
Quality Specialist Full-time Leiden

Production
Biotechnician Full-time Oss
Animal Care Taker Full-time Oss
Senior Biotechnician Full-time Oss
Animal Caretaker Full-time Eindhoven
Biotechnician Full-time Eindhoven

R&D
Scientist Formulation Development Full-time Leiden

Technical Operations & QC
CQV Engineer Full-time Oss
Junior F&E (Facility & Equipment) Engineer Full-time Oss
External Manufacturing Manager Full-time Leiden

Medical Affairs
Regional Medical Director DACH Full-time DACH
Regional Medical Director UK Full-time UK
Regional Medical Director FR/BENELUX Full-time The Netherlands
Regional Medical Director Iberia/Italy Full-time Spain
Regional Director Medical Information and Communication Full-time The Netherlands
MSL Diagnostic Specialist Full-time The Netherlands
Medical Writer Medical Affairs Full-time The Netherlands

Regulatory Affairs
Medical Writer Regulatory Affairs Full-time Leiden
Regulatory Affairs (Senior) Specialist CMC Full-time Leiden
Associate Director Regulatory Affairs Full-time Warren, New Jersey USA

Recruitment
Corporate Recruiter Full-time Leiden
Senior Corporate Recruiter Full-time Leiden

ICT
Servicedesk Engineer Full-time Leiden
Functional Application Manager Full-time Leiden

Downstream Processing
Downstream Processing Specialist Full-time Oss

Investor Relations
Investor Relations Assistant Full-time Leiden

Bijgekomen;

Afgenomen:
Sr. Servicedesk Engineer Full-time Warren, New Jersey USA
Financial Reporting Manager Full-time Leiden

Aantal openstaand: 26

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 63
Vervuld: 49

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Janssen&Janssen 24 juni 2021 18:14
   Janssen&Janssen

Lid sinds: 27 jun 2020

Laatste bezoek: 27 apr 2024

   Aanbevelingen

Ontvangen: 9421

Gegeven: 2037

   Aantal posts: 4.275
Quality Assurance
Quality Specialist Full-time Leiden

Production
Biotechnician Full-time Oss
Animal Care Taker Full-time Oss
Senior Biotechnician Full-time Oss
Animal Caretaker Full-time Eindhoven
Biotechnician Full-time Eindhoven

R&D
Scientist Formulation Development Full-time Leiden

Technical Operations & QC
CQV Engineer Full-time Oss
Junior F&E (Facility & Equipment) Engineer Full-time Oss
External Manufacturing Manager Full-time Leiden

Medical Affairs
Regional Medical Director DACH Full-time DACH
Regional Medical Director UK Full-time UK
Regional Medical Director FR/BENELUX Full-time The Netherlands
Regional Medical Director Iberia/Italy Full-time Spain
Regional Director Medical Information and Communication Full-time The Netherlands
MSL Diagnostic Specialist Full-time The Netherlands
Medical Writer Medical Affairs Full-time The Netherlands

Regulatory Affairs
Medical Writer Regulatory Affairs Full-time Leiden
Regulatory Affairs (Senior) Specialist CMC Full-time Leiden
Associate Director Regulatory Affairs Full-time Warren, New Jersey USA

Recruitment
Corporate Recruiter Full-time Leiden
Senior Corporate Recruiter Full-time Leiden

ICT
Servicedesk Engineer Full-time Leiden
Functional Application Manager Full-time Leiden
Functional Application Manager SAP Full-time Leiden

Downstream Processing
Downstream Processing Specialist Full-time Oss

Investor Relations
Investor Relations Assistant Full-time Leiden

Bijgekomen;
Functional Application Manager SAP Full-time Leiden

Afgenomen:

Aantal openstaand: 27

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 64
Vervuld: 49

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Janssen&Janssen 24 juni 2021 18:15
   Janssen&Janssen

Lid sinds: 27 jun 2020

Laatste bezoek: 27 apr 2024

   Aanbevelingen

Ontvangen: 9421

Gegeven: 2037

   Aantal posts: 4.275
Functional Application Manager SAP Full-time Leiden

Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Functional Application Manager.

About the role:
The functional application manager advises and supports the business on ICT application requirements and collaborates with them to ensure best fit of application and optimal use by the organization. He/she is responsible for the life cycle management of a set of allocated applications, from operational functionality to maintenance, version control and upgrades of these applications.

Areas of responsibilities:

Partners with managers on ICT requirements in order to optimize existing and new application functions
Provides guidance to managers to define their requirements and translates these needs into new and/or improved solutions

Together with external partners develop and maintain the applications assigned to you to ensure availability, reliability and continuity

Collaborate with the ICT team/IT Infrastructure Specialist to maintain company infrastructure standards

Initiates, formulates and implements new features, processes and procedures within own functional area.

Provides trainings to employees both written manuals as classroom to ensure the optimal level of knowledge of users
Manage and implement changes and new releases
Required skills and qualifications in order to be successful in this role:

Organizational Sensitivity with a strong customer focus
Planning and organizing
Excellent communication skills in English and Dutch
Problem analysis skills
Agile
Result oriented
Knowledge:

HBO ICT
SAP knowledge & experience

Database knowledge

Power B.I.

Exact online knowledge

Experience:
Minimum of 4 years experience in a similar role

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Janssen&Janssen 29 juni 2021 20:58
   Janssen&Janssen

Lid sinds: 27 jun 2020

Laatste bezoek: 27 apr 2024

   Aanbevelingen

Ontvangen: 9421

Gegeven: 2037

   Aantal posts: 4.275
Quality Assurance
Quality Specialist Full-time Leiden

Production
Biotechnician Full-time Oss
Animal Care Taker Full-time Oss
Senior Biotechnician Full-time Oss
Animal Caretaker Full-time Eindhoven
Biotechnician Full-time Eindhoven

Technical Operations & QC
CQV Engineer Full-time Oss
Junior F&E (Facility & Equipment) Engineer Full-time Oss
External Manufacturing Manager Full-time Leiden

Medical Affairs
Regional Medical Director DACH Full-time DACH
Regional Medical Director UK Full-time UK
Regional Medical Director FR/BENELUX Full-time The Netherlands
Regional Medical Director Iberia/Italy Full-time Spain
Regional Director Medical Information and Communication Full-time The Netherlands
MSL Diagnostic Specialist Full-time The Netherlands
Medical Writer Medical Affairs Full-time The Netherlands

Regulatory Affairs
Medical Writer Regulatory Affairs Full-time Leiden
Regulatory Affairs (Senior) Specialist CMC Full-time Leiden
Associate Director Regulatory Affairs Full-time Warren, New Jersey USA

Recruitment
Corporate Recruiter Full-time Leiden
Senior Corporate Recruiter Full-time Leiden

ICT
Servicedesk Engineer Full-time Leiden
Functional Application Manager Full-time Brabant
Functional Application Manager SAP Full-time Leiden

Downstream Processing
Downstream Processing Specialist Full-time Oss

Procurement
Manager Procurement Full-time Leiden

Investor Relations
Investor Relations Assistant Full-time Leiden

Bijgekomen;
Manager Procurement Full-time Leiden

Afgenomen:
Scientist Formulation Development Full-time Leiden

Aantal openstaand: 27

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 65
Vervuld: 50

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Janssen&Janssen 29 juni 2021 20:58
   Janssen&Janssen

Lid sinds: 27 jun 2020

Laatste bezoek: 27 apr 2024

   Aanbevelingen

Ontvangen: 9421

Gegeven: 2037

   Aantal posts: 4.275
Manager Procurement Full-time Leiden

Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Manager Procurement for our HQ in Leiden.

About the role:

The Manager Procurement will support the business in the sourcing and procurement process. You will help develop and implement a best-practice procurement strategy and build the new department within Pharming.

In this role you will analyze organizational spend, determine business procurement needs, assess market conditions, set clear objectives and KPIs, define procurement policies and develop the procurement strategy. You will lead the negotiations on key business contracts.

The Manager Procurement will also be the SAP Business Process Owner during the SAP implementation that is currently ongoing. In that role, you will shape the Purchase to Pay process as well as contract management and supplier management. As such you will have a pivotal role in change management for these areas across the Pharming business.

Areas of responsibilities:

Develop and implement the Procurement strategy, policy and procedures, to ensure that we specify, select and contract our procurement needs
Create willingness in the organization to actively support the procurement policies and procedures, by showing the added value to the organization
Lead negotiations on key business contracts, ensuring efficient buying in line with business needs
Analyze procurement data to support decision making, ensuring partnerships with the correct suppliers
Set procurement objectives and KPIs for business needs
Lead (is Business Process Owner) in SAP implementation and after SAP go-live on Purchase to Pay process as well as contract management and supplier management
Set priorities by analyzing spend data from multiple sources with analytics tools such as PowerBI, Microsoft Excel
Serve as the primary contact for procurement related questions, training, policy and procedure interpretation and alignment by all departments
Required skills and qualifications in order to be successful in this role:

Initiative
Networking skills
Strong focus on results
Strong negotiation skills
Analytical thinker with excellent problem analysis/solving skills
Organizational sensitivity
Knowledge:

MSc. degree with a focus on Procurement, Supply Chain Management, Operations Management, Mathematics/Engineering or MBA
Nevi-2 or comparable qualification
SAP working knowledge
Sound knowledge of sourcing/procurement strategies
Knowledge of Contractual terms including IP, data protection regulation
Strong communication and presentation skills
Fluent in English and Dutch language
Experience:

At least 6 years of Procurement experience (contracting/negotiations)
Experience in the pharmaceutical industry is preferred

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Janssen&Janssen 1 juli 2021 18:39
   Janssen&Janssen

Lid sinds: 27 jun 2020

Laatste bezoek: 27 apr 2024

   Aanbevelingen

Ontvangen: 9421

Gegeven: 2037

   Aantal posts: 4.275
Quality Assurance
Sr. QA Full-time Leiden

Production
Biotechnician Full-time Oss
Animal Care Taker Full-time Oss
Senior Biotechnician Full-time Oss
Animal Caretaker Full-time Eindhoven
Biotechnician Full-time Eindhoven

Technical Operations & QC
CQV Engineer Full-time Oss
Junior F&E (Facility & Equipment) Engineer Full-time Oss
External Manufacturing Manager Full-time Leiden

Medical Affairs
Regional Medical Director DACH Full-time DACH
Regional Medical Director UK Full-time UK
Regional Medical Director FR/BENELUX Full-time The Netherlands
Regional Medical Director Iberia/Italy Full-time Spain
Regional Director Medical Information and Communication Full-time The Netherlands
MSL Diagnostic Specialist Full-time The Netherlands
Medical Writer Medical Affairs Full-time The Netherlands

Regulatory Affairs
Medical Writer Regulatory Affairs Full-time Leiden
Regulatory Affairs (Senior) Specialist CMC Full-time Leiden
Associate Director Regulatory Affairs Full-time Warren, New Jersey USA

Recruitment
Corporate Recruiter Full-time Leiden
Senior Corporate Recruiter Full-time Leiden

ICT
Servicedesk Engineer Full-time Leiden
Functional Application Manager Full-time Brabant
Functional Application Manager SAP Full-time Leiden

Downstream Processing
Downstream Processing Specialist Full-time Oss

Procurement
Manager Procurement Full-time Leiden

Investor Relations
Investor Relations Assistant Full-time Leiden

Bijgekomen;
Sr. QA Full-time Leiden

Afgenomen:
Quality Specialist Full-time Leiden

Aantal openstaand: 27

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 66
Vervuld: 51

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Janssen&Janssen 1 juli 2021 18:41
   Janssen&Janssen

Lid sinds: 27 jun 2020

Laatste bezoek: 27 apr 2024

   Aanbevelingen

Ontvangen: 9421

Gegeven: 2037

   Aantal posts: 4.275
Sr. QA Full-time Leiden

Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a (Sr.) Quality Assurance Officer.

About the role:

As a valuable team member of the QA Systems team, the (Sr.) QA officer improves and maintains part of the Quality Management System. This to ensure that the quality system at Pharming (including Pharming’s external partners and contractors) is compliant with EU and USA GMP legislation, guidelines and/or Pharming quality expectations. He/she assists and advises colleagues (in- and outside own department) regarding GMP compliance and plays a substantial role QA-related projects.

Areas of responsibilities:

Improve and maintain parts of the Quality Management System (QMS).
Write, implement, review, and maintain SOPs, policies, and other QA related documentation in alignment with applicable GxP guidelines relevant for a QMS.
Write and review quality agreements and ensure timely approvals.
As a co-auditor, perform internal and external audits, to determine compliance with applicable guidelines (like GMP, GLP, ISO, GDP, GCP, GVP). Act as lead auditor when trained sufficiently.
Ventilate the need for compliancy with EU and USA GMP legislation, guidelines and/or Pharming quality expectations throughout the company.
Give general GMP training to Pharming colleagues.
Represents QA Systems in significant complex projects, identifies compliance risks and ensure these are addressed adequately.
Communicate and negotiate with contractors and suppliers, with respect to deviations, configuration, validation, implementation, and complex projects.
Proactively propose ideas for improvements; and provide subject matter expert reports as required.

Required skills and qualifications in order to be successful in this role:

Initiative
Persuasiveness
Organizational sensitivity
Problem analysis
Oral and written communication
Teamwork
Decisiveness

Knowledge:

Bachelors or University degree biopharmaceutical sciences, (bio)chemistry, engineering, or equivalent
Goodknowledge of GMP regulations for EU and US (GMP, GLP and GDP).
Preferably knowledge and experience with ERP (e.g. SAP) and e-DMS (e.g. Master Control) systems
Preferably knowledge and experience of Project management

Experience:

Four to six years of experience in (bio)pharmaceutical environment with at least four years in Quality Assurance.
Minimum four years of experience with GMP regulations for EU and US (GMP, GLP and GDP).

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Janssen&Janssen 6 juli 2021 18:38
   Janssen&Janssen

Lid sinds: 27 jun 2020

Laatste bezoek: 27 apr 2024

   Aanbevelingen

Ontvangen: 9421

Gegeven: 2037

   Aantal posts: 4.275
Quality Assurance
Sr. QA Full-time Leiden

Production
Biotechnician Full-time Oss
Animal Care Taker Full-time Oss
Senior Biotechnician Full-time Oss
Animal Caretaker Full-time Eindhoven
Biotechnician Full-time Eindhoven

Technical Operations & QC
CQV Engineer Full-time Oss
Junior F&E (Facility & Equipment) Engineer Full-time Oss
External Manufacturing Manager Full-time Leiden
Facility and Equipment (Sr) Director Full-time Leiden/Brabant
QC Lead Full-time Oss
CMC Lead Full-time Leiden/Brabant

Medical Affairs
Regional Medical Director DACH Full-time DACH
Regional Medical Director UK Full-time UK
Regional Medical Director FR/BENELUX Full-time The Netherlands
Regional Medical Director Iberia/Italy Full-time Spain
MSL Diagnostic Specialist Full-time The Netherlands
Medical Writer Medical Affairs Full-time The Netherlands

Regulatory Affairs
Medical Writer Regulatory Affairs Full-time Leiden
Regulatory Affairs (Senior) Specialist CMC Full-time Leiden
Associate Director Regulatory Affairs Full-time Warren, New Jersey USA

ICT
Servicedesk Engineer Full-time Leiden
Functional Application Manager SAP Full-time Leiden
Functional Application Manager Full-time Brabant

Downstream Processing
Downstream Processing Specialist Full-time Oss

Procurement
Manager Procurement Full-time Leiden

Investor Relations
Investor Relations Assistant Full-time Leiden

Bijgekomen;
Facility and Equipment (Sr) Director Full-time Leiden/Brabant
QC Lead Full-time Oss
CMC Lead Full-time Leiden/Brabant

Afgenomen:
Regional Director Medical Information and Communication Full-time The Netherlands
Corporate Recruiter Full-time Leiden
Senior Corporate Recruiter Full-time Leiden

Aantal openstaand: 27

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 69
Vervuld: 54

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Janssen&Janssen 6 juli 2021 18:40
   Janssen&Janssen

Lid sinds: 27 jun 2020

Laatste bezoek: 27 apr 2024

   Aanbevelingen

Ontvangen: 9421

Gegeven: 2037

   Aantal posts: 4.275
Facility and Equipment (Sr) Director
Full-time · Oss

Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Facility and Equipment (Sr) Director

About the role:

The F&E (Sr) Director designs and implements the F&E strategy for the growing company, ensures that the right capital investments are made to support the growth, builds the F&E organization and ensures that appropriate resources are in place to ensure that facilities, utilities, automated systems and equipment are commissioned, qualified, revalidated and maintained according to the regulatory expectations

Areas of responsibilities:

To ensure that a robust global F&E strategy and organization is developed and implemented to support the growth of Pharming (balanced model of internal resources and external contracts). S(he) is responsible for the facilities related to Operations and R&D
To ensure that the right capital investments are made timely to support the growth
To lead the group that installs and maintains the facilities, utilities, automated systems and equipment in line with regulatory expectations (e.g. commissioning, qualification, validation, cleaning, security, maintenance, calibration)
To approve documents related to CQV/CSV (commissioning qualification, validation and computer systems validation), regulatory submissions, contracts and policies
To ensure that facilities, utilities, automated systems and equipment can be used safely (by people and towards the environment)
To ensure that Lean principles and risk assessments are used in execution of the strategy
Required skills and qualifications in order to be successful in this role:

Leadership: encourages others to take action and ensures that employees understand how their results affect the rest of the organization. Strives towards a high level of performance. Ability to build an organization from scratch and create a high performing team
Decisiveness: makes timely decisions, even if all information is not available, considering the consequences
Persuasiveness: makes his/her point and achieves a positive result with a difficult proposition. States the common interest.
Collaboration: actively contributes to a common result or problem solving, even when this cooperation is for a subject that is not of immediate personal interest
Excellent verbal and technical writing skills both in English and Dutch, separating main issues from secondary issues and sharing information in a logical order
Knowledge:

Master's degree or PhD e.g. Engineering, (Bio)Pharmaceutical Sciences, Life Science & Technology
Sound knowledge and understanding facilities, utilities, automated systems, equipment and documentation requirements
Very knowledgeable of Current Good Manufacturing Practices (cGMPs) and regulatory guidelines (EMA, FDA, ICH, GAMP)
Knowledgeable on lean principles
Experience:

Minimal 15 years of relevant working experience in the pharma/biotech industry and minimal 10 years managerial experience

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Janssen&Janssen 6 juli 2021 18:41
   Janssen&Janssen

Lid sinds: 27 jun 2020

Laatste bezoek: 27 apr 2024

   Aanbevelingen

Ontvangen: 9421

Gegeven: 2037

   Aantal posts: 4.275
QC Lead Full-time · Oss

Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a QC Lead.

About the role:
The QC Lead will be responsible for ensuring all analytical testing either in our own (to be build) QC lab or at CLOs is performed timely and with high quality.

The QC Lead will be responsible of oversight of CLOs once transferred from the R&D (early phase development) organization through commercial production.

The QC Lead will be responsible for improvement activities to increase efficiency and robustness wrt analytical testing.

Areas of responsibilities:

To develop and lead the group that performs in-house analytical testing for late phase/commercial testing of products including issue resolution (deviations/CAPAs), changes and support of audits.
To lead the group that oversees the CLOs, including CLO issue resolution (deviations/CAPAs), changes and support of audits.
To define the strategic landscape for CLOs based on company needs.
To ensure that a QC lab is developed/built in line with the company strategy.
To approve documents related to qualification and validation for analytical equipment, analytical (stability) protocols/reports, analytical policies and SOPs, and documents for regulatory submissions.
To ensure that the labs and equipment can be used safely (by people and towards the environment).
To identify opportunities for and provide technical leadership to improve quality testing (using lean principles).
To identify opportunities for life cycle management.
To ensure sufficient resources for analytical testing/oversight to support the growing and changing needs of Pharming.
To represent QC in cross-functional, company-wide teams.

Required skills and qualifications in order to be successful in this role:

Leadership: encourages others to take action and ensures that employees understand how their results affect the rest of the organization. Strives towards a high level of performance. Ability to build an organization and create a high performing team
Decisiveness: makes timely decisions, even if all information is not available, considering the consequences
Persuasiveness: makes his/her point and achieves a positive result with a difficult proposition. States the common interest.
Collaboration: actively contributes to a common result or problem solving, even when this cooperation is for a subject that is not of immediate personal interest
Excellent verbal and technical writing skills both in English and Dutch, separating main issues from secondary issues and sharing information in a logical order
Knowledge:

Master's degree or PhD e.g. Analytical Sciences, (Bio)Pharmaceutical Sciences, Life Science & Technology
Sound knowledge and understanding analytical techniques, equipment and documentation requirements
Very knowledgeable of Current Good Manufacturing Practices (cGMPs) and regulatory guidelines (EMA, FDA, ICH, GAMP)
Knowledgeable on lean principles

Experience:

Minimal 10 years of relevant working experience in the pharma/biotech industry (including working with CLOs) and minimal 7 years managerial experience

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Janssen&Janssen 6 juli 2021 18:42
   Janssen&Janssen

Lid sinds: 27 jun 2020

Laatste bezoek: 27 apr 2024

   Aanbevelingen

Ontvangen: 9421

Gegeven: 2037

   Aantal posts: 4.275
CMC Lead Full-time · Oss

Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a CMC Lead

About the role:

The CMC lead will have the primary responsibility of ensuring the successful CMC development (from early development through commercial launch) of Pharming’s products and taking care that products are developed with high quality within the given timelines and budget.

Areas of responsibilities:

To serve on Tactical teams as the CMC representative and lead the CMC Operational Team. To align program goals with CMC goals. This cross-functional CMC Operational team is charged with managing the technology transfer and development/manufacturing/testing/logistics CMC activities internally and at the C(D)MO/CLOs.
To partner with R&D, Quality, Clinical, Medical Affairs, Supply Chain, Regulatory and Marketing functions for a seamless transition between (pre-)clinical and launch/marketed phases.
To lead development activities including product development, process transfer and validation, analytical method transfers and life cycle management. Write/ review/approve related documents including regulatory submissions.
To oversee outsourced operations such that all technical, quality, cGMP and SHE compliance, and supply and business requirements are clearly understood, well documented and are consistently met.
To provide a single point of accountability for identifying and managing timely resolution of operational and quality issues through the established C(D)MO/CLO site governance structure
To prepare all operational (financial and timeline planning) activities needed to deliver the pharmaceutical development program on-time, with high quality, and within budget.
To develop and negotiate Statements of Work (SOW) in collaboration with the CMC Operational Team, Supplier Relationship Management, Procurement, Legal, and Finance.
To identify potential C(D)MO/CLOs, prepare and evaluate Requests for Proposals (RFPs).
To conduct due diligence for new C(D)MO/CLOs for future work.
To drive the CMC risk management process and prepare mitigating actions.
To lead and/or support department company-wide business initiatives and facilitate their implementation, including developing and/or improving phase-appropriate business processes across the contract manufacturing lifecycle in collaboration with key stakeholders (operational excellence).
Required skills and qualifications in order to be successful in this role:

Teamwork: Connects interests/actions/activities of different parties to create a win-win situation
Collaboration: actively contributes to a common result or problem solving, even when this cooperation is for a subject that is not of immediate personal interest
Decisiveness: makes timely decisions, even if all information is not available, considering the consequences
Persuasiveness: makes his/her point and achieves a positive result with a difficult proposition. States the common interest.
Adaptability: Quickly oversees new situations and can provide solutions to deal with the situation or work on parallel tracks.
Excellent verbal and technical writing skills in English, separating main issues from secondary issues and sharing information in a logical order
Knowledge:

Master's degree or PhD e.g. (Chemical) Engineering, (Bio)Pharmaceutical Sciences, (Bio)Chemistry, Life Science & Technology, Biology
Sound knowledge and understanding of pharmaceutical development (variety of modalities including biologics, small molecule, process as well as analytical)
Knowledgeable of Current Good Manufacturing Practices (cGMPs) and regulatory guidelines (e.g. EMA, FDA, Japan, ICH)
Experience:

Minimal 10 years of relevant (CMC) working experience in the pharma/biotech industry preferably both in a development and commercial production environment and minimal 5 years project management experience

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Janssen&Janssen 9 juli 2021 21:27
   Janssen&Janssen

Lid sinds: 27 jun 2020

Laatste bezoek: 27 apr 2024

   Aanbevelingen

Ontvangen: 9421

Gegeven: 2037

   Aantal posts: 4.275
Quality Assurance
Sr. QA Full-time Leiden

Production
Animal Caretaker Full-time Eindhoven
Biotechnician Full-time Eindhoven

Technical Operations & QC
CQV Engineer Full-time Oss
Junior F&E (Facility & Equipment) Engineer Full-time Oss
External Manufacturing Manager Full-time Leiden
Facility and Equipment (Sr) Director Full-time Leiden/Brabant
QC Lead Full-time Oss
CMC Lead Full-time Leiden/Brabant

Medical Affairs
Regional Medical Director DACH Full-time DACH
Regional Medical Director UK Full-time UK
Regional Medical Director FR/BENELUX Full-time The Netherlands
Regional Medical Director Iberia/Italy Full-time Spain
MSL Diagnostic Specialist Full-time The Netherlands
Medical Writer Medical Affairs Full-time The Netherlands

Regulatory Affairs
Medical Writer Regulatory Affairs Full-time Leiden
Regulatory Affairs (Senior) Specialist CMC Full-time Leiden
Associate Director Regulatory Affairs Full-time Warren, New Jersey USA

ICT
Functional Application Manager SAP Full-time Leiden
Functional Application Manager Full-time Brabant

Downstream Processing
Downstream Processing Specialist Full-time Oss

Procurement
Manager Procurement Full-time Leiden

Investor Relations
Investor Relations Assistant Full-time Leiden

Bijgekomen;

Afgenomen:
Servicedesk Engineer Full-time Leiden
Biotechnician Full-time Oss
Animal Care Taker Full-time Oss
Senior Biotechnician Full-time Oss

Aantal openstaand: 23

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 69
Vervuld: 58

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Janssen&Janssen 28 juli 2021 17:48
   Janssen&Janssen

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Quality Assurance
Sr. QA Full-time Leiden

Production
Animal Caretaker Full-time Eindhoven
Biotechnician Full-time Eindhoven

Finance
Finance Manager Full-time Leiden

Technical Operations & QC
CQV Engineer Full-time Oss
Junior F&E (Facility & Equipment) Engineer Full-time Oss
External Manufacturing Manager Full-time Leiden
Facility and Equipment (Sr) Director Full-time Leiden/Brabant
QC Lead Full-time Oss
CMC Lead Full-time Leiden/Brabant

Medical Affairs
Regional Medical Director DACH Full-time DACH
Regional Medical Director UK Full-time UK
Regional Medical Director FR/BENELUX Full-time The Netherlands
Regional Medical Director Iberia/Italy Full-time Spain
MSL Diagnostic Specialist Full-time The Netherlands
Medical Writer Medical Affairs Full-time The Netherlands

Regulatory Affairs
Medical Writer Regulatory Affairs Full-time Leiden
Regulatory Affairs (Senior) Specialist CMC Full-time Leiden
Associate Director Regulatory Affairs Full-time Warren, New Jersey USA

ICT
Functional Application Manager SAP Full-time Leiden
Functional Application Manager Full-time Brabant

Procurement
Manager Procurement Full-time Leiden

Investor Relations
Investor Relations Assistant Full-time Leiden

Bijgekomen;
Finance Manager Full-time Leiden

Afgenomen:
Downstream Processing Specialist Full-time Oss

Aantal openstaand: 23

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 70
Vervuld: 59

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Janssen&Janssen 28 juli 2021 17:49
   Janssen&Janssen

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Finance
Finance Manager Full-time Leiden

Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Finance Manager in Leiden.

About the role:

As Finance Manager you will be leading the accounting department with 8 FTE. The accounting department will be organized in line with the future SAP processes: Order-to-cash (AR), Source-to-Pay (AP), Record-to-Record (GL) and further taking care of the Payroll, SBC (share based compensation) and VAT accounting.

In this role you report to the Group Financial Controller who reports directly to the CFO. As finance manager you will have the opportunity to professionalize the finance processes and broaden your working experience while ensuring the financial accounting is done in an accurate, transparent, traceable, reliable, timely and compliant manner.

Areas of responsibilities:

Manage and coordinate the monthly closing process for the Dutch entities
Monitor & deliver monthly, quarterly and annually all GL specifications for both Balance Sheet and P&L
Build and coach international accounting team
Standardize the recording process while also working to improve, optimize and streamline further the finance process flow

Assist in managing and providing evidence for the external auditors

Coordinate and oversee SOX implementation within the accounting team

Support the financial accountant in resolving any reporting errors or discrepancies identified and providing required reconciliations for consolidation purposes

Support the Vice President Accounting in TAX, VAT, WBSO and CBS requirements

Implement and maintain IC procedures to comply with internal control requirements

Required skills and qualifications in order to be successful in this role:

Accuracy
Leadership
Strong communication skills
Result oriented
Business acumen
Stress resistant
Knowledge:

Master degree in: Accounting & Control, Accountancy, Accounting & Finance Management or similar
Strong Accounting skills and preferably IFRS knowledge
Extended finance process flow knowledge
SAP knowledge is a must and familiar with Sox is a pre
Ability to work in a fast-changing environment
Experience:

At least 3 years of experience in managing a financial accounting team in a multinational company. Experience in pharma, biotech and/or a patent driven organization is beneficial.

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lucas D 1 augustus 2021 09:39
   lucas D

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Weet niet wat anderen er van vinden maar kunnen die lappen tekst niet voor plaatsing vertaald worden.
Dan is alles voor iedereen gelijk leesbaar.

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Janssen&Janssen 2 augustus 2021 22:30
   Janssen&Janssen

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quote:
lucas D schreef op 1 augustus 2021 09:39:
Weet niet wat anderen er van vinden maar kunnen die lappen tekst niet voor plaatsing vertaald worden.
Dan is alles voor iedereen gelijk leesbaar.
Dat kan zeker, doen we dat vanaf nu

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Janssen&Janssen 3 augustus 2021 20:43
   Janssen&Janssen

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Quality Assurance
Sr. QA Full-time Leiden

Production
Animal Caretaker Full-time Eindhoven
Biotechnician Full-time Eindhoven

Finance
Finance Manager Full-time Leiden

Technical Operations & QC
CQV Engineer Full-time Oss
Junior F&E (Facility & Equipment) Engineer Full-time Oss
External Manufacturing Manager Full-time Leiden
Facility and Equipment (Sr) Director Full-time Leiden/Brabant
QC Lead Full-time Oss
CMC Lead Full-time Leiden/Brabant

Medical Affairs
Regional Medical Director DACH Full-time DACH
Regional Medical Director UK Full-time UK
Regional Medical Director FR/BENELUX Full-time The Netherlands
Regional Medical Director Iberia/Italy Full-time Spain
MSL Diagnostic Specialist Full-time The Netherlands

Regulatory Affairs
Medical Writer Regulatory Affairs Full-time Leiden
Regulatory Affairs (Senior) Specialist CMC Full-time Leiden
Associate Director Regulatory Affairs Full-time Warren, New Jersey USA

ICT
Functional Application Manager SAP Full-time Leiden
Functional Application Manager Full-time Brabant

Procurement
Manager Procurement Full-time Leiden

Investor Relations
Investor Relations Assistant Full-time Leiden

Bijgekomen;

Afgenomen:
Medical Writer Medical Affairs Full-time The Netherlands

Aantal openstaand: 22

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 70
Vervuld: 60

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Janssen&Janssen 6 augustus 2021 10:47
   Janssen&Janssen

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Gegeven: 2037

   Aantal posts: 4.275
Quality Assurance
Sr. QA Full-time Leiden

Production
Animal Caretaker Full-time Eindhoven
Biotechnician Full-time Eindhoven

Finance
Finance Manager Full-time Leiden

Clinical and Medical
Clinical Trial Assistant Full-time Warren, New Jersey

Technical Operations & QC
CQV Engineer Full-time Oss
Junior F&E (Facility & Equipment) Engineer Full-time Oss
External Manufacturing Manager Full-time Leiden
Facility and Equipment (Sr) Director Full-time Leiden/Brabant
QC Lead Full-time Oss
CMC Lead Full-time Leiden/Brabant

Medical Affairs
Regional Medical Director DACH Full-time DACH
Regional Medical Director UK Full-time UK
Regional Medical Director FR/BENELUX Full-time The Netherlands
Regional Medical Director Iberia/Italy Full-time Spain
MSL Diagnostic Specialist Full-time The Netherlands

Regulatory Affairs
Medical Writer Regulatory Affairs Full-time Leiden
Regulatory Affairs (Senior) Specialist CMC Full-time Leiden
Associate Director Regulatory Affairs Full-time Warren, New Jersey USA

ICT
Functional Application Manager SAP Full-time Leiden
Functional Application Manager Full-time Brabant

Procurement
Manager Procurement Full-time Leiden

Investor Relations
Investor Relations Assistant Full-time Leiden

Bijgekomen;
Clinical Trial Assistant Full-time Warren, New Jersey

Afgenomen:

Aantal openstaand: 23

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 71
Vervuld: 60

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Janssen&Janssen 6 augustus 2021 10:48
   Janssen&Janssen

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Clinical Trial Assistant Full-time Warren, New Jersey

Over Pharming:
Pharming is een wereldwijd, commercieel biofarmaceutisch bedrijf dat innovatieve eiwitvervangende therapieën en precisiegeneesmiddelen ontwikkelt voor de behandeling van zeldzame ziekten en onvervulde medische behoeften. Het bedrijf is klaar voor verdere wetenschappelijke, technologische en nieuwe productontwikkeling en aanvullende commerciële uitrol. Het bedrijf is internationaal gevestigd en groeit snel. Als gevolg van deze groei zijn we op zoek naar een Clinical Trial Assistant voor ons kantoor in New Jersey.

Over de rol:
De CTA biedt algemene administratieve ondersteuning aan de afdeling klinische operaties en assisteert projectmanager(s), klinische projectcoördinator(en) en afdelingsmanager/directeur(en) bij de verschillende taken die verband houden met het uitvoeren van klinische onderzoeken. De CTA is verantwoordelijk voor alle administratieve taken en assisteert het projectteam bij het opstarten, uitvoeren en afsluiten van de proef.

Verantwoordelijkheden:

Opzetten, organiseren en onderhouden van klinische onderzoeksdocumentatie, inclusief voorbereiding op interne/externe audits, definitieve afstemming en archivering
Werkt mee aan de ontwikkeling van studiedocumenten en -rapporten, inclusief laatste kwaliteitscontrole, bewerking en koppeling van referenties, om te zorgen voor een juiste opmaak en nauwkeurigheid van de inhoud
Neem contact op met klinische locaties voor specifieke verzoeken
Biedt geplande en ad-hocrapporten om de status van de studievoortgang te geven
Verzamel, bekijk en volg documenten voor CA/RA- en EC/IRB-indieningen om te bevestigen dat de aanvragen volledig zijn vóór indiening en volg indieningen en goedkeuringen voor nauwkeurige indiening in het TMF
Voorbereiden, verzenden en beheren van de inventaris van studiegerelateerde materialen en benodigdheden of de activiteiten coördineren met de leveranciers, indien van toepassing (bijv. CRF's, dagboekkaarten, ISF-mappen, enz.)
Contacten onderhouden met toepasselijke leveranciers en klinische proeflocaties om de verzending van laboratoriumbenodigdheden, verzending van bloedmonsters van locaties naar het centrale laboratorium, verzending van onderzoeksmedicatie, enz.
Beoordeel de facturen van de onderzoeker/site en stem ze af op de case report-formulieren (CRF's) en het budget om ervoor te zorgen dat facturen correct zijn en worden verwerkt onder de juiste factureringscodes
Samenwerken met de juridische afdeling om de beoordeling en afronding van contracten met vestigingen, leveranciers en consultants te coördineren en ervoor te zorgen dat facturen correct worden verwerkt
Plannen, organiseren en bijwonen van interne en externe projectteamvergaderingen
Assisteren bij de organisatie van internationale meetings

Vereiste vaardigheden en kwalificaties om succesvol te zijn in deze rol:

Zeer georganiseerd en detailgericht
Effectieve communicatie
Strategische planning en tijdbeheer
Flexibel
Vindingrijk
Team speler

Ervaring:

Minimaal 2 jaar relevante ervaring in een klinische onderzoeksomgeving

Kennis:

Vaardig in MS-Word, Excel en PowerPoint
Beschikken over een algemeen begrip van het proces van klinische proeven en geneesmiddelenontwikkeling, sterke aandacht voor detail en nauwgezette opvolging;
Kennis van toepasselijke regelgevingsrichtlijnen (dwz ICH en GCP) heeft sterk de voorkeur
Bij voorkeur ervaring met eTMF-systeem

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