Perrigo Co. of Allegan is seeking a scientist for research and development.
Provides technical support to assigned projects, using robust scientific methods which comply with standard operating procedures and scientific standards. Works with limited direction. As appropriate, may serve as a project leader to manage analytical support for projects with minimal supervision.
1. Prepare documents for regulatory filings (ANDA, NDA, ANDS). Design experiments and provide data to support responses for FDA minor deficiency letters.
2. Perform physical and chemical testing on raw material, in-process, finished product and stability samples. This includes documentation and review.
3. Successfully investigate and resolve analytical problems, project issues and deviations. Accurately maintain all related documentation in compliance with SOPs.
4. Research, prepare and review technical documents, including but not limited to SOPs, drug master files, technical packages, vendor qualification, raw material and release and stability specifications, stability summaries, test methods, and certificates of analysis which conform to company standards.
5. Attend and present data at project-related meetings, interact with other departments and outside testing laboratories to ensure proper analytical testing.
6. Participate in cross-functional project teams, and exercise and build basic team effectiveness skills.
7. Utilize skills, established procedures, new methodologies, and experience to complete tasks; and provide formal and informal mentoring to junior team members.
8. Develop, validate and transfer non-complex to complex analytical methods.
Demonstrated proficiency in the use of a variety of standard analytical instruments, such as HPLC, UPLC, GC, Dissolution, UV-Vis and AA.
Demonstrated proficiency in the use of instrument software applications. Familiarity with a variety of compendial references, including USP or European Pharmacopeia. The ability to develop, document and execute analyses or experiments of moderate complexity, ensuring methods are robust and reliable.
The ability to maintain high quality research documentation, analyze and interpret data, and prepare reports, qualification documents, SOPs or other technical reports is necessary.
Must be able to work independently on multiple concurrent projects, and communicate effectively with interdisciplinary project teams.
These required skills are normally acquired through completion of a bachelor degree in Chemistry or Pharmaceutical Sciences combined with 4 to 6 years of relevant experience in a cGMP or cGLP laboratory, or a master degree in Chemistry or Pharmaceutical Sciences combined with 0 to 2 years of relevant experience in a cGMP or cGLP laboratory.
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