Complete Technology Transfer activities by performing manufacturing process development for Injectables products to commercial lines. Using experimental design, establish formulation processes, product pathway and select components for successful scaleup. Support client calls, prepare necessary documentation (including but not limited to work orders, protocols, summaries, with minimum supervision), and provides scientific justification as needed and update status of project work.

Discover Impactful Work!

• Technically supports day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant.
• May be involved in clinical stage of drug development.
• Works on technical/scientific process/product/project activities to implement strategies and technical solutions that meet client needs and expectations.
• Assists in the creation of processes and equipment design for clinical, scale up, and/or registration batches, including technology transfer of projects to and from clients.
• Evaluates and contributes to the design of manufacturing processes and supports problem solving when needed within defined procedures and practices.
• Makes decisions that involve direct application of technical knowledge.

A Day in the Life.

• Design, implement, and evaluate studies, lead tech transfer, commercial scale-up and support process validation.
• Represent the organization on formal technical and scientific forums.
• Lead and/or participate in problem solving and project deliverables for formulations, equipment and processes.
• Write/revise work orders for new processes, FORMs, reports, memos, and protocols as the need arises.
• Lead projects with minimal to no supervision, can review and plan all technical aspects of the project to meet appropriate timeline and milestones.
• Support manufacturing operations, change controls, investigations as subject matter expert (SME), resolve accurate CAPAs.
• Assess material changes and determine change impact.
• Contribute to development of proposals and timelines for projects, leading relevant client meetings.
• Review new bid quotes, protocols, technical documents, results, and reports.

Keys to Success.

Education:

• Bachelor’s of Science in Chemistry, Biochemistry, Biology, Pharmaceutical or related physical science.

Experience:

• Bachelors and 3 years proven experience
• CMO or Pharmaceutical product development experience PREFERRED

Equivalency:

• Equivalent combinations of education, training, and meaningful work experience may be considered.

Knowledge, Skills, Abilities:

• Advanced knowledge of varied aspects or a specialized aspect of a subject area and working knowledge of principles and concepts in other relevant subject areas.
• Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry.
• Detailed knowledge of Good Manufacturing Practices.
• Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Excellent critical and logical thinking skills.
• Effective written, interpersonal, and presentation skills, including managing technical discussions with internal and external clients.
• Ability to work on multiple projects simultaneously.
• Ability to develop knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.
• Ability to keep current with scientific literature and industry trends relating to process technologies.
• Ability to develop technical solutions.
• Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods.

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office 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. Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally.

BENEFITS

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

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 with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

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.

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