Staff Scientist, Chemistry Manufacturing

Staff Scientist, Chemistry Manufacturing

Austin, Texas

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like enabling our customers to make the world healthier, cleaner and safer. Your work will have real-world impact, and you'll be supported in achieving your career goals.

Our team in Austin, TX is at the heart of the global response to COVID-19. In addition to our sample isolation and viral testing reagents and workflows, the Biosciences Division (BID) of Thermo Fisher Scientific is expanding our capacity in Austin with new cGMP facilities dedicated to nucleotide (NTP) manufacturing to support vaccine manufacturers.

How will you make an impact?

The Staff Scientist, Chemistry Manufacturing is the technical lead responsible for cGMP nucleotide (NTP) manufacturing activities in at the Austin, Texas site. The staff scientist leads cross functional projects and provides scientific and technical expertise in development and troubleshooting activities, directly supporting the Chemistry Manufacturing team. The staff scientist reports to the Chemistry Manufacturing Senior Manager and is responsible for operating within project and department budgets.

What will you do?

• Supports the day-to-day cGMP manufacturing activities for nucleotide (NTP) synthesis as technical lead in the manufacturing team.
• Develops and optimizes manufacturing processes for use by organic chemists and manufacturing technicians. Provides feedback and coaching, often designated as a substitute for the senior manager.
• Leads efforts to implement new and scaled-up organic chemistry processes.
• Seeks the highest level of compliance, efficiency, and robustness of specified manufacturing and in-process testing methodologies.
• Manages process improvements utilizing PPI, 5S, Lean, and Six Sigma methodologies and works proactively with the team and internal customers to implement opportunities for continuous improvement.
• Supports internal, external and regulatory inspections as needed. Serves as chemistry manufacturing technical lead for regulatory inspections and/or client audits.
• Provides support of equipment/method qualification and validation from Development teams and/or clients.
• Working with team managers and supervisors, ensures adequate training within the chemistry manufacturing department.
• Serves as technical lead on problem resolution, CAPA, and deviations via Trackwise.
• Reviews and drafts standard operating procedures/manufacturing batch records.

How will you get here?

• Master's Degree in organic chemistry or similar scientific/technical discipline required. PhD is a plus.
• 10+ years of experience in a manufacturing position within the chemistry and/or pharmaceutical industry.
• 2+ years of project leadership experience is highly preferred.
• Experience with organic chemical synthesis and purification instrumentation and methodologies is required; knowledge of quality analysis a plus.
• Experience with writing Deviations, Lab investigations, OOS, and Root Cause Analysis a plus.
• Experience operating within ISO 9001 and 13485 guidelines.
• Excellent communication skills.
• Ability to apply cGMP regulations and international guidelines to all aspects of the position.
• One or more advanced quality, business, Six Sigma, and project management degrees or certifications, e.g. CQE, MBA, CSSBB, and PMP, a plus.

Knowledge, Skills, Abilities

• Ability to write reports, business correspondence and procedure manuals.
• Strong organizational skills; ability to prioritize and manage through complex processes/projects.
• Ability to read, analyze and interpret business periodicals, common scientific, professional and technical journals, financial reports, governmental regulations and legal documents.
• Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community.
• Ability to define problems, collect data, establish facts and draw valid conclusions.
• Ability to apply principles of logic or scientific thinking to a wide range of intellectual and practical problems.
• Ability to deal with abstract and concrete variables in situations where only limited standardization exists.
• Ability to utilize various standard programs for data entry and word processing.
• Ability to utilize software and customized programs to meet business needs; familiarity with SAP, Agile, and other business software a plus.

At Thermo Fisher Scientific, each one of our 90,000 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.

Apply today! http://jobs.thermofisher.com
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