- Ability to work in a GLP or GMP environment with appropriate documentation and safety practice.
- Independently develop utilize and validate test methods containing advanced analytical techniques such as liquid chromatography (HPLC UPLC) USP/EP dissolution testing mass spectrometry vibrational spectroscopy gas chromatography and/or Karl Fischer titration to characterize drug products APIs intermediates and impurities in support of formulation.
- Develop dissolution methodologies that will provide some measure of an in vivo / in vitro relationship and serve as a quality control procedure.
- Develop and execute studies to ascertain degradation mechanisms in a variety of environmental formulation and stress conditions.
- Assess stability risks by evaluating process changes and impact on degradation chemistry or dissolution profile. This would involve DoEs and accelerated stability studies.
- Develop assay/purity methods and assessment of method robustness/ruggedness
- Develop and execute method validation protocols.
- Transfer analytical methods to other laboratories and remote sites.
- Hands-on generation of data in support of accelerated and registration stability studies.
- Mentor junior chemists by guiding analytical best practices experimental design and data interpretation.
Qualifications :
- Bachelors degree in chemistry or other related degree concentration with 5 years of experience or a Masters degree with 2-4 years of experience.
- At least three years of experience in product development and analytical chemistry
- Strong computer scientific and organizational skills
- Excellent communication (oral and written) and attention to detail
- Ability to work independently and as part of a team self-motivation adaptability and a positive attitude
- Ability to learn new techniques perform multiple tasks simultaneously keep accurate records follow instructions and comply with company policies
Additional Information :
- The position is full-time Monday through Friday 8 a.m. to 5 p.m.
- May be requested to work on weekends overtime and holidays based on business needs.
- Candidates currently living within a commutable distance of Groton CT are encouraged to apply.
- Ability to work overtime as required.
- 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
- #LI-EB1
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
Ability to work in a GLP or GMP environment with appropriate documentation and safety practice.Independently develop utilize and validate test methods containing advanced analytical techniques such as liquid chromatography (HPLC UPLC) USP/EP dissolution testing mass spectrometry vibrational spectros...
- Ability to work in a GLP or GMP environment with appropriate documentation and safety practice.
- Independently develop utilize and validate test methods containing advanced analytical techniques such as liquid chromatography (HPLC UPLC) USP/EP dissolution testing mass spectrometry vibrational spectroscopy gas chromatography and/or Karl Fischer titration to characterize drug products APIs intermediates and impurities in support of formulation.
- Develop dissolution methodologies that will provide some measure of an in vivo / in vitro relationship and serve as a quality control procedure.
- Develop and execute studies to ascertain degradation mechanisms in a variety of environmental formulation and stress conditions.
- Assess stability risks by evaluating process changes and impact on degradation chemistry or dissolution profile. This would involve DoEs and accelerated stability studies.
- Develop assay/purity methods and assessment of method robustness/ruggedness
- Develop and execute method validation protocols.
- Transfer analytical methods to other laboratories and remote sites.
- Hands-on generation of data in support of accelerated and registration stability studies.
- Mentor junior chemists by guiding analytical best practices experimental design and data interpretation.
Qualifications :
- Bachelors degree in chemistry or other related degree concentration with 5 years of experience or a Masters degree with 2-4 years of experience.
- At least three years of experience in product development and analytical chemistry
- Strong computer scientific and organizational skills
- Excellent communication (oral and written) and attention to detail
- Ability to work independently and as part of a team self-motivation adaptability and a positive attitude
- Ability to learn new techniques perform multiple tasks simultaneously keep accurate records follow instructions and comply with company policies
Additional Information :
- The position is full-time Monday through Friday 8 a.m. to 5 p.m.
- May be requested to work on weekends overtime and holidays based on business needs.
- Candidates currently living within a commutable distance of Groton CT are encouraged to apply.
- Ability to work overtime as required.
- 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
- #LI-EB1
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
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