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Contract Manufacturing Manager
Job Description
- Provides support to the primary point of contact for all communications pertaining to the drug product manufacturing at an external manufacturing site
- Serve as primary Person in Plant with responsibility to provide oversight during DP manufacturing
- Oversee and support exception management during manufacturing
- Provide technical support and oversight of SM DP manufacturing operations including granulation, blending, compression and coating.
- Participate in FMEA or other risk-based approaches to assess process performance
- Provide PM on site support to support on time manufacturing and respond to risk
- Act as main on site contact, escalating as appropriate and seeking cross functional alignment and clarifications as needed to ensure product quality, on time manufacturing and availability of product for forward processing.
B. Sc in related scientific discipline
Minimum 7-10 years of experience in Quality / Technical role, PM experience is an advantage. Strong knowledge of Good Manufacturing Practices (GMP), specifically for small molecule drug product operations Ability to effectively manage time, multiple overlapping priorities and progress tasks to meet timeline in a fast pace/dynamic environment. Experience working cross-department with CMC, regulatory, MSAT and other quality functions across multiple countries / time zones Ability to evaluate and understands quality risk, including risk mitigation Computer Skills: PC, including MS Office Suite
Travel: Occasionally, as required
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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