Associate Director, Biologics Downstream Process Lead

Job Description

We are seeking a highly motivated individual for the role of Associate Director, Biologics Down Stream Process Lead within the Enterprise Go To Market (EGTM) team, part of the larger Biologics Large Molecule Science and Technology (LMS&T) team. This role will serve as a scientific and technical resource for downstream operations (e.g. chromatography, tangential flow filtration, etc.), lead investigations and provide guidance and training to operations staff. The incumbent will demonstrate deep expertise for people management leadership and product/process sciences and engineering. The incumbent will have broad, experience-based skillsets in technology transfers of downstream operations.   The incumbent must focus on standards and right first-time success for PPQ of commercial scale manufacturing processes.  In addition, the incumbent will adhere to applicable business processes including program/portfolio management tools while working with internal and external manufacturing partners and influencing technical strategy.

The incumbent will partner with groups across our Company and that includes the Global Human Health, Process Development, Commercialization, Operations, Technical Operations, Analytical, Quality, Regulatory-CMC, and Supply Chain. The end-to-end scope includes Drug Substance for all large molecules. The Associate Director is expected to contribute to ongoing business process improvements and all Tech Transfer activities.

Key Responsibilities:

• Leading Downstream processing (DSP) Technical Transfer (TT) activities ensuring On-time Delivery: Manages and accountable for the overall DSP technology transfer activities with end-to-end visibility on sending and receiving site deliverables for DSP operations readiness. Manages and leads collaboration for TT related regulatory authoring and filing activities.
• Accountable to ensure the DSP TT project deliverables (metrics) are met and are on time. Includes regulatory filing of related sections and regulatory approval of the TT node.
• Working with the TT Lead and matrix team members, accountable for detailed TT planning, TT schedules, gap assessments, risk assessments and mitigations, knowledge and data plans for that TT, stage gate readiness and reviews, supporting sending and receiving unit deliverables, authoring facility fit assessment and validation strategy documents, reviewing various sending (control strategy, comparability strategy etc.), and receiving site documents (validation protocols, Batch Reports, campaign summary reports, PPQ reports, investigation reports etc.), authoring BLA/MAA sections.
• Supports Person In Plant (PIP) activities.
• Manages TT Technical Issues and escalations. Works under and with program leadership teams for program escalations and works with New Product Introduction/Operations lead for business unit operations escalations.
• Ensures TT standards and workflows are applied during TT.
• Supports After Action Reviews and knowledge sharing with other TT teams.
• Required to comply with our Company Global and regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
• Work collaboratively to drive a safe and compliant culture.
• Leads cross-functional, matrixed tech transfer team focused on Large Molecule TT of DSP processes to achieve right first-time PPQ validation with line-of-sight to filing and licensure.
• Builds strong cross-divisional partnerships with site leaders, functional management, and other stakeholders (Research & Development, Commercialization, Tech Ops, Ops, Quality, Analytical Regulatory-CMC, and Supply Chain, etc.)
• Contributes to presentations at stage gates and other TT local governance meetings.
• Aligns program and site goals to execute the TT.

Minimum Education Requirements and Experience

• Bachelor of Science (B.S.) in Biological Sciences, Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with minimum of seven (7) years of experience in Downstream Processing (DSP) Operations, technical proficiency in downstream biologics processing, and compliance with cGMP and global standards for biologics. OR
• Master of Science (M.S.) in Biological Sciences, Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with minimum of five (5) years of experience in Downstream Processing (DSP) Operations, technical proficiency in downstream biologics processing, and compliance with cGMP and global standards for biologics. OR
• Ph.D. degree in Biological Sciences, Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with minimum of three (3) years of experience in Downstream Processing