Staff R&D Manufacturing Scientist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Do you have a passion for innovative ideas and groundbreaking discoveries? With over $1 billion invested annually in R&D, at Thermo Fisher Scientific you'll help solve some of the world's toughest challenges, from giving cancer patients hope, ensuring safe drinking water and helping law enforcement tackle cases through forensics. We empower our teams to put science into meaningful action and give our R&D colleagues the autonomy, resources and tools they need to take science a step beyond!

Location/Division Specific Information
Greenville, NC - Pharma Services Group

POSITION SUMMARY

The Staff R&D Manufacturing Scientist will lead and/or execute activities for the technology transfer of client-developed dosage forms to mfg facility, manufacturing processes development for Injectables, liquids, and semi-solid dosage forms. Using experimental design, establish formulation processes for successful scaleup; Create processes and equipment design for clinical, scale-up, and/or registration and commercial batches of delegated projects.

Role Summary

• Designs, completes and evaluates studies, leads tech transfer, commercial scale-up and supports process validation.
• Represents the organization on formal technical and scientific forums.
• Leads and/or participates in problem-solving and project deliverables for formulations, equipment and processes.
• Writes/revises work orders for new processes, FORMs, reports, memos, and protocols as the need arises.
• Leads projects with minimal to no supervision, review and plan all technical aspects of the project to meet appropriate timelines.
• Supports manufacturing operations, change controls, investigations as subject matter expert (SME), and determines accurate CAPAs.
• Review new bid quotes, protocols, technical documents, results, and reports.
• Mentors entry-level scientists to increase technical knowledge.
• Contribute to development of proposals and timelines for projects, leading relevant client meetings.
• Assess material changes and determine change impact.
• Leads research (identification) of industry standard methodologies and internal processes.
• Leads development and coordination of realistic proposals and timelines. Leads meetings with clients.
• Interact with site SMEs and Business Segment Leaders (BSL) to develop scientific strategy.

Qualifications Required

• High school diploma with 10+ years of experience in a CMO or product development field in pharma; or
• Bachelor's degree in a science or technical field (Chemistry/Biochemistry/Pharmaceutical) with 10+ years of experience in a CMO or product development field in pharma; or
• Master in science (Chemistry/Biochemistry/Pharmaceutical sciences) with 7+ years of experience in a CMO or product development field in pharma.

Knowledge, Skills, Abilities

Prioritizes customer requirements and is dedicated to meeting or exceeding customer expectations. Continuously improves internal processes to create value for the customer. Challenges the status quo. Introduces and proactively seeks out new ideas and solutions to strengthen team/site performance.

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