Principal Scientist, Quality Control Lts - Chestnut Ridge, United States - Strides Pharma Inc

Strides Pharma Inc

Verified Company

Chestnut Ridge, United States

2 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

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 Strides business, at a single site

Key Accountabilities _- key outcomes/deliverables, the major responsibilities, and % of time_

Accountability

Responsibilities:

% 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

65%

Lab Equipment

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

20%

Investigations

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

10%

Training

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 incompliance
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
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

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 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

Knowledge