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Process Development Downstream & Assay Leader
Job Opportunity at
Spark Therapeutics, Inc
Posted on Jan 26
This role is a critical member of the Process Development Leadership team. The PD Downstream & Assay Leader will direct, lead and manage the development of industry scale downstream purification processes for Spark’s purification platforms. This includes, but is not limited to, all the serotypes of recombinant adeno-associated viral vectors (rAAV) from bench research to full scale cGMP manufacture. She/he is responsible for the successful transfer of the developed downstream process to Spark’s cGMP internal manufacturing operations group and externally to collaborators/contactors.
In addition, the Process Development Downstream & Assay Leader will direct, lead and manage the analytical team to deliver reliable analytical data of various assays across the Process Development function.
Responsibilites include the following:
Applies QbD principles and scientific knowledge to develop efficient, robust and scalable rAAV purification processes for cGMP manufacture, including any serotypes of rAAV vectors Spark is interested in working on. Proves and demonstrates process scalabilities and achieves high vector recovery, high vector potency and high vector purities through the purification process. Ensures timely completion and successful development and transfer of the downstream purification process to either internal or external manufacturing partners.
Provides technical expertise for downstream process development, scaling up and technical transfer, including good knowledge of instruments of downstream process. Ensures the downstream process developed and instruments used are suitable for cGMP operation.
Leads and manages PD assay team to deliver reliable analytical data to support PD upstream, downstream and PCO needs of analytical work, including various assays. Provides scientific expertise and advises on the design and execution of analytical work and troubleshoots experimental issues.
Champions all safety aspects in the Process Development downstream and assay labs.
Oversees Process Development Downstream performance designs and develops downstream purification process for all rAAV serotypes Spark is interested in.
Leads team of Downstream scientists in the design and execution of experiments, including hands-on bench work if needed. Leads data analysis and troubleshooting. Writes, reviews and finalizes downstream technical reports. Oversees and manages the day-to-day operations of vivarium.
Oversees the Process Development Assay team. Prioritizes assay projects to support across all Process Development functions. Provides scientific and technical guidance for all PD assay related tasks and troubleshooting for assay related issues. Writes, reviews and finalizes PD assay protocols.
Leads the technical transfer of newly developed downstream purification processes to cGMP manufacturing operations, internally and externally. Prepares technical transfer related documents, works together with other PD and Manufacturing teams to ensure smooth and successful technical transfers. Troubleshoots cGMP downstream process related operation issues.
Advises Head of Process Development and senior management on goals and project direction.
Designs strategies to characterize and validate newly developed downstream processes, leads the execution of downstream process validation projects. Writes downstream process validation reports.
Participates in the design of Spark new facilities, including cGMP manufacturing facilities and PD labs. Identifies and brings in appropriate instruments for PD downstream and assay operations, ensures professional, safe and efficient lab working environments.
Develops and implements Spark culture in PD day by day operation. Lead the PD downstream and assay teams and develop the team members; manage team operation, recognize achievement, inspires and provide constructive feedback. Work with PD seniors personals to ensure department goals and objectives are met and aligned to company goals and objective. Provide advices to PD head about PD operation.
Robust understanding of FDA and EMEA regulatory requirements associated with process validation and viral clearance for biologic products.
Excellent writing and verbal communication skills.
Proven ability to work in a fast-paced environment with demonstrated capacity to juggle multiple competing tasks and prioritize accordingly to meet program timelines.
Uses extensive project leadership experience to drive the planning and management of risks, priorities and contingencies.
Team work a must.
Must be comfortable in the fast-paced, biotech start-up environment and interact with multi-disciplinary research teams at Spark.
Ph.D. in bioscience or bioprocess related fields required, rAAV related working experience preferred.
Minimum 15 years of biotech process development working experience required.
Must have previous experience managing and leading teams.
Excellent working knowledge of cGMP manufacturing, and working experience on process validation preferred.
Highly knowledgeable in downstream process development and analytical work is required; with a proven record of success working on the development of large scale purification process of large biomolecules, including protein, mAbs and viral vectors preferred.
In-depth knowledge of scale-up principles, scale-down models, tech transfer concepts, and process characterization and validation is a must. Must be able to identify, investigation and solve process and equipment problems.
Strong downstream purification working experiences, familiar with all essential downstream process development techniques. Working knowledge and skills for viral vector production is a plus. Deep knowledge and broad working experience on biotech analytical work and technologies.
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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