Engineer/Scientist I, QC [Remote]

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

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.

Location/Division Specific Information:

First Shift: Monday - Friday 8am - 430pm (may require start and end time flexibility based on training and production needs)

The Thermo Fisher Scientific BioProduction division, located at 3175 Staley Road Grand Island NY 14072, supports developers and manufacturers of biological-based therapeutics and vaccines with a portfolio of premium cell culture media and buffers as well as on site custom services dedicated to upstream cell culture, downstream purification, analytics for detection and quantitation of process/product impurities, and a catalog of single-use solutions spanning the biologics workflow.

How will you make an impact?

We need a self starting individual with excellent communication and laboratory skills to complete planned and detailed activities within a quality system to ensure product, process, system, or equipment quality requirements are met.

A Day in the Life:

The Scientist I QC is responsible to perform a large variety of routine and complex Quantitative and Qualitative procedures in the analysis of raw materials for cell culture media by various testing techniques including but not limited to FTIR, UV-Vis, purity and water determination by auto titrator, Polarimetry, GC and HPLC. Follow and adhere to GLPs, cGMPs, SOPs and all safety regulations as they apply to the laboratory and work areas. Subject matter expert for testing methodologies, providing technical expertise for raw material release decisions, and serving as a key point of contact for internal site teams and off-site testing partners.

Key Responsibilities:

• Execute lot management activities, including logging, review, and documentation in LIMS and other systems.
• Provide technical expertise and support for raw material testing, evaluation, and release decisions.
• Perform and/or delegate wet chemical analyses using internal methods and compendial methodologies (USP, EP, ACS, etc.).
• Operate and oversee use of laboratory instrumentation, including FTIR, UV-Vis spectrophotometer, polarimeter, pH meter, autotitrator, HPLC, GC, filtration equipment, and endotoxin detection systems.
• Support internal method and instrument validations.
• Utilize computer-based tools such as Sample Manager (LIMS), Smartsheet, and Microsoft Office (Outlook, Excel, Word).
• Support training and development of QC technicians.
• Drive investigations related to testing issues and deviations.
• Support updates and continuous improvement of testing procedures and laboratory processes.
• Provide guidance to supervision on factors that may impact data quality.
• Recommend corrective and preventive actions (CAPA) as needed.
• Foster a positive laboratory culture by supporting team engagement, motivation, and morale.
• Demonstrate sound judgment, tact, and diplomacy when interacting with internal and external customers, including document requests and audits.
• Perform additional laboratory functions as assigned.

Education

Required: BS degree in Chemistry, Biology, or other Sciences

Preferred: BS Degree or higher in Chemistry

Experience

Required: 1-2 years of experience in a Chemistry lab/cGMP environment/QC or QA related field.

Preferred: 5 years of experience in a Chemistry lab/cGMP environment/QC or QA related field.

Knowledge, Skills, Abilities

Required:

• Functional knowledge of laboratory equipment and techniques such as wet chemistry techniques, autotitrators, polarimetry, Refractive index, UV-Vis, FTIR, Moisture determination,  TLC, GC and HPLC.
• Strong organizational skills and the ability to work independently.
• Ability to work in a high-paced team environment, prioritize work accordingly.
• General digital literacy, specifically in Microsoft office programs.

Preferred:

• Experience with method verifications and validations in a cGMP QC environment.

Physical Requirements / Work Environment:

• Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
• Able to lift 40 lbs. without assistance
• Adherence to all Good Manufacturing Practices (GMP) Safety Standards
• Occasionally required to enter Cold Room/Freezers -22degreesF/-6degrees C
• Required to enter warehouse area to perform inspections
• Will work with hazardous/toxic materials

What We Offer:

• Compensation
• Competitive Pay
• Performance Related Bonus where eligible
• Annual merit performance-based increase
• Excellent Benefits
• Medical benefits
• Paid Time Off/Annual Leave
• Employee Referral Bonus
• Career Advancement Opportunities

Compensation and Benefits

The salary range estimated for this position based in New York is $48,400.00–$72,550.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: