Senior USP Labs Scientist

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, 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., 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!

• 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.

We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. With $1.4 billion invested annually in R&D, our collaborative and diverse teams have the resources they need to drive new discoveries and do cutting-edge research and develop important applications and tools that help millions of lives around the world.
Thermo Fisher Scientific Inc. is the world leader in serving science, with an annual revenue of approximately $40 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, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000+ colleagues deliver an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.