Associate Director / Small-Molecule Drug Substance Development

Location
Hayward, California
Posted
Apr 29, 2021
Ref
218
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

Position Description

 

  • This individual will be a key member of the Small Molecule Drug Substance group as well as the CMC Team and will support early and late phase development of the company’s experimental therapies.
  • She/He will be responsible for the design, development and optimization of synthetic processes that are suitable for drug substance manufacturing on production scale.
  • She/He will mentor and lead less experienced team members both in technical skills development and foster a creative, collaborative team environment that strives for the highest standard.
  • She/He will manage consultants, and CROs/CMOs to develop robust, scalable manufacturing processes while meeting aggressive program timelines/budgets and long-term company goals.
  • She/He will author technical and regulatory documentation as required, including development plans, engineering protocols, risk assessments, technical reports, change controls, and IND/IMPD/NDA/MAA Quality sections.
  • She/He will collaborate with Drug Product, Analytical Sciences, Toxicology, Discovery Chemistry, Quality areas to ensure effective collaborations across functional areas in support of company priorities.
  • She/He will perform other duties as assigned.

 

 Position Requirements

 

  • PhD in organic chemistry or equivalent with a minimum 8+ years of experience in API process development in the biotech or pharma industry, including top tier CDMOs. 
  • Demonstrated track record of innovation and problem solving in process chemistry.
  • Project leadership experiences from early-stage to late-stage drug substance process development, preferably through registration batches and validation batches. Experiences in commercial manufacturing support is a plus. 
  • Hands on working experience with all stages of drug development, as well as in-depth knowledge and understanding of cGMP requirements and CMC regulatory requirements for small molecule drug candidates.  
  • First-hand experience in writing/assisting with CMC documents for regulatory submissions and a good understanding of pharmaceutical development, quality and regulatory issues.  
  • Demonstrated ability to effectively manage CROs and CDMOs to accomplish process development and drug substance manufacturing goals. Ability to collaborate with teams across different cultures.
  • Excellent communication skills and the ability to work in a goal and team-oriented setting. 
  • Ability to travel occasionally, as needed, to the sites of partner CROs.