PD Upstream Cell Culture and Media Lead

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
Salary
Salary not provided
Closing date
May 28, 2022

View more

Discipline
Life Sciences, Cell Biology
Organization Type
Pharma

Job Details

The Upstream Cell Culture process development group is seeking a highly motivated and innovative Cell Culture and Media Lead. S/he will be responsible for leading a team of scientists and associate scientists to develop robust and scalable cell culture processes in support of Spark’s gene therapy clinical pipeline. The incumbent will supervise the planning and execution of development activities, as well as monitor and maintain the quality of the team's project outputs to meet organizational objectives. The incumbent will work with the downstream team and partner with the R&D organization to accelerate clinical candidates to the clinic, and partner with MS&T to support internal and external technical transfers of early-stage and late-stage clinical programs.

He/she will be responsible to:

  • Lead the efforts of platform medium development to support growth and production of rAAV via triple transfection and/or use of a packaging and/or producer cell line.
  • Provide technical leadership in upstream process design, optimization, characterization, and tech transfer, apply Quality by Design, risk assessment / prioritization to balance speed to clinic and product quality/yield/economic considerations to guide phase appropriate process development.
  • Analyze and interpret process and analytical data and understand the process implications to make decisions on projects
  • Oversee the preparation of technical reports, data summaries, tech transfer reports and technical presentations
  • Author and review CMC sections to ensure high quality content for regulatory submissions. Serve as upstream technical SME for regulatory responses.
  • Provide technical support for tech transfer, process validation and PAI.
  • Represent Process Development group on cross-functional CMC teams, working proactively and collaboratively with other functional areas including R&D, Analytical Development, MS&T, Regulatory, Quality, internal manufacturing, external Manufacturing & CDMO group and Project Management.
  • Drive new technology initiatives, establishing internal and external collaborations, and directing the necessary experiments for evaluation and implementation
  • Manage an upstream team to achieve business goals and objectives.
  • Hire & onboard new talent into the organization, manage performance and develop talent.
  • Model the company’s values & culture in accordance with established policies

The PD Upstream Cell Culture and Media Lead position requires the following:

  • The successful candidate will have in-depth familiarity and deep knowledge of cell culture development and use cutting edge techniques.
  • He/she should have hands on working experience in media and feed development, suspension cell culture, and capability for troubleshooting process and/or equipment issues.
  • He/she should have experience in mentoring and providing technical leadership to scientists and associates in cell culture and media development related activities.
Responsibilities

% of Time

Job Function and Description

30%

Responsible for leading the effort for a Cell Culture Team in alignment with Corporate Objectives and Process & Technology Development Department Goals. Fosters the Spark Culture: hires & integrates staff, manages performance and develops people. Actively participates as a member of the Upstream Process Development management team. Serves as an SME on upstream process and media development.

30%

Responsible for leading the effort for Medium Development in alignment with Corporate Objectives and Process & Technology Development Department Goals. This effort will consist of parallel paths of in-house and outsourced efforts.

10%

Responsible for Technology Transfer of upstream production processes to both internal and external stakeholders.

10%

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

20%

Attend meetings and perform administrative duties as needed.

Education and Experience Requirements

  • Ph.D. in Chemical/Biochemical engineering, Biochemistry, Virology, Cell Biology, Molecular Biology or a related scientific discipline with greater than >6 years of upstream process and media development experience in the biopharmaceutical industry.
  • B.S./M.S. in Biology, Virology, Cell Biology, Molecular Biology, Biochemistry, Chemical Engineering or a related discipline with greater than >10 years of relevant experience
  • In depth knowledge in upstream unit operations including harvest
  • Versed in biologics CMC regulatory requirements and cGMPs
  • Experience with process scale up, tech transfer, process characterization, PPQ and regulatory filing
  • Effective project management and matrix leadership experience of technical teams/programs
  • Experience with gene therapy product is a plus.
  • Knowledge on microbial production processes is a plus.
Key Skills, Abilities, and Competencies

  • Applies QbD principles and scientific knowledge to the development of upstream manufacturing production processes that are robust, reproducible, and scalable.
  • Expertise in developing media and feeds for mammalian cell culture processes
  • Self-motivated, take initiatives and result oriented
  • Expertise in Design of Experiments (DOE). Applying Quality by Design, risk assessment / prioritization to process development and characterization. Strong process data management and statistical analysis skills.
  • Needs to be comfortable in a fast-paced environment and be able to collaborate with multi-disciplinary research teams at Spark.
  • Ability to develop solutions to a variety of complex problems
  • Excellent verbal and written communication skills
  • Demonstrated ability to build and manage a high performing team
Complexity and Problem Solving

  • Demonstrate expert problem-solving skills when faced with technical issues; capable of working on multiple tasks and developing solutions for a variety of highly complex problems.
  • Ability to work collaboratively across a collaborative scientific and development environment.
  • Must be comfortable in the fast-paced, biotech environment and interact with multi-
disciplinary Research and Development, Technical Development, Manufacturing, Quality

Assurance, Quality Control and Regulatory Affairs teams at Spark, as well as with Roche family

companies.

Internal and External Contacts

  • Fellow Upstream PD Team Members including Cell Line Development
  • Fellow Technical Development Team Members such as: TD Downstream, TD Formulation, Pre-Clinical Operations (PCO), TD Lab Operations, and TD High-Throughput Automation.
  • Cross-functional Team Members – Discovery Research, Quality Assurance, Analytical and Quality Control, Manufacturing Science & Technology, Manufacturing, Materials Management, Facilities, EHS, Regulatory Affairs and CMC Program Management.
  • External Vendors that offer equipment and/or services for various aspects of Cell Culture process & technology 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.
  • Ability to travel domestically and internationally as needed.

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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