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