Work Schedule

Other

Environmental Conditions

Laboratory Setting, 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

Pilot plant job posting 

Job Description  

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, or improving patient diagnostics and therapies, we are here to support them.  

  

When you join the team at Thermo Fisher Scientific, you’ll do important work. Things like helping customers in finding cures for cancer and genetic disorders, protecting the environment, or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals. You’ll also have the opportunity for continual growth and learning in an environment that will support your development.   

  

We are seeking an energetic and enthusiastic individual with strong communication, leadership, technical and operational skills to join our growing Process Development team.   

This position is focused on service delivery excellence for Unity Lab Services (ULS). The team lead will perform process manufacturing duties under the direct supervision of research staff and ULS management in a team environment. The candidate will routinely perform moderate to complex processes according to Standard Operating Procedures, operating guidelines, instructions, and departmental policies. Generally, this will include all aspects associated with small molecule drug substance research and manufacturing. 

Responsibilities: 

· Assistance with production runs on a multi-kilo scale 

· Operation and process monitoring of reaction equipment 

· Equipment and parts assembly, disassembly, and cleaning 

· Execution of equipment commissioning and qualification 

· Equipment maintenance and mechanical support for research equipment, including assisting with design and equipment modifications, development and execution of preventative maintenance schedules, review and upkeep of safe operating guidelines 

· Maintain good house keeping 

· Work in a team environment with scientific staff 

· Partner with Research staff and Environmental Health and Safety to ensure safe operations at all times. 

· Adhere to all customer cGMP SOP’s 

· Responsible for maintaining cGMP logs daily 

· Maintain compliance with cGMP training 

· Archiving GMP documents 

Raw material inventory and consumables stocking and control using SAP inventory systems 

Position work hours. 

Work hours are Monday-Friday 8-430pm. Weekend and holiday work is required on an as needed basis.  

How will you get there?  

Bachelor’s Degree in biology, chemistry, biochemistry, (bio)chemical engineering, biomedical engineering, or a related field.   

1+ years’ experience in a process development / manufacturing environment preferred.  

Industry experience in aseptic technique, cell culture, single-use bioreactors (SUBs), wave reactors preferred.  

Demonstrated knowledge of cGMPs/GLP or regulatory affairs pertaining to the pharmaceutical and biological industries is preferred.  

Knowledge of gene therapy product and/or process development preferred.  

Excellent problem solving and critical thinking skills, including strong attention to detail.  

Advise supervisor of factors that may affect quality, accuracy, timeliness, and usefulness of data.  

Excellent organization, planning, and time management skills.  

Self-motivated, willing to learn, independent and a proactive driving force of efficient execution.  

Strong interpersonal and communications skills (written and oral).  

Able to work effectively with a wide range of constituencies in a diverse environment.  

Good comprehension of Microsoft Office Suite software.  

A flexible work schedule may be required including weekends and evenings as needed to complete client work.  

While performing the duties of this job, the employee:  

Will be expected to function in a dynamic environment and balance multiple priorities simultaneously.  

Will be expected to learn new software and tools quickly.  

Will use highly specialized equipment and instrumentation in daily manufacturing.  

Will proactively identify areas for opportunity and drive efficiency results.  

Will critically review processes and provide input to supervisor/manager.  

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner, and safer.  

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability , or any other legally protected status.