Downstream GMP Manufacturing Associate

About the role

The Downstream GMP Manufacturing Associate will work as part of a team in a cleanroom environment, following aseptic techniques and procedures in a cGMP setting to execute complex purification operations for clinical and commercial-stage gene-therapy medicines.

Responsibilities

• Train on and perform Downstream purification activities such as Chromatography, Tangential Flow Filtration (TFF), Ultracentrifugation, and Final Formulation steps.
• Work in a cleanroom environment while adhering to Standard Operating Procedures (SOPs) and Batch Production Records (BPRs).
• Prepare, sanitize, and disinfect equipment to prevent microbial contamination.
• Monitor processes using automated production systems and controls with supervision.
• Obtain and perform in-process sampling.
• Prepare buffers and solutions needed for Downstream activities, including at large scale (≥ 20L).
• Perform various filter integrity tests throughout the process.
• Document all activities in Batch Records, Logbooks, Forms, etc.
• Follow verbal and written procedures in operating production equipment and performing processing steps; accurately complete appropriate production documentation.
• Effectively communicate and interface with the team to ensure completion of daily activities.
• Operate manual and semi-automated equipment in support of routine production with minimal supervision.
• Edit and review Production Batch Records and Standard Operating Procedures.
• Interact with other departments to complete activities associated with Downstream operations.
• Perform other tasks as assigned to support GMP Manufacturing that ensures sustainable right-first-time performance.

Requirements

• High School Diploma or Associate Degree with 0-2 years of experience in Downstream biologic production processes in a GMP environment in a Life Sciences Company; or Bachelor of Science in Science or Engineering and 0-1 years of experience in Downstream biologic production processes in a GMP environment in a Life Sciences Company.
• Basic knowledge and understanding of purification processes.
• Ability to obtain sufficient hands-on experience with chromatography systems (AKTA systems at different scales) and approaches (Affinity, IEX, MMC), TFF modalities, and single-use mixing systems.
• Ability to learn to operate manual and semi-automated equipment in support of routine production with supervision.
• Experience in the preparation of buffers.
• Organizational and planning skills.
• Ability to work in a team and collaborative environment.
• Attention to detail and time management.
• Basic computer skills including Microsoft (Word, Excel, Teams, etc.).
• Ability to work in a fast-paced environment.

Preferred Qualifications

• Experience editing and reviewing Production Batch Records and Standard Operating Procedures.
• Previous work in viral or vaccine production highly desired.
• Previous experience working for a Contract Manufacturing Organization (CMO) highly desired.
• Strong communication skills (writing, speaking, comprehending) highly desired.

Key Competencies

• Demonstrates integrity and respect.
• Delivers results.
• Demonstrates business acumen.
• Fosters collaboration and teamwork.
• Champions change.

Working Conditions

• Operations are 24 hours per day, 7 days per week; shift work will be required.
• Must be able to gown and pass gowning qualification to work inside a cleanroom for at least 4 consecutive hours.
• Must be able to work flexible hours and outside of normally-scheduled hours as necessary.
• Must have reliable transportation to travel between sites in the Rockville area.
• Standing (sometimes prolonged), sitting, pushing, pulling, walking, bending, stooping, kneeling, and ability to lift up to 50 lbs.

Pay

Pay ranges between $20.00–$23.50/hour based on experience.