Scientist III, Manufacturing Sciences at Thermo Fisher Scientific in Greenville, North Carolina

Posted in Other 18 days ago.





Job Description:

Job Description




COMPANY INFORMATION



Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 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 complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 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 and Patheon. For more information, please visit www.thermofisher.com.



GROUP/DIVISION SUMMARY



The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.



POSITION SUMMARY



As a Manufacturing Scientist, you will complete activities for the development of new and established manufacturing processes for oral solid dosage products in a traditional batch manufacturing and well as a continuous manufacturing environment.



Key Responsibilities:



  • Complete technical activities with cross functional teams including validation, operations, quality, analytical development and process development.

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

  • Participate in 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.

  • Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintain the necessary compliance status required by company and facility standards.


Qualifications:



  • Bachelor's degree in chemical engineering (or other engineering field), chemistry, pharmacy, or other related science or technical field is required.

  • Minimum of five (5) years of experience in a manufacturing environment. Experience in product or process development, including scale-up and technology transfer processes for both immediate and controlled release dosage forms preferred. Advanced degree with less experience would be considered techniques, working knowledge of EMPOWER is a plus.

  • 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.

  • Skilled in MATLAB or Python programming and data analysis.

  • 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.


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.



Accessibility/disability access



Job 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.


This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
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