Drug product development lead
- Employer
- Spark Therapeutics
- Location
- Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
- Salary
- Salary not provided
- Closing date
- Sep 14, 2022
View more
- Discipline
- Life Sciences, Biotechnology
- Organization Type
- Pharma
Job Details
% of Time
Job Function and Description
25
Lead project and manage project, strategic and innovative activities20
Write, review and/or approve protocols, reports, guidelines, white papers, filing sections (IND/BLA), presentations and tech transfer documents20
Meetings, preparation and presentations20
Manage/lead lab activities (study executions, data analysis etc)15
Hands on activities and supervision Education and Experience Requirements- Ph.D. in biochemistry, pharmaceutics, chemical engineering, or related discipline with 6+ years of meaningful industry experience or MS with over 9+ years of meaningful industry experience is strongly preferred. BS with 12+ years of experience is preferred
- Experience in formulation, device development, container closures, in use and administration studies, fill/finish process development for sterile large molecule parenterals i.e., gene therapies (RNA LNPs, AAVs), vaccines, cell therapies, and/or biological molecules is preferred. Strong experience on closely related sterile parenterals may be considered.
- Experience on cryopreservation is a strong plus. Good understanding of Freeze Drying/ Lyophilization of biologics is plus.
- Experience with high throughput formulation development is preferred. Experience on setting up high throughput and automation/programming platforms as they relate to biopharma development is a plus.
- Experience in large molecule analytics and biophysical characterization is strongly preferred.
- Experience of working in a DP manufacturing setting is a plus. Experiences of large scale GMP manufacturing and GXP compliant documentation is plus
- Strong scientific publication record and/or patent filing is plus.
- Strong organizational skills and documentation abilities is required.
- Should be adaptable/flexible and able to work independently and in teams as needed
- Strong writing and verbal communication skills is required
- Demonstrate independent problem-solving skills of technical issues
- Work to establish best practices.
- Mentor and advise other scientists to effectively leverage tools
- Leverage tools to solve difficult technical challenges as a member on technical or project teams
- Fellow team members to develop new strategies and capabilities
- Cross functional team members
- CROs and CMOs
- Must be able to lift 25 pounds
- Must be able to wear appropriate clean room attire and all Personal Protective Equipment
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.
Learn more about Spark Therapeutics and view other openings.
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.
- Website
- http://sparktx.com/
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