Kelly Services Director of Drug Development in South San Francisco, California
Director of Drug Development and Manufacturing – San Francisco, CA
Exciting opportunity for a Director of Drug Development and Manufacturing with a privately-held, clinical stage, biopharmaceutical company located in South San Francisco.
The ideal candidate will have extensive drug development experience, CMO/CRO management skills, and supply chain logistics experience which will be critical in this role. You will be part of a team that will be responsible for the development, implementation, and oversight of effective strategies to supply drug product for clinical and commercial needs. This includes manufacturing, supply chain, procurement and distribution activities, as well as preparation of CMC sections for regulatory submissions.
Essential Duties and Responsibilities:
Develop and implement comprehensive strategies for formulation and packaging development of solid dosage drug products, as well as technology transfer.
Oversee production activities at CMOs and provide technical support and troubleshooting. Manage contract manufacturing organizations (CMOs) to produce Drug Product supply for clinical trials and commercial use.
Manage supply chain logistics for drug product manufacturing activities.
Provide technical expertise for manufacturing deviations, OOS/OOT investigations by working in concert with Quality Assurance to ensure proper disposition of affected materials.
Review and approve master batch records, executed batch records, manufacturing deviations and investigations.
Provide in-depth technical reviews for manufacturing and support CMC regulatory submissions.
Generate and/or review Process Validation documentation, including Product Validation Master Plans, Cleaning Validation Plans, and Process Performance Qualification Protocols.
Develop budgets for Process Development & Engineering for approval by executive management.
Interface effectively with other disciplines (e.g., Clinical, Nonclinical, Drug Substance Development, Quality Assurance, Analytical Development and Quality Control).
Support operational budgets, cost controls and resource planning to meet corporate strategic objectives.
Write, review and approve CMC portions of study reports and manufacturing process documentation for compliance with cGMP and other appropriate regulations and guidelines.
Prepare technical reports in support of planned regulatory submissions.
M.S./Ph.D. degree in pharmaceutical science, chemical engineering, or other related scientific discipline.
8+ years of hands-on experience with increasing responsibility in solid dosage formulation development.
Experience and in-depth knowledge in powder for oral suspension products (sachets, stick pouches) and engineering aspects of large scale processes involved in manufacturing.
Successful track record in selection and management of CROs/CMOs including site qualification, technical transfer, clinical supply logistics and oversight of activities.
Experience in writing CMC documents for regulatory submissions (IND/NDA).
Strong understanding of pharmaceutical development, quality and regulatory issues.
Hands on GMP experience with all phases of drug development, as well as in-depth knowledge and full understanding of GMP requirements.
Demonstrated ability to flexibly manage tasks (directly and indirectly) and variable workloads with demanding timelines.
Strong verbal & written communication skills, with the ability to effectively interact with and influence different functional groups across all levels of management.
Position requires up to 10-20% travel.
Apply Today! Questions? Call Justin at 714.602.1217 or email your resume to Justin.email@example.com
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm