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Job Title: Downstream GMP Manufacturing Associate

Site Location: Rockville, MD, 20850

Contract Duration: 3 months, 2 weeks, 3 days, Temp to possible perm

Core hours M - F 8:30 am to 5 pm with flexible hours/shifts needed.

Job Description:

The Downstream GMP Manufacturing Associate will work as part of a team and work directly in activities associated with purification that applies a broad knowledge of biological, bioprocess, and mechanical principles to execute complex operations that result in clinical and commercial stage medicines to dramatically improve the human condition through gene therapy. The activities will take place in a cleanroom following aseptic techniques and procedures in a cGMP environment.

Duties and Responsibilities:

• Train on and perform Downstream purification activities such as Chromatography, Tangential flow filtration (TFF), Ultracentrifugation, and Final Formulation steps.
• Work in 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 team to ensure the 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
• Work in cleanroom environment while adhering to Standard Operating Procedures (SOPs)
• 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.

Preferred Qualifications for the role:

• 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.
• Experience editing and reviewing Production Batch Records and Standard Operating Procedures preferred.
• Organizational and planning skills.
• Ability to work in a Team and collaborative environment.
• Attention to detail and time management.
• 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.
• Basic computer skills including Microsoft (Word, Excel, Teams etc.).
• Ability to work in a fast-paced environments

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, and 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
• Must be willing to work outside of normally-scheduled hours as necessary
• Must have reliable transportation to travel between sites in Rockville area
• Standing, (sometimes prolong standing), sitting, pushing, pulling, walking, bending, stooping, kneeling, and must be able to lift up to 50 lbs.