Director / Associate Director, Small Molecule Drug Substance Development
- 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
- 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