POSITION SUMMARY

The Principal Scientist is responsible for the coordination and leadership of the introduction of non-routine and/or complex analytical methodologies (i.e. non-chromatographic analytical techniques) to the Quality Control laboratory. The position requires a broad and strong knowledge of analytical chemistry, pharmaceutical development, and regulatory requirements. The Principal Scientist will perform method development and assist with instrument qualifications to introduce these new techniques. They will also perform method transfers/method verifications/co-validation of compendial and non-compendial analytical methods utilized in the QC lab. They will evaluate, develop and introduce new techniques to the QC lab to improve lab efficiency. They will be the recognized SME in key analytical areas of interest. They will also be recognized as SME’s outside of MP (i.e. NAM and Global). They will work with plant operations to resolve complex analytical and manufacturing issues with respect to the chemistry of the process. The Principal Scientist will join outside organizations such as PDA, USP subcommittees, etc. In addition, the Principal Scientist will publish articles in pharmaceutical/technical journals on relevant analytical topics. The Principal Scientist reports directly to QC management and may provide project coordination to scientists at grade levels 15 and below. The Principal Scientist works closely with Product Development, Technical Transfer and Manufacturing Operations personnel.
Salary Range: $100,000 to $125,000 per year
Position is eligible to participate in an annual bonus plan with a target of 10% of the base salary.
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.
Responsibilities

REQUIREMENTS

• Possess a B.S. in Chemistry or Biology, or equivalent physical science. Typically, 10 or more years of experience in the pharmaceutical industry, or M.S. degree with 7+ years’ experience, or Ph.D. with 5+ years’ experience in analytical chemistry.
• Extensive knowledge of analytical chemistry as well as concepts in developing and validating methods to correct pharmaceutical standards.
• Extensive knowledge of parenteral formulations.
• Strong knowledge of GMP’s, GLP, ICH, and USP guidance and regulations.
• Preparation of documentation for Regulatory Submissions as required.
• Able to review/approve/update documentation such as protocols, test methods, SOPs, specifications, ANDA submissions, etc.
• Strong analytical and problem-solving skills.
• Strong interpersonal skills and highly effective in team settings.
• Strong project management skills, written, and oral communication skills.
  Additional Information
  We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
  Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status

Please refer the Job description for details