City of Shakopee

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. Senior Director Formulation Process Development As the Senior Director, Formulation and Process Development, you will lead the drug product formulation and process development department in Berkeley CA and oversee pre-clinical and clinical drug product development activities to support clinical regulatory filings. Scope includes proteins, monoclonal antibodies, and new therapeutic modalities including cell therapy in different stages of clinical development and a variety of primary and secondary containers. Products may be liquid, frozen, or lyophilized; new therapeutic modality products may be frozen or cryopreserved Your Tasks And ResponsibilitiesThe primary responsibilities of this role, Senior Director Formulation and Process Development are to:

• As drug product process development and device compatibility assessment leader, leads the Formulation, Freeze-drying and clinical drug delivery development function for Global Biologics Development (GBD) at the Berkeley site;
• Provide oversight and innovative leadership for formulation development, process design & development, process scale-up and transfer, and optimization of patient experience;
• Ensure that processes developed are scalable to produce clinical and commercial drug product in compliance with cGMPs and regulatory guidance, and that materials and components used are in full compliance with Bayer, FDA, global regulatory guidelines;
• Oversee pre-clinical DP manufacturing at the Berkeley site and clinical DP manufacturing at Bayer US, Europe, or outsourced facilities. Works closely with medical device organization for late stage clinical and commercial development;
• Review and monitor team delivery of regulatory submission documents for all clinical stages and responds to agency questions and audits;
• Lead harmonization of Formulation and DP process development processes and policies globally, with timely implementation. Monitors implementation and performance of current systems and keeps management informed of needs for future internal innovation or acquisition of external technologies;
• Provides effective leadership including: development and implementing objectives and business strategies; selecting key personnel and motivating members of the functional area; challenging employees to develop as leaders while serving as a role model and mentor; assisting with Performance Calibration, Talent Pool Management, Succession Planning; individual goal setting/performance reviews; training and development; supporting workforce diversity, quality and safety and supporting managers in management of their employees which support achievement of individual, department, and business objectives.

Who You AreYour 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:

• Bachelor of Science in pharmaceutical or biological sciences;
• Working knowledge of cGMP, protein and cell therapy formulation and pre-formulations experiments, biophysical characterization, drug product process development, packaging development and regulatory compliance (US and non-US regulatory);
• Thorough knowledge of freezing and thawing of bulk protein solutions and cell therapy products, and freeze-drying processes for protein products;
• Strong leadership, interpersonal, communication, and team building skills;
• Ability to multi-task and adapt to changing business requirement in a dynamic, matrix environment. Understands business on a global scale;
• Ability to make decisions in a cost-effective and timely manner, sometimes with incomplete information and under tight deadlines;
• Ability to maneuver through complex political situations effectively;
• Builds and maintains trust with business partners within and outside Global Biological Development. Effectively ensures global cross-functional communication and collaboration.
• Prior experience with IND/IMPD submissions for biologics
• Practical knowledge and sound understanding of pharmaceutical, biologics, and medical drug product and device manufacturing processes
• Knowledge of manufacturing process technical transfer and validation support.

Preferred Qualifications:

• 5+ years managerial experience in drug product development operations;
• Bachelor of Science with 14+ years of experience or Masters of Science with 10+ years of experience or PhD with 8+ years of experience;
• Experience with cell therapy formulation, filling or cryopreservation

Employees can expect to be paid a salary between $191,600 to $287,300. 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. YOUR APPLICATION Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.To all recruitment agencies: Bayer does not accept unsolicited third party resumes.Bayer is an Equal Opportunity Employer/Disabled/VeteransBayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. IMPORTANT NOTE for POTENTIAL US CANDIDATES: Bayer expects its colleagues to be fully vaccinated against COVID-19. Bayer defines fully vaccinated in alignment with CDC which is two weeks after completing the two-dose vaccine regimen or two weeks after completing the one-dose regimen. Additionally, Bayer colleagues are also required to comply with state, local and customer requirements. Location: United States : California : Berkeley Division: Pharmaceuticals Reference Code: 789307 Contact Us Email: hrop_usa@bayer.com