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Process Development Lab Associate
Job Opportunity at
Spark Therapeutics, Inc
Posted on Jan 3
The Process Development Lab Associate will be primarily responsible for daily operations of the development labs and enabling the advancement of project work. Reporting to the Project & Lab Manager, the incumbent will work closely with development scientists, including upstream, downstream, analytical, and formulation functions to drive projects to key milestones. This role will also collaborate with Pre-Clinical Operations (PCO) to ensure timely delivery of raw material supply to various R&D organizations.
The Process Development Lab Associate will:
Work closely with the Process Development scientists and PCO team to ensure timely raw material supply, implement and manage an inventory system for chemicals and biological reagents; work closely with Spark facilities team and others to maintain instruments function, including installation, caliberation, maintenance, and reparation.
Collaborate with lead lead scientists in R&D and Tech Dev organizations to develop and establish best practices for material and equipment management, non-GMP documentation.
Design, prepare, and perform bench experiments to support the successful development, scale-up, and tech transfer of PD projects.
Champion all safety aspects in the PD and PCO labs. Ensure adequate personnel, space, equipment, and facilities remain available to progress project timelines. This may include representing PD in site-wide safety and EHS teams.
As needed, represent PD in project meetings and facilities meetings and report outcomes to Project & Lab Manager and Head of Process Development.
Faciliate regular project and PD meetings, responsible for meeting agendas, minutes, and monthly reports to department and project stakeholders
Interact with cGMP manufacturing and R&D to ensure efficient communication and progress of the inter-department projects in which PD is involved.
Manage short and long term planning for all aspects of lab operations, oversee and manage the day-to-day operations of our external vivarium vendor/s.
Manage day to day operations of the lab, establish best practices, collaborate with facilites and external partners and vendors to ensure success of process development
Independently design and perform experiments on the bench to progress PD projects
Represent PD in inter-departmental meetings, for both project planning and lab operations
Oversee and manage the day-to-day operations of our external vendors
Strong organizational skills and process development working experience in Biotech industry.
Excellent writing and verbal communication skills.
Proven track record of engaging on multiple projects and initiatives.
Bachelor’s degree in relevant biology or engineering discipline required, Master’s degree is a plus
Generally 2-5 years of biotech industry working experience, preferably in process development of early-phase and late-phase biologics.
Laboratory experience with cell culture and purification of biologics, including viral products, is a plus.
Experience with scale-up and tech transfer of bioprocesses both internally and to CDMOs is a plus
Broad understanding of the operational and equipment needs in a development lab as well as extensive hands-on experience with standard cell culture and purification techniques.
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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