Technical Services Scientist
Company: Thermo Fisher Scientific Inc.
Location: High Point
Posted on: June 7, 2021
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
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
Troubleshooting and advising on analytical methods/transfers as
Daily troubleshooting, process optimization, technical review of
process issues and increased efficiency via continuous improvement
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
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
Identification, execution, project management and delivery of
continuous improvement projects.
Preparation of capital estimates and schedules for future new
Project Management of small to medium scale capital
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
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
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
Writing risk assessments.
Providing support in investigations and other troubleshooting
- 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
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
Keywords: Thermo Fisher Scientific Inc., High Point , Technical Services Scientist, Other , High Point, North Carolina
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