Senior Scientist, Global Pathogen Safety Support

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 2 hours ago

Vacancies: 1 Vacancy

Job Summary

Eurofins PSS is looking for a candidate to join the mission of the Global Pathogen Safety (GPS) Support Team is the development and evaluation of reduction strategies for viruses and other pathogens/adventitious agents to provide products that patients can trust and know to be safe.

Main Responsibilities and Accountabilities:

Be the subject matter expert for all pathogen safety aspects of the biological products in scope. This includes providing expertise and documentation with regards to drug product development manufacturing procedures (pathogen reduction steps cleaning etc.) starting material selection and testing.
Collaborate with various functions across the global company organization including Global Regulatory Affairs and Pharmacovigilance as well as the local Manufacturing/Operations units on Pathogen Safety relevant matters. Provide global and local deviation and change risk assessments regulatory submission documents position papers presentations training materials and data analyses in support of the business needs.
Ensure global alignment both with regulatory guidelines/expectations and within GPS. Organize and assemble data and supporting documentation and conduct scientific literature searches. Analyze epidemiological data and monitor and assess emerging pathogens.
Effective contributor to the Global Pathogen Safety Support Team. Actively participate in meetings and seek innovative solutions to provide excellent support across the company. Create efficiencies across the global Pathogen Safety organization i.e. setting up standard procedures (SOPs) white papers etc.

Actively participate on cross-functional project teams and global project teams. E.g. provide Guidance on and co-development of pathogen reduction steps for new products in development and for Life Cycle of existing commercial products. You collaborate with the GPS Virological Development Laboratories to evaluate experimental results and contribute to establishment of Quality by Design e.g. definition of targets robustness ranges and critical parameters.

Qualifications :

University Degree in life sciences: Masters or PhD in Virology Biochemistry Biology or in a related field.
Authorization to work in the United States indefinitely without restriction or sponsorship
2-5 years of experience in R&D Manufacturing Sciences Quality or a related field in the pharmaceutical industry.
Strong scientific and analytical skills in biochemistry virology and/or microbiology. Ability to work independently to address scientific questions. Previous experience in pathogen safety vaccines and/or plasma-derived drug products is a plus.
Ability and flexibility to work across sites and across international teams (including willingness to participate regularly in global teleconference meetings outside local business hours).
Works effectively across varied and different international conditions. Understands and respects differences in people and cultures.

Additional Information :

Additional information

Position is full-time Monday-Friday 8am-5pm with overtime as needed. Candidates currently living within a commutable distance of Holly Springs NC are encouraged to apply.

What we offer:

Excellent full time benefits including comprehensive medical coverage dental and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

Employment Type :

Full-time

Main Responsibilities and Accountabilities:

Be the subject matter expert for all pathogen safety aspects of the biological products in scope. This includes providing expertise and documentation with regards to drug product development manufacturing procedures (pathogen reduction steps cleaning etc.) starting material selection and testing.
Collaborate with various functions across the global company organization including Global Regulatory Affairs and Pharmacovigilance as well as the local Manufacturing/Operations units on Pathogen Safety relevant matters. Provide global and local deviation and change risk assessments regulatory submission documents position papers presentations training materials and data analyses in support of the business needs.
Ensure global alignment both with regulatory guidelines/expectations and within GPS. Organize and assemble data and supporting documentation and conduct scientific literature searches. Analyze epidemiological data and monitor and assess emerging pathogens.
Effective contributor to the Global Pathogen Safety Support Team. Actively participate in meetings and seek innovative solutions to provide excellent support across the company. Create efficiencies across the global Pathogen Safety organization i.e. setting up standard procedures (SOPs) white papers etc.

Actively participate on cross-functional project teams and global project teams. E.g. provide Guidance on and co-development of pathogen reduction steps for new products in development and for Life Cycle of existing commercial products. You collaborate with the GPS Virological Development Laboratories to evaluate experimental results and contribute to establishment of Quality by Design e.g. definition of targets robustness ranges and critical parameters.

Qualifications :

University Degree in life sciences: Masters or PhD in Virology Biochemistry Biology or in a related field.
Authorization to work in the United States indefinitely without restriction or sponsorship
2-5 years of experience in R&D Manufacturing Sciences Quality or a related field in the pharmaceutical industry.
Strong scientific and analytical skills in biochemistry virology and/or microbiology. Ability to work independently to address scientific questions. Previous experience in pathogen safety vaccines and/or plasma-derived drug products is a plus.
Ability and flexibility to work across sites and across international teams (including willingness to participate regularly in global teleconference meetings outside local business hours).
Works effectively across varied and different international conditions. Understands and respects differences in people and cultures.

Additional Information :

Additional information

Position is full-time Monday-Friday 8am-5pm with overtime as needed. Candidates currently living within a commutable distance of Holly Springs NC are encouraged to apply.

What we offer:

Excellent full time benefits including comprehensive medical coverage dental and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

Employment Type :

Full-time

Key Skills

Laboratory Experience
Mammalian Cell Culture
Biochemistry
Assays
Protein Purification
Research Experience
Next Generation Sequencing
Research & Development
cGMP
Cell Culture
Molecular Biology
Flow Cytometry

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About Company

Eurofins

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eur ... View more

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