Scientist II, Formulation & Process Development

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Will work with hazardous/toxic materials

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

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 emerging diseases. 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.

What will you do?

• Perform complex 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 in both GMP and non-GMP environments.
• 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.
• On-site presence during critical batch manufacturing to support operations via observation, assisting in decision making, troubleshooting, and providing technical input.
• Lead client calls as primary technical representative and provide scientific justification for the project decisions and recommendations.
• Work closely with project teams of analytical, quality, and project management representatives to support formulation and process development activities.
• 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, 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.

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

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

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 preferred 
• 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.
• Experience working with DEA controlled substances is preferred
• Experience with statistical software and analysis is preferred 

Location, Work Authorization & Pre-Employment Requirements

Please review the following requirements before applying:

• Relocation: Relocation assistance is not available for this position.
• Work Authorization: Applicants must be legally authorized to work in the United States without current or future employer-sponsored work authorization.
• Pre-Employment Screening: Employment is contingent upon successful completion of all applicable pre-employment requirements, including a background check and drug screening, in accordance with company policy and applicable law.

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)