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Technical Services Scientist

Company: Thermo Fisher Scientific Inc.
Location: High Point
Posted on: June 7, 2021

Job Description:

Job Description

Job Title: Technical Services Scientist

Requisition ID: 148892BR

When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of over $28 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location:

This role will be based at our High Point, NC facility.

How will you make an impact?

Manages the life cycle for products including scale-up, technology transfer, alternate source evaluations and Validation (All 3 phases) of products from development/clients into manufacturing by coordinating the activities between Research and Development, Clinical Supplies, and Manufacturing.

What will you do?

  • Technical expert for assigned product formulations and processes. You will be the on-site subject matter expert (SME).

  • Providing technical expertise to all product formulations, processes and control system related issues.

  • Managing the technology transfer and Validation for products into and out of the site.

  • Managing and ensuring analytical method and process transfers are completed within the appropriate timelines.

  • Liaising with external customers, and external staff ensuring successful transfer of information between both parties.

  • Liaising with engineering personnel to ensure optimal processing for each formulation.

  • Planning, coordinating, and managing the technical teams ensuring appropriate target dates and budget targets are adhered to.

  • Troubleshooting and advising on analytical methods/transfers as required.

  • Daily troubleshooting, process optimization, technical review of process issues and increased efficiency via continuous improvement measures.

  • Managing the design and execution of experiments which may serve one or more of the following purposes: method and process development, method validation, cleaning validation, technology transfer, QC, stability etc. as required.

  • Utilize internal expertise to direct the implementation of product/process transfer/development and improvement.

  • Preparing and reviewing protocols, reports, SOPs etc. and other documentation as required

  • Participation in goal setting for Technical Support team members.

  • Planning, coordination and leadership of technical transfers for future product introductions.

  • Active collaboration between technical support team, engineering and R&D groups to ensure successful new product introductions and technical transfer activities.

  • Directing activities of the new product phase-in teams as necessary through the course of the technology transfer phase.

  • Ensuring the new team possesses the skill, knowledge, and abilities necessary to support the pending new product transfer.

  • Identification, execution, project management and delivery of continuous improvement projects.

  • Preparation of capital estimates and schedules for future new product introductions.

  • Project Management of small to medium scale capital projects.

  • Coaching and training of manufacturing personnel on technical/ engineering elements to increase knowledge sharing.

  • Ensure adequate & effective cross-site communication of Technical Support activities.

  • Ongoing support of existing production.

  • Generation of batch records, SOP's, technical process investigation and development of training methods for production personnel.

  • Interfacing with Quality Assurance and Research and Development (R&D) on process requirements for new and current products.

  • Assisting with on-site transfer projects and product scale-up activities.

  • Evaluating and recommending continuous improvement in manufacturing processes and control systems.

  • Writing, reviewing, approving of technical protocols; assuring that protocols are approved through proper channels.

  • Assuring that all test data is gathered and recorded in accordance with cGMP requirements.

  • Analyzing data to ascertain if it meets related protocol acceptance criteria; writing deviation reports as required upon failures to meet protocol acceptance criteria.

  • Writing reports and assures that they are approved through proper channels.

  • Writing risk assessments.

  • Providing support in investigations and other troubleshooting activities.

  • Adhering to all GMP and safety requirements, SOP's and Company policies and procedures.

How will you get here?

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Additionally, an individual must uphold the standards of conduct of the company, which include confidentiality, cooperation, and respect for people and property. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education & Experience:

Ph.D. in a Science related field and 0-2 years of scientific experience, or BA/BS in Science or related field with 2-4 years of process or formulation experience which must include specific experience coordinating new product phase-in and Validation activities in the pharmaceutical industry, or equivalent combination of education and experience.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 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 75,000 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.

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.

Keywords: Thermo Fisher Scientific Inc., High Point , Technical Services Scientist, Other , High Point, North Carolina

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