• Sarepta Therapeutics
  • $108,380.00 -167,060.00/year*
  • Winchester , MA
  • Pharmaceutical/Biotechnology
  • Full-Time
  • 1 Willow St


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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
Director, Drug Substance
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Description
The Position:
The Director of Drug Substance Quality will manage a team responsible for providing quality oversight of cGMP activities at Contract Manufacturing Organizations (CMOs) and service providers used to manufacture clinical and/or commercial product. This individual is part of a multifunctional team and works within the Quality organization to ensure appropriate scientific, regulatory, and quality standards are followed to assure product quality and compliance. Activities include oversight of process performance qualifications, technology transfers, pre-approval inspection readiness at contract sites, investigations, change controls, and batch disposition. He/she will provide strategic leadership, direction, and is responsible for fostering a culture of quality and continuous improvement.
Primary Responsibilities include:
* Provide leadership, development and direction to the Drug Substance Quality Assurance team
* Ensure that functional areas of responsibility are staffed, organized, and resourced to ensure GxP obligations are fulfilled
* Coach and mentor staff in all aspects of their job performance and career development including training, feedback, rewards and disciplinary action
* Collaborate with senior management, peers and team to establish priorities that are aligned with business objectives
* Provides expert input into quality issues associated with ongoing operations, projects, and programs; demonstrate knowledge of biologics manufacturing and testing requirements in an evolving regulatory environment
* Ensure that Corporate Procedures and Standards are properly deployed in to the local QMS and managed according
* Identify quality improvement opportunities and implement solutions
* Investigate quality issues and/or review results provided by other departments
* Provide input into the department budget (forecasting, headcount allocation, spending), as required
* Interface with external regulatory agencies as required
* Represent Sarepta quality management during internal and external audits and inspections
* Establish/maintain key performance indicators (KPIs) for CMOs within area of responsibility, monitor performance, and promptly address undesirable trends
* Ensure third party suppliers / vendors or Business Partners are properly qualified, monitored and processes are compliant (e.g. warehouse, distribution, redress/relabeling, etc.)
* Support in negotiation of relevant agreements including but not limited to Master Services Agreement (MSA) and Quality Technical Agreement (QTA) for vendors as requested
* Ensure products are released to the local market according to the proper requirements
* Work in partnership with other departments / functions to ensure proper support to product launches and achievement of commercial timelines
* Ensure all necessary cGMP / cGDP Licenses are obtained to keep the business operational and complaint, plus provide expertise to support product registration
Education and Skills Requirements:
* University degree in Chemistry, Pharmacy, Biology or other related scientific discipline
* 15+ years' experience, including leadership experience, within Gene Therapy, Pharmaceutical Quality, Bio-tech products
* Experience with Quality Control Lab activities, processes, analytical method transfers, Stability Studies, etc, is preferred.
* Experience interfacing / working with regulatory bodies or supporting regulatory submissions
* Exceptional understanding of cGMP/cGDP regulations, guidelines and compliance requirements.
* Practical experience in the pharmaceutical industry in commercial quality, distribution, manufacturing or QC role(s) for drugs or biologics
* Demonstrated leadership management, coaching, development and technical capabilities.
* Excellent verbal, written, interpersonal communication skills
* Ability to work collaboratively and effectively with internal and external teams and to build relationships
* Proven ability to plan, implement and achieve significant complex goals and objectives with flexibility
* Proven track record of successful leadership, strength of character and ability to articulate and defend business approaches
* Demonstrated exercise of sound judgment, discretion, and business decisions
* Ability to travel domestically and internationally
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: 47786679
* Posted: April 8, 2019
* Position Title: Director, Drug Substance
* 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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* University degree in Chemistry, Pharmacy, Biology or other related scientific discipline * 15+ years' experience, including leadership experience, within Gene Therapy, Pharmaceutical Quality, Bio-tech products * Experience with Quality Control Lab activities, processes, analytical method transfers, Stability Studies, etc, is preferred. * Experience interfacing / working with regulatory bodies or supporting regulatory submissions * Exceptional understanding of cGMP/cGDP regulations, guidelines and compliance requirements. * Practical experience in the pharmaceutical industry in commercial quality, distribution, manufacturing or QC role(s) for drugs or biologics * Demonstrated leadership management, coaching, development and technical capabilities. * Excellent verbal, written, interpersonal communication skills * Ability to work collaboratively and effectively with internal and external teams and to build relationships * Proven ability to plan, implement and achieve significant complex goals and objectives with flexibility * Proven track record of successful leadership, strength of character and ability to articulate and defend business approaches * Demonstrated exercise of sound judgment, discretion, and business decisions * Ability to travel domestically and internationally Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.


Associated topics: administrative, administrative assistant, administrative officer, asso, associate, food, operation, operational assistant, records management, staff

* 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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