Process Development Associate II (Downstream) *PC 415

Process Development Associate II (Downstream)
* PC 415

• Posted on August 20, 2026

Showing 1 location

Gaithersburg, MD
1201 Clopper Road
Gaithersburg, MD 20878, USA

Gaithersburg, MD
1201 Clopper Road
Gaithersburg, MD 20878, USA

• On-site
• Manufacturing
• Full-Time
• Requisition #: PROCE
  003634

Your 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 position will also support the technical needs of the department as they relate to site specific products and/or processes. Duties and level of responsibility will be based on previous experience and demonstrated ability to provide consistent results.

Essential Duties and Responsibilities:

• Responsible to perform downstream operations independently or with minimal supervision.
• Responsible for preparing necessary materials (buffer, packed columns, filters) in support of downstream activities.
• Execute experiments, with minimal supervision, designed by senior team members.
• Responsible for the proper use of equipment and perform cleaning of the equipment 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 reports on status.
• Assist and may independently execute assays to characterize processes such as (ELISA, qPCR, ddPCR, Flow Cytometry, SDS-page, Western Blot, Total protein and DNA,etc...).
• Complete Purchase Order requests and restock supplies as needed to maintain inventory of critical reagents and materials, may be required to work cross-functionally.
• Train junior team members in all aspects of current responsibilities, with direction from senior team members.
• May assist in the development of manufacturing documentation with limited scope, and full oversight from senior team members.
• As needed, support and perform necessary operations to manufacture materials needed for commercial and collaborator evaluation and pre-clinical studies, including assembly and sterilization of single-use materials.
• Assist on projects of moderate scope, with execution of pre-defined test variables supervised.
• Perform necessary operations to maintain laboratory infrastructure.
• Carry out tasks in support of on-going experiments and runs in PD.

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 to improve existent processes. Understand and apply scale-up principles and strategies.
• Experienced in protein and/or viral particle purification methods that include cell culture supernatant harvest and clarification, column/membrane chromatography (AEX, CEX, affinity, HIC, mixed-mode, and SEC), filtration technologies (UF/DF, Dead-end, etc.)
• Experience with operating 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 different unit operations (filtration, chromatography)
• Interact with upstream and analytical functional teams to determine appropriate method for protein purification
• Actively engage in scientific and technical discussions
• Draft and execute SOPs, BPRs
• Superb documentation and organizational skills, often providing summaries and generating development reports
• Highly proficient in the use of Microsoft Office products
• Experience with late-stage product development as well as the statistical design of experiments is a plus
• Experience with upstream techniques and performing analytical assays is a plus
• Experience with QbD and JMP software is a plus

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands or finger, handle, or feel;

reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a sanitized…