Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, 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

Title: QC Microbiology Associate III

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

Position reports to Plainville, MA site. Thermo Fisher Scientific’s Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.

Discover Impactful Work:

The key focuses will be to assist in the timely routine testing of in-process and release testing of toxicological, clinical, and commercial grade biopharmaceuticals, qualification/validation of analytical methods for support of vector cGMP compliant Manufacturing and the transfer and validation of assay methods from clients and/or Assay Development & Analytics to the cGMP QC testing. The incumbent will be a lead in the lab helping management to interview and train new employees, schedule testing, troubleshoot assays and equipment, and act as an SME on the path to operational readiness.

A Day in the Life:

The QC Microbiology Associate III will use their depth of experience to drive on time routine testing, submission of suitability reports, contamination control assessments. This role is important to the continuing effort to ensure we align with regulatory standards. As part of this endeavor, the following areas will be the key areas of focus:

Perform routine testing for bioburden, endotoxin, plate enumeration, growth promotion, and suitability testing.

Prepare/author final reports for compendial suitability reports.

Drive the contamination control aspect for change controls, impact assessments, ect.

Authors technical documents (SOPs, Work Instructions, Gap Analyses).

Authors and complete investigations and change controls.

Assist in building a trained competent team of QC analysts to support GMP testing.

Assist with required studies and corrective actions in response to microbial trends.

Works closely with QC Management to develop testing plan for clients.

Leads morning huddles and afternoon schedule review meetings, as needed.

Troubleshoots assay and equipment failures with analysts.

Act as a QC SME during internal/external audits, risk assessments, and investigations.

Interacts with clients for technical transfer and onboarding activities.

Onboard new equipment with a cross functional team (procurement, validation).

Coordinates QC return to service activities for action notices or shutdowns.

Keys to Success: Education

Bachelor’s degree in biological sciences, or related field required.

Master's degree, or higher is highly preferred.

Experience

3-5 years of related experience in a regulated environment, or 2 years with a master or higher degree.

Experience with endotoxin, bioburden, method suitability, and contamination control highly preferred.

Knowledge, Skills, Abilities

Ability to handle timelines and meet internal/external commitments.

Strong social skills and ability to work cross functionally with a diverse group of individuals.

Ability to gown and gain access to cleanroom areas.

Ability to work with strong chemical odors such as Spor-Klenz and bleach.

Position is considered essential personnel and may be required to staff the lab during inclement weather or other internal/external emergency situations.

Ability to work occasional off shift or weekend hours may be required to meet business needs.

Physical Requirements/Work Environment

Position requires frequent standing, bending, stopping, and the ability to lift 40 lbs.

Benefits

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.