Principal Engineer - Cell & Gene Therapy

Company: Theragent Inc
Location: Arcadia
Posted on: May 12, 2022

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