Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Role Overview
Complete Technology Transfer activities by performing manufacturing process development for injectable products and transferring them to commercial lines. Using experimental design, establish formulation processes, product pathways, and select components for successful scale-up. Support client calls, prepare necessary documentation (including but not limited to work orders, protocols, and summaries) with minimal supervision, provide scientific justification as needed, and communicate project status.
Discover Impactful Work!
- Technically support day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant.
- Lead technical/scientific process, product, and project activities to implement strategies and solutions.
- Drive the creation of processes, single-use systems, and equipment designs for clinical, scale-up, and/or registration batches.
- Support the development and implementation of new technologies, including isolator-based filling.
- Support lyophilization development, cycle optimization, scale-up, and troubleshooting.
- Make sound technical decisions with minimal supervision.
A Day in the Life
- Design, implement, and evaluate studies; lead Tech Transfer and commercial scale-up, and support process validation.
- Represent the organization in formal technical and scientific forums.
- Lead and/or participate in problem-solving activities related to formulations, equipment, and manufacturing processes.
- Write/revise work orders, FORMs, reports, memos, and protocols as required.
- Independently manage projects and organize technical activities to achieve key milestones.
- Support manufacturing operations, change controls, and investigations as an SME and develop appropriate CAPAs.
- Assess material and process changes and determine potential impact.
- Support development of proposals and project timelines and lead relevant client meetings.
- Review bid quotes, protocols, technical documents, results, and reports.
- Provide technical guidance to less-experienced scientists as needed.
Keys to Success
Education & Experience
- Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related physical science with 5+ years of relevant experience; or
- Master’s degree in a related scientific discipline with 4+ years of relevant experience; or
- PhD in a related scientific discipline with 2+ years of relevant experience.
- CMO/CDMO or pharmaceutical product development experience preferred.
- Experience with Technology Transfer, process development, and sterile manufacturing preferred.
- Experience with formulation and lyophilization development and troubleshooting preferred.
- Experience with DSC, Freeze-Drying Microscopy (FDM), and SP Scientific LyoStar or similar development-scale lyophilization systems is a plus.
- Experience with isolator technology, PFS, cartridge filling, two-compartment cartridge systems, and/or Media Fill is a plus.
Equivalency
Equivalent combinations of education, training, and meaningful work experience may be considered.
Knowledge, Skills & Abilities
- Advanced knowledge of pharmaceutical process development and related technical principles.
- Excellent knowledge of scientific methodology and pharmaceutical development.
- Working knowledge of basic analytical laboratory techniques and common laboratory equipment used to support formulation and process development.
- Detailed knowledge of Good Manufacturing Practices.
- Strong critical thinking, troubleshooting, and problem-solving skills.
- Ability to independently lead Technology Transfer activities and make sound technical decisions with minimal supervision.
- Strong team player with demonstrated ability to collaborate across functions, share knowledge, and support common project goals.
- Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
- Effective written, interpersonal, and presentation skills, including leading technical discussions with internal and external clients.
- Ability to manage multiple projects and competing priorities.
- Ability to remain current with pharmaceutical processes, equipment, technologies, scientific literature, and relevant industry trends.
- Position requires ordinary ambulatory skills and physical coordination sufficient to move throughout office, laboratory, and manufacturing locations; ability to stand and walk; and ability to lift and/or carry light objects up to 25 lbs. for brief periods.
