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Upper Merion Township, Pennsylvania, United States
Onsite
Not Available
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Laboratory SettingJob Description
Job Title: Scientist
This is a fully onsite role based at our customer’s site in Upper Merion, PA.
Please note: This role will eventually move to an onsite role in Marietta, PA.
Hours: 7:00am to 3:00pm, with flexibility to work earlier mornings or evenings as needed to support the manufacturing schedule.
We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.
Our Laboratories Functional Service Partnership (FSP) team plays a direct role in advancing drug development by creating sustained groups of talent within our customers’ organizations to provide long-term support. Through this collaborative approach, our professionals bring their commitment to excellence, industry knowledge, and operational strength directly into customer environments, helping to enhance capabilities and advance the delivery of life-changing therapies.
Job Summary:
The Scientist will perform the services to support sterile drug product manufacturing related activities as needed and directed to support sterile drug product manufacturing clinical deliverables.
Key responsibilities:
Please note: This role will eventually move from an onsite role in Upper Merion, PA to an onsite role in Marietta, PA.
Hours: 7:00am to 3:00pm, with flexibility to work earlier mornings or evenings as needed to support the manufacturing schedule.
· Perform drug product manufacturing operations in a GMP environment in accordance with client procedures and training; prior experience in aseptic manufacturing is considered a plus but is not a requirement for the role.
· Draft and update batch records and associated documentation in compliance with cGMP regulations, Standard Operating Procedures (SOPs), and CLIENT standards of documentation.
· Apply awareness of GMP principles and documentation practices; prior investigation and change management experience is considered a plus but is not a requirement for the role.
· Support and contribute to 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 current manufacturing and documentation practices within Sterile Operations (e.g., procedure updates, records filing and archiving).
EDUCATION AND EXPERIENCE
Education & Experience
Scientist: Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Biology, Engineering or similar and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-4 years) OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1+ years)
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, and Abilities
Previous work experience in a GMP environment
Experience with steriles, parenteral products or similar
Anti-body drug conjugate (ADC) experience
Experience within an aseptic manufacturing environment
Good documentation practices (GDP)
Working Environment:
Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
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, ability to work in classified space with specified gowning.
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 under pressure while prioritizing and handling multiple projects or activities.
Benefits
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!
