Scientist III, QC Analytical Support

Work Schedule

Environmental Conditions

Job Description

When youre part of the team at Thermo Fisher Scientific, youll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and youll be supported in achieving your career goals. At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.

Location/Division Specific Information

This position supports the QC Analytical Support team for our Biologics Division in St. Louis, MO.

How will you make an impact?

The QC Scientist III (Analytical Support) will be responsible for technical input for analytical proposals, work statements, test methods, investigations, risk assessments and client inquiries. The person will be responsible for following Current Good Manufacturing Practices (cGMP) while assisting the QC Analytical department in support of Commercial and Clinical Biopharmaceutical Manufacturing as mandated by Corporate Standards.

What will you do?

• Provide support for QC Analytical by performing the following: providing technical input for analytical proposals, work statements, test methods, investigations, risk assessments and client inquiries.
• Collaborate cross-functionally to identify, develop, strengthen, and implement departmental policies and procedures. Assist in technical training for analysts, data reviewers and investigation writers.
• Interface between AFS and QC Analytical during method transfer, qualification and validation. Perform method risk assessments for QC Analytical prior to validation activities. Assist with method language and form optimization.
• Advise on language for CAPAs to ensure compliance with analytical methods, SOPs, site policies and scientific robustness.
• Participate, advise, and support in FDA inspections, ISO and customer audits, and support external audit response management for analytical concerns.
• Attend new client meetings and on-site visits; high involvement with clients during method validation/transfer.
• Manage critical reagent changes, review/approve internal reference material qualifications and recertifications.
• Expand scientific, technical, and compliance knowledge by reading the relevant scientific literature, attending industry conferences and completion of relevant training
• Participate in continuous process improvement initiatives, provide support to site safety initiatives.
• Other job duties as assigned.

How will you get here?

• Bachelors Degree in a Biological Science related field (preferably Chemistry, Biochemistry)

Industry Experience

• Proven experience (5+ years) related experience in a GMP facility (biopharmaceutical or pharmaceutical industry) in a quality control role.
• 2+ years related experience aligned to Quality Control in a client-facing role.

Knowledge, Skills, Abilities

• Routine use of MS Excel, MS PowerPoint, MS Teams, and MS Word is crucial.
• Outstanding technical reading and writing skills.
• Background in analytical theory and technical competency of various biological and physical characterization techniques: capillary electrophoresis (cIEF/ICE, CE-SDS), UPLC/HPLC (excipient quantification, glycan analysis, proteolytic mapping, IEX, SEC), ELISA and cell-based assays (process impurities assessments and potency determinations).
• Knowledge of US and international (e.g. EU, ICH, GXP) regulations and guidance applicable to clinical and commercial pharma/biopharma products.
• Strong interpersonal skills including actively listening, conflict resolution and the ability to effectively influence diverse stakeholders for positive outcome.
• Ability to build strong relationships with client while instilling trust and confidence.
• Highly organized with attention to detail, proven time management skills with the ability to work on multiple projects simultaneously
• Familiar with standard project management concepts, tools and responsibilities (objectives, scope, results).

• Ability to inspire and foster innovation, collaboration, transparency and team effectiveness.

Physical Requirements / Work Environment:

A flexible work schedule is required.

Ability to lift up to 25 lbs independently, with occasional heavier objects of up to 50lbs with assistance.

Loves to wear gloves and other PPE to enter laboratory spaces.

Loves to sit or stand for extended periods of time, as needed.

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.

Apply today

Disclaimer:

This job description presents the general content and requirements for the performance of this job. The description is not to be construed as an extensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to describe an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully abide by all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

Thermo Fisher Scientific is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We strive to build an inclusionary work environment and prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.