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Pre-Clinical Manufacturing Associate

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
Salary
Salary not provided
Closing date
Aug 30, 2022

View more

Discipline
Other, Manufacturing/QA/QC
Organization Type
Pharma
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Job Details

This position is a key participant in the day-to-day operation and planning of recombinant Adeno-Associated Virus (rAAV) vector assays, with primary responsibility to execute established protocols of research and pre-clinical (GLP) grade rAAV vectors. The individual in the role will participate in (but not be limited to) the following tasks:

  • Perform rAAV vector production intermediate sample assays, such as ddPCR, qPCR and SDS PAGE for determination of vector yield/recovery and purity to support upstream and downstream production.
  • Perform rAAV vector release assays, such as vector genomic titer by ddPCR or qPCR, SDS PAGE, Endotoxin, Bioburden, Visual inspection, pH, Osmolality, Spectrophotometry, etc. for vector characterization.
  • Perform timepoint assays for stability studies on but not limited to diluents and rAAV vectors.
  • Ensure delivery of reliable high-quality assay data and prepare assay reports in a timely manner.
  • Participate in technical transfer and generate or revise SOPs to support research and GLP grade rAAV vector assays.
  • Participate in sample management activities, instrument maintenance and qualification.
  • Provide assay expertise to troubleshoot issues and resolve in a timely manner.
  • Participate in manufacturing of diluents and rAAV vectors including cell culture and purification.
  • Prepare laboratory reagents/raw materials for rAAV assays and manufacturing of research and pre-clinical (GLP) grade rAAV vectors.
  • Assist vector production when as needed.
This position requires good knowledge, experience, and skills with bio-product assays. Good written and verbal communication skills and the ability to work effectively in a team environment are required.

Responsibilities

% of Time

Job Function and Description

60%

Hands-on rAAV vector assays, such as vector genomic titer by ddPCR or qPCR, SDS PAGE, Endotoxin, Bioburden, Visual inspection, pH, Osmolality, Spectrophotometry, etc. and assay records.

20%

  • Assay sample management.
  • Prepare laboratory reagents/raw materials for rAAV assays (such as buffers, primers, probes, qPCR standards).
  • Participate in manufacturing of research and pre-clinical (GLP) grade rAAV vectors and diluents.

15%

  • Generate, review and revise SOPs and batch records for vector assays, production, and purification.
  • Perform routine calculations and maintain appropriate records.
  • Maintain assay, manufacturing equipment and records.
  • Participate in investigations.
  • Comply with laboratory safety procedures and maintain records.

5%

Participate in other projects upon request

Education and Experience Requirements

  • A Bachelor's degree or M. S. degree in biology, biochemistry, biomedicine, cell biology, or bioengineering.
  • 1-2 years of relevant work experience.
  • Experience with analytical assays, and cell culture or protein purification.
  • Experience in industry laboratory under GLP or GMP requirements.
  • High degree of flexibility of skills.
Key Skills, Abilities, and Competencies

  • Value research integrity and collaborative research.
  • Strong interpersonal, communication, analytical, and critical thinking skills, including being able to adapt to work areas requiring various intellectual and professional approaches.
  • Excellent organizational and time management skills.
Complexity and Problem Solving

  • Discuss process variations and/or out of range results with supervisor and refer to
policies/practices for guidance.

  • Exercise judgment within defined procedures and practices to determine appropriate action.
  • Must be comfortable in the fast-paced, biotech environment and interact with multi-
disciplinary Research and Development, Process Development, Quality Assurance, Quality

Control and Tech Operations teams.

Internal and External Contacts

  • Fellow Pilot Scale Operations (PSO) Team Members
  • Cross-functional Team Members such as: Process Development, Quality Assurance, R&D,
Translational Research, Quality Control, Analytical Sciences, Facilities, Materials

Management, and Service Personnel/Vendors.

Other Job Requirements

  • Must be able to lift 25 pounds.
  • Due to the inherent nature of production and assays, some weekend work and/or work on holidays may be needed. On occasion, long work hours may be required depending upon the production schedule.

Handling large volumes of product or related materials, such as tens of liters, may be required

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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