Assistant / Associate Scientist / Pharmaceutical Materials Characterization
The Allegan Michigan based Analytical Research and Development department, specializing in solid and liquid Over-the-Counter (OTC) product development, is looking to add a talented colleague to our New Product Development team.
Our focus is to perform Quality By Design risk-based assessments of available supplier technical information (DMF), perform physicochemical testing of various materials (raw materials, intermediates and finished dose form), develop and validate analytical test methods, contribute to clinical and regulatory batch filings, contribute in the development and validation of analytical methods (compendial and novel testing) and author specifications and other technical documents in support of new and reformulated drug products.
- There is an expectation of both direct hands-on laboratory work as well as, depending on level of experience, collation and communication of data from supplier and in-house results, and mentoring/training of colleagues.
- This is a great career move for someone who wants to be involved in the entire drug product life cycle, participating from initial concept to commercial production, with opportunities to contribute to a successful global pharmaceutical business focused on Quality Affordable Healthcare Products.
- Chief techniques include physicochemical methods ranging from USP and or EP compendial techniques, chromatographic separation (GC and HPLC), particle size distribution (laser diffraction and mechanical sieving), light microscopy, and spectrophotometric (FTIR).
- Alternate methods such as viscosity/rheology, texture analyzer, thermal analysis (DSC and TGA), and powder properties characterization (XRPD, SEM, contact angle, BET surface area, porosity, dynamic vapor sorption, flow rate) are performed as needed.
- Perform physical and chemical testing on raw materials, in-process and finished product samples in support of project timelines. This includes documentation, protocol and report writing and review.
- Research, prepare and review technical documents, including but not limited to: SOP's, drug master files, vendor qualification, technical packages, compendia, protocols, raw material and intermediate specifications, test methods, certificates of analysis, and method validation reports which conform to company and regulatory standards.
- Develop, validate and transfer analytical methods of varying complexity.
- Prepare documents for regulatory filings and internal company use.
- Participate in cross-functional teams at project-related meetings and technical discussions. Advanced level would be expected to lead such meetings as necessary.
- Generate high quality analytical data, provide downstream data analysis, and deliver knowledge growth and flow.
- Demonstrated proficiency with a variety of analytical instruments for physical and chemical analyses including but not limited to analytical balances, pH meters, GC (direct inject, headspace), laser diffraction PSD, FTIR, HPLC, wet chemistries techniques, and moisture analysis by Karl Fischer, infrared, gravimetric techniques.
- Familiarity with a variety of compendial references including the United States and European Pharmacopeia.
- The ability to clearly document and precisely execute analyses and experiments of moderate to high complexity which includes maintenance of high quality documentation, analysis and proper interpretation of data, and preparation of reports, presentations, or other technical communications as necessary.
- Must be able to work independently on multiple concurrent projects and significantly contribute to process and material knowledge.
- Effective communication within direct Analytical team, on focused technical and non-technical teams, and with cross-functional groups.
- Demonstrated ability to operate effectively in a team-oriented culture focused on a sense of shared scientific inquiry, collaborative engagement, innovation, and the pursuit of scientific excellence.
- Problem-solving and critical thinking skills required
- Bachelor’s degree in Chemistry or Pharmaceutical Sciences combinedwith bench internship or co-op experience while in University at the entry level OR a
- Bachelor’s degree in Chemistry or Pharmaceutical Sciences and 2 to 4 years of cGMP or cGLP laboratory experience at the more senior level OR a
- Master's degree in Chemistry or Pharmaceutical Sciences with up to 2 years of experience in a cGMP or cGLP laboratory at the more senior level.
We're proud to be an equal opportunity employer- and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status. Different makes us better.
Due to the highly regulated pharmaceutical industry and legal requirements, you may be subject to post employment background checks.