Director, Process Chemistry

BBOT is a private biotech company dedicated to developing innovative new therapeutics to address dire unmet needs in oncology. Founded on a commitment to patients, scientific excellence, and operational agility, we understand that every minute counts in our efforts to develop new therapies to transform the lives of people living with cancer. Driven by a team of experienced scientists, clinicians, and industry experts, our team utilizes cutting-edge structure-based drug discovery techniques to target some of oncology’s most challenging and validated molecular targets, including KRAS and PI3Ka. BBOT has a pipeline of several promising differentiated drug candidates and strong investor support, the combination of which positions us to deliver meaningful benefit to patients. Our offices and laboratory are in South San Francisco, though our colleagues and collaborators span the country and globe.

We are seeking a dynamic and experienced Director of Process Chemistry to join our small molecule drug substance development and manufacturing efforts. This role is pivotal in advancing compounds from early-stage development (preclinical and Phase I) through late-stage and commercial development. The ideal candidate will possess a strong background in synthetic organic chemistry, coupled with extensive experience in process development, scale-up, and cGMP manufacturing. Effective interactions across the CMC and Discovery Chemistry teams are key deliverable in the role. 

Key Responsibilities:

• Identify and develop synthetic routes for small molecule APIs, focusing on scalability, efficiency, and sustainability.
• Oversee contract development and manufacturing organizations (CDMOs) for the synthesis of non-GMP and cGMP materials to support toxicology studies and initial clinical trials.
• Implement strategies to improve yield, reduce impurities, and enhance process robustness during early development phases.
• Work closely with discovery teams to facilitate the transition from lead optimization to process development.
• Lead the scale-up of chemical processes from laboratory to pilot and commercial scales, ensuring compliance with cGMP standards.
• Manage the transfer of processes to external CDMOs, ensuring knowledge transfer and process reproducibility. 
• Provide on-site technical support at CDMO’s on an as-needed basis to oversee various manufacturing/scale-up/validation activities. Provide technical expertise to troubleshoot manufacturing process issues.
• Apply QbD principles to understand critical process parameters and establish control strategies. 
• Support, author, and review CMC sections of regulatory submissions (IND, NDA, IMPD) and address regulatory inquiries. 
• Regularly and clearly communicate Process Chemistry both verbally and in visual presentation form, efficiently and contextually.
• Support Quality Assurance audits, on site at CDMO’s or remotely, as a technical subject matter expert, as required.

Competencies:

• Proven ability to work with CMO’s to deliver on time.
• Demonstrated expertise in good manufacturing practices (GMP).
• Working knowledge of relevant ICH and FDA guidelines.
• Ability to deliver under tight timelines and adapt to changing project needs.
• Ability to work on multiple projects concurrently.
• Ability to communicate, organize and write well and interact with other groups.
• Strong verbal and written communication skills, interpersonal skills, ability to work well within a team, attention to detail, analytical, judgment and problem-solving skills.

Qualifications:

• Ph.D. or M.S. in Organic Chemistry, Synthetic Chemistry.
• Minimum of 10 years of experience in pharmaceutical process chemistry, with a focus on small molecule development and manufacturing.
• Proven track record in developing and scaling up synthetic processes, with a fundamental understanding of cGMP requirements, quality, and regulatory expectations. Experience with reviewing master batch records, executed batch records, manufacturing deviations, and investigations.
• Excellent written and verbal communication skills, with the ability to effectively present complex information to diverse audiences.
• Strong analytical and problem-solving abilities, with a proactive approach to addressing challenges in process development and manufacturing.
• Strong initiative and desire to work in a fast-paced, team-oriented, dynamic environment.

The annual salary range for this position is $229,000 - $240,000 in the San Francisco Bay Area. BBOT considers a variety of factors when determining base compensation, including experience, skills, education, qualifications, and geographic location. Actual compensation will vary, and it is not typical to be hired at or near the top of the range for the role. 

Base compensation is part of a robust total rewards offering at BBOT. Additional total rewards elements include annual bonus, stock-based long-term incentives, medical, dental, and vision benefits, retirement, wellness stipend, and flexible time off.