Manager/Sr. Manager, CMO Support/Tech Transfer GT

  • Sarepta Therapeutics
  • $108,380.00 - 167,060.00 / Year *
  • 413 Market St, Brighton, MA 02135
  • Full-Time
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Sarepta Therapeutics, headquartered in Cambridge, Massachusetts, is a commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates. For more information, please visit us at www.sarepta.com.

Sarepta Therapeutics
Manager/Sr. Manager, CMO Support/Tech Transfer GT
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Description
The Position:
The Manager/Sr. Manager will work within QA to support outsourcing of Sarepta technology and CMO start-up and scale up for Gene Therapy products. He/she will support work within QA and at CMOs for technical transfer, risk assessments, process control strategy, product lifecycle management, design space, change control activities for clinical/commercial Gene Therapy, drug product, packaging/labeling, and shipping activities. The role will involve close collaboration with small teams to meet program deliverables.
Primary Responsibilities include:
* Work with cross-functional teams during development and pilot scale batch production, scale-up/transfer trial at new or existing CMOs.
* Assist in Quality Risk Assessment processes at applicable development gates, and in conjunction with Director of QA propose remediation plans to address them.
* Collaborate with development to ensure that new products meet requirements for quality and compliance.
* Ensure risk assessments and change controls are followed and completed in a timely manner.
* Ensure tech transfer plans (e.g. protocols and reports) risk assessment, change controls are completed in a timely manner.
* Review process and/or product documentation Master Manufacturing Batch records, etc to ensure accuracy to process control strategy.
* Execute assigned Quality project deliverables with occasional consultation with functional management as required.
* Assist with writing and reviewing comparability reports.
* Assist with deviations and investigations related to tech transfer, start up and scale up activities.
Ensure that new CMO start up is compliant to FDA/EU and Sarepta compliance expectations.
* Ensure that all quality project activities are completed per timeline.
* Ensure successful project transfer to Sarepta QA Validation.
Education and Skills Requirements:
* Bachelor's Degree required; Bachelor's Degree or higher in a scientific discipline preferred
* Minimum 7-10 years' experience in a regulated industry required in a Quality Assurance Technology Transfer/Validation role preferred
* Excellent organizational skills; ability to work independently and in team environments; understanding of FDA/EU GMP Quality Requirements, ISPE Tech Transfer and ICH Q8.
* Experience with biologics/gene therapy processes, technology transfer, risk assessments, change controls is a must.
* Experience in supporting CMO audits a plus.
* Knowledge of, aseptic filling, packaging/labeling, and ICH Q8 is preferred.
* Quality Assurance, Validation, and Technology Transfer experience with general Quality Management Systems in a regulated environment.
* Proficiency in Microsoft Office Suite including editing, formatting, utilizing templates, creating forms and embedding hyperlinks, and basic experience and competency with Excel and Adobe Acrobat Professional is required.
* Ability to travel domestic and international 25%
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.
Job Information
* Location: Andover, Massachusetts, 01810, United States
* Job ID: 46596957
* Posted: February 4, 2019
* Position Title: Manager/Sr. Manager, CMO Support/Tech Transfer GT
* Company Name: Sarepta Therapeutics
* Job Function: Quality Assurance
* Entry Level: No
* Job Type: Full-Time
About Sarepta Therapeutics
Sarepta Therapeutics, headquartered in Cambridge, Massachusetts, is a commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates. For more information, please visit us at www.sarepta.com.
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* Bachelor's Degree required; Bachelor's Degree or higher in a scientific discipline preferred * Minimum 7-10 years' experience in a regulated industry required in a Quality Assurance Technology Transfer/Validation role preferred * Excellent organizational skills; ability to work independently and in team environments; understanding of FDA/EU GMP Quality Requirements, ISPE Tech Transfer and ICH Q8. * Experience with biologics/gene therapy processes, technology transfer, risk assessments, change controls is a must. * Experience in supporting CMO audits a plus. * Knowledge of, aseptic filling, packaging/labeling, and ICH Q8 is preferred. * Quality Assurance, Validation, and Technology Transfer experience with general Quality Management Systems in a regulated environment. * Proficiency in Microsoft Office Suite including editing, formatting, utilizing templates, creating forms and embedding hyperlinks, and basic experience and competency with Excel and Adobe Acrobat Professional is required. * Ability to travel domestic and international 25% Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.



* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.