Assoc Director, BioPharm Develop
Location San Diego, CA
Job Category Biopharmaceutical Sciences (MFG)
Requisition Number 6578BR
Job Description General Summary:
Responsible for pharmaceutical development in the area of Chemistry, Manufacturing and Control (CMC) to evaluate and develop new chemical entities (NCE, small molecule) from research through development.
The CMC activities include preformulation, analytical development, and formulation development.
Leading a team of scientists on site and managing the respective lab function accordingly.
Develop pre-clinical formulations using clinically acceptable excipients suitable for the intended route of administration to support in-vivo research studies such as pharmacokinetics, efficacy studies, and toxicology.
Participate in the nomination of a new chemical entity from research to discovery identifying the strengths and weakness of lead chemical candidates and potential impact on formulation and development strategies.
Conduct preformulation experiments such as solubility assessments, pH-stability, and pH-solubility to characterize new chemical entities and devise appropriate formulation strategies.
Develop formulations using clinically acceptable excipients and scaleable process to support clinical trials.
Develop, validate and document necessary assays (e.g., HPLC) and methods for the drug substance and drug product for new chemical entities in develop for human use.
Familiarity and experience in a GMP environment regarding CMC activities.
Interact with Regulatory and Contract Manufacturing departments to select a suitable contract research organization for the GMP manufacture of drug substance and drug product, assist in method and technical transfers, and manage the development activities taking place at each CRO.
Communicate results, devise strategies and resolve development issues in a team environment.
Manage budgets for CMC activities
Participate and contribute CMC support and guidance to support discovery research
Attend and participate in development meetings and scientific meetings to remain current with development technologies and regulatory guidelines pertaining to CMC activities.
Lead a team of > 3 FTEs to run a pharmaceutical development lab
Qualifications >10 years experience in pharmaceutics or pharmaceutical analytical development.
Familiarity with FDA requirements, ICH guidelines and GMP guidelines
Experience in managing lab functions in pharmaceutical development
Education PhD + 10 years in Pharmaceutics