Associate Director / Director, CMC Project Management
Location: South San Francisco, California, United States
The Associate Director / Director, CMC Project Management will plan, manage and drive the execution of CMC development and manufacturing activities for all of Assembly’s clinical assets. Reporting to the Executive Director, Program Management and partnering closely with the Senior Vice President, Pharmaceutical Development and Manufacturing, the Associate Director will develop and implement CMC project plans and ensure alignment of deliverables with the clinical development plan.
Key responsibilities include:
- Partners with the Senior Vice President, Pharmaceutical Development and Manufacturing to plan and prioritize CMC activities across the clinical portfolio.
- Works with process chemistry, formulation development, analytical development and clinical supply to develop and maintain integrated CMC project plans and timelines for all clinical assets. Ensures that plans incorporate cross-functional input from regulatory CMC, quality, toxicology and clinical.
- Leads CMC cross-functional and department team meetings to develop strategy and monitor progress. Develops agendas and produces high quality meeting minutes and related outputs to monitor program status.
- Ensures timely communication of changes in program strategy, issues and risks to team members and other functional areas as appropriate.
- Facilitates team discussion and agreement on clear, concise program goals. Oversees deliverables to support program objectives; identifies risks and supports the development of risk mitigation plans.
- Interfaces with global project management and clinical operations functions to ensure alignment of CMC activities and timelines with the global clinical development plan.
- Provides project management support for functional areas. Organizes subteam meetings and ad-hoc working groups as needed to address specific topics.
- Works with functional leads and finance to develop budgets for CMC activities.
- May interface with vendors to maintain manufacturing activities on track.
- Provides input for regular project status updates to senior leadership.
- Leads or contributes to department and company initiatives for continuous improvement.
Preferred Qualifications include:
- Bachelor’s degree in engineering, physical or life sciences; advanced degree or MBA preferred. Project management certification (PMP or equivalent) is a plus.
- 10+ years of relevant development experience in the pharmaceutical or biotech industry as a CMC functional area scientist and/or project manager, including 3+ years managing cross-functional CMC or R&D project teams for multiple projects. Candidates with advanced degrees will be considered in lieu of years of experience. Candidates at the Director level should have additional years or experience.
- Demonstrated understanding of the drug development process from a CMC perspective – drug substance development, formulation development, analytical, quality, regulatory.
- Self-motivated, comfortable in fast-paced small company environment with minimal direction. Able to orchestrate multiple projects simultaneously and adjust workload based upon changing priorities.
- Effective communication, interpersonal, collaboration, and negotiation skills. Demonstrated ability to drive results without formal authority.
About Assembly Bio
Assembly Biosciences (NASDAQ: ASMB) is an ambitious clinical stage biopharmaceutical company with cutting-edge therapeutics potentially capable of improving the lives of millions living with chronic hepatitis B virus (HBV) infection around the world. We are currently focused on an HBV program intent on creating a new class of oral therapeutics to finally cure hepatitis B. Our program is built on ingenuity, vision and experience and has the potential to improve cure rates for individuals with chronic hepatitis B (HBV) in our lifetime. Our strong scientific expertise in discovering small molecules targeting the HBV core protein has made us a leader in the field.
We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add great people to our dynamic team who are driven to transform the lives of patients. We set our sights high—and pursue our goals with determination. Our unique organization stands ready to welcome talented, motivated individuals, who share our ambitions.
Assembly Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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