Lead Scientist - Analytical Program Development

The Lead Scientist in Analytical Program Development and Management will work with scientists in Analytical Development, Analytical Sciences, Quality Control, and across interdisciplinary CMC project teams to develop and manage analytical strategy for rAAV gene therapies. She/he will work in a highly diverse environment and be expected to communicate effectively and productively with research, development, technical operations, regulatory, quality, and other departments as needed to ensure that rigorous scientific, technical, and product quality expectations are achieved.

The Lead Scientist for Analytical Program Development and Management will:

• Work closely with the CMC teams and analytical subject matter experts to develop and drive analytical strategy across the portfolio
• Define phase-appropriate analytical control strategy
• Work across analytical teams to manage project timelines and analytical deliverables
• In conjunction with process and formulation development, develop innovative and robust process and products
• Proactively identify and help to resolve scientific (analytical and process) issues during product development
• Represent Analytical at project team/CMC meetings
• Facilitate method transfers to other analytical functions and/or CROs
• Engage in technical process development and cross functional area team meetings as a subject matter expert for analytical development and investigational product characterization
• Work with CMC-Regulatory to author regulatory submissions and support responses to regulatory agency questions as needed.

Responsibilities
60% Analytical strategic development

30% Logistical execution of analytical strategy

10% Training, meetings and other administrative work

Requirements

• Ph.D. in a relevant scientific or engineering discipline with 6+ years of applicable experience or Bachelors/Masters in a relevant scientific or engineering discipline with 9+ years of applicable experience.
• 3+ years being a part of CMC development teams preferred, especially including late-stage and/or commercial experience
• Extensive experience with and knowledge of analytical methods applied to biologics, vaccines or gene therapies
• Has authored regulatory submissions and responses to regulatory requests
• In-depth experience with CMC and analytical development for gene therapy, biologics, or vaccines is required
• Ability to scientifically understand, integrate, and communicate diverse analytical datasets
• Knowledge on setting product specifications is highly desired
• Experience in developing analytical strategies for critical reagents is preferred

#LI-AK1

Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.

Nearest Major Market: Philadelphia

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.