Associate Director, Product Development Biologics
The Associate Director of Product Development for Biologics will oversee pharmaceutical product development for Biosimilar products starting with insulin analogs in vials and pen configurations. This role will be responsible for leading drug development of pharmaceuticals from early phase: scale down batch process, technology transfer through commercialization including the establishment of a development plan with strategic CMC and establish technical direction for the successful product development. The position will plan, execute drug product development, and CMC strategies in a collaborative manner across internal disciplines and external partners and contractors. Additionally, the position will oversee the preparation of the Biologic License Application (BLA) documentation to support regulatory filings.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Lead R&D activities for developing products to support BLA enabling product development.
- Translate product development project requirements into a robust, scalable technical design.
- Resolve complex problems by applying sound engineering principles, utilizing experimental, and analytical methods to a range of technical product development challenges over a range of products from simple sterile injectable vial products to more complex pre-filled syringe – disposable auto-pen injector combination products.
- Understand the scientific principles for manufacturing parenteral drug products, device assembly and packaging, including the interaction of chemistry, equipment, aseptic processes, and container closure systems.
- Support R&D leadership to build a diverse and capable product development team, supporting the areas of preformulation, fill and finish, filtration and filling assembly build up, device assembly, and inspection parenteral operations.
- Deliver technology Transfer Plan through product life cycle technology transfer, engineering, clinical, PPQ, and process validation, and control strategy development.
- Participated in and lead the development and implementation of product Failure Modes Effect Analysis (FMEA), particle investigations, filtration and filling assemblies, Root cause analysis.
- Support product preapproval inspection. The role has direct interaction with regulatory agencies during site inspections.
- Understand and implement manufacturing control strategy for various unit operation areas.
- Define BLA enabling studies necessary for product submission and conduct those internally and externally with collaboration from different departments.
- Review and approve cGMP documents such as Product Development Report, batch records, technical reports, change controls, validation protocols, and summary reports.
- Represent the organization to establish an R&D laboratory at the manufacturing site including hiring of R&D process scientists.
- Oversight and management of the development of Biosimilar aseptic products at the site.
- Work closely with both functional and project managers to identify and mitigate technical issues, manage project milestones to adhere to project timelines.
- Improve product development cycles and quality via the application of Quality by Design and Lean Product Development Tools.
- Guide multi-function teams comprising of QA, Regulatory Affairs, Hospital network partners, Contract Development and Manufacturing operations team members by facilitating effective communication and engagement.
- Mentor and motivate team members and junior associates while coaching them through activities such as bench studies, pharmaceutical product development data analysis, FMEAs, combination product development, validation requirements, vendor interactions, material, and component specifications.
MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES)
- Bachelor of Science Engineering or a similar technical degree. A post graduate degree is desired, but not required.
- Preferred minimum of 12 years in related industry.
- Experience working in sterile injectables, biologics.
- Strong working knowledge of current standards and regulatory expectations for pharmaceutical product development, regulatory filing, and commercialization.
- Willingness to travel up to 20% of the time (preferred).