Scientist

Thermo Fisher Scientific•King of Prussia, PA

18h•Onsite

About The Position

The Scientist supports sterile drug product manufacturing activities and related clinical deliverables at a customer site. The role is fully onsite, initially in Upper Merion, Pennsylvania, and is expected to move to an onsite role in Marietta, Pennsylvania. The standard schedule is Monday through Friday, 7:00 a.m. to 3:00 p.m., with flexibility to work earlier mornings or evenings as needed to support manufacturing schedules. The Scientist performs drug product manufacturing operations in a GMP environment, prepares and updates batch records and related documentation, supports safety and compliance, communicates work status to client stakeholders, and contributes to continuous improvement and administrative activities within Sterile Operations. Prior aseptic manufacturing experience is described as a plus, but is not required. The position requires legal authorization to work in the United States without sponsorship and passing a comprehensive background check, including drug screening. Applicants may be located anywhere in the United States, but relocation assistance is not provided and relocation costs are the candidate’s responsibility.

Requirements

Bachelor’s degree in laboratory sciences, such as Chemistry, Biochemistry, Biology, Engineering, or a similar field, plus experience comparable to 2–4 years; or a master’s degree plus experience comparable to 1 or more years.
An equivalent combination of appropriate education, training, and/or directly related experience may be considered.
Previous work experience in a GMP environment.
Experience with steriles, parenteral products, or similar.
Good documentation practices (GDP).
Legal authorization to work in the United States without sponsorship.
Ability to pass a comprehensive background check, including drug screening.
Ability to communicate, receive, and understand information and ideas with diverse groups of people.
Ability to work upright and stationary and/or standing for typical working hours.
Ability to lift and move objects up to 25 pounds.
Ability to work in non-traditional work environments and classified space with specified gowning.
Ability to use and learn standard office equipment and technology proficiently.
Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Nice To Haves

Prior experience in aseptic manufacturing.
Investigation and change-management experience.
Antibody drug conjugate (ADC) experience.

Responsibilities

Perform drug product manufacturing operations in a GMP environment according to client procedures and training.
Draft and update batch records and associated documentation in compliance with cGMP regulations, SOPs, and client documentation standards.
Apply GMP principles and appropriate documentation practices.
Support work-area safety and compliance with client safety codes and regulations.
Communicate the status of assigned work and compliance systems to client stakeholders as appropriate.
Contribute to continuous improvement initiatives, administrative tasks, and optimization of manufacturing and documentation practices in Sterile Operations, including procedure updates and records filing and archiving.