R&D/Mfg Scientist II

Work ScheduleFirst Shift (Days)Environmental ConditionsSome degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job DescriptionThe Analytical Development Laboratory offers an environment of deep scientific and technical expertise, a collaborative culture, and rich resources to developing/validating or transferring a wide range of analytical methods for testing different types of Drug Products.How will you make an impact:By taking part in the method validation and transfer activities, you will have a positive impact on different patients' quality of life. You will perform all your testing/documentation tasks according to the highest quality standards, the governing standard operating procedures, the regulatory expectations and compendial requirements!What will you do:

Conducts chemical and physical testing of pharmaceutical raw materials, incoming materials, finished products, and stability samples using internally developed and validated methods, methods transferred from clients, and/or Compendial methods.

Lead and participate in the validation and/or transfer of test methods for raw materials and finished drug products. Drug products include small molecules and biologics such as vaccines, proteins, monoclonal antibodies, and others.

Preform testing using HPLC, GC, spectroscopy, LC/MS, ICP, CE/SDS, icIEF, SDS-PAGE, ELISA, diverse immunoassays, and wet chemistry techniques.

Support method development and optimization for product testing and manufacturing processes development and optimization.

Participate (and lead if needed) meetings/teleconferences with clients. Coordinate method development/validation/transfer activities delivering work that meets and exceeds clients’ expectations.

Perform all duties in strict compliance with SOPs, GMP, GLP and Safety guidelines.

How will you get here:

Minimum BS/BA with a concentration in Chemical or Biological Science or related field with 2+ years related experience, or Master’s degree, 1+ year related pharmaceutical experience is strongly preferred.

Experience:

Proficient with HPLC, GC, LC/MS, ICP, CE/SDS, ELISA, icIEF techniques.

Must be experienced and have a detailed understanding of GMP testing requirements.

Must have an extensive experience with analytical methods development and validation, and highly skilled in analytical methods troubleshooting.

Must have experience with technical writing-method validation protocols and reports, testing documents.

Knowledge, Skills, Abilities:

Outstanding analytical capability and problem-solving skills.

Ability to work as part of a team and influence others to achieve results.

Self-motivated with bias for action.

Strong communication (oral and written).

Excellent interpersonal and persuasive communications.

Outstanding follow up and planning skills.

Strong attention to details and ability to multitask.

Demonstrate the Thermo Fisher values (The Four I’s) – Integrity, Intensity, Innovation, and Involvement

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.