GMP Manufacturing Associate

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

Virtual Interview

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 environment's

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.