Sr Scientist

Fresenius Kabi•Grand Island, NY

About The Position

The Senior Scientist is responsible for the coordination and leadership of method transfer/method verification/co-validation of compendial and non-compendial analytical methods utilized across Fresenius Kabi. Leads planning and coordination of method transfer/method verification activities in the transfer of analytical methods from the Innovation & Development (I&D) department or between Fresenius Kabi facilities to the Quality Control laboratory. Additionally, the Senior Scientist will become the expert within the Quality Control organization for the critical tests associated with new product launches and knowledge leader on the conformance of the release and stability profile as documented in development reports and the regulatory submission.

Requirements

Possess a B.S. in Chemistry or Biology, or equivalent physical science.
Typically, 8-10 years of experience in the pharmaceutical industry, or M.S. degree with 5+ years’ experience, or Ph.D. with 3+ 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.

Responsibilities

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.
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.
Subject matter expert for performance of critical tests in support of new product launches.
Knowledge leader within QC on the conformance of the release and stability profile as documented in the I&D development reports and regulatory submission.
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.