Associate Director, Biologics Drug Product
Other Locations:US- NJ- Summit West
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.Associate Director, Biologics Drug Product Process DevelopmentSummit, NJ
This is a functional leadership position reporting to the Head of Biologics Drug Product (DP) Development. This role provides committed and accountable leadership for development of phase-appropriate DP manufacturing processes from early development through late stage and commercial launch, and support during life cycle management.
- Serve as a functional leader for DP process development activities for therapeutic protein products in various stages of development
- Lead the scientific, strategic, planning and execution aspects of DP process development including unit processes such as sterile filtration, mixing/compounding, lyophilization, fill/finish, etc for all biologic molecules
- Lead a team of scientists, ensuring their individual and organizational development.
- Lead DP process characterization activities for a variety of biologic molecule types in-house and oversee similar activities at CROs.
- Strengthen internal science and systematically build appropriate technical development capabilities for future need.
- Demonstrate independent, scientifically-directed and innovative thinking.
- As a subject matter expert within drug product development, lead lyophilization development, scale-up, scale-down, and related activities as appropriate for early and late stage biologics projects.
- Develop and support the transfer of robust DP processes to manufacturing sites; provide in-plant support.
- Maintain current knowledge of applicable global regulations and industry standards
- Participate in regulatory strategy development, regulatory filings, and meetings with regulatory agencies.
- Collaborate effectively with other Biologics Development groups, Quality Operations, Supply Chain and other business partners to establish high performing teams and ensure successful outcomes.
- Manage resources, contracts and external relationships. Establish new external relationships, as required.
- Participate in and lead due diligence assessments of new business development opportunities, as required
- Interact effectively with members of the Biologics Development & Manufacturing department, and with other Celgene stakeholders (Quality, Regulatory CMC, Project Leadership, Business Development, Commercial, and Clinical organizations).
- Degree in Chemical Engineering, Pharmaceutical Sciences or relevant scientific discipline with experience in DP process development, and registration of therapeutic protein products is required.
- Experience requirements: PhD > 12 years; or M.S. > 15 years; or B.S. > 20 years of relevant experience
- Demonstrated prior record of successful DP development, supporting clinical/commercial programs for recombinant protein products, including authoring of regulatory submissions globally.
- Experienced in planning and executing late stage robustness studies and control strategy is a requirement.
- Experience in authoring relevant sections of BLAs is highly desired
- Must have significant prior experience in working with CMOs/CROs.
- Must have in-depth understanding of all aspects pertaining formulation and drug product development of liquid and lyophilized biological products, including experience with multiple primary packaging configurations.
- Demonstrated ability for critical thinking, problem solving and innovation.
- Must have a good understanding of GMP manufacturing and GMP compliance.
- Working knowledge of current US, EU, and global Regulations, ICH guidance and relevant standards and quality system requirements for biological product manufacturing.
- Strong communication skills, good interpersonal skills, ability to multi-task, publication track record and a strong desire to learn, contribute and collaborate.
- Proven ability to work effectively within the department and with cross-functional stakeholders.
#LI-POSTCelgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.