Senior Chemist: Analytical Method Leader

New York Technology Partners

City of Rochester (NY)

On-site

USD 90,000 - 140,000

Full time

7 days ago

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Job summary

New York Technology Partners in Rochester seeks an experienced scientist to lead Analytical Method Development & Validation for regulated pharmaceutical projects. You will design, develop, validate, and transfer methods with limited supervision, acting as SME on product transfers.

You will write protocols, reports, and data packages, review peer data for accuracy and compliance, and mentor lab staff in best practices.

Qualifications

Bachelor's, Master's, or Ph.D. in Chemistry or related field.
Strong experience in analytical method development and validation in regulated environments.
Experience supporting GMP laboratory operations and quality systems.
Ability to lead complex technical projects independently.
Strong technical writing for protocols, investigations, and reports.
Experience interacting with regulatory agencies and audits is desirable.
Excellent communication, collaboration, and leadership skills.

Responsibilities

Design, develop, validate, and transfer analytical methods with minimal supervision.
Serve as SME on new product development and product transfer projects.
Write and execute protocols, reports, and analytical data packages.
Review analytical data for accuracy, compliance, and data integrity.
Lead investigations related to laboratory incidents and CAPAs.
Provide analytical expertise to support manufacturing and quality initiatives.
Mentor and train laboratory personnel on methods and best practices.
Evaluate regulatory updates and support audits/inspections.