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Work Schedule

Flex 12 hr shift/nights

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, No contact lens allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Summary

Join our elite team as a Lead Formulation Technician at Thermo Fisher Scientific Inc. in the United States. This position is essential in producing drug product injectables in a controlled environment. You will function as the tactical lead technician, ensuring flawless compliance with GMP standards, procedures, and timelines. You will also mentor junior associates, offering feedback on training requirements and process enhancements, and lead activities in collaboration with the Team Leader and supervisor. This is your chance to define a significant impact on global health!

Responsibilities

+ Serve as the subject matter expert on the floor, guiding other technicians and driving daily operations.

+ Monitor operations to ensure safety, quality, and compliance with regulatory requirements.

+ Train and qualify in Aseptic Gowning, material flow, applicable processing equipment, and SAP/BLV.

+ Assist management in determining new methods and procedures.

+ Review, revise, and author manufacturing batch records and SOPs.

+ Lead PPI initiatives and continuous improvements.

+ Supply feedback to the Team Leader and supervisor to boost performance.

+ Ensure schedules are executable from an equipment, raw material, and documentation perspective.

+ Maintain a culture of safety by identifying near misses and resolving safety observations.

Work Hours

+ This position requires working a 12-hour rotating shift in a 24-hour, 7-day per week operation, including evenings and holidays.

Education/Experience/Equivalency

+ High school or STEM/Biotechnology certificate preferred.

+ 5 years of industry experience with 1 year of proven leadership; or a Bachelor’s degree and 2 years of experience with 1 year of demonstrated leadership.

+ An equivalent combination of education and experience may be considered.

Knowledge, Skills and Abilities

+ Full understanding of GMP.

+ Ability to mentor and drive process improvement.

+ Strong communication skills (verbal and written).

+ Autonomous problem-solving and investigative skills.

+ Capability to adhere to instructions, collaborate effectively in a team, and uphold meticulousness.

+ Knowledge of pharmaceutical processes, equipment, instrumentation, and procedures.

Physical Requirements

+ Regularly required to stand, use hands, reach, sit, talk, or hear.

+ Must be able to walk, stoop, kneel, and crouch for around 80% of the work duration.

+ Climb or descend stairs around 20% of the time, lift up to 50 lbs., and sit for a maximum of 4 hours.

+ Specific vision abilities include close vision and the ability to adjust focus.

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.