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Downstream Process Development Lead
Job Opportunity at
Spark Therapeutics, Inc
Posted on May 27
The Downstream Development Lead will be responsible for design, development, and tech transfer of unit operations supporting the purification of Spark’s gene therapy assets. This role is responsible for all phases of downstream development from bench-scale through cGMP-scale processes. This individual will be a key player in downstream technical transfers to both internal cGMP manufacturing and CDMOs, as well as troubleshooting of cGMP manufacturing technical issues related to the purification process.
The Downstream Process Development Lead will :
Lead a team of scientists to apply QbD principles and scientific knowledge to develop efficient, robust, and scalable purification processes for cGMP manufacture of multiple rAAV serotypes in Spark’s portfolio.
Oversee efforts to establish a purification platform which leads to superior vector recovery, potency, and purity of rAAV product through the purification process. Ensures timely completion of development, scale-up, and technolofy transfer of the downstream purification processes to internal and external manufacturing partners.
Lead the design and execution of experiments to execute the characterization of downstream processes to support successful PPQ runs and cGMP manufacture
Ensure accurate and timely analysis of data to support preparation and submission of development reports. Author relevant sections for regulatory submissions (pre-IND, IND, BLA) consistent with high industry standards for thoroughness, data integrity, clarity, quality assurance, and compliance
Represent Downstream Process Development on various cross-functional teams, including interactions with Spark’s external manufacturing partners.
Works with project and program management to establish timelines, resources, and budgets for downstream process development for multiple assets progressing through the development pipeline. Reports progress to project teams and senior leaders on delivering goals in line with project milestones and deadlines.
Work with other members of PD management to provide guidance and leadership for internal Process Development efforts, including safety and data integrity initiatives. Lead by example on best working practices in line with industry standards across the Process Development organization.
Represent Downstream Process Development on meetings pertaining to facilities and PD lab designs.
Oversee the Downstream Process Development organization, design and develop downstream purification process for all rAAV serotypes Spark is interested in. Work together with Downstream scientists to design and execute experiments. Provide technical input in data analysis and troubleshooting. Write, review and finalize downstream technical reports and regulatory documents as needed.
Lead technical transfer of newly developed downstream purification process to cGMP manufacture internally and externally. Prepare technical transfer documentation, work together with PD teams and the others to ensure timely and successful technical transfers. Troubleshoot cGMP downstream process related operation issues.
Advises Head of PD and senior management on goals and project direction.
Design strategies to characterize newly developed downstream processes, leading into process validation in collaboration with cGMp manufacturing. Author downstream process characterization reports as needed.
Represent Downstream Process Development on internal and external project management meetings to ensure that timely delivery of phase-appropriate processes to meet program milestones.
Establish Spark culture in downstream day-by-day operations. Develop team members and spearhead safety and data integrity initiatives. Work with PD senior personnel to ensure department goals and objectives are met and aligned to corporate goals and objectives. Provide input to Head of PD on department operations.
Some detailed understanding of FDA and EMEA regulatory requirements associated with process validation and viral clearance for biologic products.
Strong organizational skills and management working experience in Biotech industry.
Excellent writing and verbal communication skills.
Strong downstream purification working experiences, familiar with all essential downstream process development technicques. Working knowledge and skills for viral vector production is a plus. Deep knowledges and broad working experiences on biotech analytical work and technologies.
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.
Ph.D. in relevant scientific or engineering discipline, with rAAV related working experience preferred in an industrial setting.
Minimum 10 years of biotech downstream process development working experience required. Previous scientific management and supervisory experience a must.
Good working knowledge of cGMP manufacturing is desired, working experience with late-phase development, scale-up, tech transfer, and characterization preferred.
Highly knowledgeable in downstream process development is required. Records of success working experience on development of large scale purification process of large biomoleculas, 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. Ability to identify, investigation and solve process and equipment problems.
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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