BioProcess Engineer II, Upstream

Description

The company is a vertically integrated, commercial-stage biotechnology firm building next-generation immunotherapies and cell therapies that strengthen the body's own immune response against cancer and infectious disease.

Its lead product is the first FDA-approved immunotherapy for bladder cancer that has not spread into the muscle wall, specifically CIS, and it holds FDA Breakthrough Therapy designation.

The company also develops potential cancer vaccines and other immunotherapies and cell therapies that it believes can sharply cut or remove the need for standard high-dose chemotherapy.

Its platforms are meant to be more effective, easier to access and simpler to administer than current oncology and infectious disease treatments.

The company is publicly traded, headquartered in Southern California and still growing, with a collaborative team, cross-area work and room for professional development.

This role sits within upstream viral vector manufacturing for the gene therapy programs, where you act as the technical expert for cell culture and bioreactor steps, from cell bank thaw and seed train expansion through transfection or infection, vector production and harvest.

Responsibilities

• Act as process owner and subject matter expert for upstream viral vector steps: cell bank thaw, seed train, adherent and suspension culture, transient transfection or infection, vector production and harvest.
• Design and run experiments, including DOE, to develop, optimize and characterize upstream processes aimed at better cell growth, productivity, titer and quality.
• Scale processes up from bench to pilot and cGMP scale, including single-use stirred-tank bioreactors up to 200L, using engineering principles such as P/V, tip speed, kLa, mixing time and gas sparging.
• Build, qualify and maintain scale-down models for troubleshooting, characterization and robustness studies.
• Set up, inoculate and run bioreactors, monitoring and controlling critical parameters including pH, DO, temperature, agitation, feed and gassing.
• Collect, trend and interpret data from bench and large-scale runs, and help organize it for statistical process control.
• Support tech transfer and scale-up to internal cGMP manufacturing and to external CDMO partners.
• Investigate deviations and process issues through root cause analysis, and recommend corrective and preventive actions.
• Work with facilities, quality and manufacturing to bring the process into cGMP clinical facilities, covering FAT/SAT, commissioning, qualification, user requirements and process input to validation.
• Support single-use equipment for upstream work, including custom single-use consumables from design through testing to cGMP use.
• Write and review batch records, SOPs, qualification protocols, development and tech transfer reports, and investigation reports.
• Keep detailed experimental records and maintain laboratory equipment.
• Train manufacturing staff and less experienced team members on equipment and process operations.
• Take on ad hoc and cross-functional lab work or projects as business needs arise.

Requirements

• Bachelor's degree in chemical engineering, bioengineering, biotechnology or a related field, plus 5+ years in biopharmaceutical process development and/or cGMP manufacturing, including hands-on downstream processing.
• Alternatively, a Master's degree in one of those fields with 3+ years in biopharmaceutical process development and/or cGMP manufacturing, including hands-on downstream processing; MS preferred.
• Hands-on viral vector purification experience for gene therapy applications is required.
• Industrial or cGMP experience running upstream cell culture and bioreactors is required.
• Demonstrated experience developing process scale-up and scale-down models is required.
• Working knowledge of gene therapy biology and viral vector critical quality attributes, including vector genome titer, infectious titer, potency, and product- and process-related impurities.
• Strong expertise in mammalian cell culture for viral vector production, including media and feed optimization.
• Knowledge of cell banking and seed train expansion.
• Extensive hands-on work with upstream equipment such as incubators, biosafety cabinets, cell counters, metabolite analyzers and single-use stirred-tank bioreactors.
• Strong grasp of bioreactor engineering and scale-up and scale-down principles, including mass transfer, mixing, shear, power input and gassing strategy, plus qualification of scale-down models.
• Familiarity with upstream harvest operations, such as cell lysis and nuclease treatment, and with in-process analytics for viral vectors.
• Good aseptic technique and strong knowledge of cGMP aseptic manufacturing.
• Strong authorship skills, with the ability to critically review technical GMP documents, interpret results and draw technical conclusions.
• Understanding of cGMP and gene therapy regulations and guidance, such as 21 CFR 210-211, FDA CBER guidance for human gene therapy products (CMC), ICH Q5A, Q8, Q9, Q11 and USP.
• Ability to build strong working relationships with quality and manufacturing to keep the environment compliant and to move processes from process development into manufacturing.
• Good computer skills, including MS Office, and familiarity with JMP or similar statistical software.
• Ability to adapt to shifting priorities and to manage time and multiple tasks across functional areas.
• Ability to work independently with minimal supervision and also as part of a team.
• Good interpersonal skills and strong written and verbal communication.
• Strong problem-solving and technical writing skills, with high honesty and integrity, and a motivated, detail-oriented approach.
• A plus: cross training across viral vector manufacturing, including upstream, harvest, downstream purification, and formulation and fill.

Conditions

Based on site in Louisville, CO.

Standard weekday hours, Monday to Friday. Off hours, weekend work and extended runs may be needed to support manufacturing campaigns.

Work takes place in labs, manufacturing areas, warehouses and classified cleanrooms, requiring specific gowning and exposure to ambient, refrigerated and frozen temperatures.

You must be able to gown up and enter lab, manufacturing and cleanroom areas.

Handling BSL-2 materials, including viral vectors, is part of the job and requires following biosafety and PPE requirements.

Travel is about 10%, including occasional trips to support tech transfer at internal or CDMO manufacturing sites.

Standard office setting work, including using a computer.

Ability to lift and carry materials up to 50 pounds on occasion.

Annual base pay is $99,100 to $109,000. The exact rate depends on qualifications, prior experience and geographic location.

Eligible for a discretionary bonus and an equity award.

The application window is expected to close 60 days after posting, or sooner if the role is filled or closed.

The company is an equal opportunity employer and assesses candidates on qualifications, skills and experience through human review.

Benefits

• Medical, dental and vision plan options.
• Health and financial wellness programs and an employee assistance program.
• Company-paid and voluntary life and AD&D insurance, plus short-term and long-term disability cover.
• Healthcare and dependent care flexible spending accounts.
• 401(k) retirement plan with company match, and a 529 education savings program.
• Voluntary legal services, identity theft protection, pet insurance, employee discounts, and rewards and perks.
• 11 paid holidays.
• Exempt employees get unlimited PTO. Non-exempt employees get 10 vacation days, 56 hours of health pay, 2 personal days and 1 cultural day.