Junto HLS has been exclusively engaged by a leading pharmaceutical company to recruit a Leadership Position – Commercial QC/ Analytical with accountabilities covering both API and drug product for all small molecules across the entire company.
- Very competitive compensation
- Impressive volume of new products coming to market each year
- Accountability to lead across Billions in revenue and well know product families
- Direct Reports – Initially 5-6
- PhD – Highly preferred
- A leader in Commercial Analytical Operations. An analytical steward and subject matter expert (SME) of commercial products – from API process chemistry, control, drug product formulation and process, specification history, justification, and variations between regulatory regions, API and DP stability trends, shelf-life and justification, process impurities and source of these impurities, to critical quality attributes that are shelf-life limiting.
- Lead a team and provide technical directions for all areas of responsibility – study protocols, reports, investigations, internal and contract site change controls, customer complaint sample handling, and annual product quality reports.
- Serve as the backup for the Director of Commercial Analytical Operations, responsible for all aspect of analytical needs pertaining to marketed drug products including method transfer to establish new contract sites or qualify new suppliers, supplier qualification, review of data from contract sites, and timely initiation of commercial stability studies to fulfill regulatory commitment and process validation/qualification requirements.
- Provide leadership in method optimization, revision, method transfer, supplemental validation, shipping studies, bulk hold studies, in-use testing for post approval commercial products. Provide necessary technical support during regulatory inspections at contract partner sites.
- Partner with QA and development to support the selection and establishment of new contract partners or new site of existing contract partners – This includes perform technical audit, on-site data review, on-site troubleshooting of method implementation challenges, and necessary submission CMC documents to support the changes or additions.
- Provide technical leadership in handling customer complaint samples and investigation of potential counterfeiting samples.
- Documentation responsibilities include annual product quality reviews for APIs and drug products, annual reports of existing submissions, Commercial Product Contractor Manuals, method and study protocols and report, and sNDA CMC documentations.
- Partner with cross-functional partners, critically review changes and impacts to product and process, and regulatory commitment. Being a steward of company commitments post approval, with marketing partners, and supporting change assessments and ensure these commitments are fulfilled in an expedient manner. This includes fulfilling annual stability commitments.
- Accountable for CMC documents and responsible for addressing deficiencies to support regulatory filings in ROW post product approval in major markets.
- Oversee review of data from contract laboratories. Lead on-site data based review of contract partners at specified frequency and verify data integrity and technical appropriateness. Serve as a key member of the company team in the contract lab qualification and requalification process.
- Take leadership to monitor and drive for excellence in Analytical Operations’ performance metrics including initiatives to enhance the existing processes.
- Greater San Francisco, CA
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.