Who we are
Atreca is an integrated biotechnology company located in South San Francisco, California (moving in 2021 to a new campus in San Carlos, CA). We apply our proprietary drug discovery platform to profile clinically relevant, active B cell responses in patients receiving successful treatment and, in turn, develop a portfolio of antibody therapeutics against novel tumor targets with the potential to treat large patient populations. Atreca seeks talented, driven individuals who are dedicated to making a positive impact on human health and are motivated to become key members of a growing biotechnology company.
The ideal candidate must be an outstanding leader with a proven track record of strategic planning and execution having advanced molecules from pre-clinical manufacturing to late-stage clinical trials. The candidate must have experience in all aspects of DP and DS manufacturing including the oversight and management of remote CDMOs. In addition, the role requires authoring, reviewing, and editing of CMC related regulatory submissions and associated quality documents. The candidate must have exceptional organizational and communication skills, be capable of communicating strategic plans to upper management, summarize data, and effectively manage interactions with stakeholders across functions.
Duties and Responsibilities
- Develop, plan and oversee CMC programs (drug substance and drug product manufacturing), from preclinical development through clinical supplies for Phase 3 registration studies, including projection of DS/DP needs, budgets, and timelines.
- Manage Contract Development and Manufacturing Organizations (CDMOs) for process technology transfer and optimization, non GMP and cGMP manufacture and supply of Drug Substance (DS) and Drug Product (DP) in support of ongoing clinical programs.
- Execute plans in accordance with cGMP, ICH, and FDA regulations.
- Partner with and maintain regular contact with key stakeholders including, Discovery, Quality Assurance, Regulatory Affairs, Finance, and Program Management. Write and review relevant sections for regulatory submissions.
- Prepare, review, or edit cGMP batch records, CMC regulatory and quality documents
Required Skills and Qualifications
- PhD/MS in relevant life sciences or engineering discipline is required.
- Minimum of 10 years of Pharmaceutical/Biotechnology industry experience (Director level) or 15 years (Senior Director level) in cGMP manufacturing operations, technology transfer, process development of biologics.
- Experience in CMC for biologics and antibodies including drug conjugates and broad knowledge of all aspects of CMC including upstream and downstream process development, technology transfer, regulatory and quality requirements, analytical development, formulation, and drug product technologies.
- Experience with projects preclinical through commercial.
- Experience in managing US/international CDMOs for the manufacture of non GMP and cGMP DS and DP. Working knowledge of ICH and FDA guidelines and regulations.
- Experience with regulatory, QA, and cGMP requirements for biologics.
- Experience with IND and BLA filings; knowledge of relevant FDA regulations and guidelines is required.
- Proven leadership and cross-functional management of CMC related programs. Track record of successfully driving and managing programs, overcoming challenges and managing risks.
- Strong organizational and project management skills, including proficient use of MS Project and other tools.
- Excellent communication and interpersonal skills in working across the organization.
Exact title commensurate with experience. Atreca is an equal opportunity employer.