Lead Scientist, Analytical QC
About The Position
The QC Analytical Lead Scientist is a key position within the QC team supporting method transfer activities, and performing process improvement initiatives to support the laboratory testing as per USP and ICH guidelines. Method development, verification and validations will be required. This role will report to the Principal Scientist, Analytical QC while working in a collaborative team setting. This role is responsible for supporting and assisting with the delivery of project timelines and critical milestones. This role will be an inward and outward facing role working with contract testing labs as required. This role will also work in a manner that assures quality, safety, efficacy, and compliance to regulatory requirements.
Requirements
- Bachelor's Degree in a Scientific field from an accredited university required.
- Minimum ten (10) years of experience in the pharmaceutical industry required.
- Experience with method validation/verification/transfers required.
- Experience in performing instrument and software qualifications is preferred.
- Experience with USP, CFR, ICH, and ISO regulations and guidelines as well as Quality by Design (QbD) principles is preferred.
- Experience in relevant laboratory, computer, and data analysis skills required.
- Strong organizational abilities and problem-solving skills.
Nice To Haves
- NMR experience is preferred but not required.
Responsibilities
- Work with Contract Testing Laboratories (CTL) and ensure testing is completed in a timely manner. Participate in resolving technical issues, OOS results and the review/approve testing CoAs.
- Support stability storage and testing in house or at CTL.
- Support the start-up of the QC Laboratory and transition to routine analytical testing, as required.
- Support current and new product technology transfer to the manufacturing site by performing method verifications, validations, and transfers for the QC Laboratory and any additional studies related to Manufacturing.
- Assist in significant OOS investigations, deviations and ensure implementation of appropriate corrective actions.
- Perform and review instrument qualifications, equipment repairs, preventative maintenance calibrations.
- Author, revise, and implement documentation such as standard operation procedures for the QC Laboratory.
- Support the evaluation of test methods and the adaptation of processes and techniques for commercial purposes.
- Independently write and implement study protocols and reports.
- Keep accurate documentation as per current Good Manufacturing Practices (cGMP).
- Experience performing QC analyses with different instruments (wet chemistry, HPLC, GC, KF, FTIR, UV-VIS) is required.
- Perform analyses and peer reviews.
- Any other duties as determined by management to support the QC team.
Benefits
- 3 weeks' vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st
- 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay
- U.S. Employee Stock Purchase Plan- 15% Discount
- Comprehensive Medical, Dental, Vision, Life and Disability coverage
- Health, Dependent Care and Limited Purpose Flex Spending and HSA options
- Adoption assistance
- Tuition reimbursement
- Concierge/personal assistance services
- Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage
- Gym, fitness facility and cell phone discounts
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Chemical Manufacturing
Number of Employees
1,001-5,000 employees
