Principal Scientist

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

* Identifies and evaluates new analytical technologies that can improve the operational efficiency and capabilities of the QC laboratories and leads the acquisition and implementation of the new technology

* Knowledge leader within QC on the conformance of the release and stability profile as documented in the I&D development reports and regulatory submission.

* Publishes articles in pharmaceutical/technical journals on relevant analytical chemistry topics.

* Coordinates and executes method transfers/method verifications/co-validations of testing procedures utilized within the Quality Control laboratory

* Coordinates and executes the verification protocols to verify the vendor and USP analytical methods.

* Evaluates methods in USP/PF and coordinates with USP to address potential issues.

* Submits new methods to the USP as needed.

* Reviews the obtained results and verification reports after the execution of method transfers and verification protocols.

* Acts as liaison between I&D departments or Production Units and the QC Chemistry laboratory for the transfer and implementation of new testing procedures.

* Actively participates in outside organizations such as ACS, PDA, USP.

* Subject matter expert for performance of critical tests in support of new product launches.

* Identifies and investigates complex problems occurring in the QC laboratories and provides technical support in solving the problems.

* Prepares documentation for Regulatory Submission, as required.

* Reviews/updates/approves documentation such as protocols, test methods, SOPs, raw material/finished product specification, etc.

* Participates in the orientation and training of lab employees in new analytical method techniques.

* Capable of handling complex projects with only general guidance.

* Establishes work priorities for assignments within his/her authority and keep assignment completion on schedule.

* Functions as the analytical project leader in inter-departmental meetings.

* Provides project leadership to assigned scientists (i.e. grade 15 and below) and monitors performance of these individuals. Provides input to laboratory management of their performance to support the performance review, recognition and disciplinary processes.

* Interfaces with Plant Operations and Technical Transfer personnel to support and resolve plant technical issues where analytical expertise is needed.

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.

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness 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.