- Support R&D initiatives and related project teams through development and implementation of robust drug product formulations and processes.
- Support lifecycle management initiatives of existing products.
- Write and provide peer review of technical documents including those supporting CMC regulatory submissions.
- Participate in development project teams as CMC functional area representative and SME.
- Interface and collaborate with research and operation-focused functional teams including manufacturing and quality functions.
- Execute the development plan to support global submissions.
- Maintain a high-level of understanding of global (ICH, FDA, EMA) regulatory requirements (in particular Chemistry, Manufacturing, and Controls) including those for filing and approval of investigational and commercial products.
- Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
- Please note that this position does not require working at the bench.
- At present time, the position does not have any direct reports.
- MS or Ph.D. in Chemistry, Chemical Engineering, Biochemistry, or a related field preferred; BS degree minimum requirement.
- Must have eight or more years of relevant work experience in pharmaceutical industry (cGMP, FDA, EMA, USP, NRC, and ICH guidelines) with extensive experience writing scientific reports and providing critical peer review. Experience preparing CMC regulatory filings.
- Must have experience and be knowledgeable about New Product Development Processes and the introduction of these products to market. Preferred product development of diagnostics/therapeutics of radiopharmaceuticals and/or injectables preferred.
- Proficiency in analysis of scientific data and results with ability to review scientific documents including reports, publications, and regulatory submissions.
- Ability to demonstrate a strategic mind-set with the ability to translate strategies into operational plans.
- Strong attention to detail with a technical mind-set – application of product knowledge is imperative to success.
- Behavioral requirements for success in this position include: critical thinking, excellent communication skills, team-focused attitude, and a strong work ethic.
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Description
Beacon Hill Life Sciences is actively recruiting for a Sr. Scientist (Lead Chemist) for a perm (direct hire) opportunity
Location: Onsite; Maryland Heights, MO
Work Schedule: Full-time (Core hours are M-F; 9am - 3pm, so there is flexibility with start/end times.)
Salary: Based on experience, range between $100K - $150K
The successful candidate will serve as a key functional member and will drive the development of new products and/or support of life-cycle management products including the preparation of reports and documents for regulatory submissions.
Essential Functions
Requirements
