Lead Process Development Scientist - Upstream
Company: Spark Therapeutics
Posted on: February 25, 2021
Lead Process Development Scientist - Upstream 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 Lead Process Development Scientist - Upstream is a key
member of the upstream bioreactor team within the Upstream PD
Group. He/she will be responsible for:
- Applying quality-by-design and risk-based approach to the
development of recombinant adeno-associated viral vector (rAAV)
production processes that are robust, reproducible and scalable up
to and --- 200L.
- Planning and performing experiments in the development,
optimization and scale-up of rAAV production processes in
suspension cell culture systems, with a focus on stirred tank
- Conducting rAAV production studies in shake flasks, stirred
tank bioreactors, AMBR systems, etc.
- Addressing complex production process challenges by
demonstrating and applying cross-functional knowledge with a keen
understanding of industry best operating procedures and regulatory
- Analyzing and interpreting experimental results; suggesting
changes or additional experiments to improve the robustness and/or
reproducibility of the production process.
- Participating in discussions regarding the troubleshooting of
production processes and/or investigations; performing supporting
studies as needed.
- Contributing to the evaluation and implementation of new
- Participating in Technology Transfer from process development
to manufacturing sites; assisting in training manufacturing staff
- Designing and executing protocols, assembling data and drafting
appropriate technical documentation, which may include, but is not
limited to SOPs and Process Development Reports. The Lead Process
Development Scientist - Upstream position requires the following:
- The successful candidate will be skilled in suspension cell
culture, stirred tank bioreactor operation including batch,
fed-batch and perfusion modes, principles of stirred tank
bioreactor scale-up to --- 200L, and scale-down model
- He/she should have hands on working experience in upstream
process development, including in-depth familiarity and knowledge
of production processes, capability for troubleshooting process
and/or equipment issues, and ability to work/communicate
effectively with fellow team members, as well as with project
teams. Responsibilities 20% Play a lead role in the
planning/prioritization of projects, balancing in-house work and
outsourced work/activities. Design experiments, prepare protocols,
and ensure execution of said experiments. Assemble experimental
data and prepare data summaries. 50% Hands-on execution of
experiments on the bench, deliver reliable experimental results for
the various development projects. Troubleshoot any issues that
arise. 20% Write and/or review technical process development
reports and any other relevant process documentation (e.g. SOPs,
Process Descriptions, etc.) 10% Manage raw material/instrument
supplies to ensure efficient and timely upstream operations.
Prepare documents/presentations/materials for meetings, conferences
and/or publications. Attend internal meetings, participate in
training sessions, perform administrative duties. Requirements
- Typically, has a Ph.D. or master's degree in relevant
scientific discipline (e.g. chemical engineering, molecular
biology, virology, biochemistry, etc.).
- Generally, has 8+ years of relevant scientific and/or technical
experience in the life sciences/Biotech industry.
- Hands on experience in upstream process development with
suspension cell culture in shake flasks, Ambr15/250, rocker-style
bioreactors and/or benchtop stirred tank bioreactors is
- Experience in scaling-up suspension cell culture stirred tank
bioreactor production processes to --- 200L is essential.
Experience in scale-down model qualification is a plus.
- Adept technical writing skills with experience
authoring/reviewing protocols, reports, SOPs, and batch records is
- Experience in Technology Transfer of suspension cell culture
stirred tank bioreactor production processes from Process
Development to cGMP receiving entities (internal MFG, CDMO, CMO,
etc.) is preferred.
- Experience with viral vector production is preferred.
- Experience with development and optimization of cell culture
media and/or feeding strategies in bioreactors is a plus.
- Familiarity with statistical design/analysis software is a
plus. Spark Therapeutics is an equal opportunity employer. We do
not discriminate on the basis of race, color, gender, gender
identity, sexual orientation, age, religion, national or ethnic
origin, disability, protected veteran status or any other basis
protected by applicable law. Spark Therapeutics does not accept
unsolicited resumes from any source other than directly from
candidates. For the protection of all parties involved in the
recruiting process, resumes will only be accepted from recruiters
if a signed agreement is in place at the inception of the
recruiting effort and authorized for a specified position.
Unsolicited resumes sent to Spark Therapeutics from recruiters do
not constitute any type of relationship between the recruiter and
Spark Therapeutics and do not obligate Spark Therapeutics to pay
fees if we hire from those resumes. Federal law requires employers
to provide reasonable accommodation to qualified individuals with
disabilities. Please tell us if you require a reasonable
accommodation to apply for a job or to perform your job. Examples
of reasonable accommodation include making a change to the
application process or work procedures, providing documents in an
alternate format, using a sign language interpreter, or using
specialized equipment. Please reach out to
Accomodations@sparktx.com if you require reasonable
Keywords: Spark Therapeutics, Philadelphia , Lead Process Development Scientist - Upstream, Other , Philadelphia, Pennsylvania
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