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Manufacturing Operations Lead
Job Opportunity at
Spark Therapeutics, Inc
Posted on Jan 4
The Manufacturing Operations Lead has overall responsibility for the Spark Manufacturing Facility at 3737 Market St. This individual will ensure organizational effectiveness by providing leadership and guidance for the team. They will hire and train key manufacturing personnel for both upstream (cell culture) and downstream (purification) activities. Initiate continuous improvement and operational excellence projects to help drive efficiency, while error proofing the process. Ensure the successful, time-sensitive, GMP-compliant manufacture of clinical and commercial gene therapy products. Promote a Right First Time culture of quality and compliance all while driving a sense of continuous improvement and operational excellence mind set.
Manage the overall day-to-day manufacturing activities. Ensure all manufacturing deliverables to key quality systems (Change Control, Deviations, CAPA, etc) are completed on a timely basis.
Coordinate production activities with Facilities (efficiency and site improvement projects), QA, QC and supply chain functions.
Drives site schedule by prioritizing resources/activities for manufacturing and support functions.
Responsible for ensuring organizational effectiveness by providing leadership and guidance to team
Effectively interface and collaborate with stakeholder/partner organizations, including but not limited to PD, MS&T, Facilities, QA and QC. Actively participate in meetings where Drug Substance manufacturing input is needed and encourage interdepartmental communication
Participate in the interpretation of data and collaboration with other departments on all manufacturing related issues
Participate in new product implementation product transition processes to ensure smooth transition from process development into GMP manufacturing
Participate in all regulatory and internal audits of the manufacturing facilities and processes and respond to any observations received
Demonstrated ability to lead manufacturing operations teams to achieve objectives. Acts to promote a productive and cooperative climate. Helps to promote team effectiveness by engaging in a trusting, supportive partnership with others. Encourages or facilitates a beneficial resolution of purpose. Resolve conflicts in a constructive manner that allows win/win solution
Demonstrated ability to prioritize and coordinate activities within and across work groups; able to anticipate priority differences and issues and resolves these before problems occur, exceeds desired results.
Participates in the budget development process; effectively controls the controllable expenses (OT, Supplies, T&E) within their influence.
Develops stretch goals and uses effective motivation techniques to achieve them. Strong team diagnostic skill and strategy for team growth. Shapes site goals and policies. Able to effectively lead cross functional teams.
Ability to motivate staff, foster a culture of continuous improvement and operation excellence
Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere
BS/MS/PhD in Life Science/Engineering or related field required.
Minimum 15 years of experience in the Biotechnology or Pharmaceutical industry.
>10 years of direct supervisory experience of technical professionals and managerial level staff with demonstrated effectiveness in providing guidance, mentorship and support to staff.
Experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery and purification
Proven track record organizing and operating a manufacturing facility
Demonstrated technical project management experience to develop project goals, deliverables and timelines
Manufacturing for orphan disease indications is a plus
Knowledge of GXP compliance
WHO WE ARE:
Transforming Patient’s Lives. Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.
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