Process Development Associate II (Downstream) *PC 415

About the Role

This position is primarily responsible for performing routine tasks related to the development of site-specific products and/or processes with limited supervision. This role will also support the technical needs of the department as they relate to site-specific products and processes. Duties and level of responsibility will be based on previous experience and demonstrated ability to provide consistent results.

Responsibilities

• Perform downstream operations independently or with minimal supervision.
• Prepare necessary materials (buffer, packed columns, filters) in support of downstream activities.
• Execute experiments, with minimal supervision, designed by senior team members.
• Ensure proper use of equipment and perform cleaning as required.
• Maintain complete and detailed lab notebooks and other documentation.
• Contribute to evaluation and implementation of process improvements (process troubleshooting, evaluating new methods, techniques).
• Participate in department and team meetings and report on status.
• Assist and may independently execute assays to characterize processes (e.g., ELISA, qPCR, ddPCR, Flow Cytometry, SDS-page, Western Blot, Total protein and DNA).
• Complete Purchase Order requests and restock supplies to maintain inventory of critical reagents and materials; may work cross-functionally.
• Train junior team members in all aspects of current responsibilities, with direction from senior team members.
• Assist in the development of manufacturing documentation with limited scope and full oversight from senior team members.
• Support and perform operations to manufacture materials for commercial, collaborator evaluation, and pre-clinical studies, including assembly and sterilization of single-use materials.
• Assist on projects of moderate scope, executing pre-defined test variables under supervision.
• Perform operations to maintain laboratory infrastructure.
• Carry out tasks in support of ongoing experiments and runs in process development.
• Apply scientific understanding of protein purification technologies and explore new approaches to improve existing processes.
• Apply scale-up principles and strategies.
• Perform protein and/or viral particle purification methods, including cell culture supernatant harvest and clarification, column/membrane chromatography (AEX, CEX, affinity, HIC, mixed-mode, and SEC), and filtration technologies (UF/DF, Dead-end, etc.).
• Operate AKTA Systems or similar chromatography systems.
• Prepare solutions required for production.
• Perform lab-scale and/or pilot-scale experiments to support process development and optimization of unit operations (filtration, chromatography).
• Interact with upstream and analytical functional teams to determine appropriate methods for protein purification.
• Actively engage in scientific and technical discussions.
• Draft and execute SOPs and BPRs.

Requirements

• Degree in the life sciences with at least 2 years of relevant experience.
• Scientific understanding of protein purification technologies and ability to learn and explore new approaches.
• Experience with protein and/or viral particle purification methods, including chromatography (AEX, CEX, affinity, HIC, mixed-mode, SEC) and filtration (UF/DF, Dead-end).
• Experience operating AKTA Systems or similar chromatography systems.
• Superb documentation and organizational skills, including generating development reports.
• Highly proficient in Microsoft Office products.

Preferred Qualifications

• Experience with late-stage product development and statistical design of experiments.
• Experience with upstream techniques and performing analytical assays.
• Experience with QbD and JMP software.

Physical Demands

The physical demands described here are representative of those required to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

• Regularly required to walk; use hands or fingers to handle or feel; reach with hands and arms; talk and hear.
• Required to stand; climb or balance; and stoop, kneel, or crouch.
• Must occasionally lift and/or move up to 50 pounds.
• Specific vision abilities required include close vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
• Ability to handle multiple tasks simultaneously and work at a rapid pace while maintaining attention to detail.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

• Performed in a temperature-controlled facility without exposure to extreme temperatures.
• Routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes, and computers.
• Frequently exposed to blood, viruses (e.g., HIV-1), bacteria, body fluids, and other tissues that may be infectious.
• Must wear appropriate protective equipment such as scrubs, coveralls, masks, face shields, glasses, and gloves.
• The noise level in the work environment is usually moderate.

Pay

The hiring range for this position is $42.99/hr - $50.60/hr, reflecting the range candidates can reasonably expect to be considered for at the time of offer. The salary of the finalist(s) selected will be set based on factors such as internal equity, experience, education, specialization, skills, abilities, and training.

Benefits

• Comprehensive benefits package, including health, vision, and dental insurance.
• 401(k) plan.
• Certain positions may also be eligible for additional compensation such as bonuses or commissions.