Job Openings

Vice President, Product Development

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Location
Princeton, NJ
Job Type
Direct Hire
Date
Dec 04, 2019
Job ID
2678794



Vice President, Product Development (CMC) 


Our client is a biopharmaceutical company located in the Princeton, NJ area.  With strong financials, a marketed product and promising pipeline, over 50 patents, and proprietary, patented platform technology this company has a strong foundation to continue to build upon.   The correct individual for this role will thrive in a fast paced culture where you are free to lead.  Someone who can make an immediate, lasting impact on the organization.







Core Duties









  1. Leads all CMC activities including analytical (drug substance and drug product) and drug substance (API) and drug product process development groups, devising and implementing strategic analytical and process development plans and providing vision, direction and mentorship for employees.




  2. Oversees (Director Formulation & Manufacturing) manufacturing, technology transfer and implementation of processes and operations with contract manufacturers for new and existing products and technologies (preclinical through commercial). Ensures appropriate documentation, reports, SOP’s, regulatory documents and technology scale- up and transfers are completed in a timely manner.




  3. Acts as a scientific advisor to executive management in the formulation of related corporate strategies and objectives. Develops proposals, recommendations and presentations related to the identification, implementation and communication of Analytical and API Process development program strategies.




  4. Makes proposals and recommendations to executive management related to internal and external resource allocation for analytical and API and drug product process development/ manufacturing activities including identification and evaluation of contract API and drug product manufacturers and contract analytical laboratories. Participates in negotiation of agreements with pertinent contractors on new and existing projects and maintains business relationships with the contractors.




  5. Directs analytical development activities, methods and new assay development and validation, and transfers to Contract Research Organizations including, but not limited to, raw material, Active Pharmaceutical Ingredients (API), in-process controls, impurity profiling and drug product.












  • Manages internal and external resources to develop analytical methods for new products




  • Responsible for technology transfer of new analytical methodology to and between internal labs/CROs/CMOs as necessary




  • Responsible for the development of relevant SOPs, validation, stability, and product investigation reports




  • Responsible for the development new analytical assay procedures or adaptation of existing methodology for new and existing formulations in support of Product Development






  1. Directs API process development, scale-up and technology transfer activities including but not limited to new API scale-up, process optimization and validation, as well as technology development to facilitate implementation of commercial processes for new products as well as for support of existing third-party manufacturing. Carries out pilot plant experiments, engineering calculations and process simulations as required to meet these objectives.




  2. Ensures timely supply of drug substance (API) for preclinical development as well as API and drug product for clinical trials throughout the drug development cycle. Provides technical support and expertise relating to the supply of new compounds and currently marketed products, including the design and implementation of manufacturing processes, technical aspects of bulk sourcing, pilot scale up and production for third party manufacturing as well as instrumentation and equipment through pilot and manufacturing scale.




  3. Oversees CMC compliance and manages the preparation of analytical sections (e.g. characterization, stability, specification justification, etc. for both drug substance and drug product) and drug substance manufacturing sections of regulatory submissions. Keeps abreast of regulatory procedures, acts as an advisor and participates in the preparation of document packages and submissions (BLA, IND and NDA) and responses to regulatory agencies.




  4. Develops budgets and monitors expenditures for internal and external resources for the Analytical & API Process Development functions/departments.




Reports to the Chief Operating Officer (COO)


Requirements:




  • PhD or BS/MS and 8-15 years related experience within the pharmaceutical industry




  • 5+ years managing pharmaceutical development




  • Computer literate; MS Office Suite (Word, Excel, Power Point), Outlook