Foster City

POSITION SUMMARY 

Will lead the technical drug product development and manufacturing function within a completely outsourced environment. The ideal candidate is a self-starter with the ability to work independently under minimal supervision, and who is seeking to be part of an innovative and fast-paced team. This role will provide scientific and technical oversight for activities occurring in the development and cGMP space.

JOB FUNCTIONS/RESPONSIBILITIES

• Lead mid to late-stage drug product development and validation for multiple programs in a 100% out-sourced environment.
• This position will be responsible for drug product development activities leading to NDA submission and commercialization and development and execution of the CMC strategy.
• Design and oversee execution of QbD and risk-based studies, as well as process development activities in preparation for registration, validation, and commercialization activities.
• This role also leads investigations into manufacturing related deviations, implementation of CAPAs, change management, and process monitoring, as well as lifecycle management of commercial and development products.
• Author and review technical reports and CMC-related documents required for regulatory submissions.
• Collaborate with cross-functional teams (manufacturing, analytical development, supply chain, quality, regulatory) to meet CMC goals.
• Travel to CDMOs for vendor assessment and qualification and manufacturing oversight as needed.
• Develops and delivers effective presentations with strong written and verbal communication.
• Problem-solving and critical thinking skills.

QUALIFICATIONS

Education/Experience:

• 5+ years in small molecule drug product development and manufacturing.
• Expertise in development of novel formulations, technology transfer, process optimization and validation.
• Track record of success in leading small-molecule drug product programs in a 100% outsourced small-team environment.
• Thorough knowledge of the drug development process and sound understanding of CMC regulatory requirements.
• Direct experience with compiling CMC sections for INDs, NDAs, and MAAs and responding to regulatory queries.
• Experience with quality management systems for managing quality events and documents.

Knowledge, Skills and Abilities:

• Strong ability to communicate effectively with team members, creating an environment that fosters successful teamwork, collaboration and cooperation.
• Has integrity, honesty, conscientiousness, and is self-motivated.
• Meticulousness with details while able to see “big picture”.
• Strong collaborative vendor/supplier management skills.
• Competency in developing, implementing, and delivering aggressive CMC project plans.
• Ability to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands, all while maintaining positive attitude.
• Proactive, pragmatic, team player who can make decisions decisively in the face of ambiguity, demonstrates flexibility, possesses a “can do” attitude and can come up with creative solutions when faced with novel program challenges while showing good judgement and anticipating future consequences. Can prioritize and quickly re-prioritize as needed.
• Experience in a small company environment strongly preferred.
• Must be available for some teleconferences outside of standard California business hours.
• Ability to travel up to 25% of time required.

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