Senior Manager, Project Management (CMC)

PepGen is an innovative biotech company dedicated to developing transformative therapies for rare genetic diseases. We are looking for a dynamic and experienced Senior Manager, Project Management in Chemistry, Manufacturing, and Controls (CMC) to join our growing team. Reporting to the Senior Director, Head of Drug Product, you will work collaboratively with cross-functional teams to ensure the successful development and commercialization of our pipeline products. This is a high-impact role requiring deep expertise in CMC project management, strong leadership skills, and a solid understanding of regulatory requirements in the biotech/pharmaceutical industry.

Responsibilities:

• Organize CMC-related projects from early-stage development through preparation for commercialization, ensuring alignment with company goals and timelines, budgets, and regulatory requirements.
• Partner with CMC teams, including regulatory, quality, and manufacturing to drive project success and ensure timely delivery of project milestones.
• Create and maintain detailed project plans, timelines, and resource allocation strategies to support the progression of drug development in line with business objectives.
• Track project milestones, timelines, and deliverables, providing regular status updates to senior leadership and key stakeholders. Identify potential risks and proactively address them to avoid project delays.
• Work with functional CMC leads to manage business relationships with external partners and provide internal support to ensure on-time execution of manufacturing and development activities.
• Support the preparation of regulatory submissions (e.g., IND, IMPD, BLA) by coordinating the CMC aspects and ensuring that project timelines and deliverables align with regulatory expectations.
• Support the development of CMC budgets and ensure team maintains visibility to financial objectives.
• Maintain ongoing CMC spend and report to appropriate resources.
• Work with CMC Functional Leads to identify program risks and develop strategies to mitigate
• Identify opportunities for operational improvements and implement best practices to optimize CMC operations.
• Support administrative functions, including preparing meeting agendas, capturing meeting minutes, and ensuring follow-up on action items to keep projects on track and ensure clear communication among stakeholders.

Requirements (Education, Skills, Competencies):

• Bachelor’s degree in Life Sciences, Engineering, Chemistry, or a related field.
• Minimum of 7 years of experience in project management, 3+ years within the CMC space of the biotech or pharmaceutical industry, with a strong understanding of drug development processes.
• Proven track record of managing complex CMC projects from development through commercialization, with the ability to manage multiple priorities in a fast-paced environment.
• Excellent interpersonal, communication, and team leadership skills, with the ability to collaborate effectively with internal and external stakeholders.
• Knowledge of PM principles of project planning, tracking, and resource and budget planning
• Strong analytical skills with the ability to identify issues, assess risks, and develop solutions to keep projects on track.
• Experience working with CMOs and external partners to drive product development.
• Ability to work in a fast-paced, dynamic environment, adapting quickly to changing priorities and timelines.
• Exceptional written and verbal communication skills, with the ability to present complex information clearly to various stakeholders.
• Experience with regulatory submissions including IND, IMPD, BLA, and other relevant filings, with experience in coordinating CMC aspects for successful submission and alignment with regulatory expectations.
• Proficient in MS Office Suite, MS Project, Smartsheet, Timeline Pro.

Note: This is not a remote role. We like to work together and operate in a hybrid model in office Tues, Weds & Thurs each week.