Analytical R&D Scientist - Allegan MI

Kelly Science & Clinical has a new, long-term, fully enhanced benefits contract opportunity as an Analytical R&D Scientist with one of our sought-out clients in Allegan MI!

Shift: M-F, OT flexibility desired, rotating schedule for summer hours of 5 8-hr shifts one week and then 4-10hr shifts the next week; normal schedule outside of that.

Day to Day Responsibilities:

• Perform physical and chemical testing on raw material, in-process, finished product and stability samples. This includes documentation review.
  
• Develop, validate, and transfer analytical methods of varying complexity in compliance with both internal and external customer standards.
  
• Provide multiple options to successfully resolve complex analytical problems and deviation investigations that significantly impact project timelines.
  
• Uses a high level of scientific judgement based on prior work experience to perform tasks.
  
• Accurately maintain all related documentation in compliance with SOPs.
  
• Prepare documents for regulatory filings (ANDA, NDA, ANDS).
  
• Design experiments, provide data and provide responses to comments on FDA deficiency letters.
  
• Attend and present data at project-related meetings, interact with cross functional teams and external testing laboratories to ensure proper completion of analytical aspects of projects.
  
• 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.
  
• Conduct technical document review for external departments.
  
• Approve analytical reports, CofAs, specifications, test methods and deviations related to own or other projects.
  
• Provide technical and procedural training and mentoring for junior team members.

Qualifications:

• Bachelor degree or higher in Chemistry or Pharmaceutical Sciences combined with relevant professional experience with at least 2-4 years of experience within a cGMP/cGLP laboratory.
  
• Demonstrated ability to develop and perform critical reviews of a wide variety of technical and scientific documents, including but not limited to drug master files, certificates of analysis, qualification, and technical packages for conformance to country-specific scientific documentation requirements, such as USP, FDA submissions or European Pharmacopeia.
  
• Experience in raw material analysis and familiarity with DMFs preferred.
  
• Demonstrated ability to develop and validate complex analytical test methods which are robust and reliable, using a variety of analytical techniques and instrumentation, including but not limited to advanced HPLC, GC, LC/MS, dissolution, UV-Vis and FTIR, especially LC.
  
• Excellent communication skills are essential to work effectively in interdisciplinary teams and investigate and resolve technical problems or deviations.
  
• A thorough working knowledge of cGMP, cGLP, other US FDA regulations, and ICH guidance documents is essential.
  
• Must be able to work independently on multiple concurrent projects, develop testing plans that significantly contribute to process and material knowledge, discern specification and testing criticality and communicate effectively with cross-functional teams.

Pay will be determined based on title, education, and related industry experience. If you are interested in this opportunity, apply today as well as send resumes directly to me at ... or call at ....

9852015