GMP Analyst I, II or III

Pharmaron Beijing Co. Ltd.; Winchester; On-site; USD 55,000 - 75,000

Job description

Position: GMP Analyst I, II or III

FLSA Status: Exempt

Salary Range: $55,000 - $75,000 / yr

Location: Exton, PA (ON-SITE)

Job Overview:

The GMP Analyst II/III will be responsible for GMP bioanalytical/analytical LC-MS/MS sample analysis, LC-MS/MS method development and validation, study design and execution, and data analysis using critical thinking. This role may also involve participating in developing GMP studies to optimize product outcomes. The GMP Analyst II/III will excel in quantitative LCMS/MS method development and validation for cell and gene therapy, biologic and biomarker analytes, possess strong troubleshooting and problem-solving skills, and provide mentorship to junior staff. Additionally, they will contribute to designing, developing, and validating study methodologies that bridge the gap between in vitro assays and in vivo outcomes.

Responsibilities:

• Design scientifically sound studies that meet sponsors' or internal needs as per GMP guidelines.
• Perform sample analysis as per approved SOPs in compliance with GMP requirements.
• Develop and validate LC-MS/MS methods as needed.
• Author and execute study protocols, assist in drafting analytical SOPs.
• Take an active role in problem-solving and troubleshooting studies.
• Analyze and report study data. Peer review data.
• Maintain laboratory instruments, equipment, and lab space.
• Collaborate with various teams, including scientists, management, and vendors.
• Manage project timelines and provide updates to the project management, QA teams, and sponsors.
• Author ISUs, development summaries, and study reports.
• Serve as a scientific resource for internal and external clients.
• Perform other assigned tasks as required.

What We're Looking For:

• BS, MS, or PhD in pharmaceutical sciences, life sciences, or a related analytical field.
• Experience in GLP/GMP bioanalysis, including method development and GLP/GMP method validation activities: 3+ years for BS, 2+ years for MS or Ph.D.
• Good record with the completion of paperwork per GDP.
• Experience in LC-MS/MS (Sciex or Waters LC and mass spectrometer experience preferred): 3+ years for BS, 2+ years for MS or Ph.D.
• Strong professional communication skills and attention to detail.
• Strong work ethic, self-motivation, and ability to thrive in a dynamic team environment.
• Ability to multitask and prioritize effectively.
• Proficiency with Microsoft Office products, including Excel, Outlook, PowerPoint, and Word.

Why Pharmaron?

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.

Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package:

• Insurance including Medical, Dental & Vision with significant employer contributions
• Employer-funded Health Reimbursement Account
• Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance
• 401k plan with generous employer match
• Access to an Employee Assistance Program

How to Apply:

Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!

As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.

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