Job Title: Associate Director or Director, Drug Product Development
Job Number: 29444
Location: Raleigh, NC
This position will report directly to the Head of Drug Product Development. This individual will be responsible for the development of formulations and associated manufacturing processes of the drug products. This individual will work independently to support drug product development activities in contract development and manufacturing organizations (CDMOs) with the goal of delivering preclinical and clinical drug product batches meeting program needs.
Obtain the drug substance pre-formulation information internally, collect relevant characteristics of the raw materials, and establish the formulation and process development strategies based on the project’s Target Product Profile. Oversee the implementation of phase appropriate formulation and process development and optimization, clinical supply and registration batch manufacturing, and validation activities at external contract development and manufacturing organizations (CDMOs) by following the FDA guidance and QbD principles in accordance with documented work plans and cGMP requirements to ensure on time delivery of drug product. Oversee the batch manufacturing, intermediate sampling, bulk intermediates and the finished product characterization. Establish the critical raw material attribute control and in-process control strategies. Review Master and Executed Batch Records, protocols and reports related to all GMP operations related to the finished product. Coordinate with Analytical Function for completing testing of new drug products and initiating stability studies on selected batches of products in a timely manner. Support technical transfer between sites as needed. Monitor deviations and process changes; ensure appropriate technical and management visibility within Brii Biosciences and facilitate feedback and decisions to the CDMOs. Work collaboratively with Clinical Trial Material group for timely delivery of clinical supplies. Work collaboratively with Quality Assurance and Regulatory Affairs to ensure a high- level of cGMP compliance and ensure that FDA guidelines are followed. Contribute to drafting documents for the IND/NDA and IMPD/MAA submissions as well as for the regulatory filings in the other regions of the world.
Ph.D. in Pharmaceutics, Chemical Engineering, Bioengineering, Pharmaceutical Chemistry, or related scientific disciplines with 10+ years of experience in the Pharmaceutical or Biotech industry with a focus on small molecules drug product development and manufacturing. Hands-on experience in developing and scaling up formulations for oral solid dosage forms and parenteral formulations from pre-IND through late stage development. Experience in developing immediate, modified, and controlled release formulations for oral solid dosage forms and bioenhanced formulations. Experience in developing immediate, modified, and controlled release formulations for parenteral dosage forms including solutions, lyophiles, suspensions, etc with good understanding of aseptic processing, sterilization processes, and sterile drug product manufacturing. Familiarity with drug substance physiochemical characterization. Proficiency with drug product physiochemical and mechanical characterization, and drug-excipient compatibility study. Proficiency with Quality by Design (QbD) concepts and design of experiments (DoE). Experience working with a contract manufacturing environment with an in-depth knowledge of unit operations for small molecule oral and parenteral drug products. Ability to effectively work with external CDMOs to meet the timelines while staying within approved budgets. Experience in drafting relevant sections of INDs and NDAs. Ability to effectively work independently in a team environment with the internal department including but not limited to the Drug Substance, Analytical, Regulatory, Clinical Supplies, and Quality Assurance Department in a fast-paced collaborative environment. Ability to travel up to 25% of the time.