Sr. Scientist, QC

Pharmaron Beijing Co. Ltd.; Coventry (RI); On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

Medical Insurance

401(k) Retirement Plan

Paid Time Off

Job summary

Pharmaron Beijing Co. Ltd. is seeking a Senior Scientist, QC, to support technology transfer and GMP manufacturing through analytical method transfer, verification, validation and sample testing in compliance with regulatory guidelines.

The role includes supervising QC staff, coordinating testing, reviewing data, and participating in investigations and audits to ensure high-quality QC output in a fast-paced, matrix environment.

Qualifications

• MS with 8+ years of pharmaceutical QC experience
• BS with 10 years of pharmaceutical QC experience
• Experience applying analytical skills to method transfer/validation
• Strong troubleshooting and problem-solving abilities
• Supervisory experience of QC staff and cross-functional teams
• Knowledge of cGLP/cGMP and FDA/EMA/ICH guidance

Responsibilities

• Participate in method transfer activities, write protocols and reports
• Supervise QC scientists and provide guidance
• Review data, notebooks, methods, protocols and reports
• Investigate deviations and write investigation reports
• Coordinate QC testing and data reviews
• Present data summaries to cross-functional teams
• Maintain GMP compliance and proper documentation
• Support site audits and instrument training

Skills

Analytical skills

Troubleshooting

Staff supervision

cGMP knowledge

Cross-functional collaboration

Education

MS with 8+ years

BS with 10 years

Tools

HPLC

GC

FTIR

Mass Spectrometry

Job description

Position: Senior Scientist, QC

Salary Range: $100,000 - $140,000/yr.

Location: Coventry, RI

About Pharmaron

Pharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 28 locations in the US, UK, China, and Singapore, we support drug discovery through to manufacturing with fully integrated high-quality services.

Pharmaron is proud of the impact we make and just last year, we supported 887 discovery projects, 1,100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,300 global customers. To learn more, visit www.pharmaron.com.

Job Overview

The Senior Scientist - QC will support technology transfer and GMP manufacturing activities through analytical method transfer, verification, validation and sample testing in compliance with all applicable guidelines. Will also solve moderate complexity analytical and quality control issues for assigned projects and/or initiatives

Key Responsibilities

• Participate in method transfer activities, including writing protocols, executing experiments and writing reports.


• Supervise QC scientist daily work, provide technical and compliance related guidance.


• Review experimental data, notebooks, method, protocols / reports.


• Actively participate in investigations, problem solving, and troubleshooting. Write investigation reports.


• Coordinating QC testing, notebook and data review.


• Prepare and present data summaries (written and oral) as necessary. Present to cross functional teams and effectively communicate critical QC/analytical issues and solutions.


• Ability to work successfully in both a team/matrix environment as well as independently.


• Ensure high-quality QC work and accurately document all necessary and relevant information in a clear concise manner as per cGMPs.


• Participate, support and facilitate site audits as directed and required.


• SME for instrument training.


• Maintain good laboratory practices and GMP in compliance with safety and environmental requirements.


• Write, revise, develop, and evaluate SOPs.


• Perform other related assignments and duties, as required and assigned.

What We're Looking For

• MS with 8+ years of experience or BS with 10 years of experience in pharmaceutical industry.


• Evidence of experience in successful application of analytical skill sets to resolve scientific problems related to method optimization and/or implementation


• Experienced troubleshooter of technical problems


• 6 years of experience with core analytical instrumentation such as HPLC, GC, FTIR, Mass Spectrometry.


• Evidence of ability to effectively contribute to multi-disciplinary scientific teams


• Working knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidance


• Evidence of ability to effectively scientifically supervise staff


• Expert application of core laboratory techniques and instrumentation to impact API, intermediates and starting materials

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 25,000 employees and operations in the US, UK, China, and Singapore. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Collaborative Culture:

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:

• Comprehensive Medical, Dental & Vision Insurance with significant employer contributions


• 401(k) Retirement Plan with generous employer matching


• Generous Paid Time Off (PTO), Paid Sick Leave & Company Holidays to support work-life balance


• Employer-funded Health Savings Account (HSA) contributions (for eligible plans), plus Healthcare & Dependent Care Flexible Spending Accounts


• 100% Employer-paid Employee Life Insurance, AD&D, Short- and Long-Term Disability Insurance


• Employee Assistance Program (EAP), mental health resources, and wellness programs


• Family-friendly benefits, including fertility support and maternity resources


• Professional development and career growth opportunities within a leading global CRO/CDMO

As an Equal Employment Opportunity and Affifnc 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.