Senior Scientist, Analytical Development
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: Senior Scientist, Analytical Development
The Senior Scientist of Analytical Development will support all aspects of analytical development activities including characterization and control of drug substances and drug products. Knowledge of a broad range of analytical techniques commonly used in the analysis of pharmaceuticals and experience in method development, transfer and validation are required.
Duties and Responsibilities:
- Provide analytical oversight of external vendors for preclinical and Phase I – III CMC activities for small molecule drug substance (DS) and drug product (DP) with limited supervision.
- Provide oversight and direction in phase appropriate method development, validation and transfer for raw/starting materials, in-process control, DS and DP testing for CMOs
- Excellent problem-solving skills are essential.
- Participate in the development and revision of product specifications, provide scientific input and critique of analytical results.
- Review QA/QC documents of clinical trial supplies manufactured at CMOs.
- Manage and oversee reference standard program with CRO/CMO.
- Manage stability studies for DS and DP to establish retest period/shelf life.
- Participate in the preparation of CMC sections of regulatory submissions such as IND/IMPD/NDA/MAA along with other functional groups.
- Ensure compliance with analytical requirements for CMC regulatory submissions.
- Familiarity with a broad range of analytical techniques for the characterization of pharmaceuticals including thermal methods, HPLC & GC with a variety of detection methods, wet chemical analysis (KF, dissolution, etc.), spectroscopic techniques, particle size, and heavy metal analysis.
- Performs other duties as assigned
Qualification and Skill Requirements:
- Master’s degree or PhD in Chemistry, Pharmaceutical Chemistry or related discipline required
- Minimum 8 years (with MS) or 5 years (with PhD) of experience in analytical development in a CMC environment required
- Strong analytical, communication, presentation, and writing skills
- Ability to manage priorities and maintain timelines in a fast-paced environment
- Ability to exercise independent judgment with minimal supervision
- Ability to work cross-functionally and in virtual teams
- Demonstrated ability to effectively manage outsourced analytical activities
- Skill/knowledge in QbD, DOE, PAT, statistics, solid state characterization, biopharmaceutical classification system (BCS) are a plus
- Regulatory experience a plus
- Ability 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