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Job Details

Staff Scientist Formulations

Company name
Thermo Fisher Scientific Inc.

Location
Fremont, CA

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Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll 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 you’ll be supported in achieving your career goals.

The Staff Scientist, Formulations is a manufacturing lead/specialist who works on resolving quality issues, driving manufacturing improvements and leading team of chemists as needed to meet the production schedule. This role may manufacture complex products and completes associated documentation, as well as contribute to the transfer of new products into Production.

Responsibilities:

Manufactures complex products following cGMP and completes all necessary documentation in accordance with quality system

Serves as back-up to supervisor for all department activities and has decision making and signature authority in the absence of supervisor

Leads and manages the team’s daily accountability and management boards

Attends required meeting (e.g. New Product Development, Design control, scheduling, etc.) as department representative

Resolves department NCAR and CAPA

Performs in-process assays using clinical analyzers. Review and analyze data. May perform product filtrations

Performs inventory transactions using MRP system

Provides direction, coordination, training and mentoring for all chemists, associate chemist, and associates

Writes, reviews, and modifies SOPs, work instructions, and reports

Reviews and approves completed batch records

Writes and executes validation protocols for equipment or processes

Has great technical knowledge of products and works with other departments to troubleshoot process and procedures and recommend solutions

Keeps department supervisor or manager updated on all issues

Maintain and analyze lot histories for trends and discrepancies

Leads Practical Process Improvement (PPI), Lean, and 5-S programs

Perform other job duties as required

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle or feel objects, tools, or controls; talk and hear; and smell

Regularly required to reach with hands and arms and stoop, kneel, crouch, or crawl

Frequently lift and/or move up to 50 pounds

Minimum Qualifications:

Bachelor’s degree in Biology, Biochemistry or scientific related discipline

5 years of related experience and/or training

Demonstrated leadership abilities with projects and/or teams

Strong understanding of Quality System Regulations, cGMP, and ISO; experience with NCAR and CAPA

Strong interpersonal skills

Experienced in working with potentially hazardous chemicals and human source materials

Preferred Qualifications:

Experience manufacturing In-Vitro Diagnostic quality control products

At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today

http://jobs.thermofisher.com

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.

Company info

Thermo Fisher Scientific Inc.
Website : http://www.thermofisher.com

Company Profile
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Our four premier brands - Thermo Scientific, Life Technologies, Fisher Scientific and Unity Lab Services - offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.

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