Associate Director, Process Chemistry
Europe
CMC /
Full time /
Remote
About Prilenia
Prilenia Therapeutics, a clinical-stage biotech company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for an Associate Director, Process Chemistry to join its remote-based team in Europe.
We are a flexible, fast-moving team that is quickly advancing a potential therapy poised to have major impact on the lives of patients and their families. Our lead product candidate, pridopidine, holds Orphan Drug Designation in both Huntington’s disease (HD) and Amyotrophic lateral Sclerosis (ALS) in the U.S. and EU, as well as Fast Track designation from the FDA for the treatment of HD. Prilenia is working on preparing for a potential regulatory filing for HD and for starting a global phase 3 in ALS with pridopidine.
Pridopidine has the potential to be the first treatment to address HD disease clinical progression. Prilenia also believes pridopidine’s novel mechanism of action as a Sigma-1 receptor agonist gives it potential in numerous other neurological diseases.
About the role
The Associate Director*, Process Chemistry position is ideal for someone who thrives in a dynamic and fast-paced work environment and rises to meet challenges. Reporting to the Head of CMC, the Associate Director will oversee and manage DS GMP production activities and preparation for registration. You will work closely with contract manufacturing organizations (CMOs) on commercial and clinical manufacturing, as well as on process scale updates and related activities. In addition, you will identify, escalate, and solve any obstacles to ensure all DS production activities run smoothly and the documentation is accurate and comply with regulatory guidelines and quality standards.
*title commensurate with experience
Roles & Responsibilities
- Oversee and manage CMOs counterparts including delivering feedback and holding others to timelines and deliverables while maintaining strong professional relationships and ensuring compliance with quality standards (SOPs, GMP etc.)
- Manage tasks and deliverables towards assembling required information and contribute to respective documents (e.g. risk analysis, briefing books, IND, IMPD, study plans and reports) in close collaboration with other relevant stakeholders
- Responsible for ensuring that drug substance (DS) plan aligns with overall development program and supports future commercial demands
- Support (review and author) the company’s regulatory submissions and documentations (clinical and commercial)
- Review and approve batch records, product specifications and all other documents related to drug substance manufacturing
- Lead DS manufacturing process scale up and all related activities
- Review stability results and conduct trend analysis
- Lead qualification of secondary sources for key starting materials
Qualifications & Experience:
- M.Sc. in Organic Chemistry, PhD preferred
- 7+ years’ experience in Chemical Research & Development and Commercial product manufacturing in GMP environment
- Demonstrated track record of working with CMOs in line with contractual deliverables within timelines and budgets
- Experience in multi-step chemical process development and manufacturing, including process parametrization, validation and scale-up
- Experience with regulated industry Product Development and Regulatory requirements (knowledge of FDA and EMA requirements e.g., cGMP and marketing applications, and ICH guidance affecting drug substance development (ICH Q1 to ICH Q13)
- Working and theoretical knowledge of manufacturing, processing and testing equipment
- Demonstrated experience with regulatory submissions in various markets with emphasis on marketing authorization, post-marketing and late stage development
Skills:
- Fast-paced, high-capacity, versatile and energetic with demonstrated ability to manage multiple parallel assignments effectively with sense of urgency and reputation for meeting timelines and milestones
- Well organized and detail oriented with a history of strong chemical and analytical skills supporting the development and implementation of strategic plans
- Prior history of effectively conducting remote oversight/supervision
- Track record of being successful in ambiguous environments and adapting to a rapidly changing work environment
- Hands-on, flexible and team player, often under pressure
- Excellent problem-solving skills
- Outstanding verbal and written communication skills in English
Location
This is a remote position based in Europe (preferably Netherlands, Germany, UK)
Time commitment
Full time
Travel
· Requires travel to DS manufacturing sites in Europe
· Frequent calls with Israel, EU and North America.
For more information about Prilenia visitwww.prilenia.com
