Job Title: Sr Engineer, Drug Product Technology Transfer
About Us: BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
Job Description:
We are hiring a Senior Engineer with expertise in MSAT or process development/technology transfer, with a background in large-scale processing of biologic drug products. The successful candidate will lead the technical delivery of new product introductions and tech transfer projects by collaborating closely with cross-functional project teams. This includes ensuring compliance with specifications, regulatory guidelines, and right-first-time delivery.
The ideal candidate will have a strong understanding of regulatory requirements and guidelines, be proficient in technical writing, and possess excellent organizational, interpersonal communication, and problem-solving skills. They will also be capable of identifying, communicating, and implementing continuous process improvements, as well as working effectively with diverse team members in a dynamic environment.
Key Responsibilities:
1. Lead the technical delivery of new product introductions and tech transfer projects by closely collaborating with cross-functional project teams, ensuring compliance with specifications, regulatory guidelines, and right-first-time delivery.
2. Act as the technical SME for drug product (DP) filling operations, working in a matrix team environment with process development, QA, QC, analytical sciences, packaging, supply chain, and regulatory teams to achieve project objectives.
3. Lead DP partner team comprising of various cross functional members, for overall process development, scale-up and PPQ manufacturing activities, including regulatory filing.
4. Support aseptic filling operations (vials and pre-filled syringes) for technology transfers and life cycle management, overseeing new product introductions from development batches to approval and commercialization.
5. Lead process comparisons, risk assessments, manage DP technical and manufacturing risks and identify appropriate mitigations.
6. Develop data-driven strategies for process development/product characterization including pre-PPQ FMEA and/or NOR/PAR range finding efforts.
7. Design experiments for lab studies/analytical work with a high level of autonomy.
8. Author technical reports to support DP technology transfer and DP process and product characterization.
9. Manage change control, deviations, and CAPAs through the quality management system until closure.
10. Support on-site implementation of changes and DP launch activities.
11. Facilitate investigations, root cause analysis for deviation resolution, data gathering/analysis, and provide technical assessments for deviations.
12. Assist with PPQ campaign readiness and provide in-person, on-the-floor execution support for technical runs and PPQ campaigns as required.
13. Initiate and lead process improvement projects, involving cross-functional teams.
14. Author CMC sections of US and international regulatory dossiers, draft responses to the information requests during health agency review.
15. Assist with regulatory inspections and present technical topics related to process aspects of assigned products when necessary.
16. Assist in the development of global technical policies, standards, and guidelines for Drug Products as needed.
17. Ensure a thorough understanding of all quality policies and BioMarin system items as outlined in the training curriculum.
18. Other duties as assigned.
Requirements:
1. A degree in engineering or science with 8 years of relevant experience in the biotech/pharmaceutical field.
Estimated Salary: $120,000 - $150,000 per year.