Principal Engineer - Cell & Gene Therapy
Company: Theragent Inc
Location: Arcadia
Posted on: May 12, 2022
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Job Description:
What We Do Theragent is a privately-owned Contract Development
and Manufacturing Organization (CDMO) focused on novel Cell and
Gene Therapy medicines to meet unmet patient needs. We are a small,
biotech startup headquartered in Arcadia, CA. Our state of the art
facility provide high-quality, reliable, and value-added solutions
to our clientele for challenging pre-clinical and clinical trial
projects. Our innovative cGMP facility offers comprehensive
end-to-end manufacturing and testing capabilities for clinical and
commercial purposes. Why Theragent? Take the next step in your
career and join Theragent today to change patient lives through the
products we help develop and manufacture. Here, you will contribute
your talents in a purposeful way that impact the lives of patients
around the world. You will develop as an individual by working
directly with a team of seasoned experts and rising stars. Our
values of Innovation, Transparency, Accountability, Integrity,
Diversity, Humility to name a few are embedded in everything we do.
No matter your role may be, Theragent strives to ensure all our
teammates are empowered and given the necessary tools to lead us in
our relentless pursuit to extending patient lives. Our Mission: To
Manufacture and Deliver high-quality, reliable, and value-added
Therapeutic Solutions for Biopharma clients and patients. JOB
SUMMARY: Theragent is seeking a highly motivated Principal
Engineer, Cell & Gene Therapy professional with upstream and
downstream process development and tech transfer experience to lead
autologous and allogenic cell and gene therapy process development
and execution efforts. These efforts can include process design,
scale-up, media prep, cryopreservation, process validation, PPQ,
and LCM (process monitoring and verification inclusive). He/she
will be responsible for leading a small group, reporting to the
Director of Process Sciences. This position will work closely with
various partner organizations such as Research, Analytical, QC,
Manufacturing, Quality, and Regulatory for the tech transfer and/or
hand-off of processes. The successful candidate will have extensive
experience with developing cell and gene therapy processes
utilizing QbD and DoE concepts and possess expertise in critical
material and equipment knowledge to achieve an efficient, robust
process development from Stage 1 to Stage 3 of product development.
A great-fit candidate has demonstrated knowledge and experience in
developing cell and gene therapy processes and participated in
co-authorship of relevant IND and/or BLA sections.
RESPONSIBILITIES: Build up a team of talents to establish process
capabilities to support process development of various cell and
gene therapeutic modalities. Establish critical templates for
sampling plans, tech transfer SOPs, gap and risk assessments,
exceptional conditions process, process change controls, and other
process-related protocols and technical reports. Serve as a
technical SME and Tech Transfer lead for unit operations such as
harvest formulation fill/finish, media prep, in-line purification
of drug substance, and drug product cryopreservation. Develop
robust processes implementing QbD and DoE concepts, and closed
system solutions for activation/stimulation, transduction,
expansion, and formulation fill/finish. Capable with identifying,
instituting, and refining TPP/QTPP, CQAs, CPPs, KPPs, and CMAs for
cell and gene therapy processes throughout phases of product
development. Evaluate and integrate novel automated technology
platforms to streamline scaled-up/optimized processes.
Establish/nurture strong working relationships with both internal
and external vendors, and partner organizations. Train and mentor
process staff on platform process. Assist with process and product
characterization, and process monitoring efforts. Keep abreast on
latest process technology platforms and analytical methods for
process performance evaluations. QUALIFICATIONS : Bachelor's degree
in Engineering or Life Science related discipline preferred.
Advanced degree is a plus. Minimum of 8 years of process
development experience with at least 3 to 5 years of direct cell
and gene therapy working experience. Understanding of cellular
immunology will be advantageous. Mastery of scientific and
engineering principles. Practical experience in GMP operations.
Experience with optimization and manufacturing of viral vectors
will be a plus. Demonstrated knowledge of pharmaceutical
manufacturing of biotechnology products, gene editing approaches,
and cell and gene therapy process development. Ability to think
critically, demonstrated troubleshooting, and problem-solving
skills. Possess excellent interpersonal, verbal, and written
communication skills. Ability to function efficiently and
contribute as part of a team, and attribute to team-based decisions
in a fast-paced environment. Experience with process design,
optimization, validation, qualification, and verification
experience are highly desirable. Familiar with data analytics
software such as JMP, Minitab, and/or GraphPad Prism. Knowledge of
product lifecycle --- product and process development throughout
early to late-phase trials and product commercialization. CORE
COMPETENCIES: Professional Knowledge Problem Solving Team Player /
Building Relationships Multi-tasking Customer Focus Action and
Detail-oriented Active Listening Accountability to the team
Decisive Professional Maturity PHYSICAL/MENTAL DEMANDS: Occasional
stooping, bending, stretching, pushing, pulling, reaching, and/or
lifting to 40 lbs. Ability to sit, stand, walk, and move within
workspace for extended periods. Ability to perform repetitive tasks
including hand to finger manipulations, grasping, pushing, and
pulling. ENVIRONMENTAL CONDITIONS: Both office and laboratory
environment but will be required to cGMP laboratories and
manufacturing facilities donning proper gowning / lab coats or PPE
such as safety glasses and shoes Ability to work safely and
effectively when working alone or working with others This
description outlines the basic responsibilities and requirements
for the position noted. This is not a comprehensive listing of all
job duties of position. Duties, responsibilities and activities may
change at any time with or without notice. Theragent Inc is an
equal opportunity employer and prohibits unlawful discrimination
based on race, color, religion, gender, sexual orientation, gender
identity or expression, national origin or ancestry, age,
disability, marital status, and veteran status. All qualified
applicants will receive consideration for employment. Theragent,
Inc. requires employees to be vaccinated against COVID-19. To the
extent permitted by applicable law, candidate must be able to
provide proof of full vaccination or receipt of the first dose of a
two-dose COVID-19 vaccine, or request an exemption due to a medical
reason, a sincerely held religious belief of practice, or
pregnancy, as of the first day of work, to be considered for a
U.S.-based job.
Keywords: Theragent Inc, Arcadia , Principal Engineer - Cell & Gene Therapy, Engineering , Arcadia, California
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