CMC Technical Writing Lead
Date: Jul 2, 2022
Location: Philadelphia, PA, US, 19104
Company: Spark Therapeutics
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.
The CMC Technical Writing Lead will work closely and coordinate Technical Development and Operations (TD&O) subject matter experts, interdisciplinary CMC teams and interface with the CMC Regulatory organization to develop templates and draft complex technical documents for rAAV gene therapies. This includes procedures, protocols, input to regulatory submissions, responses, information requests, briefing documents & clinical trial applications
She/he will operate in a highly interdisciplinary environment and be expected to communicate effectively and productively with research, development, operations, regulatory, quality, and other departments as needed to ensure that rigorous scientific, technical, and product quality expectations are achieved.
Responsibilities Describe the essential daily job functions and include % of time spent on each. |
|
% of Time |
Job Function and Description |
70% |
The primary responsibilities of the CMC Technical Writer are to:
|
20% |
|
10% |
|
Requirements
- Ph.D. in a relevant scientific or engineering discipline with 5+ years of applicable experience or Bachelors/Masters in a relevant scientific or engineering discipline with 9+ years of applicable experience.
- In-depth CMC experience in analytical, process or formulation development for gene therapy, biologics, or vaccines is required
- 3+ years being a part of CMC development teams preferred
- Has previously authored technical reports, regulatory submissions, and/or responses to regulatory requests
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