Job SummaryWe are seeking an experienced and highly collaborative Small Molecule Drug Product Formulation specialist to lead the design, early-phase development, and manufacturing scale-up of our oral solid dose drug product candidates. In this role, you will drive the progression of pipeline molecules from initial pre-formulation characterization through successful technology transfer into GMP manufacturing for clinical trials. You will serve as the technical lead overseeing external contract manufacturing organizations, reviewing production records, and continuously optimizing drug product formulations to align with our target product profiles (TPP). This role requires a strong balance of hands-on technical expertise and cross-functional leadership, working in lockstep with internal Discovery, Supply Chain, Quality, and external CDMO partners.
Your Role- Lead phase-appropriate small molecule drug product formulation development for C4T's clinical portfolio, applying scientific principles to design, optimize, and scale robust formulations that meet target product profiles, stability requirements, and clinical delivery needs.
- Oversee formulation development, process optimization, scale-up, and technology transfer activities for oral drug products, working closely with external CDMOs and contract manufacturing partners to ensure scalable, GMP-compliant manufacturing processes.
- Direct and evaluate the work of external scientists and suppliers, including vendor identification, RFP technical input, CDMO selection, and review of emerging formulation, manufacturing, and analytical data.
- Provide technical leadership for engineering, clinical, and validation batches by reviewing master batch records, executed production documents, change controls, deviations, and analytical data to ensure alignment with GMP requirements and product specifications.
- Support CMC strategy and regulatory readiness by authoring and reviewing technical memos, specifications, and relevant sections of regulatory filings, including INDs and IMPDs.
- Serve as the drug product technical representative across Discovery, Supply Chain, Quality Assurance, Tech Ops, project management, and external partners, building effective relationships and helping establish efficient process development practices.
Your BackgroundRequired:- A PhD in in Pharmaceutical Chemistry, Formulation Sciences, or related scientific discipline with a minimum of eight years of post-graduate experience, including time spent in an industry setting with hands-on experience in formulation development, process optimization, scale-up, technology transfer, and manufacturing of solid oral and parenteral dosage forms of small molecules, developing excellent science-based problem-solving and critical-thinking abilities.
- Experience in a cross functional drug product leadership role advancing clinical-stage programs that requires frequent interaction with internal and external stakeholders relevant to early & late-stage product development, with strong written communication skills for authoring regulatory documents.
- Familiarity with quality-by-design (QbD) approaches to drug product development, working knowledge of Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents as they relate to manufacture and quality testing of pharmaceutical products.
- Experience with creating RFPs, and managing CDMOs performance for formulation development, process optimization, and manufacturing of drug product.
- Ability to multi-task and manage several projects in parallel, interpret and present data to all levels of stakeholders, design tests, and articulate results in an effective manner with a sense of urgency to drive development progress.
CompensationThe base pay range for this position at commencement of employment is expected to be between $230,090.00 and $254,310.00 annually; however, base pay offered may vary depending on multiple individualized factors, including job-related knowledge, skills, and experience.
