QC Scientist II

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.)

Job Description

How will you make an impact?
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.

We have 2 positions available.

A Day in the Life:

• Perform testing on In-Process, DS release, DP release, DS stability, DP Stability, and various other non-routine samples, ensuring timely delivery for projects
• Participate in analytical method validation/transfer, method establishment/qualification routine and stability analysis.
• Conduct GMP testing in an analytical laboratory environment using Separation Techniques, BioAssay Analysis and Compendia test methods (i.e. Reverse Phase, SEC, Titer concentration, iCE, pH, Osmolarity, Residual DNA, Appearance)
• Compiles data for documentation of test procedures, prepares reports. Ensures all testing processes, monitoring, and departmental documentation meet SOPs and cGMP regulatory standards.
• Participate in the development of new concepts, techniques, and standards. Involved with assisting in the preparation of CoAs. 
• Recognize and report out-of-specification/ out-of-trend results to laboratory management; recommend solutions.
• Perform all duties in compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines
• Partake in laboratory activities, including safety inspections and client audits in a timely matter. 

Keys to Success:
• Advanced degree with no prior experience, or Bachelor's degree with 2 years of experience in a GMP regulated laboratory environment performing analytical testing
• Preferred Fields of Study: Chemistry, Biology, Biochemistry, or related scientific field
• Expertise in analytical techniques such as HPLC, GC, CE, ELISA, PCR, and other bioanalytical methods
• Proficient in aseptic techniques and environmental monitoring procedures
• Strong knowledge of cGMP regulations and quality control requirements
• Experience with laboratory information management systems (LIMS) and quality management systems
• Excellent documentation practices and attention to detail
• Strong problem-solving and analytical skills
• Ability to work both independently and collaboratively
• Proficiency with Microsoft Office applications
• Strong written and verbal communication skills
• Ability to lift up to 30 pounds and stand for extended periods
• Willingness to wear required PPE including lab coat, safety glasses, and gloves
• May require flexible scheduling including occasional weekend work
• Experience with method validation and transfer activities preferred
• Knowledge of data integrity requirements and good documentation practices
• Demonstrated ability to investigate out-of-specification results and author technical reports

Excellent Benefits

• Benefits & Total Rewards | Thermo Fisher Scientific
• Medical, Dental, & Vision benefits-effective Day 1
• Paid Time Off & Designated Paid Holidays
• Retirement Savings Plan
• Tuition Reimbursement

OTHER

• Relocation assistance is NOT provided
• Must be legally authorized to work in the United States now or in the future, without sponsorship.
• Must be able to pass a comprehensive background check, which includes a drug screening