Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.
We don’t follow footsteps. We create the path.
This role is a critical member of the Technology Leadership Team. The candidate will be responsible for leading, directing, and managing all upstream process development needs of Spark Therapeutics. Specific responsibilities include:
- Establish an overall process strategy that accounts for platform and pipeline status and aspirations for cell-line development, fermentation and cell culture development
- Provide industry-leading technical leadership for upstream process design. Leverage state-of-the art technologies in molecular and cell biology, fermentation/cell/virus culture, bioreactor engineering, and in-process analytics to come up with the industry leading upstream process platform. Utilize data analytics and process modeling. Apply QbD principles and scientific knowledge to develop efficient, robust and scalable upstream manufacturing processes.
- Interface with Research to drive candidate design to ensure developability.
- Transfer technology to internal and external stakeholders including Preclinical Operations, Internal Manufacturing, and External Manufacturing.
- Provide input into the design of future lab and manufacturing facilities.
- Contribute to regulatory filings, health authority meetings and inspections
- Participate in due diligence of CMOs and business development opportunities.
- Build and lead a team of scientists and engineers.
- Champion all safety aspects in the upstream laboratories.
- Engage the outside scientific and regulatory community to obtain input and to showcase technology advancements
RESPONSIBILITIES:
20% Establish an overall process design strategy for the company
20% Provide industry-leading technical leadership for upstream process design
20% Transfer technology to internal and external stakeholders; provide input into the design of future lab and manufacturing facilities; participate in due diligence activities
20% Contribute to regulatory filings and interactions. Engage with external scientific and regulatory community.
20% Build and lead a team of engineers and scientists. Champion safety.
REQUIREMENTS:
- Masters Degree required, Ph.D. in bioprocess related field strongly preferred.
- Minimum 10 years of upstream process development experience.
- Previous management or supervisory experience required.
- Good working knowledge of cGMP manufacturing is desired.
- Highly knowledgeable in mammalian cell culture and upstream operations. Proven success working experience on large scale bioreactor operation for mammalian cell culture.
- In-depth knowledge of scale-up principles, scale-down models, tech transfer concepts, and bioreactor characterization is a must.
- Experience on upstream technology transfer, equipment validation and facility startup for large-scale multiple bioreactor-based production process. Ability to identify, investigation and solve process and equipment problems.
COMPETENCIES:
- 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 mammalian cell culture experience, particularly on suspension bioreactor cell culture. Working knowledge and skills for viral vector production is a plus.
- 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.
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Source: Indeed.com
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