This role will be based on site in Collegeville, PA. Activities will include:

Job Purpose

• Provide scientific support for project teams.

• Coordinate purchase orders for outsourced testing.

• Provide backup support for stability operations.

• Perform data entry and review using LIMS system.

• Ensure data meets compendial and GSK quality Standards.

Key Responsibilities:

• Co-ordinate microbiological testing of samples for clinical manufacture.

• Provide backup support for stability operations.

• Enter microbiological test results from in house or contract microbiological testing labs.

• Review microbiological results for completeness, accuracy, and quality, in addition to assessing trends to draw conclusions.

• Work with UP microbiology team to define microbiological control strategies for drug products (both API and Formulations).

• Transcription checking or review of microbiology data and submissions.

• Maintain partnerships with clinical manufacturing and product development teams to provide timely and high-quality data and service.

• Support project teams through clinical progression helping to deliver validated microbiological testing procedures.

• Maintain training records and familiarity with current SOPs and controlled documents.

• Proactively seek assistance from other scientists to solve problems.

• Work to GMP standards as appropriate.

• Follow safe Laboratory Practices, regular safety training, and maintain accurate and complete safety records consistent with company policy and legal requirements.

Education and Experience

• Bachelors and 2+ years Previous research experience in or directly related to the biopharmaceutical industry or Masters and 1+ year of experience

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills & Abilities

• Bachelor's degree in a scientific or technical discipline.

• General compendial knowledge of USP Microbiology.

• Experience with GMP laboratory operations and FDA regulations.

• Excellent verbal and written communication skills

• Ability to prioritize and organize tasks.

• A high level of learning agility.

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully while prioritizing and handling multiple projects or activities.

We offer competitive remuneration, annual incentive plan bonus, 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!

Our 4i Values:

Integrity - Innovation - Intensity - Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, submit your application - we'd love to hear from you!