Job Description
Job Description
Job Summary
Responsible for leading and managing the development, manufacturing, and lifecycle strategies of biologic drug product, with a focus on ensuring manufacturing production, quality, compliance, and clinical supply. Collaborates cross-functionally with scientific functions as well as Quality Assurance, Regulatory Affairs, and Clinical Supply Chain teams to oversee technology transfers and new formulation development. Provides technical and strategic guidance to internal teams and external partners, ensuring adherence to industry standards and regulatory requirements while driving innovation and operational excellence in drug product development.
Responsibilities
- Lead the on-going drug substance manufacturing activities at CMO including process validation, PPQ, stability, and additional GMP production runs.
- Lead the development and manufacturing of drug products in 1 ml and 2.25 ml PFS dosage forms at CMO.
- Provide scientific, technical and hands-on leadership to progress through drug development, clinical supply, and commercialization.
- Drive activities related to technology transfer, process scale-up, validation, and manufacturing at CDMO, including Final Drug Product assembly and release.
- Guide CROs and CMOs to design and execute plans for formulation development, testing and manufacturing based on phase-appropriate approaches for combination products such as PFS and auto-injectors, as well as various administration routes such as subcutaneous, IV, and inhalation.
- Work with the CDMOs/CROs to manage project scope, data quality and timelines.
- Oversee shipping and final process for all drug product batches.
- Manage the development and execution of experimental plans, master batch records, study protocols and supporting documentation for all manufacturing productions.
- Collaborate with QA and Regulatory Affairs to facilitate development of specifications and stability programs compliant with ICH guidelines.
- Support clinical product complaints logistics and investigations.
- Contribute to risk analysis and mitigation plans to secure timelines, cost, and quality at all stages of project progression as a part of Quality Risk Management (QRM).
- Review external reports (batch records, analytical data, validation protocols etc.) and take appropriate action as required.
- Review and summarize process and batch data, conduct trend analysis, provide feedback and recommendation to assist the timely resolution of technical and/or quality issues.
- Write technical reports and author CMC sections of regulatory submissions related to drug product.
- Assist in the responses to health authority questions.
- Work with leadership on annual budgeting.
Education Requirement
Advanced degree (PhD or Masters degree plus extensive relevant experience) in Bioengineering, Biology, Cell Biology, Chemical Engineering, Biochemistry or other relevant scientific discipline.
Qualifications
- 12+ years of related experience in a pharmaceutical or biotechnology company working in a bioengineering, pharmaceutical science or biochemistry function within an outsourced model partnering with CMOs and/or CDMOs.
- 12+ years hands-on and leadership experience (internal and with external partner) in process development for biologic molecules, preferably monoclonal antibodies with combination products including prefilled syringes, needle guard safety systems and autoinjectors.
- Demonstrated understanding of the principles and practices of formulation and device science and effective application in the development of pharmaceutical products.
- Deep understanding of late phase drug substance and drug product development and process scale-up to support BLA enabling activities for biologics.
- A proven track record in developing various product presentations, including vials, PFS, auto-injectors, inhalers, etc.
- Knowledge of analytical methods for biologics and device function (HPLC, HIAC, Glide Force, etc.) is required.
- Working knowledge of GMP, regulatory guidance, and compendial requirements, including FDA, EMA, ICH, WHO, USP-NF and EP.
- Experience authoring CMC sections in regulatory filings (IND, IMPD and BLA).
- Excellent interpersonal skills.
- Excels in team settings with an ability to think critically and work independently.
- Highly motivated self-starter with an entrepreneurial spirit and commitment to personal and career development.
- Desire to work in a quickly changing and fast-paced growing business.
- Unrelenting dedication to delivering results and a desire to shape the strategic goals of the business.
- Ability to overcome ambiguity and challenge the status quo.
- Manage multiple programs with competing and aggressive timelines, prioritize activities.
- Excellent written and oral communication skills; experienced presenter of key messages to broad audiences including Senior Stakeholders.