Location: Groningen , Groningen
Language(s): Only English Required
One of our favourite pharmaceutical clients islooking for a Technical Project Manager for their Biostatistics andStatistical Programming team. The contract is on-site in the Northof the Netherlands until the end of 2021 for 40 hours a week. Alonger collaboration between both parties is anticipated.Technical Project ManagerProject overview In this role you canleverage your scientific and leadership expertise to optimize thetechnical performance of biopharmaceutical products in the supplychain. As Technical Manager (Product Leader/Owner) you will provideproject technical leadership and oversight for New ProductIntroduction and ongoing manufacturing to ensure process robustnessand successful commercial supply. This role will provide you theopportunity to lead key activities to progress your career,including some of the following responsibilities:
- Serve as the Technical Lead on manufacture of criticalspecialty products, including serving as technical lead /Person-In-Plant representing the pharmaceutical company at ContractManufacturing Organizations (CMOs)
- Ensure thatany issues related to product or process technology are identified,a root cause analysis conducted, and corrective actions implementedto ensure resolution
- Maintain productrobustness through continued process verification plan and periodicproduct reviews. Support ongoing product supply by ensuring robustand capable processes are in place and monitored.
- Support of product transfers from the pharmaceuticalclient sites to a CMO, between CMOs or from CMOs to thepharmaceutical client sites
- Impact assessmentand support of changes (the pharmaceutical client or CMO driven)including change control and risk assessment
- Ensure with Quality Assurance that necessary validationactivities have been planned and executed to current standards (Product Lifecycle Management) in line with the pharmaceuticalclient''s QMS
- Lead technical risk assessment ofnew and existing products and facilities and identify/drivemitigation plans
- Apply OE tools and principalsin the implementation of technical projects and improvementinitiatives
- Support due diligence activitiesby providing technical assessment of potential newproducts/CMOs
- Work with multi-functional teamsof Procurement, Quality, Technical, Supply, Project management,Strategy, Regulatory, Finance and Business Developmentprofessionals across the Global network.
- Provide leadership of key improvement initiatives withthe pharmaceutical client''s partner organizations on delivery ofobjectives
- Work to implement standards ofquality by design into robust manufacturing operations
- Represent Technical at CMC Steering Team and New ProductSupply Board as required
- Support mid-latephase portfolio projects and provide Pharma Supply Chain Technicalinput into design selection and manufactureconsiderations.
- Provide Pharma Supply ChainTechnical input into developing product control strategy, authorrelevant sections of NDA/MAA, conduct OpTRA with contractmanufacturers and ensure implementation of product control strategyon to shop floor/manufacturing operations.
- Agree and enforce all Technical standards related to themanufacture and supply of the pharmaceutical client''s products byContract Manufacturers, including new product introduction andvalidation of facilities, equipment and processes.
- Start date: ASAP
- Project length:December 2021
- Location: Groningen area (theNetherlands)
- BS inChemical/Biochemical Engineering, Biochemistry, Chemistry orequivalent
- 10+ years'' experience in technicalsupport of biopharmaceutical manufacturing and/or processdevelopment
- Excellent verbal and writtencommunication skills
- Ability to influence,lead and drive change
- Demonstrated record ofachievement, including ability to work effectively incross-functional teams
- Broad and integratedknowledge and experience that can impact project and teamdirection
- Working knowledge of regulatoryrequirements in the industry and drug development
- Ability to manage across multiple projectssimultaneously, lead matrix teams, and mentor site based technicalstaff members
- MS or PhD Chemical/Biochemical Engineering, Biochemistry,Chemistry or equivalent
- Experience intechnical support of commercial products, program management,technology transfer to commercial manufacturing sites (internal andto external CMO)
- Experience in processvalidation, regulatory file preparation, PAI support
- Technical support of product lifecycle activities ( CPV,PPR, Change and Deviation Management)
- Excellent oral and written communication skills inEnglish; Dutch is preferred.