Position Title: Associate Director/Director – Analytical Development
Proteostasis Therapeutics is seeking a talented individual with strong technical and leadership skills for the Analytical Development department.
The Associate Director/Director of Analytical Development will lead and coordinate with contract manufacturers all analytical activities to support drug substance and drug product manufacturing and testing, and all regulatory filings.
The successful candidate will:
- Apply creative ideas and scientific rigor to overcome challenges and ensure robust analytical methods are developed and validated as per international guidance across multiple projects?Coordinate and build effective collaboration with CDMOs, CMOs and CROs Direct, and nurture strong partnerships to enable timely deliverables of high quality products and documentation
- Possess a theoretical and hands on experience with a wide array of analytical techniques to enable the coordination of work with contract laboratories
- Work collaboratively in a multidisciplinary environment
- Ensure timely phase appropriate development and validation of analytical methods to support in process and product testing by contract manufacturers
- Review analytical test methods, protocols, and technical reports
- Develop phase appropriate specifications in collaboration with CMC and Regulatory colleagues and CDMOs/CMOs.
- Closely monitor stability programs and trend stability data to relate it to retest and shelf life extensions
- Actively collaborate with chemical development, formulation, CMC project/documentation management, and Regulatory to maintain high quality source documents and draft/review CMC sections of regulatory filings
- Draft necessary SOPs to define the analytical activities within Proteostasis and in collaboration with contract laboratories?Communicate progress cross functionally and to management. ?Manage analytical activities with CROs within budget
- Other duties and ad hoc projects as assigned.
Education and Experience:
- PhD in chemistry or related discipline with 10 years of industrialexperience
- Have a thorough knowledge of ICH, FDA and EMA guidance documents
- Possess in depth knowledge and prior practice of domestic and European regulatory filings (IND, IMPD, NDA, MAA)
- Have a proven track record of applying fundamental scientific principles and thorough compliance experience to analytical development, investigations, and control strategy
- Proficient in Microsoft Office, specifically Excel and Word;
- Prior work experience in the pharmaceutical, biotech or life sciences industry preferred
- Must be able to manage work load, and prioritize as necessary to meet deadlines while exhibiting a strong attention to detail;
- Excellent verbal and written communication skills and ability to work with all organizational levels;
** To comply with regulations by the American with Disabilities Act (ADA), the principal duties in job descriptions must be essential to the job. To identify essential functions, focus on the purpose and the result of the duties rather than the manner in which they are performed. The following definition applies: a job function is essential if removal of that function would fundamentally change the job.