Scientist, Manufacturing Sciences

at  Thermo Fisher Scientific

JOB DESCRIPTION

Job Title: Scientist, Manufacturing Sciences
Division/Location: Pharma Development Services/Greenville, NC
Work Schedule: Monday - Friday, Onsite
Thermo Fisher Scientific Inc. is seeking a motivated Scientist with a strong work ethic to join our PDS Manufacturing Sciences team in Greenville, NC. As a Scientist within Pharma Development Services (PDS), this position will have a crucial role in developing new formulations and drug product manufacturing processes for sterile injectables (liquid & lyophilized vials/PFS). By joining our organization, you will be able to actively contribute towards our mission of facilitating a healthier, cleaner, and safer world for our customers.

TARGET COMPETENCIES:

• Customer Focus: Prioritize customer requirements and dedicate efforts to consistently meeting and exceeding customer expectations.
• Improving Processes: Continuously enhance internal procedures to benefit the customer and contribute to the team’s achievements.
• Innovation: Challenge the status quo by introducing and proactively seeking out new ideas and solutions to strengthen team and site performance.
• Thorough knowledge of the pharmaceutical industry, particularly formulation and process development.
• Knowledge of cGMP and regulatory requirements of biopharmaceutical manufacturing, FMEA, and technology transfer.
• Knowledge of drug product formulation and fill finish.
• Strong communication skills.

EDUCATION:

Bachelor’s degree in a technical field such as Biochemistry, Chemistry, Biology, or Medical Engineering or related field with a minimum of 5+ years of experience in a CDMO or product development in pharma/biopharma or PhD in relevant program.
Apply today and join our team of dedicated professionals who are making a difference in the world. Visit our careers page at http://jobs.thermofisher.com.
Thermo Fisher Scientific is an Equal Opportunity 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

• Drive the development of new formulation and manufacturing processes.
• Drive drug product processes development activities (Hold time study, material contact study, free/thae study, mixing, filtration, filling pump/shear stress, etc).
• Process and SUS Design: Develop processes and design single-use systems for clinical, scale-up, and registration batches, including the tech transfer of projects.
• Formulation Development: Responsible for formulation and process development of sterile injectables, including high concentration mAb and protein molecules. Troubleshoot and problem-solve unresolved or new formula issues.
• Draft production batch records, protocols, reports, and memos and review protocols, results, and reports for projects.
• Batch support during manufacturing: Provide support during manufacturing batches to ensure successful production runs.
• Problem Solving: Actively participate in or lead problem-solving initiatives for formulations, equipment, and processes for assigned projects.
• Project Leadership: Lead projects with minimal supervision, ensuring all technical aspects are reviewed and planned to meet appropriate timelines and milestones.
• Project Management: Handle projects autonomously, ensuring timely completion by meticulously planning and being responsible for all technical aspects.
• Client Interactions: Lead clinical interactions during client calls, providing scientific justification for development decisions.
• Cross-Functional Collaboration: Work with project managers, Analytical, Quality Control, Quality Assurance, and other departments on projects.
• Client Engagement: Contribute to the development of project timelines and lead relevant client meetings.
• Make scientific presentations to internal and external teams.
• Maintain the development lab and ensure compliance with safety and operational standards.
• Write SOPs for lab equipment, perform periodic reviews of SOPs, and maintain lab equipment.
• Equipment Maintenance: Work with vendors to perform preventive maintenance on lab equipment.
• Lab Training: Provide general lab training for new hires.
• Single-Use Systems: Demonstrate some understanding of disposable single-use systems.
• Time Management: Exhibit good time management skills, ensuring efficient and effective use of time.
• Organization: Maintain a well-organized workspace and approach to project management.