Consistently performs routine and more complex analytical chemistry activities with a high degree of independence. Demonstrates technical expertise in one or more analytical areas. Develops and validates analytical methods relating to the support of marketed products. Compiles validation data into comprehensive reports. Transfers analytical methods in support of new product launches and existing marketed products. Applies creative ability and specialized scientific knowledge to solving marketed product analytical problems or evaluating changes to APIs and critical excipients used in marketed products. Evaluates and implements new measurement technologies to improve sensitivity, selectivity, and/or the ability to characterize API’s, excipients, in-process materials, and finished products. Applies statistics to data analysis and the design of experiments. Generates analytical data for the purposes of determining the level of correlation to measurements that use Process Analytical Technology techniques. The position is accountable for ensuring that analytical measurements are accurate and that methods are in compliance with FDA and/or other applicable regulatory agency guidelines, cGMP, and corporate requirements. POSITION RESPONSIBILITIES Conducts assays: In addition to high technical competence understands and can articulate the scientific/regulatory principles that underlie practices and guide future projects/studies/reviews development. Continues to expand breadth of technical expertise. Analyzes results: Analyzes and interprets project/study/investigation/review results independently. Makes tactical decisions independently based on the results. Learns to develop project strategy in consultation with supervisor. Trains and Mentors : Trains more junior analysts in new and existing procedures, techniques and governmental regulations as directed by supervisor. Mentors analysts by providing technical knowledge and support in resolving technical problems. Takes initiative; seeks out additional assignments, etc. Lab Support: Designs, develops and evaluates plans for projects/studies/ investigations/reviews. Completely responsible for planning and execution of all tasks needed to achieve routine goals. Seeks advice on planning from supervisor when there are priority conflicts. Begins to consider and consult with supervisor in area of long range planning for further development of the function. SOPs and Admin: Able to make independent contributions to the development of new technologies developing and revising methods and procedures to assure compliance with applicable regulations; carries out technical and administrative duties as assigned. ORGANIZATIONAL RELATIONSHIPS Quality Mgmt: General & specific discussions of analytical issues; recommends corrective action to potential or observed cGMP violations. Workload priorities; consult on analytical interpretations of methods and SOPs. Builds credibility within the group by performing high quality work. Outside laboratories Coordinate communication and information. Ordering equipment & laboratory supplies; pricing. EDUCATION AND EXPERIENCE B.S. in Biology, Chemistry, Microbiology, Biochemistry or relevant science discipline. M.S. in Biology, Chemistry, Microbiology, Biochemistry or relevant science discipline.
With a B.S., minimum of 8 years of relevant Quality experience, preferably in the bio/pharmaceutical industry
With an M.S., a minimum of 6 years of relevant Quality experience, preferably in the bio/pharmaceutical industry
Strong background in relevant analytical methods and techniques
TECHNICAL SKILLS REQUIREMENTS
Analytical Techniques & Methods In addition to high technical competence understands and can articulate the scientific/regulatory principles that underlie practices and guide future projects/studies/reviews development. Continues to expand the breadth of technical expertise
Documentation & Systems Use:
Ability to interpret and document test results according to standard operating procedures using all standard Quality systems; strong background using LIMS may be desirable. Advancing Methods Demonstrated ability to independently develop, document and troubleshoot methods of moderate complexity.
Extensive practical and solid theoretical knowledge of
1) applicable compliance guidelines of the FDA or other regulatory bodies, 2) test procedures such as USP, NF and ASC, and 3) relevant Client's SOPs.
Ability to review workload and determine most efficient and effective testing plan schedule
Building Effective Teams:
Ability to leads teams comprised of immediate group members or to work cross functionally, if necessary
Can independently design and carry out a series of studies/ reviews to solve a problem or evaluate a process/procedure. Solutions may involve the development of new techniques and procedures. Uses the literature and colleagues as resources in order to solve problems.