Director / Associate Director, Small Molecule Drug Substance Development

Location
Hayward, California
Posted
Sep 29, 2021
Ref
oBK2gfwn
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

Responsibilities

 

  • Key member of the Small Molecule Drug Substance group/CMC Team and will support early and late phase development of Arcus’ experimental therapies
  • Provide strategic and technical input to senior leadership to inform pipeline development and other relevant business activities
  • Design, development, and optimization of synthetic processes suitable for drug substance manufacturing on production scale
  • Mentor and lead junior team members in technical skills development and foster a creative, collaborative team environment striving for the highest standard
  • Manage consultants and CROs/CMOs to develop robust, scalable manufacturing processes while meeting aggressive program timelines/budgets and long-term company goals
  • 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
  • Collaborate with Drug Product, Analytical Sciences, Toxicology, Discovery Chemistry, Quality areas to ensure effective collaborations across functional areas in support of company priorities

 

 Requirements

 

  • PhD in organic chemistry with 10+ years (for Dir) or 8+ years (for Assoc. Dir) experience in API process development in the biotech or pharma industry
  • Demonstrated track record of innovation and problem solving in process chemistry
  • Project leadership experiences from early-stage to late-stage drug substance process development, 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
  • Demonstrated track record for developing and mentoring direct reports and other team members
  • 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