Scientist / Sr. Scientist - Materials Characterization, GC-MS
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 an experienced and talented colleague to our New Product Development Analytical R&D team.
This is an advanced role within Analytical R&D with expectations of both direct hands-on laboratory work as well as collation and communication of data from supplier and in-house results and has opportunities for mentoring/training of colleagues.
The areas of focus of the position include performing Quality By Design risk-based assessments of available supplier & technical information, performing physicochemical testing of various materials (including raw materials, intermediates and finished dose form), develop and validate analytical test methods, contribute to clinical and regulatory batch filings, complete method 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.
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 Job Duties and Responsibilities:
- Perform and communicate risk assessments of material attributes leveraging technical information from suppliers Drug Master Files, patents, scientific literature, as well as in-house testing results
- Develop, validate and transfer analytical methods of varying complexity.
- Perform physical and chemical testing on raw materials, in-process and finished product samples in support of project timelines.
- 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).
- Various additional characterization methods such as viscosity/rheology, texture analyzer, thermal analysis (DSC and TGA), and powder properties characterization (XRPD, Scanning electron microscopy, contact angle, BET surface area, porosity, dynamic vapor sorption, flow rate) are utilized as needed.
- Independently research and review relevant technical documents as well as prepare documents for regulatory filings and internal company use.
- Participate in cross-functional teams at project-related meetings and technical discussions, advanced role is expected to lead such meetings as necessary.
Required Experience and Skills:
The skills required for this technical role are normally acquired through completion of a Bachelor’s degree in Chemistry or Pharmaceutical Sciences combined with a minimum of 4 years of hands-on R&D related laboratory and technical writing support. Applicants with relevant on-the-job experience combined with an advance degree are welcome to apply.
- 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.
- The successful candidate must have demonstrated success to independently investigate and identify residual solvent related unknowns via GC-MS
- Requires familiarity with a variety of compendial references including the United States and European Pharmacopeia, applicable FDA Guidance and ICH Guidelines including risk-based assessments, QbD, analytical methods validation and specification development expectations for API and product.
- Must be able to work both independently and collaboratively 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.
- The ability to clearly document and precisely execute analyses and experiments of moderate to high complexity with independence, which includes maintenance of high quality documentation, analysis and proper interpretation of data, the preparation of reports
- Reviews / authors protocols, reports and technical documents in support of new product development and when applicable, facilitates succinct technical meetings and data presentations
Helpful Experience and Skills:
- Ability to contribute to reviewing and authoring relevant CMC sections of NDA / ANDA / PAS filings and be a major contributor to providing scientifically sound responses to FDA communications.
- Experience in maintaining GC-MS equipment.
- Polymorphic form characterization techniques including polarized light and scanning electron microscopy
- Determining BCS-style aqueous solubility properties
- Experience with statistical analyses of data and design of experiment concepts
- Empower 3, ChemStation, Omnic, Malvern 3000 software experience
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.