Associate Scientist / 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.
The individual will be responsible for development of assay, impurities, dissolution, and physical characterization methods for oral and nasal drug products. There is an expectation of both direct hands-on laboratory work as well as 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 Self-Care Products.
Major Duties and Responsibilities to include:
- Perform physical and chemical testing on raw materials, in-process and finished product samples with superior attention to detail and a focus on operational excellence.
- Clearly document and precisely execute analyses and experiments of moderate to high complexity. Analyze and properly interpret data, prepare reports, give presentations, or author other technical communications as necessary.
- Develop, validate and transfer analytical methods of varying complexity on the following platforms: HPLC, UPLC, GC, dissolution, and others as needed.
- Collaborate effectively with other departments and/or sites on project deliverables.
- Participate in/lead cross-functional teams at project-related meetings and technical discussions.
- Carry forward multiple concurrent projects and significantly contribute to product knowledge.
- Proficiency with a variety of analytical instruments for physical and chemical analyses, including but not limited to: HPLC, UPLC, GC, Dissolution.
- Ability to develop, trouble-shoot, and validate complex or innovative analytical methods which are robust and reliable, with minimal supervision, in a fast-paced and dynamic environment.
- Familiarity with calibration, maintenance, installation, and qualification of lab equipment.
- A working understanding of chemical structure at the molecular level.
- Judgement to make clear and concise decisions regarding project execution. Strong organizational, communication, and project management skills are a must.
- Passion for a team-oriented culture focused on shared ownership and responsibility.
- Familiarity with a variety of compendial references including the United States and European Pharmacopeia, as well as FDA Guidances and ICH Guidelines related to analytical methods validation and drug product development.
- Experience with statistical analyses of data and Design of Experiment concepts.
- Waters Empower software experience highly desired.
The skills required for this role are normally acquired through completion of a:
- Bachelor’s degree in Chemistry or Pharmaceutical Sciences with 2-4 or more years of cGMP or cGLP laboratory experience, or
- Master's degree in Chemistry or Pharmaceutical Sciences with 1-2 or more years of experience in a cGMP or cGLP laboratory, or
- PhD degree in Chemistry or Pharmaceutical Sciences