Technical Services Scientist

Thermo Fisher Scientific•High Point, NC

23h•Onsite

About The Position

Join our team at Thermo Fisher Scientific as a Technical Services Scientist, where you'll contribute to global health through innovative process development and optimization. You'll provide technical leadership in technology transfer, process validation, and manufacturing support across our facilities. Working at the intersection of R&D and manufacturing, you'll collaborate with cross-functional teams to ensure successful execution of manufacturing processes while driving continuous improvement initiatives. Your expertise will be vital in resolving complex technical challenges, conducting investigations, and implementing solutions that maintain our high standards of quality and efficiency. Location: This role will be based at our High Point, NC facility.

Requirements

Ph.D. or master’s in 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 phase-in and validation activities in the pharmaceutical industry, or equivalent combination of education and experience.
Strong technical expertise in process development, scale-up, and technology transfer
Proven ability to lead complex investigations and implement effective solutions
Experience with process validation and qualification activities
Expert knowledge of cGMP regulations and quality systems
Advanced project management and documentation skills
Strong analytical and statistical analysis capabilities
Excellent verbal and written communication skills
Ability to work collaboratively in a matrix environment
Proficiency with statistical analysis software and Microsoft Office suite
Experience mentoring colleagues and providing technical training
Strong problem-solving skills and attention to detail
Ability to support manufacturing operations as needed, including some weekend/off-hours coverage
Travel up to 10% may be required

Nice To Haves

Preferred Fields of Study: Chemical Engineering, Chemistry, Biochemistry, Biotechnology, or related scientific field
Experience with recipe building is desired.

Responsibilities

Manages the life cycle for products including scale-up, technology transfer, alternate source evaluations and validation of products from development/clients into manufacturing by coordinating the activities between Research and Development and Manufacturing.
Technical Expert for assigned product formulations and processes. The individual will be the on-site subject matter authority.
Coordinate and lead the technology transfer and validation of new products which require liaising between internal and external customers to ensure appropriate target dates are met.
Daily troubleshooting, process optimization, technical review of process issues and increased efficiency via continuous improvement measures. Tasks include execution of feasibility studies and supporting production/validation personnel during execution of validations and commercial batch production.
Generation, review, and approval of master recipes, protocols, reports, SOPs, batch records, technical process investigations, risk assessments, and training for production personnel.