Director, Process Chemistry
Proteostasis Therapeutics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of novel therapeutics that treat diseases caused by an imbalance in the proteostasis network, a set of pathways that control protein biosynthesis, folding, trafficking and clearance. Our initial therapeutic focus is on cystic fibrosis, or CF, which is caused by defects in the cystic fibrosis transmembrane conductance regulator, or CFTR, protein and insufficient CFTR protein function. CF is an orphan disease that affects an estimated 70,000 to 100,000 patients worldwide, with the vast majority of affected individuals in the United States, Canada, Europe and Australia. CF is the most common fatal inherited disease in Caucasians, and there is presently no cure.
We seek to hire talented people and to create an environment that facilitates continued professional growth. The extensive and ongoing work with our founders and collaborators adds an outward-looking, collaborative aspect to the company’s culture. This blend of internal and external talent, combined with cutting-edge science and an innovative business model, make Proteostasis Therapeutics an exceptional place to work.
Position Title: Director, Process Chemistry
The Director of Process Chemistry is responsible for process optimization and scale up of existing chemistries to prepare for manufacturing of API registration/validation batches. This individual will work closely with CDMOs and CMOs to ensure timely delivery of robust processes and reproducible drug substances. He/She will also be responsible for the Drug Substance sections of the IND/IMPD/NDA/MAA.
Duties and Responsibilities:
- Work with API vendors to schedule manufacturing campaigns of drug substance for clinical trials, review and approve batch records, change controls
- Collaborate with drug substance vendors and provide direction for process optimization of small molecule drug substance (DS) for clinical phases and registration/validation batches
- Focus on designing with the vendors, the appropriate experiments to generate the necessary data to maximize process capabilities, ensure process robustness and delivery of reproducible drug substance
- Carefully review process optimization data from vendors and use the acquired knowledge to make improvements on yield, impurity profiles and cost of goods
- Participate in the development and revision of drug substance specifications, provide scientific input and critique of analytical results at release and on stability
- Participate in the preparation of CMC sections of regulatory submissions (briefing packages, IND/IMPD/NDA/MAA
- Closely collaborate with Analytical and Formulation within CMC, Regulatory and QA to ensure information is shared most efficiently.
Qualifications and Skill Requirements:
- PhD in organic chemistry or chemical engineering
- Minimum 10 years of experience in chemical development in a CMC environment
- Demonstrated ability to successfully manage outsourced chemical development activities
- Prior successful experience in process optimization and scale up of synthetic chemistry of small molecule drug substance
- Ability to manage priorities and maintain timelines in a fast-paced environment
- Excellent problem-solving skills and independent judgement
- Ability to work cross-functionally and in virtual teams
- Thorough interpretation of analytical data
- Strong communication, presentation, and writing skills
- Strong knowledge of Regulatory requirement
- Willingness to travel to various meetings or vendor sites. Some international travel may be required
Candidates must be authorized to work in the U.S. and live locally only – we will not support relocation for this position. Applicants should send a resume and cover letter to: Human Resources at email@example.com