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Lead Scientist - Analytical Program Development

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
Salary
Salary not provided
Closing date
Jul 7, 2022

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Job Details

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.

Company

At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.

Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), our investigational therapies have the potential to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed our scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases. Our initial focus is on treating orphan diseases.

Headquartered in dynamic Philadelphia, we are a diverse, experienced team united in our goal to break down barriers for people and families affected by genetic diseases. As our name suggests, our investigational, one-time therapies are designed to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease. Spark is a member of the Roche Group.

Find Us
Website
Telephone
215-989-1149
Location
3737 Market Street
Suite 1300
Philadelphia
PA
19104
United States
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