Analytical Chemist Biophysical Characterization

Boston, NH - USA

Monthly Salary: Not Disclosed

Posted on: 4 hours ago

Vacancies: 1 Vacancy

Job Summary

Eurofins is seeking a highly skilled passionate and motivated scientist to join our client Analytical Development team to support testing non-GMP samples for development studies such as comparability assessments process development stability product and process characterization. The Analytical Development team is responsible for developing and implementing new analytical methods as well as optimizing and improving current methods for the characterization of raw materials RNA drug substances and LNP products and programs at various development stages.

Develop optimize and execute analytical methods intended for a variety of purposes including release and stability testing product characterization high-throughput analysis and perform assays for characterization of complex raw materials.
Review interpret and present data within the analytical team and cross-functionally.
Provide technical oversight for troubleshooting and phase-appropriate qualification and validation of analytical assays for the analysis of gRNA mRNA and LNP.
Work in partnership with internal and/or external QC to coordinate analytical method transfer within the organization or at Contract Manufacturing Organizations (CMOs)/Contract Testing Laboratories (CTLs).
Author review and revise technical source documents to support phase-appropriate comparability.
Serve as the CMC representative on cross-functional project teams.
Provide technical oversight to guide analytical/QC investigations as needed.
Actively collaborate with internal and external process development and quality teams.
Train and mentor junior team members.

Qualifications :

Basic Minimum Qualifications:

Ph.D. in Analytical Chemistry Biochemistry Biophysics or related field with 2-4 years of biotech industry experience or M.S. degree with 3-7 years of biotech industry experience or B.S. degree with 5 years of biotech industry experience.
Hands-on experience developing qualifying and troubleshooting biophysical assays using analytical techniques such as HPLC/UPLC MS UV/Vis and FTIR.
Hands-on experience developing analytical methodologies such as IP-RP IEX LC-fluor multi-modal LC etc.
Strong technical background on advanced characterization instrumentation such as MALS and LC-MS NTA.
Proficiency with Waters and Agilent LCs.
Proficiency with software systems such as OpenLab Empower and ELN (Benchling is a plus).
Previous experience developing methods for mRNA (gRNA and LNP are a plus).
Excellent scientific knowledge in analytical chemistry with a conceptual understanding of solid-phase oligonucleotide synthesis and purification strategies.
Familiarity with applicable ICH regulations and multi-compendial guidelines related to method validation.
Experience in assay development qualification validation and implementation to support target candidate validation from non-GxP to GMP environments.
Proven track record of success collaborating effectively with cross-functional teams.
Ability to balance multiple responsibilities prioritize activities and navigate ambiguity.
Demonstrated learning agility scientific problem solving and strong written and verbal communication skills.
Proactive creative and positive attitude.
Unwavering commitment to safety protocols and procedures.

Preferred Qualifications:

Strong understanding of advanced characterization technologies and data interpretations such as cryo-TEM NMR DLS AUC etc.
Advanced understanding of lipid nanoparticle delivery production and purification.
Authorization to work in the United States indefinitely without restriction or sponsorship.

Additional Information :

The position is full-time first shift Monday-Friday with overtime as needed. Candidates living within a commutable distance of Boston MA are encouraged to apply.

Excellent full-time benefits include:

Comprehensive medical coverage dental and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Compensation: $50.00-$54.00 per hour based on education and experience

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

Remote Work :

Employment Type :

Full-time

Develop optimize and execute analytical methods intended for a variety of purposes including release and stability testing product characterization high-throughput analysis and perform assays for characterization of complex raw materials.
Review interpret and present data within the analytical team and cross-functionally.
Provide technical oversight for troubleshooting and phase-appropriate qualification and validation of analytical assays for the analysis of gRNA mRNA and LNP.
Work in partnership with internal and/or external QC to coordinate analytical method transfer within the organization or at Contract Manufacturing Organizations (CMOs)/Contract Testing Laboratories (CTLs).
Author review and revise technical source documents to support phase-appropriate comparability.
Serve as the CMC representative on cross-functional project teams.
Provide technical oversight to guide analytical/QC investigations as needed.
Actively collaborate with internal and external process development and quality teams.
Train and mentor junior team members.

Qualifications :

Basic Minimum Qualifications:

Ph.D. in Analytical Chemistry Biochemistry Biophysics or related field with 2-4 years of biotech industry experience or M.S. degree with 3-7 years of biotech industry experience or B.S. degree with 5 years of biotech industry experience.
Hands-on experience developing qualifying and troubleshooting biophysical assays using analytical techniques such as HPLC/UPLC MS UV/Vis and FTIR.
Hands-on experience developing analytical methodologies such as IP-RP IEX LC-fluor multi-modal LC etc.
Strong technical background on advanced characterization instrumentation such as MALS and LC-MS NTA.
Proficiency with Waters and Agilent LCs.
Proficiency with software systems such as OpenLab Empower and ELN (Benchling is a plus).
Previous experience developing methods for mRNA (gRNA and LNP are a plus).
Excellent scientific knowledge in analytical chemistry with a conceptual understanding of solid-phase oligonucleotide synthesis and purification strategies.
Familiarity with applicable ICH regulations and multi-compendial guidelines related to method validation.
Experience in assay development qualification validation and implementation to support target candidate validation from non-GxP to GMP environments.
Proven track record of success collaborating effectively with cross-functional teams.
Ability to balance multiple responsibilities prioritize activities and navigate ambiguity.
Demonstrated learning agility scientific problem solving and strong written and verbal communication skills.
Proactive creative and positive attitude.
Unwavering commitment to safety protocols and procedures.

Preferred Qualifications:

Strong understanding of advanced characterization technologies and data interpretations such as cryo-TEM NMR DLS AUC etc.
Advanced understanding of lipid nanoparticle delivery production and purification.
Authorization to work in the United States indefinitely without restriction or sponsorship.

Additional Information :

The position is full-time first shift Monday-Friday with overtime as needed. Candidates living within a commutable distance of Boston MA are encouraged to apply.

Excellent full-time benefits include:

Comprehensive medical coverage dental and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Compensation: $50.00-$54.00 per hour based on education and experience

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

Remote Work :

Employment Type :

Full-time

Key Skills

Gas Chromatography
Laboratory Experience
Analytical Chemistry
FDA Regulations
Wet chemistry
Biochemistry
Chromatography
High-Performance Liquid Chromatography
Industrial Laboratory Experience
Spectroscopy
GLP
cGMP

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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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