Mfg Scientist III (Building 8 Operations)

Work ScheduleStandard (Mon-Fri)Environmental ConditionsAble to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc allowed, Cold Room/Freezers -22degrees, Fluctuating Temps hot/cold, Loud Noises (Equipment/Machinery), Office, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Various outside weather conditions, Will work with hazardous/toxic materialsJob DescriptionCOMPANY INFORMATIONThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies or growing efficiencies in their laboratories, we are here to support them. Our global organization of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com .GROUP/DIVISION SUMMARYThe Drug Product Division (DPD) is one of the three divisions that make up the Pharma Services Group (PSG) in the Biopharma Services (BPS) Sector at Thermo Fisher. We have more than 9,000 colleagues across 13 sites who specialize in taking sterile injectable, oral solid dose and softgel drug products from development to commercialization.As the Contract Development Manufacturing Organization (CDMO) market leader, we have built a reputation for scientific and technical excellence, and DPD has benefitted from capital investments in capacity expansion and new capabilities to ensure our long-term growth as we continue to meet our customers' evolving needs.DPD take sterile injectable, oral solid dose and softgel drug products from development to commercialization, enabling our customers to get critical medicines and vaccines to patients faster.POSITION SUMMARYAs a Manufacturing Scientist, you will 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 documentation (including but not limited to work orders, protocols, summaries, with minimum supervision), and provides scientific justification and update status of project work as needed.Key Responsibilities:

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 as necessary within defined procedures and practices.

Makes decisions that involve direct application of technical knowledge.

Design, implement, and evaluate studies, lead tech transfer, commercial scale-up and support process validation.

Represent the organization on internal technical discussions.

Lead and/or participate in problem solving and project work for formulations, equipment and processes.

Write/revise work orders for new processes, FORMs, reports, memos, and protocols as required.

Lead projects with minimal to no supervision, can review and plan all technical aspects of the project to meet appropriate timeline.

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.

Qualifications:

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

3+ years of experience in a manufacturing environment required.

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

Experience in a CMO or Pharmaceutical product development field PREFERRED

Advanced knowledge of multifaceted aspects or a specialized aspect of a subject area and solid understanding 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 running technical discussions with internal and external clients.

Ability to work on multiple projects simultaneously.

Ability to acquire 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 run technical solutions.

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.BENEFITSWe 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 at http://jobs.thermofisher.comThermo 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.Accessibility/disability accessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process.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.