• Sarepta Therapeutics
  • $108,380.00 -167,060.00/year*
  • Newton Center , MA
  • Executive Management
  • Full-Time
  • 101 Olde Field Rd


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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
Associate Director, Validation
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Description
The Position:
The Associate Director will be responsible for providing direct CMO oversight and support to ensure alignment with Sarepta validation procedures. The candidate will support validation activities encompassing clinical to commercial production for drug substance, API, drug product, packaging/labeling, and shipping/distribution.
The successful candidate will have direct, in-depth experience with Validation Principles and Quality Management Systems in a regulated environment. The individual will interface multi-functionally and across levels in the organization. Experience with chemical synthesis and biological process systems, equipment and processes is strongly preferred. Technical experience with reactors, bioreactors, chromatography, filtration, automation, computerized systems, filling and capping lines and lyophilizers is desired.
Primary Responsibilities include:
* Assist team management in the development and implementation of validation policies, procedures and master plans.
* Manage the development, review and approval of plans, protocols and reports for validation activities.
* Write, review and/or approve process comparability reports
* Ensure process control strategies are implemented, and validation strategies are executed at CMOs.
* Drive validation strategies and decisions based on standard approaches, critical process reviews, and experience
* Write, review and approve risk assessments at applicable development gates, in collaboration with process development and operations counterparts.
* CMO point of contact as SME for validation issues
* Alignment with QC to ensure analytical methods are transferred and validated.
* Review and approve Change Controls related to validation activities.
* Contribute to annual Product Quality Reports as applicable.
* Manage validation discrepancies and determine impact to validation.
Education and Skills Requirements:
* 8+ years of direct, relevant experience and bachelor's degree in science or related field. Biopharmaceutical or Pharmaceutical experience preferred
* Direct experience working in a GMP environment with experience in validation, quality systems, operations, or engineering.
* Experience in a risk-based approach to validation.
* Deep knowledge of FDA/EU GMP Quality Requirements, Validation Principles, and ICH Q7, Q8, Q9, Q10.
* Experience with deviation investigation, root cause analysis, product/process impact assessment and development of corrective and preventative actions.
* Ability to work as part of a high performing team and collaborate effectively with staff at all levels. Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company.
* Able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories
* Able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness
* Able to exercise judgment and independently determine and take appropriate action where precedent may not exist
* Excellent technical writing and verbal communication skills.
* Demonstrates knowledge of industry
* Travel required, up to 25% domestic and international.
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: 47833736
* Posted: April 11, 2019
* Position Title: Associate Director, Validation
* Company Name: Sarepta Therapeutics
* Job Function: Quality Assurance
* Entry Level: No
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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The successful candidate will have direct, in-depth experience with Validation Principles and Quality Management Systems in a regulated environment. The individual will interface multi-functionally and across levels in the organization. Experience with chemical synthesis and biological process systems, equipment and processes is strongly preferred. Technical experience with reactors, bioreactors, chromatography, filtration, automation, computerized systems, filling and capping lines and lyophilizers is desired., * 8+ years of direct, relevant experience and bachelor's degree in science or related field. Biopharmaceutical or Pharmaceutical experience preferred * Direct experience working in a GMP environment with experience in validation, quality systems, operations, or engineering. * Experience in a risk-based approach to validation. * Deep knowledge of FDA/EU GMP Quality Requirements, Validation Principles, and ICH Q7, Q8, Q9, Q10. * Experience with deviation investigation, root cause analysis, product/process impact assessment and development of corrective and preventative actions. * Ability to work as part of a high performing team and collaborate effectively with staff at all levels. Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company. * Able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories * Able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness * Able to exercise judgment and independently determine and take appropriate action where precedent may not exist * Excellent technical writing and verbal communication skills. * Demonstrates knowledge of industry * Travel required, up to 25% domestic and international. Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.


Associated topics: administrative coordinator, administrative staff, assist, assistant, asso, beverage, food, operational assistant, records management, support

* 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.

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