Associate Director, Product Development and Manufacturing / Technical Operations - Analytical
850 Maude Ave Mountain View, CA 94043
Associate Director, Product Development and Manufacturing / Technical Operations
Mountain View, CA
MUST HAVE - Strong Analytical Development experience and background required
Working within internal functional partners, external contract development organizations and selected consultants, this individual is responsible for the development and overseeing the execution of technical activities associated with late stage product development and manufacturing in support of clinical development, regulatory filings and product commercialization.
Key individual and leader of the team responsible for manufacturing, packaging and release of commercial products by the Contract Manufacturing Organizations. Additionally, this individual will support the manufacturing and release of the Drug Substance and Regulatory Starting Materials by the CMO’ s.
- Oversees program plan development, tracks and updates milestones and key activities
- Working with PD management and other internal partners, establish and track progress in the execution of the technical drug product strategies in support of NDA/MAA filings, product approvals and commercialization
- Responsible for providing project management and technical expertise to late phase CMC activities, in particular with those activities associated with drug product manufacturing, packaging and release.
- Responsible for providing technical expertise to all the GMP activities associated with the outsourcing the development and manufacturing of drug substance, starting materials, analytical development formulation and manufacturing process for product in late development and during commercialization.
- Responsible for overseeing the manufacture of clinical trial materials at the selected CMO
- Responsible for overseeing the manufacturing packaging and release of commercial products
- Working closely with the QA organizations provide solid input in the resolution of issues associated with the manufacture and release of clinical supplies and commercial products
- Working closely with QA responsible for the development and maintenance of an accurate inventory of the Clinical Supplies and commercial product
- The scope of the responsibility is from IND, Phase 1, 2, 3 to NDA filing and approval and during the commercialization of products.
- The Associate Director participates in all projects and manages multiple program collaborating with the following groups: Process Chemistry, Biology, DMPK, Pre-Clinical, Outsourcing, Clinical Operations, Quality, Finance and Regulatory Affairs.
- The Associate Director will support project management in all technical activities associated with all development programs and product in commercialization
- Facilitates the design and implementation of initiatives with the CMO’ s that improves business performance
- Able to develop a strong background in performance metrics and reporting for business review meetings with the CMO’ s
- Follows up and drives the closure of action items from the team meetings and business review meetings
- The Associate Director should have significant knowledge, experience and skills with compliant Quality Management Systems in support of Product Development and overall business
- Collaborating with Quality Organization, establishes, oversees, expand and maintains a SOP’ s related to Pharmaceutical Development.
- Leads continuous improvement efforts in quality systems and department infrastructure (including documentation) through the evaluation of current organizational process, audit feedback, and previous experience
- Develops plans and implements actions to ensure readiness for regulatory and audit inspections.
- Works closely with QA to support the review and approval of batch record, validation, specification and change control documentation produced by CMOs and CROs.
- Working closely with PD management and QA oversees the CMOs and CROs performance associated with the investigations and effective closing of all deviations and ensures that robust corrective actions are identified and quickly implemented.
- Establishes and maintains documentations specific for each CMO and each product related to outsourced operations (e.g. contractor manuals)
- Performs CMC technical audits potential CMO’ s to ensure technical capabilities, compliance to relevant regulations
- Provides support for the oversight of site technical validation activities (analytical, manufacturing, etc).
- Assists in the preparation and review of regulatory submissions for USA and worldwide heath agencies.
- Provide technical support during external audits of vendors and subcontractors
- Principal author of Contract Manuals
- BS, MS or PhD scientific degree with a minimum of 10 years of technical and direct product development experience for late stage Product Development and during product commercialization
- Candidate should be considered an expert in late stage small molecules product development with proven technical experience in one or more of the following areas: Process Chemistry and manufacturing scale-up for drug substance, analytical method development for drug substance and drug product formulation and manufacturing process for Phase III and commercial drug product.
- Proven experience as it relates to managing and interaction with CMO’ s from early through late drug product development
- Program Management skills highly desired.
- Experience in authoring CTD sections as they relate to drug substance, drug product, analytical chemistry and specification settings in support of IND’ s, NDA’ s, MAA’ s and IMPD’ s
- Deep knowledge of the GMP regulations requirements in product development manufacturing and release of clinical and commercial products
- Proven track record in strategic planning for late stage development programs. Commercial experience highly desired.
- Must have strong regulatory compliance working knowledge including FDA, cGXP, etc.
- Must be detail oriented with excellent prioritization, organizational and project management skills.
- Superior analytical and problem solving skills.
- Effective communication (written and verbal) skills.
- Ability to travel up to 30%