BioProcess Engineer II, Downstream

ImmunityBio, Inc.•Louisville, CO

1d•$99,100 - $109,000•Onsite

About The Position

The BioProcess Engineer II, Downstream role is responsible for process development, engineering, and technical support of downstream viral vector purification for the Company’s gene therapy programs. This position serves as a technical expert for crude harvest clarification, tangential flow filtration, chromatography, and sterile filtration unit operations, from clarified harvest through purified bulk drug substance. The individual will design and execute process development experiments, lead scale-up of purification processes, and use a data-driven approach to troubleshoot manufacturing issues, identify root causes, and implement improvements, working cross-functionally to deliver a robust and scalable clinical production process.

Requirements

Bachelor’s degree in Chemical Engineering, Bioengineering, Biotechnology, or related fields with 5+ years of experience in biopharmaceutical process development and/or cGMP manufacturing operations, including direct hands-on experience in downstream processing required; or Master’s degree in Chemical Engineering, Bioengineering, Biotechnology, or related fields with 3+ years of experience in biopharmaceutical process development and/or cGMP manufacturing operations, including direct hands-on experience in downstream processing; MS preferred.
Hands-on experience with viral vector purification for gene therapy applications required.
Industrial/cGMP experience in filtration (clarification, TFF and sterile filtration) required.
Extensive hands-on experience in process-scale chromatography required.
Working knowledge of gene therapy principles, including biology and critical quality attributes of viral vector products (vector genome titer, infectious titer, potency, and product- and process-related impurities).
Strong expertise in tangential flow filtration (concentration and diafiltration) using hollow-fiber and flat-sheet membranes, including membrane selection, flux/TMP optimization and scale-up.
Skills in sterile filtration and filter integrity testing, filter sizing studies, and filter compatibility for viral vector products.
Extensive hands-on expertise with chromatography, including affinity, anion exchange (resins, monoliths, and membrane adsorbers), and other chromatography modes; experience with ÄKTA™ systems and UNICORN™ software.
Skills 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.
Must have strong authorship and be able to critically review technical GMP documents, interpret results and generate technical conclusions.
Understanding of relevant regulations and regulatory guidance associated with cGMP and gene therapy products, 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 relationships with Quality and Manufacturing to ensure a compliant manufacturing environment and work collaboratively with other team members to support the transfer of processes from Process Development to Manufacturing.
Good computer skills, including MS Office; familiarity with JMP or similar statistical software.
Ability to adapt to rapidly changing work environment and shift in priorities; excellent skills in prioritizing, time management, and multitasking across multiple functional areas.
Ability to work independently with minimal supervision as well as being part of a team.
Good interpersonal and strong written/verbal communication skills.
Strong aptitude for problem solving and technical writing; possess a high level of honesty and integrity, highly motivated and detail oriented.
Must be able to gown and gain entry to lab, manufacturing, and cleanroom environments.
Work involves handling of Biosafety Level 2 (BSL-2) materials, including viral vectors, and requires adherence to biosafety and PPE requirements.
Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
Ability to lift and carry materials weighing up to 50 pounds on occasion.

Nice To Haves

Cross training across the entire process of viral vector manufacturing (upstream, harvest, downstream purification, and formulation/fill) is a plus.

Responsibilities

Serve as the process owner/subject matter expert for downstream viral vector unit operations, including crude harvest clarification, nuclease treatment, tangential flow filtration (TFF), chromatography, formulation/buffer exchange, and sterile filtration.
Design and execute experiments (including DOE) to develop, optimize, and characterize purification processes for viral vectors with the goal of improving step yield, impurity clearance (HCP, host cell DNA, introduced reagents) and product quality.
Develop and optimize filtration operations, including clarification (depth filtration, centrifugation), TFF (UF/DF with hollow-fiber and flat-sheet cassettes) and sterile (0.2 µm) filtration; perform filter sizing (e.g., Vmax/Pmax), membrane selection, and filter integrity testing.
Develop, optimize, and scale chromatography steps, including affinity capture, anion exchange polishing and full/empty separation, and other modes (e.g., CEX, HIC, SEC, mixed-mode) using resins, monoliths, and membrane adsorbers.
Perform column packing and qualification (HETP/asymmetry), establish dynamic binding capacity, resin lifetime, cleaning, and sanitization strategies, and define operating ranges for chromatography steps.
Lead scale-up of downstream processes from bench scale to pilot and cGMP manufacturing scale and develop representative scale-down models to support process troubleshooting, process characterization, and robustness studies.
Participate in the collection, trending, and interpretation of data from bench scale experiments and large-scale manufacturing, and aid in organization of data for statistical process control.
Provide technical support during tech transfer and scale-up to the cGMP suite, and support troubleshooting and mitigation efforts for GMP manufacturing situations.
Perform root cause analysis and recommend corrective and preventive actions for the resolution of deviations, investigations, and process issues.
Contribute to manufacturing operations, including collaboration with facilities, quality, and manufacturing groups for implementation of the production process in cGMP clinical manufacturing facilities. This can include equipment FAT/SAT, commissioning and qualification, defining user requirements, and support of validation from a process perspective.
Provide equipment engineering support for downstream processes with a focus on single-use technologies, including support in the creation of custom single-use consumables and assemblies from design through testing to GMP induction.
Draft and review documents including batch records, Standard Operating Procedures (SOPs), qualification protocols, development and tech transfer reports, and investigation reports.
Meticulously maintain experimental records with detailed observations and maintain laboratory equipment.
Train Manufacturing personnel and less experienced team members in equipment and process operations.
Perform ad-hoc and cross-functional laboratory work and/or projects assigned to support business needs and provide developmental opportunities.

Benefits

Medical, Dental and Vision Plan Options
Health and Financial Wellness Programs
Employer Assistance Program (EAP)
Company Paid and Voluntary Life/AD&D, 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 (PTO) includes: 11 Holidays
Exempt Employees are eligible for Unlimited PTO
Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day