Manufacturing Scientist II (Technology Transfer) at Thermo Fisher Scientific

Greenville, North Carolina, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, ManufacturingIndustries

Requirements

Bachelor’s of Science in Chemistry, Biochemistry, Biology, Pharmaceutical, Engineering or related physical science (or equivalent combinations of education, training, and meaningful work experience)
For Bachelor’s: 2+ years of related experience; or related Master’s degree
Experience in a CMO or Pharmaceutical product development field (preferred)
Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry
Detailed knowledge of Good Manufacturing Practices (GMP)
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
Ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods
Adherence to all Good Manufacturing Practices (GMP) Safety Standards and use of PPE (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Responsibilities

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 provide scientific justification and update status of project work as needed
Technically support day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant
Work on technical/scientific process/product/project activities to implement strategies and technical solutions
Assist in the creation of processes, single use systems, and equipment designs for clinical, scale up, and/or registration batches, including technology transfer of projects from clients
Complete studies, tech transfer, commercial scale-up and support process validation
Represent the organization on internal technical discussions
Actively participate in problem solving and project results for formulations, equipment and processes
Write/revise work orders for existing processes, FORMs, reports, memos, and protocols
Lead projects with a moderate level of supervision, implement change control actions, review and plan technical aspects of the project to meet timeline and project goals
Support manufacturing operations, change controls, investigations as expert in the field
Collect data for statistical analysis and support interpretation and summary of data

Skills

Technology Transfer

Manufacturing Process Development

Formulation

Scale-up

GMP

Experimental Design

Process Validation

Change Control

Statistical Analysis

Injectables

Filling

Freeze Drying

Single Use Systems

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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