BioProcess Engineer II, Downstream

Description

The company is a publicly traded, vertically integrated commercial stage biotechnology firm headquartered in Southern California. It develops immunotherapy and cell therapy platforms that aim to strengthen the immune system against cancers and infectious diseases, and its approved product ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS. Its platforms are being built to be more effective, accessible, and easier to administer than current oncology standards, and aim to reduce or remove the need for standard high-dose chemotherapy.

This role sits in process development for the company's gene therapy programs and acts as the technical expert for downstream viral vector purification, from clarified harvest through purified bulk drug substance. You will work across teams to deliver a robust, scalable clinical production process, using data to troubleshoot problems, find root causes, and make improvements.

The team is collaborative and you will have chances to work across different parts of the company. The company is growing and offers professional development.

Responsibilities

• Own the downstream viral vector unit operations as subject matter expert: clarification, nuclease treatment, tangential flow filtration, chromatography, formulation and buffer exchange, and sterile filtration.
• Design and run experiments, including DOE, to develop, optimize, and characterize viral vector purification, aiming for higher step yield, better clearance of HCP, host cell DNA, and introduced reagents, and better product quality.
• Develop and optimize clarification by depth filtration and centrifugation, UF/DF with hollow-fiber and flat-sheet cassettes, and 0.2 µm sterile filtration, including filter sizing such as Vmax and Pmax, membrane selection, and integrity testing.
• Develop, optimize, and scale chromatography, including affinity capture, anion exchange polishing, full/empty separation, and modes such as CEX, HIC, SEC, and mixed-mode, using resins, monoliths, and membrane adsorbers.
• Pack and qualify columns (HETP and asymmetry), set dynamic binding capacity, resin lifetime, cleaning and sanitization approaches, and define operating ranges.
• Lead scale-up from bench to pilot and cGMP manufacturing, and build representative scale-down models for troubleshooting, characterization, and robustness studies.
• Collect, trend, and interpret bench and large-scale manufacturing data, and help organize it for statistical process control.
• Support tech transfer and scale-up into the cGMP suite, and help resolve GMP manufacturing issues.
• Run root cause analysis and recommend corrective and preventive actions for deviations, investigations, and process problems.
• Work with facilities, quality, and manufacturing to implement the process in cGMP clinical facilities, including equipment FAT/SAT, commissioning, qualification, user requirements, and process-side validation support.
• Give equipment engineering support for downstream processes, mainly single-use technologies, including custom single-use consumables and assemblies from design and testing through GMP introduction.
• Write and review batch records, SOPs, qualification protocols, development and tech transfer reports, and investigation reports.
• Keep detailed experimental records and maintain lab 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

• A bachelor's degree in chemical engineering, bioengineering, biotechnology, or a related field, plus 5+ years in biopharmaceutical process development and/or cGMP manufacturing, including direct hands-on downstream processing.
• Or a master's degree in chemical engineering, bioengineering, biotechnology, or a related field, plus 3+ years in biopharmaceutical process development and/or cGMP manufacturing, including direct hands-on downstream processing.
• Hands-on experience purifying viral vectors for gene therapy.
• Industrial or cGMP filtration experience covering clarification, TFF, and sterile filtration.
• Extensive hands-on experience with process-scale chromatography.
• Experience across viral vector manufacturing (upstream, harvest, downstream purification, and formulation/fill) is a plus.
• 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 skill in TFF concentration and diafiltration with hollow-fiber and flat-sheet membranes, including membrane selection, flux and TMP optimization, and scale-up.
• Skill in sterile filtration, filter integrity testing, filter sizing, and filter compatibility for viral vector products.
• Extensive hands-on chromatography skill, including affinity, anion exchange with resins, monoliths and membrane adsorbers, and other modes, with experience on ÄKTA systems and UNICORN software.
• Skill in column packing, column qualification, and chromatography scale-up.
• Familiarity with in-process and release analytics for viral vectors.
• Good aseptic technique and strong knowledge of cGMP aseptic manufacturing.
• Strong technical authorship, with the ability to critically review 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 human gene therapy CMC guidance, ICH Q5A, Q8, Q9, Q11, and USP.
• Ability to build strong working relationships with Quality and Manufacturing to keep manufacturing compliant and move processes from process development into manufacturing.
• Good computer skills, including MS Office, and familiarity with JMP or similar statistical software.
• Ability to adjust quickly to changing work and shifting priorities, with strong prioritization, time management, and multitasking across functions.
• 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, honesty and integrity, and a motivated, detail-oriented approach.

Conditions

On-site in Louisville, CO.

Standard hours are Monday to Friday, within normal business hours. Off-hours work, weekend work, and extended runs may be required to support manufacturing campaigns.

Work takes place in labs, manufacturing areas, warehouses, and classified cleanrooms with specific gowning, and across ambient, refrigerated, and frozen temperatures.

You must be able to gown up and enter labs, manufacturing areas, and cleanrooms.

You will handle Biosafety Level 2 materials, including viral vectors, and follow biosafety and PPE rules.

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

You must be able to work in a standard office and use standard office equipment, including a computer.

Lifting and carrying up to 50 pounds on occasion.

Eligible for a discretionary bonus and equity award. The annual base pay range is $99,100 (entry-level qualifications) to $109,000 (highly experienced). The exact rate depends on qualifications, prior experience, and geographic location.

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

The company uses AI tools to help source candidates, but does not use AI to screen, evaluate, rank, assess, or make hiring decisions. Humans review all applications and make all hiring decisions.

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

Benefits

• Medical, dental, and vision plan options for eligible employees.
• Health and financial wellness programs, and an employee assistance program (EAP).
• Company-paid and voluntary life/AD&D insurance, plus short-term and long-term disability.
• Healthcare and dependent care flexible spending accounts.
• 401(k) retirement plan with company match.
• 529 education savings program.
• Voluntary legal services, identity theft protection, pet insurance, and employee discounts, rewards, and perks.
• Paid time off: 11 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.