Principal Engineer - Cell & Gene Therapy
Company: Theragent Inc
Posted on: July 30, 2022
What We DoTheragent 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
- Build up a team of talents to establish process capabilities to
support process development of various cell and gene therapeutic
- 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
- 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
- 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
- Keep abreast on latest process technology platforms and
analytical methods for process performance
- 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
- 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
- Possess excellent interpersonal, verbal, and written
- Ability to function efficiently and contribute as part of a
team, and attribute to team-based decisions in a fast-paced
- Experience with process design, optimization, validation,
qualification, and verification experience are highly
- 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
- Professional Knowledge
- Problem Solving
- Team Player / Building Relationships
- Customer Focus
- Action and Detail-oriented
- Active Listening
- Accountability to the team
- Professional MaturityPHYSICAL/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
- Ability to perform repetitive tasks including hand to finger
manipulations, grasping, pushing, and pulling.ENVIRONMENTAL
- 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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