Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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.

DESCRIPTION:

Join our team at Thermo Fisher Scientific as an MSAT TT Scientist III and make meaningful contributions to pharmaceutical development. In this role, you'll lead complex technical projects involving formulation development, process optimization, and technology transfer for pharmaceutical products. Working with advanced analytical technologies and equipment, you'll develop and validate scientific methodologies while ensuring compliance with GMP standards. You'll serve as a technical subject matter expert, collaborating with cross-functional teams and clients to implement innovative solutions that advance drug development from pre-clinical through commercialization stages.

Discover Impactful Work:

· Technically supports day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant.

· Leads technical/scientific process/product/project activities to implement strategies and technical solutions.

· Drives creation of processes, single use systems, and equipment designs for clinical, scale up, and/or registration batches, including technology transfer of projects from clients.

· Makes decisions that involve direct application of technical knowledge.

A Day in the Life:

· Design, implement, and evaluate studies, lead tech transfer, commercial scale-up and support process validation.

· Represent the organization on formal technical and scientific forums.

· Lead and/or participate in problem solving and project work for formulations, equipment and processes.

· Write/revise work orders for new processes, FORMs, reports, memos, and protocols as required.

· Independently manage projects, proficient in evaluating and organizing all technical aspects of the project to achieve necessary landmarks and turning points.

· Support manufacturing operations, change controls, investigations as subject matter expert (SME), resolve accurate CAPAs.

· Assess material changes and determine change impact.

· Support development of proposals and timelines for projects, leading relevant client meetings.

· Review new bid quotes, protocols, technical documents, results, and reports.

REQUIREMENTS:

• Advanced degree plus 3 years of experience, or Bachelor's degree plus 5 years of pharmaceutical industry experience
• Preferred Fields of Study: Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Engineering or related scientific field
• Expertise in analytical techniques including HPLC, GC, LC/MS, spectroscopy and related instrumentation
• Strong knowledge of GMP requirements and pharmaceutical regulatory guidelines
• Experience with method development, validation and technology transfer
• Demonstrated ability to manage multiple complex technical projects simultaneously
• Excellent documentation skills for technical reports, protocols and regulatory submissions
• Strong data analysis and statistical evaluation capabilities
• Experience presenting technical information to clients and cross-functional teams
• Proficiency with Microsoft Office applications and analytical software
• Advanced problem-solving and troubleshooting abilities
• Strong written and verbal communication skills
• Experience supporting and developing team members through technical guidance
• Physical requirements include standing/walking, lifting up to 35 lbs, and manual dexterity for lab work
• Ability to work safely with laboratory chemicals and equipment while following SOPs
• Experience in a contract manufacturing organization (CMO) preferred
• Knowledge of aseptic techniques and sterile manufacturing preferred for some positions