As appropriate, responsibilities include:
- GMTO representative on commercial asset team. Ensures factory or virtual plant GMS partners have established and are maintaining product campaign dashboards and monitoring tools.
- Technical point of contact for asset end-to-end and Asset Team lead GMTO representative. Requires knowledge of DS, DP, and finished goods processes, and good working relationship with lines and SMEs in those spaces.
- Partners with GMS TT, Mfg/External Mfg, QA/SQC, Global Engineering, Medical Device & Packaging, and other groups as relevant to ensure meeting timelines for product/process transfers to new/additional manufacturing sites.
- Ensures technical and project readiness for PPQ and commercialization of late-stage asset and supports Regulatory Filing Strategy
- Ensures meeting of project timelines for LCM process/product improvements and process/product transfer to new production sites
- Overall manufacturing/supply strategy for asset
- Finalizes the process general recipes in preparation for PPQ, and maintains/updates these process descriptions during on-going commercial lifecycle
- Initiates GCCs to implement LCM process improvements.
- Owns process changes that have significant cost of implementing, for example requiring an Engineering capital project, or regulatory global filing changes
- Owns LCM for technical improvements (from continuous improvement or from CAPAs) for commercial asset, from DS/API through DP to FG. Either directly owns or ensures and monitors appropriate ownership of GCCs for process and analytical method changes, and CPV/APR deliverables.
- POC for Reg/CMC on necessary authorship, filing questions, ROW lifecycle filing, and agency notifications of process/method issues or filing updates. SME during asset PAIs or GMP inspections that touch on asset
- Provides submission writing support to Reg/CMC for post-launch ROW filings, and answers to Agency questions on technical/CMC issues.
- Partners to ensure visibility to stakeholders of campaign performance and batch/lot data and status of major process/product investigations.
- Investigations where product impact cannot be ruled out, and require an material review board
- Business process development & any other assigned activities from time to time
- Ph.D. with 4 years’ experience, M.S. with 10+ years’ experience or BA/BS + 12 yrs relevant experience in the Biotech / Biopharm industry
- Position is a key supporter of PO&T commercial assets, and therefore excellent communication and partnering skills are required for being the technical point person for the broad matrix of PO&T stakeholders who are accountable for ensuring product supply and LCM of the commercial asset.
- Solid technical understanding of either drug substance or drug product manufacturing for large molecule, including transfer of such processes into full-scale manufacturing facilities.
- Ability to work independently and lead a large cross-functional group.
- Strong ability to provide matrix leadership to the organization
- Comfortable analyzing scientific datasets/strong analytical skills with excellent written skills.
- Knowledge of cGMP, FDA/EMA regulations, Process Performance Qualification
As a member of the Manufacturing Sciences Technical Product Lead (TPL) group, the TPL will provide technical expertise for a late stage/commercial asset in the Biogen portfolio. The TPL is a role that takes on technical ownership of the manufacturing process and product specification, end-to-end from Drug Substance to Drug Product to Finished Goods, for an asset whose lifecycle is moving into PPQ and commercialization. The role is the primary Global Manufacturing and Technical Operations (GMTO) representative on the commercial asset team, serving as the technical counterpart to the Asset Lead. Primary technical resource for Reg/CMC team on technical questions from agencies, lifecycle ROW filings, and any agency notifications for process/product issues. Supports sites during PAIs for asset, and during general inspections when specific questions on asset arise. Coordinates with GMS Tech Transfer and Virtual Plant Teams on ensuring success in site-to-site transfers. Sponsors continuous improvements for manufacturing process or method changes and owns GCCs for implementing lifecycle management process changes. Maintains close contact with/awareness of investigation teams for major process, analytical, or DP/FG issues, and provides product impact assessments for raw material, manufacturing, or analytical investigations, either internally or at CMOs. In particular, the TPL should provide the Gene Therapy products.