Senior Director, Quality Control Analytical Sciences
Abata TherapeuticsFull Time
Expert & Leadership (9+ years)
San Francisco, California, United States
Candidates must possess a Ph.D. in analytical sciences or biological sciences, with a minimum of 15 years of experience in analytical development and QC within the biotech/pharmaceutical industry, including over 10 years of management experience. Proficiency in cGMPs and pharmaceutical industry regulations is essential, as is extensive experience in achieving CMC deliverables through outsourcing to global Contract Manufacturing Organizations. The ideal candidate will be a critical thinker, an innovator comfortable with ambiguity, and possess strong communication and collaboration skills to build effective relationships with diverse stakeholders.
The Senior Director will lead analytical development and quality control across multiple therapeutic modalities, including proteins, antibodies, small molecules, oligonucleotides, mRNA, and AAV gene therapy. This role involves building a high-performing team, establishing internal and external analytical capabilities, and serving as the CMC and analytical lead for therapeutic programs. Responsibilities include managing contract manufacturing organizations for method development, qualification, product characterization, release, stability, and in-process testing. The position also entails establishing product specifications, supporting OOS/NCS investigations, authoring and approving controlled documents, and contributing to the Tech Ops leadership team in building organizational processes and infrastructure. Fostering strong partnerships across various scientific and business functions, and actively promoting a culture of continuous improvement, accountability, professional growth, and inclusion are also key duties.
Biotechnology focused on cell rejuvenation research
Altos Labs specializes in biotechnology with a focus on cell rejuvenation, aiming to restore cell health and resilience to reverse diseases and injuries. Their approach involves cellular rejuvenation programming, which enhances cells' ability to resist stressors that can lead to illness. Unlike competitors, Altos Labs emphasizes research and collaboration with other institutions to develop effective treatments. The company's goal is to improve patients' quality of life through breakthrough therapies.