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Senior Process Development Scientist (Microbiology)

Expired Job

Thermo Fisher Scientific Inc. Saint Louis , MO 63150

Posted 3 months ago

Job ID :
74170BR

Location :

US - Missouri - St. Louis

:

Job Description

Sr. Regulatory Compliance Associate

Requisition ID: 73858BR

When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information

St. Louis, MO

How will you make an impact?

Oversee the contamination control systems of the site as a Microbiology Subject Matter Expert (SME). Act as a liaison between the Quality Control and Manufacturing teams. Lead investigations and drive positive change towards improving the site's level of microbial control. Establish microbial testing and contamination control strategy for clients. Participate in technical discussions with clients with a high level of technical proficiency. Make decisions that require developing new options to solve complex problems. Partner with manufacturing, manufacturing technical services, process engineering (TT) and process validation to ensure that the client processes and manufacturing areas remain in a state of control.

What will you do?

  • Provide Microbiological technical expertise at the site.

  • Participate in Health Authority, client and internal audits.

  • Develop and maintain site and global policies and procedures related to microbiology, contamination control and environmental monitoring to ensure consistency and compliance across the network.

  • Lead, manage and/or participate in the investigation of non-conformances related to contamination or GMP systems e.g., water systems and HVAC (as applicable) in compliance with quality procedures, policies and regulations.

  • Ensure adequate microbiological training of employees at the site.

  • Proactively observe manufacturing activities from a microbiological perspective and communicate findings appropriately with supervision. Participate in Process Risk Assessments.

  • Perform trending of environmental data and report results to manufacturing staff and supervision.

  • Process validation including Microbial Ingress Risk Assessment and Microbial Mapping of client processes.

  • Prepare protocols, reports, and test methods and writes SOPs.

  • Maintain and ensure safe laboratory environment and work practices.

  • Remain current in the field by review of relevant scientific literature and attendance at appropriate scientific seminars and conferences.

How will you get here?

Education

  • Bachelor's degree, Master's degree, or PhD in Microbiology, Biology, Chemistry, Biochemistry or a related field.

Experience

  • With Bachelor's degree, a minimum of 8 years of experience related to pharmaceutical manufacturing, process, development or academic laboratory and that includes relevant industry and discipline experience.

  • With Master's degree, a minimum of 6 years of experience related to pharmaceutical manufacturing, process, development or academic laboratory and that includes at least 2 years of relevant industry discipline experience.

  • With PhD, significant practical scientific application directly related to job responsibilities; related industry and discipline experience preferred.

  • Advanced and deep knowledge of varied aspects or a specialized aspect of microbiology and working knowledge of principles and concepts in other relevant disciplines.

Knowledge, Skills, Abilities

  • Strong knowledge of general cGXP procedures and those specific to discipline

  • Strong knowledge of GMP/GLP regulations in cGMP/cGLP manufacturing environment.

  • Demonstrated leadership skills.

  • Excellent problem solving and critical thinking skills.

  • Strong MS Excel, PowerPoint and Word skills. Microsoft Project skills preferred.

  • Excellent writing, communication, and presentation skills.

  • Excellent organization and planning skills.

  • Strong attention to detail and ability to adhere to standard procedures

  • Ability to analyze and summarize complex scientific data

  • Ability to author reports, procedures, and other documents.

  • Ability to function in a rapidly changing environment.

  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.

  • Ability to make and communicate complex decisions.

  • Ability to speak effectively before groups of customers and employees.

  • Ability to lead and mentor less experienced staff.

  • Ability to adhere to EHS policies and procedures and ensure a safe and healthy workplace environment

At Thermo Fisher Scientific, each one of our 70,000 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.

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.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.

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.


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Senior Process Development Scientist (Microbiology)

Expired Job

Thermo Fisher Scientific Inc.