Scientist II, Formulation and Process Development

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, 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

How will you make an impact?

You enjoy working with people! You are collaborative, upbeat, and optimistic! You are passionate about science, eager to learn and develop your career in the pharmaceutical industry. When you’re part of the team at Thermo Fisher Scientific in Cincinnati, Ohio, you’ll do important work, like helping customers develop new cures for cancer and speeding up the manufacturing of treatments for COVID-19. Your work will have real-world impact for patients that are waiting for life-saving medicines. As part of the Pharma Services group, our Cincinnati site develops and manufactures oral drug products for a wide range of small- and large-pharma companies, included tablets, capsules, and other complex dosage forms employing a wide range of manufacturing processes.

As a Formulation Scientist, you will complete activities for the development of new formulations and manufacturing processes of solids, liquids, and semi-solid dosage forms by selecting proper excipients, equipment and processes. You will be the primary technical representative on client projects and will work closely with project teams of analytical, quality, and project management representatives to support formulation and process development activities.

What will you do?

• Complete activities for the development of new formulations and manufacturing processes of solids, liquids, and semi-solid dosage forms by selecting proper excipients, equipment and processes.
• Implement the design, evaluation and development of formulations for pre-clinical studies, clinical trials, process development, and process validation to be commercialized as defined by client requirements.
• Lead client calls as primary technical representative and provide scientific justification for the project decisions and recommendations.
• Own the review and planning of all technical aspects of the project which includes prioritization of multiple projects or tasks to meet the appropriate timeline milestones.
• Integrate risk-based approach during the development process and develop appropriate mitigation strategies.
• Collaborate with Manufacturing, Quality, Engineering, Analytical and other cross-functional teams to resolve technical challenges
• Draft quality batch production records, protocols, and reports to support product development and client regulatory submission to the United States Food & Drug Administration (FDA), European Medicines Agency (EMEA) or other regulatory agencies.
• Mentor junior level scientist and/or technologist to increase their knowledge base while improving one’s own career progression.
• Provide occasional weekend or off-hours support to meet manufacturing needs.

How will you get here?

Education

Minimum Bachelor of Science (B.S.) in Chemistry, Pharmacy, Biochemistry, Biology, or related physical science or engineering related field.

Experience

• 4 years of scientific experience, including 3 years in a related life sciences field. Experience in pharmaceuticals solid oral dosage manufacturing or pharmaceutical formulation development is preferred.
• If related Master's degree, typically requires 1-2 years of related experience.
• If related PhD, typically requires no experience.

Knowledge, Skills, Abilities

• Strong Understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and regulatory compliance.
• Effective project management and organizational capabilities
• Good knowledge of scientific methodology as related to the pharmaceutical industry.
• Knowledge of pharmaceutical manufacturing processes
• Communicates and co-operates with others to meet project and team objectives
• Proficiency using Microsoft (MS) Office applications
• Good critical and logical thinking skills. Effective written, interpersonal, and presentation skills, including managing technical discussions with internal and external clients.

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office and manufacturing locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Must be able to wear required personal protective equipment (PPE)

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us . As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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Thermo Fisher Scientific is an EEO/Affirmative Action 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.