Senior USP Labs Scientist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, 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

Thermo Fisher Scientific Inc. is a global leader in serving science with annual sales of more than $40 billion. Our mission is to help our customers make the world healthier, cleaner and safer. We support our customers advance life science research, solve complex analytical challenges, increase efficiency in their laboratories, improve patient health through diagnostics, or develop and manufacture life-enhancing therapies.

We are more than 100,000 colleagues to offer an unmatched combination of innovative technologies, convenient purchasing processes and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

The brand new multi-purpose manufacturing and development site in Lengnau is designed for large scale biologics manufacturing and has a vast expansion potential. Our Lengnau site offers highly flexible biomanufacturing technologies from process development to large-scale production to successfully meet the needs of our customers.

How will you make an impact?
In this position, you will lead projects related to upstream process development for our clients. You will provide complex analysis as a USP subject matter expert with independent judgment. Your role involves developing scalable processes with a focus on process improvement, facility fit to manufacturing, improved product yield, and reduced costs in a biologics environment.

You will be a key player in our day-to-day lab activities, with responsibility for specific equipment, lab areas, lab consumables, and chemicals. Additionally, you will participate in the strategic development of our process technology platform and collaborate with other areas of internal development and/or manufacturing operations. Your responsibilities include making detailed observations, analyzing, and resolving issues, documenting, and communicating test results.

What will you do?
• Lead and execute upstream process development studies to support the production of recombinant proteins (including mAbs). Perform media optimization, seed train development, bioreactor process development, and cell culture clarification.
• Represent USP Labs in cross-functional teams. Plan project scope, timing and resource requirements to meet the defined deliverables.
• Supports technology transfer as sending and/or receiving unit. Works with Process Development and Manufacturing groups to trouble-shoot process challenges.
• Author, review and approve reports, study plans, protocols, SOPs, and work instructions. Document execution and results according to good documentation practices.
• Act as equipment responsible, ensuring maintenance and the preparation of standard operating procedures for equipment and/or methods. Take ownership for housekeeping, coordination and safety for specific lab areas.
• Willingness to work weekends on a rotational basis. Infrequently, international travel (≤10%) and participation at international calls throughout various time zones may be requested.

How you will get here?

Education
• Degree (M.Sc. or PhD.) in Life Sciences (Biology, Chemistry, etc.), Dipl. Ing. or equivalent.
• 5+ years of industry experience related to Biologics manufacturing, upstream process development and process engineering for candidates with a Master’s degree. Prior exposure to GxP is an advantage.

Experience
• Upstream bioprocessing experience with mammalian cell cultures.
• Demonstrated experience working with bioreactors (bench scale, pilot scale, AMBR250). Experience with perfusion processes and Design of Experiments is an advantage.
• Excellent communication, self-organization, can-do attitude and problem-solving skills, coupled with a customer-centric focus
• Proficient with Microsoft Office applications (Word, Excel, PowerPoint)
• Reliable teammate that excels in a multicultural, international environment.

Knowledge, Skills, Abilities
• Must be able to lift 15 – 25 kg.
• Normal laboratory/office environment.
• Position may require frequent communication and walking to other areas in which designated PPE will be required.
• Position will require sitting and standing.
• Good communication skills, direct external client interactions are required
• Excellent organization, planning, and time management skills.
• Excellent problem solving and critical thinking skills, including strong attention to detail.
• Excellent writing, communication and presentation skills.
• Ability to analyze and summarize complex scientific data.
• Self-motivated, independent and a proactive driving force of efficient execution.
• Ability to work constructively on a team.
• Ability to function in a rapidly changing environment.
 

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

Work Schedule
This is a full time Monday – Friday, alternating weekend coverage, estimated 41 hours a week.

Our Offer
You can expect a varied job in a dynamic and international environment. A culture in which integrity, intensity, involvement and innovation are lived. A well-founded induction and task-specific training are a matter of course for us. You will define your future in our company - make your contribution to our joint success!

At Thermo Fisher Scientific, each one of our 65,000 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.