Work Schedule
Standard (Mon-Fri)Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.)Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Join Thermo Fisher Scientific’s Pharma Services Group, where quality and compliance are at the core of everything we do. This role supports GMP manufacturing and quality control laboratories responsible for testing biopharmaceutical products across early-stage clinical development through commercial release.
You will work on-site in a regulated laboratory environment, collaborating with cross-functional teams to ensure the highest standards of product quality, safety, and complian
DESCRIPTION:
You'll perform sophisticated analyses to ensure product quality and safety in our laboratories. As a QC Scientist II, you'll conduct complex analytical testing to support GMP manufacturing of biopharmaceutical products, from early-stage clinical development through commercial release. You'll work with analytical instruments and technologies while making a meaningful impact on patient health through precise quality control testing.
Working with cross-functional teams, you'll execute validated test methods, participate in method development and validation activities, investigate out-of-specification results, and maintain detailed documentation of analyses. You'll contribute to continuous improvement initiatives and help establish robust analytical processes while adhering to cGMP requirements and safety standards.
You will:
Perform complex analytical testing in support of GMP manufacturing, including in-process, release, and stability testing
Execute validated test methods and support method development, validation, and transfer activities
Operate and troubleshoot analytical instrumentation such as HPLC, GC, CE, ELISA, PCR, and other bioanalytical platforms
Investigate out-of-specification (OOS), out-of-trend (OOT), and atypical results, including root cause analysis and technical report authorship
Maintain accurate, thorough, and compliant documentation in accordance with cGMP and data integrity requirements
Utilize Laboratory Information Management Systems (LIMS) and quality management systems to document and review data
Support health authority and internal audits, inspections, and regulatory commitments
Collaborate with manufacturing, quality assurance, and development teams to resolve issues and improve analytical processes
Participate in continuous improvement initiatives to enhance laboratory efficiency, compliance, and robustness
Follow all safety, aseptic technique, and environmental monitoring requirements
Advanced degree (MS or PhD) in Chemistry, Biology, Biochemistry, or a related scientific field with no prior experience, or
Bachelor’s degree in a scientific discipline with 2+ years of experience in a GMP-regulated laboratory environment performing analytical testing
Hands-on experience with analytical techniques such as HPLC, GC, CE, ELISA, PCR, and other bioanalytical methods
Experience working in a cGMP-regulated environment
Demonstrated experience investigating OOS results and authoring technical documentation
Experience with method validation and method transfer activities preferred
Familiarity with health authority audits and regulatory inspections
Strong understanding of cGMP regulations, quality control principles, and data integrity requirements
Knowledge of aseptic techniques and environmental monitoring procedures
Proficiency with Microsoft Office applications
Experience with LIMS and electronic quality management systems
Strong problem-solving, analytical, and organizational skills
Excellent written and verbal communication skills
Ability to work independently and collaboratively in a fast-paced laboratory environment
Ability to manage multiple priorities while maintaining attention to detail
Willingness to work flexible schedules, including occasional weekend work
Ability to lift up to 30 pounds
Ability to stand for extended periods
Willingness to wear required PPE, including lab coat, safety glasses, and gloves
Work performed in a laboratory environment with exposure to chemicals and biological materials
We offer competitive remuneration, an annual incentive plan, and a comprehensive benefits package starting Day 1, including:
Medical, Dental, and Vision coverage
Paid Time Off and designated paid holidays
Retirement Savings Plan
Tuition Reimbursement
Career development and growth opportunities
Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization and an inclusive culture that values Integrity, Intensity, Involvement, and Innovation.
Relocation assistance is NOT provided
Must be legally authorized to work in the United States without sponsorship, now or in the future.
Must be able to pass a comprehensive background check, which includes a drug screening.