Principal Scientist, Lab Technical Services

Quality & Compliance Rochester, Michigan


Description

The Principal 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 and takes lead role in conducting all types of physical and chemical analyses (including the most complex analyses) using all equipment.  This position will have a significant role representing Quality Control in cross-functional teams supporting pending ANDA submissions, product launches, complex product investigations, product development, and method lifecycle activities to achieve company goals and initiatives, and is considered an SME for these areas.  The Principal Scientist is responsible for planning, designing, and execution of LTS activities, and also leading technical project teams of Scientists and 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

Accountability

Responsibilities

% of Time

Analysis & Testing

§  Leads the development and validation of analytical methods and the evaluation of compendial changes/updates

§  Acts as a liaison between the Analytical R&D and Quality Control groups  for transfer of knowledge and technology and supports LTS projects as part of a global team

§  Develops and validates experiments designed to provide support for process and formulation activities (e.g. excipient compatibility, solubility, dissolution studies, stability/impurity assessment)

§  Prepares method validation protocols, reports, analytical test methods, and analytical sections for regulatory submissions if required

§  Evaluates, troubleshoots/improves existing analytical methods when necessary

§  Independently performs scheduling and coordination of activities of assigned projects

§  Oversees project status to ensure that project timelines are met and the team works in compliance with cGMP, GLPs and all other applicable requirements.  Presents analytical data to project team for review and discussion

§  Writes and reviews SOPs, test methods, validation protocols and validation reports, and other technical documents as applicable

§  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, in support of regulatory filings and commercial product maintenance

§  Reviews and evaluates drug substance supplier’s technical documents and provides recommendations of API vendor selection

§  Is alert to and detects abnormalities during performances of tests and reviews

§  Identifies and implements opportunities for continuous improvement within Quality Control department

65%

Lab Equipment

§  Evaluates new technologies to improve efficiencies and to reduce cost of testing

§  Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping

§  Troubleshoots instrumentation and performs subsequent analyses

20%

Investigations

§  Investigates any out of specification or atypical results and prepares investigational reports

§  Leads root cause identification of complex laboratory investigations, including identification and qualification of unknowns

§  Evaluates questionable sample results, OOS, and aberrant results and recommends a course of action

§  Writes, edits, and reviews SOPs and laboratory investigations

10%

Training

§  Coaches and provides technical guidance to more junior Scientists in method development and validation as well as troubleshooting of methods and 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

5%

Compliance

§  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

§  Apprises management of the status of investigations and works with the Compliance group on determination of regulatory actions to be taken

§  Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs

§  Follows internal processes related to controlled substances

§  Supports regulatory inspections as scientific SME

continuous

Safety

§  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

continuous

Total

100%

 

 


Qualifications

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 10 years’ relevant pharmaceutical laboratory experience OR

§  Master’s Degree in above disciplines with 8 years’ relevant analytical lab experience OR

§  PhD in above disciplines with 4 years’ relevant pharmaceutical lab experience


Knowledge

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

Skills

&

Abilities

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, 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 Requirements

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.