Scientist II - Manufacturing Sciences

As a Manufacturing Scientist, you will complete activities for the development of new and established manufacturing processes for solids, liquids, and semi-solid dosage forms by scaling up processes, supporting new product validations and post-approval qualifications, as well as supporting routing manufacturing operations in order to assure timely release of products. You will be the primary technical representative on client projects and will work closely with project teams of analytical, quality, and project management representatives support process development and commercial activities.

What will you do?

• Complete activities for the validation of new products and manufacturing processes of solids, liquids, and semi-solid dosage forms.

• Provide support and guidance to internal team members and clients for product and process development activities performed in commercial manufacturing areas.

• Lead client calls as primary technical representative and provide scientific justification for the project decisions and recommendations.

• Lead the review and planning of all technical aspects of the project which includes prioritization of multiple projects or tasks to meet the appropriate timeline achievements.

• Integrate risk-based approach during the scale up and commercialization of processes and develop appropriate mitigation strategies.

• Draft quality batch production records, protocols, and reports to support product development, validation activities, and routine commercial batches.

• Support routine manufacturing operations in order to assure timely release of products with appropriate quality attributes and providing stewardship for commercial products of responsibility.

Education

Bachelor's D egree in Chemical Engineering (or other engineering field), Chemistry, Pharmacy, or other related science or technical field .

Experience

• 1-3 years of experience in a manufacturing environment with experience in product or process development is required.

• Scale-up and technology transfer processes for both immediate and controlled release dosage forms is preferred.

Knowledge, Skills, Abilities

• Understanding of Good Manufacturing Practices (GMP) and regulatory compliance.

• Manage projects of moderate to high complexity in scope and compliance-related challenges to implementing processes to meet changing regulations.

• Proficiency using Microsoft (MS) Office applications.

• Good critical and logical thinking skills. Effective written, interpersonal, and presentation skills, including leading technical discussions with internal and external clients.

• Self-starter, mature, independent, and dependable.

• Ability to work in a fast-paced, results oriented environment.

• Experience managing projects related to process development including scale-up and technology transfer.

• Effective time management, multi- tasking and prioritization skills to effectively manage multiple projects.

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

At Thermo Fisher Scientific, each one of our 100,000 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.

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.