Drug Product PM (Fill/Finish)
CK QLS are recruiting for a Drug Product PM to join an important project with a global Pharmaceutical Company remotely on a project for one year initially and with the possibility to get extended.
The key responsibilities are:
- Technical and manufacturing integration of new and re-developed drug products from R&D into the supply chain (large molecule).
- Leading the DP manufacturing site team and manufacturing site representative on the DPD Sub team and the Company New Product Team.
- Single point of contact for Company plant readiness and execution from technical transfer into commercial production (e.g. tech transfer implementation, site-based documentation, planning, risk management, budget) including launch support.
- Company technical input and technical acceptance of DP into the supply chain including cost and robustness metrics through a process of “touch points”, thereby ensuring “one voice of the customer” towards R&D and consistency across projects and across plants.Further responsibilities will include:
- Contribution, review and approval of drug product technical and regulatory documents (e.g., protocols, reports, filings, criticality analysis, control strategies, master plans, etc), routine technical support during execution, integration of Company technical expertise (e.g., platforms, engineering, SME's) into project execution and QbD technical implementation at the manufacturing site level.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Strong project management skills with experience in supporting the execution of large-scale projects.
- Experience working with sterile liquid/vaccine production within fill/finish, this includes introduction of pharmaceutical products to manufacturing sites and late stage development with working technical knowledge of GMP
- Knowledge in process validation, and aseptic process equipment (sterile isolators) requirements
- Hands-on experience and solving batch issues
- BS degree with a minimum of 7 years of experience or equivalent, or advanced degree MS/MBA/PhD with over 4 years' experience (Better if in this function: Small Molecule and/or Large Molecule pharmaceuticals; research and development; Technical Operations; API/ Drug Product Manufacturing; Quality; Regulatory; Drug Development )
- Ability to lead, encourage and coach project teams and individuals
- You should have a sound sense of urgency, process-oriented skills, attention to detail, outstanding teaming and collaboration skills
- Good communication skills including technical writing proficiency
For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106106 or email email@example.com. Please could you send any correspondence in English. Please quote reference QLS 00050579 in all correspondence.