Sarepta Therapeutics, Inc. (NASDAQ: SRPT) is at the forefront of precision genetic medicine, having built a world leading pipeline for the treatment of Duchenne muscular dystrophy (DMD). The Company has expanded its portfolio to include Limb-girdle muscular dystrophy (LGMD) and central nervous system (CNS) disorders across several therapeutic modalities, including RNA, gene therapy and gene editing. For more information, please visit www.sarepta.com.
The Manager will help drive the development of Sarepta's Gene Therapy platform. Working as a member of Gene Therapy group within Technical Operations department. He/she will be responsible for providing project management skills to support the Gene Therapy CMO/CRO. He/she will be a recognized expert in managing the administrative and operational aspects of assigned projects and/or processes. The position requires in-depth interactions with scientists and quality specialists from various functions and external vendors.
Primary Responsibilities include:
Responsible for the project management activities of C(D)MO and vendor capabilities critical for the successful delivery of Sarepta's Gene Therapy portfolio.
Act as an operational liaison between the CMC functions and stakeholders, Sarepta's partners and contract manufacturing organizations. Effectively engage with key stakeholders (internal and external) to ensure the timely implementation of project objectives. Identify interdependencies and connections between departments and ensure integrated end-to-end visibility and alignment.
Work closely with functional staff across all facets of Gene Therapy project development including CMC teams. Responsible for the end-to-end project success: from scoping, developing work plans for successful implementation, risk and change management and budget management.
Acts as an adviser to establish best practices, set and maintain high performance standards with vendors, and establish mechanisms for early identification of poor performance and work to address. Establish and monitor continuous improvement initiatives and performance measures with vendors.
Demonstrate an understanding of company priorities, objectives and project timelines. Define and manage critical path, proactively identify and escalate issues and help resolve them.
Maintain detailed project documentation for knowledge management. Provide document support as needed.
Identify issues and obstacles that could impact the timely completion of Gene Therapy deliverables and resolve them with team members and/or relevant functional management.
Identify and communicate opportunities for change; plans for team to meet new challenges.
Keep abreast of industry trends and standards through external entities such as conferences, publications and courses and contribute to the field through publications and poster sessions.
Education and Skills Requirements:
BS and 6+ years of experience or advanced degree and 4+ years of experience.
Must have working knowledge of CMC operations relating to research and development and clinical trial manufacturing.
Direct management experience with CMOs/CROs is a plus. Experience in vendor management, knowledge and experience of vendor selection methods, cGMP regulations, and management of suppliers of complex materials.
Demonstrate strong project management and effectively managing multiple projects/priorities. Ensures budget schedules and deliverables are met.
Experience implementing systems, processes and best practices for support of cross-functional activities.
Must have strong PC experience along with experience in MS Office suite applications. Knowledge of project reporting and/or dash-boarding tools a plus.
Ability to troubleshoot critical issues or problems and resolves routine issues using appropriate information.
Ability to work well in a cross-functional, fast-paced team environment, build consensus and drive resolution of issues while maintaining positive working relationships across functions. Experience coordinating among stakeholders with both business and technical priorities.
Strong oral and writing communications skills with the capacity to present effectively to a diverse range of audiences.
Exercises exceptional time management skills and is able to successfully manage multiple tasks simultaneously.
Recognized by former peers, colleagues, managers and direct reports for attributes congruent with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation and Compassion
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.