Associate Director of Manufacturing
Menlo Park, CA
A pharmaceutical company is seeking a Associate Director of Manufacturing to join their team!
This position will manage contract manufacturing organizations (CMOs) that produce small molecule Active Pharmaceutical Ingredients (API) in support of CTM and commercial supply. Responsibilities include managing CMO business relationship, overseeing production activities of small molecule APIs at CMOs and providing technical support and troubleshooting.
- Manage, oversee, and develop activities/processes at CMOs in support of late phase and commercial small molecule APIs; Act as company liaison, person in plant, and point of contact for CMOs. Review/approve manufacturing batch records, protocols, development reports, specifications and deviations;
- Lead process development, manufacturing, change control, troubleshooting manufacturing issues, investigations and resolution of deviations as small molecule API products transition from Phase 2 to Phase 3 and validation at CMOs;
- Design, implement, analyze and author protocols / reports for Proven Acceptable Range (PAR) Study experiments to optimize manufacturing processes; Collate manufacturing data to develop metrics, control charts and reports to improve manufacturing processes;
- Assist with drug product development and manufacturing activities, as needed
- Collaborate with cross-functionalCMC team per the following:
- Supply Chain: Work with Supply Chain organizations at the company and CMO to ensure manufacturing schedules and forecasts are aligned to meet corporate needs, prepare requests for proposals and statements of works, source raw materials, identify activities or events that may critically affect supply and act on or relay that information to management.
- Quality: Work with Quality organizations at the company and CMO to assure GMP standards are met and execute agreed-to Quality performance/improvement deliverables are completed;
- Regulatory: Work with Regulatory organization to draft/review CMC sections of regulatory submissions and agency communications;
- Legal/contractual: Enforce contractual commitments
- Finance: Assure that the financial terms and conditions of the company-CMO relationship are being met by both parties.
- Prepare performance objectives for supplier and company. Trend important performance indicators.
- Regular written communication via protocols, reports and standard operating procedures, change controls, and other related documents.
- Position may require 20-25% travel, in the future.
- Bachelors of Science degree in relevant scientific field. At least 7 years experience in pharmaceutical development and manufacturing, in outsourced manufacturing environment.
- PhD of Science in relevant field, no experience.
- Must have experience in commercial manufacturing and development of late phase small molecule APIs.
SKILLS, QUALIFICATION'S OR TECHNICAL PROFICIENCIES
- Expertise in process development, process validation and commercial manufacturing of small molecule API. Familiar with Quality Risk Assessment, Design of Experiments, Proven Acceptable Range studies and application in late phase drug product development.
- In-depth knowledge of US and EU regulatory requirements for cGMPs.
- Expertise in managing CMOs for late stage development and commercial manufacturing programs.
- Strong leadership and project management skills with ability to manage multiple technical projects successfully.
- Proficient in analyzing technical data and preparing written technical reports.
- Excellent communication and negotiation skills.
For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.
Richmar is an Equal Opportunity Employer.