Development Program and Operations Manager
Department: Drug Development
Employment Type: Full Time
Location: San Mateo, CA
Description
The Role: We are seeking a talented and experienced Program Manager with extensive expertise in biologics cGMP and Chemistry, Manufacturing, and Controls (CMC). The ideal candidate will also have strong leadership skills and broad experience in program management of IND enabling activities and outsourced biologics manufacturing. This individual will play a pivotal role in organizing and structuring the Development team at BigHat, leading strategic initiatives for the Development organization, and driving the advancement of our biologics pipeline from discovery through clinical development.
Key Responsibilities
Discovery Stage Program Management:

• Provide PM support to early-stage research programs to enable smooth progression through discovery, lead optimization, candidate selection and preclinical development.
• Organize and coordinate cross-functional discovery stage project teams, facilitating communication and collaboration between Research, Development, and other functional groups.

Program Management of CMC and IND enabling activities:

• Organize and manage CMC project teams to drive outsourced manufacturing of biologics drug candidates, ensuring alignment with project timelines and objectives.
• Organize and manage project teams conducting outsourced studies to support IND submissions.
• Coordinate activities between key development functions including Quality Assurance, Toxicology, Clinical Manufacturing and Drug Supply.
• Collaborate closely with internal teams and external partners including CROs/CDMOs, SMEs and consultants to ensure efficient prosecution of manufacturing and other IND enabling activities.
• Facilitate program decisions to ensure they are made with input from key stakeholders.
• Act as a liaison between internal teams and external partners/vendors to coordinate project activities and deliverables.
• Support and track the preparation of regulatory submissions, including IND filings.
• Identify potential risks and challenges related to CMC development and propose mitigation strategies to minimize impact on project timelines and quality.

Operations Management:

• Build and maintain internal CMC/GMP systems and business processes.
• Define roles and responsibilities of key staff positions such as Product Technical Leads.
• Identify, propose, and support solutions for a range of organizational and operational challenges.
• Lead initiatives to optimize development team culture, and staff development.
• Ensure compliance with regulatory requirements and industry standards for CMC development, including FDA, EMA ,and ICH guidelines.
• Prepare regular progress reports and presentations for internal stakeholders and external partners/investors.
• Develop and maintain a structure for accurate and comprehensive organization of CMC documents, including development reports, batch records, and regulatory filings.
• Maintain records of relevant communications within internal project teams and with external CDMOs.

Skills Knowledge and Expertise

• Bachelor's, Master's, or Ph.D. degree in a relevant scientific discipline (e.g., Chemistry, Biochemistry, Chemical Engineering, Biotechnology).
• Five or more years of experience managing CMC activities within the biotech or pharmaceutical industry, with a focus on biologics.
• Understanding of cGMP CMC principles and processes, including process development, analytical characterization, and manufacturing.
• Experience managing tech transfer of CMC manufacturing and/or analytics.
• Excellent communication, organizational, and leadership skills.
• Ability to work effectively in a fast-paced, entrepreneurial environment and adapt to changing priorities.
• Experience with biologics drug development, including monoclonal antibodies, and/or recombinant proteins.
• [Preferred] Familiarity with regulatory requirements for cGMP, CMC development, including FDA, EMA and ICH guidelines.
• [Preferred] Familiarity with discovery stage processes and experience with program management of early discovery projects.