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Cell Line Development Senior Scientist - Upstream PD

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
Salary
Salary not provided
Closing date
May 6, 2023

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Job Details

The Cell Line Development Senior Scientist is involved in the execution of recombinant adeno-associated viral vector (rAAV) production processes. The Cell Line Development Senior Scientist executes experiments, develops production procedures and other relevant documentation, and works under supervision. The Senior Scientist position requires experience with molecular biology, biochemistry, and gene and protein expression analyses. He/she will be responsible for:

  • Generating Stable Packaging and Producer cell lines for rAAV production
  • Manufacturing and characterization of research cell banks
  • Implementing molecular engineering strategies to develop and improved AAV production for gene therapy purposes.
  • Engineering mammalian cell lines to improve product titer and product quality.
  • Authoring source documents for regulatory filings (INDs and BLAs).
  • Participating in and/or overseeing process development projects, facilitating translation from small scale to large scale AAV production in support of current and future therapeutic programs.
  • Analysis and characterization of new engineered cell lines and stability studies.
  • Experience with design, execution and data analysis related to experimental studies utilizing in vitro models.
  • Culturing mammalian cells for viral production in shake flasks, spin tubes and/or benchtop bioreactors.
  • Collaborating with other Process Development Scientists at Spark to design and conduct in vitro studies to optimize development of expression vectors
  • Participating in joint programs and collaborations with external parties.
  • Writing study reports, manuscripts and present results at appropriate scientific meetings.
  • Performing experiments in the development, optimization and scale-up of pre-packaging/ packaging/producer cell line.
  • Preparing and reviewing process development protocols, data analysis summaries, technical reports, and other relevant process documentation.
  • Optimization of transfection and transduction protocols for newly engineered cell lines.
  • Maintaining an accurate laboratory notebook following ALCOA+ principles.
  • Ensuring work conforms to applicable quality and safety standards.
  • Participating in the technology transfer to commercial technical support organizations internal and external (as needed).
  • Successful training of colleagues on various experimental assays
  • Leading and participating on project teams (as needed).
  • Familiarity with gene therapy and/or AAV is preferred but not required.
  • Other duties as assigned.
Responsibilities

% of Time

Job Function and Description

60%

Perform laboratory support work and execute laboratory experiments.

10%

Analyze data from experiments and draft presentations and reports.

20%

Draft protocols for studies and the subsequent technical reports as needed.

10%

Attend meetings and perform administrative duties as needed.

Education and Experience Requirements

  • Ph.D. in Biology, Molecular Biology, Microbiology, Virology, Biochemistry, Chemistry, Chemical Engineering or related discipline with 2-5 years of relevant experience.
  • B.S./M.S. in Biology, Virology, Cell Biology, Molecular Biology, Biochemistry, Chemical Engineering or a related discipline with 6-8 years of relevant experience
  • Experience with hands-on experience in cell line development and characterization
  • Experience in cell culture including materials, instruments and technologies is essential.
  • Experience with viral vector production is preferred but not required.
Key Skills, Abilities, and Competencies

  • Prior experience with Cell Bank Development and Characterization
  • Prior experience with gene editing technologies (CRISPR/Cas9, TALEN, ZFN, etc)
  • Experience with gene circuits is a plus
  • Experience in culturing and editing mammalian cell lines
  • Experience in general and advanced lab techniques such as plasmid design and construction, molecular cloning, protein expression, qPCR, cell culture, ELISA, plate-based luciferase and/or enzymatic activity assays, SDS-PAGE/western blotting, gene expression assays, etc.
  • CMC experience in support of plasmid vector and/or cell line development and characterization
  • Hands-on experience in cell culture production processes. This includes small scale (shaker flasks, spinner flasks, spin tubes) and/or benchtop bioreactor scale.
  • Knowledge of Next Generation Sequencing techniques is a plus
  • Experience with matrixed environment is a plus
  • Familiarity with designing genetic control elements using a combination of molecular, cellular and in vitro techniques.
  • Strong analytical skills and problem-solving capabilities.
  • Proven ability to work independently in hands-on laboratory setting, self-motivated to learn and develop new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
  • Working knowledge of state-of-the-art principles, technologies, and instrumentation.
  • Effective communication skills (verbal, written, interpersonal). Must be able to draft protocols and technical reports.
  • Familiarity with ICH and regulatory guidelines for cell line development and characterization
  • Must be able to interact with and lead cross-functional teams.
  • Analytical and problem-solving skills.
  • Ability to manage time effectively.
  • Ability to communicate and negotiate with vendors in a strategic manner.
  • Ability to work well under pressure and meet deadlines.
  • Proficiency in MS Office, Spotfire, JMP, Phyton and R/RStudio and digital proficiency is a plus.
Complexity and Problem Solving

The senior Cell line Development research scientist is expected to use scientific principles and practices to solve a range of problems in creative and practical ways. The senior Cell line Development is expected to work with The Cell line Development and Molecular AAV Engineering Team in executing experiments, interpreting results, and performing any necessary troubleshooting.

Internal and External Contacts

  • Fellow Upstream PD Team Members
  • Cross-functional Team Members such as: PD Downstream, PD Analytical, Automation, PSO, Facilities, and Service Personnel/Vendors.
  • External Vendors that offer equipment and/or services for various aspects of Process Development.
Other Job Requirements

  • Must be able to lift 25 pounds.
  • Due to the inherent nature of cell culture, some weekend work and/or work on holidays may be needed. On occasion, long work hours may be required depending upon the experiment schedule.
  • Handling large volumes of cell culture or related materials, such as tens of liters, may be required. Also, several viral materials, including AAV, adenovirus and lentivirus may be involved in the work.

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.

Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.


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.

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