Job Summary - a concise overview of the job
The Scientist, Laboratory Technical Services is primarily responsible for supporting the analytical testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency in conducting all types of physical and chemical analyses (including the most complex analyses) using all equipment. This position will have a significant role supporting pending ANDA submissions, product launches, and method lifecycle activities to achieve company goals and initiatives. Write and review SOPs, test methods, validation protocols and reports. The Scientist also provides mentoring to Chemists.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Typically supports one Par business, at a single site
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
Analysis & Testing
§ Validates analytical methods for Finished Product and Raw Material release and stability testing
§ Evaluates, troubleshoots/improves existing analytical methods when necessary
§ Prepares method validation protocols, reports, and analytical test methods
§ Performs testing to support process and formulation development (e.g. excipient compatibility, solubility, dissolution studies, stability/impurity assessment)
§ Performs work to support project as assigned with little oversight
§ Presents analytical data to project team for review and discussion
§ Reviews and approves laboratory test data and documentation (e.g. notebooks, raw data and technical documentation, test method, validation protocol, or validation report) for completeness and compliance when necessary
§ Reviews and evaluates drug substance supplier’s technical documents to ensure internal test requirements are adequate
§ Uses laboratory software for analyses
§ Is alert to and detects abnormalities during performances of tests and reviews
§ Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping
§ Cleans lab working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals
§ Troubleshoots instrumentation and performs subsequent analyses
§ Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action related to LTS activities
§ Participates in root cause identification of complex laboratory investigations
§ Writes, edits, and reviews SOPs and laboratory investigations
§ Trains junior Scientists/Chemists on analytical techniques
§ Continuously updates knowledge with respect to the latest technologies related to analytical science
§ Maintains assigned training records current and in-compliance
§ Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and chemical theories, methodologies and procedures
§ Identifies need for SOPs and writes or revises, as appropriate
§ Performs work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting. Works in compliance with cGMP/cGLP regulations
§ Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs
§ Takes active role in auditing laboratory logbooks/documentation to ensure compliance
§ Follows internal processes related to controlled substances
§ Follows EH&S procedures to ensure a safe work environment
§ Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ Bachelor of Science Degree in chemistry, chemical engineering or related field with 6 years’ relevant analytical laboratory experience OR
§ Master’s Degree in above disciplines with 4 years’ relevant analytical lab experience OR
§ PhD in above disciplines with some relevant analytical laboratory experience preferred
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports
§ Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.
§ Thorough knowledge of applicable safety and standards guidelines, such as FDA, ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS
§ Has demonstrated competence in conducting chemical analyses
§ Strong knowledge of wet chemistry techniques
§ Competency in Microsoft Office Suite
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
§ Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information
§ Ability to display and analyze data in a logical manner
§ Strong verbal and written communication skills as well as good computer skills
§ Strong attention to details and accurate record keeping
§ Establish and maintain cooperative working relationships with others
§ Solid organizational skills
§ Ability to coach less senior staff and develop laboratory skills and ability
§ Ability to take initiative, set priorities and follow through on assignments
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
§ Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals
§ Must occasionally lift and/or move up to 15-25 lbs.
§ Ability to wear personal protective equipment, including respirators, gloves, etc.
§ Specific visions abilities are required by this job include close vision and color vision
§ Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.