Associate Director, Quality Control Nucleic Acids Testing (NAT)
The Associate Director of Quality Control Nucleic Acids Testing will be responsible for overseeing a laboratory charged with the execution of all GMP Nucleic Acids Tests (release and stability) related to Sarepta's Gene Therapy pipeline.
The Associate Director will build and oversee a team of four to eight QC technicians with testing responsibilities that include a variety of PCR modalities (qPCR, RT-qPCR, ddPCR, and/or digital PCR).
The AD will work with QC Data Management and QC-Operations teams to guarantee the timely delivery and authorization of test data as well as ensuring an inspection ready lab is maintained at all times.
The AD-QC Nucleic Acids Testing (NAT) will work cross-functionally with members of the Analytical Development and QC-Technical Services (QC-TS) teams to develop, transfer, and qualify phase appropriate assays in support of the Sarepta Gene Therapy pipeline.
Primary
Responsibilities:
Provide technical leadership and subject matter expertise to the Nucleic Acids testing team to ensure the successful execution of all GMP release and stability PCR testing executed in support of Sarepta' s Gene Therapy programs (currently 1 commercial program and 5
active clinical programs).
Develop and manage a team of four to eight Quality Control technicians, with a strong emphasis on training and right-first-time performance.
Schedule testing to ensure the timely delivery of data to support continuous product supply.
Track and trend all nucleic acids test data and reference standard performance data.
Identify OOS, OOT, invalid, and unexpected test results, institute swift, thorough, and compliant investigations to identify root cause and implement appropriate corrective actions.
Resolve/close all Quality Events (deviations, CAPAs, investigations, change controls, etc.
) promptly and on-time.
Maintain the laboratory in a compliant, GMP-inspection ready state at all times.
Establish cross-functional relationships with Sarepta Analytical Development and Quality Control-Technical Services (QC-TS) teams to ensure all NAT assays introduced to QC are compliant and sufficiently robust.
Work with Sarepta QC-TS to draft and execute internal tech transfers, method qualification, and method validation protocols.
Work with Sarepta Quality assurance to draft and approve method, reference standard, qualification, and validation reports.
Support all regulatory submission and address health authority questions for all IND, INDa, BLA, and NDA approvals.
Provide technical support to CTLs and CDMOs as needed.
Desired Education and Skills:
BA/BS degree in a related field with 10
years related experience, or MA/MS degree in a related field with 8
years related experience, or AA/AS degree in a related field with 12
years related experienceFive to eight years of experience building, developing, and managing GMP Quality Control testing teams is required.
Experience with Advanced Therapeutic Medicinal Products (ATMPs, gene therapies) is highly desired.
A strong understanding and practical experience with PCR, qPCR, and ddPCR is required.
An understanding and practical experience with DNA sequencing (Sanger and NGS) is highly desired.
Solid understanding and direct experience applying basic statistical tools for data analysis and trending.
A solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to nucleic acids testing and method qualification/validation is necessary.
Diligence with exceptional and demonstrable record keeping / documentation skills.
Extensive technical writing skills.
Experience drafting GMP SOPs, protocols and reports.
Project management skills including the ability to manage one's project resource requirements (material, workforce, time, etc.
), and ability to elevate relevant issues to project lead and line-management.
Strong interpersonal skills and a proven ability to communicate effectively through verbal and written formats.
Self-starter with the ability to work in a fast-paced, cross-functional, highly collaborative environment.
#LI-OnsiteThis position requires work on site at one of Sarepta's facilities in the United States.
The targeted salary range for this position is $156,000 - $195,000 per year.
Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges.
The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.
S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
SummaryLocation:
Andover, MAType:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
The Associate Director will build and oversee a team of four to eight QC technicians with testing responsibilities that include a variety of PCR modalities (qPCR, RT-qPCR, ddPCR, and/or digital PCR).
The AD will work with QC Data Management and QC-Operations teams to guarantee the timely delivery and authorization of test data as well as ensuring an inspection ready lab is maintained at all times.
The AD-QC Nucleic Acids Testing (NAT) will work cross-functionally with members of the Analytical Development and QC-Technical Services (QC-TS) teams to develop, transfer, and qualify phase appropriate assays in support of the Sarepta Gene Therapy pipeline.
Primary
Responsibilities:
Provide technical leadership and subject matter expertise to the Nucleic Acids testing team to ensure the successful execution of all GMP release and stability PCR testing executed in support of Sarepta' s Gene Therapy programs (currently 1 commercial program and 5
active clinical programs).
Develop and manage a team of four to eight Quality Control technicians, with a strong emphasis on training and right-first-time performance.
Schedule testing to ensure the timely delivery of data to support continuous product supply.
Track and trend all nucleic acids test data and reference standard performance data.
Identify OOS, OOT, invalid, and unexpected test results, institute swift, thorough, and compliant investigations to identify root cause and implement appropriate corrective actions.
Resolve/close all Quality Events (deviations, CAPAs, investigations, change controls, etc.
) promptly and on-time.
Maintain the laboratory in a compliant, GMP-inspection ready state at all times.
Establish cross-functional relationships with Sarepta Analytical Development and Quality Control-Technical Services (QC-TS) teams to ensure all NAT assays introduced to QC are compliant and sufficiently robust.
Work with Sarepta QC-TS to draft and execute internal tech transfers, method qualification, and method validation protocols.
Work with Sarepta Quality assurance to draft and approve method, reference standard, qualification, and validation reports.
Support all regulatory submission and address health authority questions for all IND, INDa, BLA, and NDA approvals.
Provide technical support to CTLs and CDMOs as needed.
Desired Education and Skills:
BA/BS degree in a related field with 10
years related experience, or MA/MS degree in a related field with 8
years related experience, or AA/AS degree in a related field with 12
years related experienceFive to eight years of experience building, developing, and managing GMP Quality Control testing teams is required.
Experience with Advanced Therapeutic Medicinal Products (ATMPs, gene therapies) is highly desired.
A strong understanding and practical experience with PCR, qPCR, and ddPCR is required.
An understanding and practical experience with DNA sequencing (Sanger and NGS) is highly desired.
Solid understanding and direct experience applying basic statistical tools for data analysis and trending.
A solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to nucleic acids testing and method qualification/validation is necessary.
Diligence with exceptional and demonstrable record keeping / documentation skills.
Extensive technical writing skills.
Experience drafting GMP SOPs, protocols and reports.
Project management skills including the ability to manage one's project resource requirements (material, workforce, time, etc.
), and ability to elevate relevant issues to project lead and line-management.
Strong interpersonal skills and a proven ability to communicate effectively through verbal and written formats.
Self-starter with the ability to work in a fast-paced, cross-functional, highly collaborative environment.
#LI-OnsiteThis position requires work on site at one of Sarepta's facilities in the United States.
The targeted salary range for this position is $156,000 - $195,000 per year.
Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges.
The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.
S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
SummaryLocation:
Andover, MAType:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
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