Assoc Director, Biologics Formulation Dev
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 Formulation 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 formulations and presentations from early development through late stage and commercial launch, and during life cycle management.
- Serve as a functional leader for DP formulation development for therapeutic protein products at various clinical stages of development based on requirements identified in the QTPP
- Lead the scientific, strategic, planning and execution aspects of biologics formulation development, primary packaging development, technology transfer, and drug product characterization activities for a variety of biologic molecule types.
- Lead a team of scientists, ensuring their individual and organizational development.
- Strengthen internal science and systematically build appropriate technical capabilities.
- Demonstrate independent, scientifically-directed and innovative thinking.
- As a subject matter expert in DP development, lead the formulation development in primary container, assess stability and robustness as appropriate for early and late stage biologics projects, make recommendations on suitable storage conditions for bulk and finished DP.
- Develop appropriate methods to support clinical compatibility of DP during use in clinical trials
- Maintain current knowledge of applicable global regulations and industry standards
- Plan and execute appropriate late stage formulation robustness studies and develop control strategies for BLA submissions
- 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 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 Pharmaceutical Sciences, Chemical Engineering, or relevant scientific discipline with experience in formulation, drug product process development, and registration of therapeutic protein products.
- Experience requirements: PhD > 12 years; or M.S. > 15 years; or B.S. > 20 years of relevant experience
- Demonstrated prior record of successful formulation and drug product 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 some 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.