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Sr. Director, Drug Product Development

Company: Cypress HCM
Location: Fremont
Posted on: September 15, 2020

Job Description:

From some of the most profitable companies in the world to many of the latest and greatest startups, Cypress’ customers are growing and in need of top talent. Whether you’re looking to pursue contract job opportunities or full-time job opportunities within engineering, information technology, marketing, or design Cypress can help. Unlike many recruitment firms, Cypress works directly with all of our customers and is a trusted partner to their internal hiring teams.

This is an exciting opportunity to join a g rowing  company that  offers  a fast-paced and exciting, startup type  environment.  This position will be responsible  for the company’s CMC projects in terms of the development of formulations and processes of the drug products .

Responsibilities:

Oversee contract development organizations (CDMOs) to lead development and optimization of drug product formulations to support the program from phase I clinical through commercial launch

Review and approve master batch records, executed batch records, manufacturing deviations and investigations in conjunction with quality assurance.

Provide on-site technical Man-In-Plant (MIP) support to oversee manufacturing activities.

Generate and/or review experimental plans and lead drug product development activities from research formulations, IND-enabling studies, preparation and optimization for registration and commercialization.

Analyze and summarize complex data sets, including the use of appropriate statistical tools for the identification of CPPs and CQAs, development of drug product specifications and shelf-life estimates for drug product formulations.

Generate and/or review Process Validation documentation, including Product Validation Master Plans, Statistical Product Sampling Plans, Cleaning Validation Plans, and Process Performance Qualification Protocols in conjunction with engineering, analytical and quality assurance representatives.

Prepare technical reports in support of planned regulatory submissions including INDs and NDAs.

Write, review, and approve CMC portions of study reports and manufacturing process documentation for compliance with cGMP and other appropriate regulations and guidelines.

Assist in supply chain logistics for drug product manufacturing activities.

Requirements  and  Desired Experience : BS/MS degree in Chemistry, Pharmaceutics, Chemical Engineering, Pharmaceutical Chemistry, or related scientific disciplines with 15+ years of experience in the Pharmaceutical or Biotech industry with the focus on the small molecule drug product development and manufacturing

Ph.D. with 10+ years of experience in the Pharmaceutical or Biotech industry with a focus on the small molecule drug product development and manufacturing

Experience in writing CMC documents for regulatory submissions (IND/NDA/MAA)

A proven track record in developing and scaling up oral solid dosage forms including immediate, modified, and controlled-release formulations for tablets and capsules from pre-IND through Process Validation using the Quality by Design ( QbD ) concepts and design of experiments (DoE)

Keywords: Cypress HCM, Fremont , Sr. Director, Drug Product Development, Other , Fremont, California

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