2018-01-03

Process Development Lab Associate
Job Opportunity at Spark Therapeutics, Inc

Posted on Jan 3

http://www.sparktx.com    215-220-9300

Location: Philadelphia, PA
Job Type: Full Time
Job ID: W4149229

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.

RESPONSIBILITIES:
40%             
  • 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
20%             
  • Independently design and perform experiments on the bench to progress PD projects
30%             
  • Represent PD in inter-departmental meetings, for both project planning and lab operations
10%             
  • Oversee and manage the day-to-day operations of our external vendors

QUALIFICATIONS:
  • 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.

REQUIREMENTS:
  • 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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