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