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

Thermo Fisher Scientific Inc. is the world leader in serving science. Whether our customers are accelerating life sciences research, solving analytical challenges, improving patient diagnostics and therapies, or growing efficiency in their laboratories, we are here to support them. 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. Discover Impactful Work

Location: Greenville, NC

How you make an impact?

The PAT Scientist will be a member of the Continuous Manufacturing (CM) development team for oral solid dosage products and lead activities related to Process Analytical Technology (PAT) to support projects from kickoff through successful commercial launch. This critical role focuses on the development, implementation and validation of process analytical methodology for evaluating critical quality attributes (CQA). This role will work closely with process development, operations, automation, and quality personnel to plan out projects and apply shared resources and equipment.

What will you do?

· Act as a subject matter expert for Spectroscopic PAT method development, validation, implementation, revalidation and model maintenance.

· Design and implement experiments to monitor product quality to achieve process understanding to develop the analytical target profile (ATP),

· Perform in-depth data analysis of PAT and continuous manufacturing process data for process insight, investigations and trending.

· Apply expertise to advance understanding of the science related to PAT across the organization.

· Work directly with clients to deliver on project goals and ensure customer and regulatory requirements are met.

· Collaborate with the ThermoFisher organization to support instrument innovation.

How will you get here?

Education

· Masters or PhD in Analytical Chemistry, Chemical Engineering or related scientific field.

Experience

· PhD with 2+ years of direct experience in PAT method development for pharmaceutical drug products or an M.S. with 4+ years of experience.

· Experience in applying at-line, on-line and in-line PAT methods for product and process insight, supporting development and manufacturing.

· Experience in Chemometrics and innovative multivariate modeling across spectroscopic techniques.

· Direct experience with oral solid dosage forms and an overall process understanding of continuous manufacturing is a plus.

Knowledge, Skills, Abilities

· Strong understanding of using spectroscopic techniques (e.g., FTIR, NIR and Raman) to develop method for process understanding and process control.

· Proficient in MATLAB programming and commercial Chemometrics software package such as Unscrambler and PLS toolbox.

· Strong statistical knowledge and capabilities.

· Excellent written and verbal communication, as well as interpersonal skills are essential.

· Comfortable working in multi-functional teams and providing professional contribution in process analytical technologies.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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 status.

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 status.