Analytical Chemist

Jubilant Pharma, LLC; Pennsylvania; On-site; USD 75,000 - 110,000; Full time

Job summary

Jubilant Radiopharma is seeking an experienced Analytical Chemist for a 12-month temporary role in our Quality Control laboratory. The role focuses on analytical method transfer, qualification, validation, and continuous improvement to meet GMP and regulatory standards.

The ideal candidate holds a Chemistry/Biochemistry degree, 7+ years in pharma analytics, and hands-on experience with HPLC, GC, LCMS, and related instrumentation, along with strong technical writing and data governance skills.

Qualifications

• Bachelor’s degree in Chemistry or Biochemistry is required.
• GMP, pharmacopoeias (USP, Ph. Eur., BP) knowledge is essential.
• Experience in analytical method qualification (transfer, verification, validation) is required.

Responsibilities

• Execute analytical method transfers in the QC lab.
• Qualify compendial methods, processes, and equipment.
• Analyze samples from validations, batches, and transfers.
• Review and optimize analytical methods and SOPs.
• Develop and maintain laboratory procedures and instructions.
• Train team members on new methods, equipment, and software.
• Prepare analytical validation protocols and reports.
• Ensure calibration and qualification documentation integrity.

Skills

Regulatory compliance

Data integrity & governance

Technical writing

Cross-functional collaboration

Education

Bachelor’s degree in Chemistry or Biochemistry

Member of Ordre des chimistes du Québec

Tools

HPLC

GC

LCMS

Spectrophotometry

Infrared spectroscopy

Titration

Wet chemistry

AAS

TrackWise

SAP

Job description

At Jubilant Radiopharma, we help advance healthcare through the manufacturing and distribution of high-quality radiopharmaceutical products. Our work is guided by collaboration, innovation, quality, and safety. We are committed to creating an environment where people can grow their expertise and make a meaningful impact.

12-Month Temporary Position

Role Overview

We are seeking an experienced Analytical Chemist to join our Quality Control laboratory team. In this role, you will play a key part in analytical method transfer, qualification, validation, optimization, regulatory compliance, equipment lifecycle management, and continuous improvement initiatives within the laboratory.

Key Responsibilities

• Execute analytical method transfers within the QC laboratory.
• Perform activities related to the qualification of compendial methods, manufacturing processes, and periodic qualification of equipment, instruments, and software applications.
• Analyze samples from process validations, engineering batches, submission batches, manufacturing batches, and analytical transfers.
• Review, evaluate, and optimize analytical methods and associated work instructions.
• Develop and maintain laboratory procedures and operating instructions.
• Provide technical support during the implementation of new methods, technologies, and instruments.
• Train team members on new analytical techniques, equipment, and software applications.
• Participate in the development and execution of analytical validation protocols.
• Conduct quality review of calibration and qualification documentation.
• Support capital investment projects involving laboratory equipment and technologies.
• Participate in the selection, procurement, and implementation of new laboratory systems and equipment.
• Author investigations, deviations, CAPAs, and change controls within TrackWise.
• Monitor updates to applicable pharmacopoeias (USP and Ph. Eur.) and revise specifications as needed.
• Troubleshoot analytical methods and laboratory equipment.
• Coordinate with external vendors for calibration, maintenance, and repair activities.
• Serve as a technical subject matter expert during regulatory inspections and audits.
• Ensure the integrity, traceability, and quality of analytical documentation and laboratory data.
• Perform all work in compliance with GMP, GLP, and HSE requirements.
• Carry out other related duties supporting laboratory operations.

Qualifications

• Bachelor’s degree in Chemistry or Biochemistry.
• Must be a member of the Ordre des chimistes du Québec.
• Minimum seven (7) years of analytical chemistry experience in a pharmaceutical laboratory environment.
• In-depth knowledge of Good Manufacturing Practices (GMPs) and pharmacopoeias (USP, Ph. Eur., and BP), including their application within laboratory operations.
• Excellent knowledge of regulatory and compendial requirements related to analytical method qualification (transfer, verification, and validation) and equipment qualification.
• Strong knowledge of electronic data management regulations (21 CFR Part 11, PIC/S, GUI-0050), including data integrity, data security, and data governance.
• Advanced theoretical and hands- on knowledge of analytical techniques and laboratory instrumentation, including HPLC, GC, AA, spectrophotometry, infrared spectroscopy, manual and potentiometric titration, particle analysis, LCMS, and wet chemistry methods.
• Strong computer skills, including Microsoft Office, SAP, and electronic data acquisition systems.
• Excellent technical writing skills for protocols and reports.
• Bilingual proficiency in English and French, both written and spoken since the role requires drafting technical protocols and reports in English, as well as documenting quality records in TrackWise in English (investigations, deviations, CAPAs, and change controls).