Otsuka
Associate Director, Biologics Drug Product Development
Otsuka, Princeton, New Jersey, us, 08543
Job SummaryAssociate Director, Biologics Drug Product Development oversees the formulation development and fill finish processes for bio-therapeutics, technology transfer to clinical and commercial CDMOs. You should have extensive experience in early and late phase Biologics development and foster productive collaborations with internal QA, Clinical Development and Regulatory teams. You will report to Director, Biologics Development.
Job Description
You will be subject matter expert in the formulation development for biologics, biophysical characterization studies, drug product process development, tech transfer and process characterization studies. Responsible for strategic oversight and leadership of the full scope of drug product activities for biologics early phase through commercialization.
Review and author development reports, comparability protocols, specifications, validation reports and other technical documents for technical correctness and regulatory compliance.
A proven track record of technical skills in this area, experience with early and late-stage regulatory filings and regulatory interactions, and experience working effectively with third-party DP CMOs is essential.
Work collaboratively with formulation, analytical, quality and regulatory SMEs to develop sound, integrated plans for development and manufacturing.
Demonstrate knowledge of drug stability evaluation and mitigation strategies for early and late phase development strategy.
Experience in DP development for commercialization including risk assessments, process characterization and validation of combination products.
Experience in authoring and reviewing CMC documents for regulatory submission documents (IND, IMPD, BLA, MAA etc.). Provide strategic guidance on regulatory interactions relating to drug product formulation and process development, specifications setting and control strategy.
Ensure effective communication, and collaboration, and preparation of dossiers in collaboration with functional CMC leads & external partners.
Manage budgets, schedules, and performance requirements to meet project goals.
Qualifications/ RequiredKnowledge/ Experience and Skills:
Ph.D preferred in a relevant field (e.g. biochemistry/chemistry, pharmaceutical sciences, chemical engineering) with 10+ years, MS with 15+ years of experience, or equivalent experience in the biopharmaceutical industry.
Ability to work in a fast-paced dynamic environment with changing priorities, forward thinking with flexibility to support multiple development programs simultaneously.
Working knowledge of ICH and FDA guidelines and global regulations.
Experience with regulatory, QA, and cGMP requirements for biologics. Assist in OOS investigations, determination of root cause, and implementation of appropriate CAPA.
Experience with IND and BLA filings; knowledge of relevant FDA regulations and guidelines is required.
Track record of successfully driving and managing programs, overcoming challenges, and managing risks.
Excellent communication and interpersonal skills in working across the organization.
Travel: Up to 25% of the time – occasional international travel to partner and/or contractor facilities related to engineering, GMP and PPQ runs.
CompetenciesAccountability for Results
- Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving
- Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity
- Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication
- Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration
- Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development
- Play an active role in professional development as a business imperative.
#J-18808-Ljbffr
Job Description
You will be subject matter expert in the formulation development for biologics, biophysical characterization studies, drug product process development, tech transfer and process characterization studies. Responsible for strategic oversight and leadership of the full scope of drug product activities for biologics early phase through commercialization.
Review and author development reports, comparability protocols, specifications, validation reports and other technical documents for technical correctness and regulatory compliance.
A proven track record of technical skills in this area, experience with early and late-stage regulatory filings and regulatory interactions, and experience working effectively with third-party DP CMOs is essential.
Work collaboratively with formulation, analytical, quality and regulatory SMEs to develop sound, integrated plans for development and manufacturing.
Demonstrate knowledge of drug stability evaluation and mitigation strategies for early and late phase development strategy.
Experience in DP development for commercialization including risk assessments, process characterization and validation of combination products.
Experience in authoring and reviewing CMC documents for regulatory submission documents (IND, IMPD, BLA, MAA etc.). Provide strategic guidance on regulatory interactions relating to drug product formulation and process development, specifications setting and control strategy.
Ensure effective communication, and collaboration, and preparation of dossiers in collaboration with functional CMC leads & external partners.
Manage budgets, schedules, and performance requirements to meet project goals.
Qualifications/ RequiredKnowledge/ Experience and Skills:
Ph.D preferred in a relevant field (e.g. biochemistry/chemistry, pharmaceutical sciences, chemical engineering) with 10+ years, MS with 15+ years of experience, or equivalent experience in the biopharmaceutical industry.
Ability to work in a fast-paced dynamic environment with changing priorities, forward thinking with flexibility to support multiple development programs simultaneously.
Working knowledge of ICH and FDA guidelines and global regulations.
Experience with regulatory, QA, and cGMP requirements for biologics. Assist in OOS investigations, determination of root cause, and implementation of appropriate CAPA.
Experience with IND and BLA filings; knowledge of relevant FDA regulations and guidelines is required.
Track record of successfully driving and managing programs, overcoming challenges, and managing risks.
Excellent communication and interpersonal skills in working across the organization.
Travel: Up to 25% of the time – occasional international travel to partner and/or contractor facilities related to engineering, GMP and PPQ runs.
CompetenciesAccountability for Results
- Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving
- Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity
- Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication
- Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration
- Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development
- Play an active role in professional development as a business imperative.
#J-18808-Ljbffr