BBOT · 2 weeks ago
Associate Director, Drug Product, CMC
United States
Full-time
Remote
Lead/Staff
$175K/yr - $202K/yr
8+ years expBBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. The Associate Director of Drug Product Development will lead formulation and process development activities for small molecules, ensuring successful advancement of programs from preclinical through commercial stages.
Biotechnology
Responsibilities
Lead the drug product development strategy for assigned small molecule programs, including solid oral dosage forms and other relevant formats
Design, review, and oversee formulation development, process development, and technology transfer activities
Develop phase-appropriate Clinical formulations with a view to overall program success on aggressive development timelines
Author, review, and approve key CMC documentation including development reports, batch records, and regulatory filings (INDs, IMPDs, NDAs, etc.)
Manage outsourced development and manufacturing activities at CDMOs, ensuring technical rigor, compliance, and timeline adherence
Collaborate with internal CMC stakeholders including Process Chemistry, Analytical Chemistry, Reg CMC, and Supply Chain
Collaborate effectively as needed with ex-CMC partners, including Clin Ops, Clin Pharm, Global Reg, Quality, DMPK and Tox
Provide technical leadership on drug product troubleshooting, risk assessments, and change controls
Ensure activities are compliant with GMP, ICH guidelines, and global regulatory requirements
Travel as needed (up to 20%) to support critical manufacturing campaigns and attend company gatherings
Qualification
Required
At least 5 years of lab-based experience specifically in small molecule drug product development
Ph.D. in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field with 8+ years of relevant industry experience OR M.S. with 12+ years of relevant industry experience
Specific experience in Pivotal drug product development, registration batches, validation or commercial
Preferred
Experience with Quality by Design (QbD) and Design of Experiments (DoE) for selection and optimization of drug product
Experience in developing BCS Class II/IV drugs
Experience directly managing CDMOs and overseeing external development and manufacturing
Tech transfer and scale up experience of drug product manufacturing processes
Benefits
Annual bonus
Stock-based long-term incentives
Medical, dental, and vision benefits
Retirement
Wellness stipend
Flexible time off
Company
BBOT
BBOT (BridgeBio Oncology Therapeutics) is a clinical-stage biopharmaceutical company advancing a next generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies.
51-200 employees
H1B Sponsorship
BBOT has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
100%
Represents job field similar to this job
Engineering and Development
Trends of Total Sponsorships
*2021 (1)
Funding
Current Stage
Growth StageCompany data provided by crunchbase