Associate Director, GxP Compliance, Clinical Assay, Supplies and Logistics (CASL)
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Posted : Sunday, September 17, 2023 08:10 PM
The Role
We are seeking a highly motivated, collaborative, and innovative Associate Director of GLP/GcLP Compliance within the Clinical Assay, Supplies and Logistics (CASL) team who will be responsible for performing and overseeing QC activities within the Clinical Biomarker Laboratories (Immuno-Assays BioAnalytics, Virus Neutralization, Biobank, Flow Cytometry, Spectrometry, etc.
) at the Moderna facility in Norwood, MA.
This position will work closely with the different Bioanalytical and Molecular Assays teams to ensure laboratory data are compliant with current regulatory, industry, and Moderna standards and that data are of the required quality (regulatory and scientific).
Additionally, the Sr.
Manager will monitor laboratory metrics and review and approve excursions associated with routine laboratory operations.
The Associate Director will perform compliance and quality control (QC) assessments related to laboratory activities and will play an integral role in the identification and management of compliance and quality issues and support deviation management, CAPA management and investigations.
The compliance and QC assessments will be performed across multiple laboratory processes including, as examples, bioanalytical assays (e.
g.
, multiplexing ligand binding assays, cell-based assays, Immunoassays, PCR assays, LC-MS assays ), and PK (pharmacokinetics, pharmacodynamics), immunogenicity assays on primary and secondary endpoints (e.
g.
, LNP and/or mRNA derived proteins).
In addition, the Associate Director will perform and evaluate QC assessments on neutralizing antibodies, e.
g.
, Virus Neutralization assays, and Flow Cytometry assays etc.
within the respective laboratories.
Here’s What You’ll Do Collaborate with Clinical Pharmacology, Clinical Biomarkers, Clinical Development/ Operations, and Research to perform on-going risk assessments and monitoring of GxP laboratory activities and processes to ensure quality, compliance, and process improvement activities across the specialty GxP Clinical Biomarker Laboratories.
Perform comprehensive Quality Check (QC) reviews and analysis of data generated from bioanalytical laboratory assay investigations.
Identify, review, and address analytical testing excursions including deviations, CAPAs and OOSs.
Performs routine assessments of the laboratory work areas, processes, and equipment for compliance to safety, quality, and regulatory requirements.
Plan and oversee compliance investigations to support root cause analysis of critical and major deviations, compliance incidents, scientific fraud, and misconduct.
Coordinate with management and site operational leadership to ensure appropriate corrective and preventative actions are taken.
Collect and monitor quality / compliance metrics to provide regular status updates on quality and compliance and training metrics and highlight ongoing trends, signals, and actions taken.
Facilitate quality and compliance review meetings, track and trend the state of quality and compliance across the specialty GxP Clinical Biomarker Laboratories.
Provide consultation and compliance advice to the operational team on GxP laboratory matters, e.
g.
, revise/re-write controlled documents, validation of GxP systems, etc.
Support the development of Inspection Readiness processes across the biomarker laboratories.
Evaluate responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution Create and/or re-write relevant SOPs based on findings from the Biomarker Laboratory quality and compliance findings.
Organize, prioritize, and manage all aspects of workload to meet business needs.
Here’s What You’ll Need (Minimum Qualifications) Master’s degree in biology, chemistry, biochemistry, pharmaceutical science, pharmacology, or a related scientific discipline, along with a minimum of 3 years of experience, or a related bioanalysis of clinical and preclinical samples.
Analytical mindset, strong-problem-solving abilities, and adaptability to changing priorities and deadlines in a fast-paced laboratory setting.
Highly motivated individual with a strong intellectual and technical background in bioanalytical methods with expert level knowledge of reviewing biomarker assays data.
Experience with bioanalysis, reporting, and interpretation of data from nonclinical and clinical studies as well as the bioanalytical flow from discovery to production including technology transfer and oversight of the Sponsor-CRO relationship.
Working knowledge of quality systems, Electronic Laboratory Information Systems, and associated regulatory requirements (21 CRF Part 11/210/211).
Demonstrated ability to build and maintain positive and collaborative relationships with management, peers, direct reports, and externally with third-party contract organizations.
Proficiency in Microsoft Office, particularly MS Excel and MS PowerPoint.
Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance.
Self-motivated, detail-oriented leader with exceptional organizational, leadership and interpersonal skills Experience with bioanalysis, reporting, and interpretation of data from nonclinical and clinical studies as well as the bioanalytical flow from discovery to production including technology transfer and oversight of the Sponsor-CRO relationship.
Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance.
Self-motivated, detail-oriented leader with exceptional organizational, leadership and interpersonal skills Here’s What You’ll Bring to the Table (Preferred Qualifications) You drive for results and set a high bar for yourself and others.
A natural ability to be organized in how you think, communicate, and conduct your work.
A ‘digital first’ mindset A curious mindset that allows you to constantly learn and challenge the status quo.
Great pride in your work - you recruit because you love it and enjoy having an impact on the growth of the Company.
Respect for others and a desire to work as a team.
We win together.
Strong Excel skills and solid experience with PowerPoint and Word A spirit of optimism, positivity and ‘anything is possible’ mindset.
Sense of humor and ability to be flexible in a fast-paced environment Preferred: Experience with Workday Recruiting Preferred: Experience conducting behavioral based interviews and leading the process with clients Preferred: Curiosity around technology and how to leverage to make better hiring decision A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including: Highly competitive and inclusive medical, dental and vision coverage options Flexible Spending Accounts for medical expenses and dependent care expenses Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities Family care benefits, including subsidized back-up care options and on-demand tutoring Free premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipment Adoption and family-planning benefits Dedicated care coordination support for our LGBTQ+ community Generous paid time off, including: • Vacation, sick time and holidays • Volunteer time to participate within your community • D iscretionary year-end shutdown • Paid sabbatical after 5 years; every 3 years thereafter Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning tools Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options Complimentary concierge service including home services research, travel booking, and entertainment requests Free parking or subsidized commuter passes Location-specific perks and extras! About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team.
We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture.
Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.
S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.
com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow.
If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.
Moderna is an E-Verify Employer in the United States.
We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society.
We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.
com .
(EEO/AAP Employer) -
) at the Moderna facility in Norwood, MA.
This position will work closely with the different Bioanalytical and Molecular Assays teams to ensure laboratory data are compliant with current regulatory, industry, and Moderna standards and that data are of the required quality (regulatory and scientific).
Additionally, the Sr.
Manager will monitor laboratory metrics and review and approve excursions associated with routine laboratory operations.
The Associate Director will perform compliance and quality control (QC) assessments related to laboratory activities and will play an integral role in the identification and management of compliance and quality issues and support deviation management, CAPA management and investigations.
The compliance and QC assessments will be performed across multiple laboratory processes including, as examples, bioanalytical assays (e.
g.
, multiplexing ligand binding assays, cell-based assays, Immunoassays, PCR assays, LC-MS assays ), and PK (pharmacokinetics, pharmacodynamics), immunogenicity assays on primary and secondary endpoints (e.
g.
, LNP and/or mRNA derived proteins).
In addition, the Associate Director will perform and evaluate QC assessments on neutralizing antibodies, e.
g.
, Virus Neutralization assays, and Flow Cytometry assays etc.
within the respective laboratories.
Here’s What You’ll Do Collaborate with Clinical Pharmacology, Clinical Biomarkers, Clinical Development/ Operations, and Research to perform on-going risk assessments and monitoring of GxP laboratory activities and processes to ensure quality, compliance, and process improvement activities across the specialty GxP Clinical Biomarker Laboratories.
Perform comprehensive Quality Check (QC) reviews and analysis of data generated from bioanalytical laboratory assay investigations.
Identify, review, and address analytical testing excursions including deviations, CAPAs and OOSs.
Performs routine assessments of the laboratory work areas, processes, and equipment for compliance to safety, quality, and regulatory requirements.
Plan and oversee compliance investigations to support root cause analysis of critical and major deviations, compliance incidents, scientific fraud, and misconduct.
Coordinate with management and site operational leadership to ensure appropriate corrective and preventative actions are taken.
Collect and monitor quality / compliance metrics to provide regular status updates on quality and compliance and training metrics and highlight ongoing trends, signals, and actions taken.
Facilitate quality and compliance review meetings, track and trend the state of quality and compliance across the specialty GxP Clinical Biomarker Laboratories.
Provide consultation and compliance advice to the operational team on GxP laboratory matters, e.
g.
, revise/re-write controlled documents, validation of GxP systems, etc.
Support the development of Inspection Readiness processes across the biomarker laboratories.
Evaluate responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution Create and/or re-write relevant SOPs based on findings from the Biomarker Laboratory quality and compliance findings.
Organize, prioritize, and manage all aspects of workload to meet business needs.
Here’s What You’ll Need (Minimum Qualifications) Master’s degree in biology, chemistry, biochemistry, pharmaceutical science, pharmacology, or a related scientific discipline, along with a minimum of 3 years of experience, or a related bioanalysis of clinical and preclinical samples.
Analytical mindset, strong-problem-solving abilities, and adaptability to changing priorities and deadlines in a fast-paced laboratory setting.
Highly motivated individual with a strong intellectual and technical background in bioanalytical methods with expert level knowledge of reviewing biomarker assays data.
Experience with bioanalysis, reporting, and interpretation of data from nonclinical and clinical studies as well as the bioanalytical flow from discovery to production including technology transfer and oversight of the Sponsor-CRO relationship.
Working knowledge of quality systems, Electronic Laboratory Information Systems, and associated regulatory requirements (21 CRF Part 11/210/211).
Demonstrated ability to build and maintain positive and collaborative relationships with management, peers, direct reports, and externally with third-party contract organizations.
Proficiency in Microsoft Office, particularly MS Excel and MS PowerPoint.
Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance.
Self-motivated, detail-oriented leader with exceptional organizational, leadership and interpersonal skills Experience with bioanalysis, reporting, and interpretation of data from nonclinical and clinical studies as well as the bioanalytical flow from discovery to production including technology transfer and oversight of the Sponsor-CRO relationship.
Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance.
Self-motivated, detail-oriented leader with exceptional organizational, leadership and interpersonal skills Here’s What You’ll Bring to the Table (Preferred Qualifications) You drive for results and set a high bar for yourself and others.
A natural ability to be organized in how you think, communicate, and conduct your work.
A ‘digital first’ mindset A curious mindset that allows you to constantly learn and challenge the status quo.
Great pride in your work - you recruit because you love it and enjoy having an impact on the growth of the Company.
Respect for others and a desire to work as a team.
We win together.
Strong Excel skills and solid experience with PowerPoint and Word A spirit of optimism, positivity and ‘anything is possible’ mindset.
Sense of humor and ability to be flexible in a fast-paced environment Preferred: Experience with Workday Recruiting Preferred: Experience conducting behavioral based interviews and leading the process with clients Preferred: Curiosity around technology and how to leverage to make better hiring decision A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including: Highly competitive and inclusive medical, dental and vision coverage options Flexible Spending Accounts for medical expenses and dependent care expenses Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities Family care benefits, including subsidized back-up care options and on-demand tutoring Free premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipment Adoption and family-planning benefits Dedicated care coordination support for our LGBTQ+ community Generous paid time off, including: • Vacation, sick time and holidays • Volunteer time to participate within your community • D iscretionary year-end shutdown • Paid sabbatical after 5 years; every 3 years thereafter Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning tools Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options Complimentary concierge service including home services research, travel booking, and entertainment requests Free parking or subsidized commuter passes Location-specific perks and extras! About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team.
We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture.
Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.
S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.
com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow.
If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.
Moderna is an E-Verify Employer in the United States.
We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society.
We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.
com .
(EEO/AAP Employer) -
• Phone : NA
• Location : Norwood, MA
• Post ID: 9004655118
