Senior Analyst/Scientist, Quality Control Chemistry
Woburn, Massachusetts
Employer: ACS Group
Industry: Biotech/R&D/Science
Salary: $45 - $55 per hour
Job type: Part-Time
Job Description
Innova Solutions is immediately hiring for a Senior Analyst / Scientist.
Position Summary
The Senior Analyst / Scientist's primary responsibility will be maintaining and troubleshooting LC-MS instruments and leading/supporting method lifecycle activities for LC-MS test method in support of routine GMP release and stability testing.
The Senior Analyst / Scientist will also support the gene therapy program pipeline including but not limited to technical transfer, method qualification, validation, verification, routine GMP testing of AAV vector analytical methods ( HPLC, AUC, UV, CE-SDS, compendia methods and other methods as needed ) for lot release and stability.
The Senior Analyst/ Scientist, Quality Control Chemistry, will support external laboratory testing and internal study protocol design, study report review and IND support as needed.
The Senior Analyst / Scientist will work cross-functionally with others in Quality Control, Analytical Development teams, Quality Assurance, and Manufacturing, as needed. The individual will also work on data trending, invalid assays investigations, quality events (investigations, deviations, Change control, CAPAs) and analytical assays for AAV efficacy (potency), safety and product quality.
Responsibilities
o Execute analytical test methods to support the clinical development of new AAV pipeline candidates and release testing of commercial products.
o Work with CROs for method development, validation, verification, and transfer, as needed.
o Verify and pre-validate analytical test methods in preparation for method transfer to GMP CMO facilities, as needed.
o Lead and supports routine laboratory operations (equipment cleaning, laboratory cleaning, inventory control, logbook management)
o Ensures laboratory operational readiness and assists with troubleshooting/continuous improvement as needed.
Support instrument lifecycle including,, but not limited to, instrument on-boarding, validation and troubleshooting/maintenance.
o Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs) for internal use and transfer to external sites.
o Performs peer review of both internal and externally generated data.
o Lead and support QC deviations, investigations, CAPA, Change control, analytical method performance trending and root cause analysis, as needed.
o Investigate and evaluate cutting edge biophysical and analytical instrumentation and stay up to date on state-of-the-art methodologies for AAV characterization.
o The job responsibilities may change as needed to support activities relevant to the clinical or commercial phase.
Qualifications:
o BS/MS Analytical Chemistry, Biochemistry, Biophysics, or a related discipline with at least 4 years of hands-on experience working with LC-MS based assays is in R&D / GLP/ cGMP environment is must.
o Experience working in the cGMP QC lab of the pharmaceutical or biopharmaceutical industry is preferred.
o HPLC/UPLC experience analyzing nucleic acids, virus capsids, antibodies, and/or other biologics materials by a variety of chromatographic methods (RP, SEC, IEX) is preferred.
o Experience working with external contract labs (CMOs, CROs) is a plus.
o Experience executing late-stage analytical comparability studies is preferred.
o Strong collaboration and team-working skills.
o Strong communication, interpersonal and organizational skills.
o Proven ability to work independently and effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
o Should be highly motivated, demonstrate good technical skills, have excellent organizational and communication skills, and be able to multitask in a fast-paced environment with changing priorities.
PAY RANGE AND BENEFITS:
Pay Range*: $45-55/hr
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
Website : https://www.innovasolutions.com/
Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
Innova Solutions is immediately hiring for a Senior Analyst / Scientist.
Position Summary
The Senior Analyst / Scientist's primary responsibility will be maintaining and troubleshooting LC-MS instruments and leading/supporting method lifecycle activities for LC-MS test method in support of routine GMP release and stability testing.
The Senior Analyst / Scientist will also support the gene therapy program pipeline including but not limited to technical transfer, method qualification, validation, verification, routine GMP testing of AAV vector analytical methods ( HPLC, AUC, UV, CE-SDS, compendia methods and other methods as needed ) for lot release and stability.
The Senior Analyst/ Scientist, Quality Control Chemistry, will support external laboratory testing and internal study protocol design, study report review and IND support as needed.
The Senior Analyst / Scientist will work cross-functionally with others in Quality Control, Analytical Development teams, Quality Assurance, and Manufacturing, as needed. The individual will also work on data trending, invalid assays investigations, quality events (investigations, deviations, Change control, CAPAs) and analytical assays for AAV efficacy (potency), safety and product quality.
Responsibilities
o Execute analytical test methods to support the clinical development of new AAV pipeline candidates and release testing of commercial products.
o Work with CROs for method development, validation, verification, and transfer, as needed.
o Verify and pre-validate analytical test methods in preparation for method transfer to GMP CMO facilities, as needed.
o Lead and supports routine laboratory operations (equipment cleaning, laboratory cleaning, inventory control, logbook management)
o Ensures laboratory operational readiness and assists with troubleshooting/continuous improvement as needed.
Support instrument lifecycle including,, but not limited to, instrument on-boarding, validation and troubleshooting/maintenance.
o Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs) for internal use and transfer to external sites.
o Performs peer review of both internal and externally generated data.
o Lead and support QC deviations, investigations, CAPA, Change control, analytical method performance trending and root cause analysis, as needed.
o Investigate and evaluate cutting edge biophysical and analytical instrumentation and stay up to date on state-of-the-art methodologies for AAV characterization.
o The job responsibilities may change as needed to support activities relevant to the clinical or commercial phase.
Qualifications:
o BS/MS Analytical Chemistry, Biochemistry, Biophysics, or a related discipline with at least 4 years of hands-on experience working with LC-MS based assays is in R&D / GLP/ cGMP environment is must.
o Experience working in the cGMP QC lab of the pharmaceutical or biopharmaceutical industry is preferred.
o HPLC/UPLC experience analyzing nucleic acids, virus capsids, antibodies, and/or other biologics materials by a variety of chromatographic methods (RP, SEC, IEX) is preferred.
o Experience working with external contract labs (CMOs, CROs) is a plus.
o Experience executing late-stage analytical comparability studies is preferred.
o Strong collaboration and team-working skills.
o Strong communication, interpersonal and organizational skills.
o Proven ability to work independently and effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
o Should be highly motivated, demonstrate good technical skills, have excellent organizational and communication skills, and be able to multitask in a fast-paced environment with changing priorities.
PAY RANGE AND BENEFITS:
Pay Range*: $45-55/hr
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
Website : https://www.innovasolutions.com/
Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
Created: 2024-06-14
Reference: 974001
Country: United States
State: Massachusetts
City: Woburn
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Senior Analyst/Scientist, Quality Control Chemistry
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