Assistant Scientist / Associate Scientist - Analytical R & D
We strive to make lives better by bringing quality, affordable self-care products that consumers trust everywhere they are sold. Help us do it.
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 on the development of analytical methods for small molecules in support of research and characterization of new and reformulated drug products. Chief techniques include HPLC/UPLC-UV stability-indicating methods with various separation chemistries. Alternate detection methods such as ELSD and RI may also be employed along with introduction of various new analytical technologies as needed.
The individual will be responsible for development of assay, impurities, dissolution, water content, and physical characterization methods for liquid and solid oral drug products. There is an expectation of both direct hands-on laboratory work as well as, depending on level of experience, mentoring/training of colleagues.
This is a great career move for someone who wants to be involved in the entire drug product lifecycle, participating from initial concept to commercial production, with opportunities to contribute to a successful global pharmaceutical business focused on Quality Affordable Healthcare Products.
Major Duties and Responsibilities to include:
- Perform physical and chemical testing on raw materials, in-process and finished product samples. This includes documentation, 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 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, HPLC, UPLC, USP dissolution testing apparatus, and moisture analysis by Karl Fischer.
- 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.
- The skills required for this role are normally acquired through completion of a:
- Bachelor’s degree in Chemistry or Pharmaceutical Sciences combined with 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.