Job Title: Senior Scientist Analytical R&D
Industry: Biotech / Pharmaceutical
Our client company develops therapeutics for respiratory diseases. Assume a key strategic role contributing to Analytical R&D at an exciting stage of company growth. This position is a key scientific role working independently in the lab, and reporting directly to the companies Director Analytical R&D.
- Analytical research and development of large molecule therapeutics (proteins, lipids).
- Analytical method development, optimization, automation, and transfer, as well as method validation and technical training on analytical methodology and laboratory software.
- Use expert knowledge of chemical and physical analytical methods, large molecule characterization, experiment design, and matrix testing.
- Function independently to plan, supervise, and lead projects and investigations.
- Lead the pursuit of scientific excellence, research publications, and development of intellectual property for the Analytical Technical Support department.
- Represents the Analytical R&D laboratory group as a member on project teams and in support of pharmaceutical and medical device development.
- Lead OOS, OOT, laboratory, and manufacturing investigations.
- Provide mentorship and training to senior scientists and research associates.
- Represent the AR&D laboratory group as a key member of project teams.
- Support pharmaceutical and medical device development.
- Independently conduct research, including large molecule characterization, degradation pathway determination, and impurity identification.
- Write technically sound data and investigation reports, method validation protocols and reports, SOPs, study protocols, and slide presentations.
- Review/audit data, notebooks and test reports in a GMP manner and work with QA to ensure total laboratory compliance of all assigned activities.
- Maintain and develop scientific awareness and identify actual and potential opportunities for the company.
- Ensure compliance with cGMP, S&IH, OSHA, EPA, and other pertinent regulations.
- Represent and interface with the FDA regarding Analytical R&D activities.
- Ph.D. in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Science, or equivalent.
- At least 5-10 years pharmaceutical industry experience, including at least 3-5 years recent hands on experience (50-80% on the bench) working in a GMP, FDA regulated pharmaceutical/biotechnology drug product development company, independently performing progressively more advanced analytical work.
- At least 5 years of recent hands on experience assaying and characterizing large molecule drug product formulations, elucidating degradation pathways, and impurity identification primarily in a pharmaceutical drug product development industry environment.
- Thorough knowledge of UV, ELSD, physical testing, CAD, LCMS, degradation assessment/pathways, and structural characterization.
- Must have experience with large molecules, specifically with protein and lipid based drug products.
- Working expertise with Waters chromatography software (preferably Empower or Millennium).
- Understands, applies and can supervise advanced analytical practices.
- Experience in representing and interfacing with the FDA regarding Analytical R&D activities.
- Excellent oral and written communication skills.
- Advanced computer skills using Excel, Word and Access. Advanced math, algebra, statistical and experimental design skills.
- Experience with SLIM stability tracking software a plus.
- Demonstrated leadership and mentorship skills.
If this opportunity does not meet your needs but you know someone qualified, please refer this opportunity to them. Refer This Opportunity to a Colleague.