Associate Director – Biologics Downstream Process Lead

Associate Director – Biologics Downstream Process Lead

Requirements

• 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.
• 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.
• 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 (DSP) Operations, technical proficiency in downstream biologics processing, and compliance with cGMP and global standards for biologics.
• Manages effectively with diverse teams (cross-functionally, cross-culturally, and across internal / external sites) to align and drive TT results.
• Viewed as an expert in DSP operations.
• Effective verbal and written communicator who keeps stakeholders / partners apprised of plans, status, and issues.
• Works well in ambiguity.
• Able to articulate TT to others.
• Establishes clear goals, delegates effectively, holds self and others accountable.
• Flexible and adaptable to dynamic situations
• Cross-functional team management; successful at indirect management.
• Ability to succeed in a dynamic environment with flexibility to respond to changing priorities.
• Effective interpersonal skills and ability to work collaboratively across diverse teams and networks; able to foster cooperation in others, using the diverse perspectives of others to generate ideas.
• Well-developed and effective team facilitation and leadership skills; ability to establish inclusive team environments.
• Expertise in technical aspects of product commercialization and life cycle management
• Strong scientific knowledge of multiple TT types including vaccines / biologics drug substance, drug product and analytical.
• Proficiency with change control, deviation management and BLA/MAA regulatory license documents.
• Demonstrated creative conflict resolution and problem-solving skill.
• Strong knowledge of global regulatory guidelines and cGMP principles.
• Demonstrated experience with lean operational excellence in manufacturing.
• Digital tool competency with One PMO, MS Teams, Power BI, MSPO, Spotfire, SharePoint and other related systems.
• Demonstrated ability to create and analyze detailed, cross-functional project plans (including Gantt charting) and manage execution and change against those plans.

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.

Preferred Qualifications

No preferred qualifications provided.