At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Associate Director Cell Therapy Analytical Development Lead

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Associate Director CT AD Lead are to:

• Represent Analytical Development (AD) in Technical Development Teams (TDT) for internal and external cell therapy projects;
• Propose specifications, stability strategy, and ensure product quality throughout the product lifecycle. Collaborate with Analytical functional leads to ensure timely completion of analytical activities;
• Author and review product regulatory filing documents;
• Participate in the identification of control strategy development requirements for cell therapy product classes (e.g., QTPP creation, risk assessments, CQA identification, specification setting, potency matrix strategy);
• Serve as a subject matter expert for CT analytical and control strategy topics for Global Biologics Development;
• Ensure Berkeley CT analytical strategies are aligned within Bayer globally (global analytics, CT ecosystem, regulatory, MSAT, QA, commercial QC);
• Provide scientific and technical evaluation of complex process and product quality data throughout the product development and product lifecycle;
• Ensure that phase-appropriate analytics and strategies are applied throughout the product lifecycle.

WHO YOU ARE

Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Ph.D. in a life science or engineering discipline (bio-/chemical engineering, biotechnology etc.);
• Experience in biologics process development or analytical characterization, especially in Cell Therapy;
• Knowledge of process characterization and validation with consideration of current regulatory expectations, e.g. quality-by-design approach for biologics and ATMPs;
• Knowledge of Regulatory requirements and standards applicable to ATMP’s;
• Knowledge of Good Manufacturing Practices requirements and experience in CMC-development and manufacturing of pharmaceutical products;
• Excellent stakeholder management and engagement skills;
• Strong communication (written and oral) and negotiation skills.

Preferred Qualifications:

• 4+ years of relevant experience in the cell therapy and/or biopharmaceutical industry

Employees can expect to be paid a salary between $108,700 to $176,600. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc. This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.