Downstream GMP Manufacturing Associate / BMA Upstream I & II

Job Description

Job Description

Job Title: Downstream GMP Manufacturing Associate

Site Location: 5 Research Court, 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.

Job Title: BMA Upstream I & II

Site Location: Rockville, MD, 20850

Contract Duration: 5 months

Initial shift schedule (core hours) is 8:00 am - 4:30 pm w/ 30 min unpaid lunch Monday through Friday

OT and weekend work may become required

there is a possibility of extension or conversion at end of 6 months

Position Summary:
The Biomanufacturing Associate II plays an integral role within gene therapy manufacturing function by applying biological, bioprocess, manufacturing, mechanical, application, system, and technology principles, processes, procedures, inputs, and outputs, for designated production processes and handovers within a regulated environment to ensure the timely production and release of quality products, based on client specifications. This role will apply solid knowledge and experience across a range of tasks, in resourceful and effective ways, requiring good judgment and initiative, when effectively executing manufacturing protocols.

Key Responsibilities and Duties:

• Apply and adhere to SOPs, cGMP, GLP, Quality, and Safety requirements.
• Effectively execute a range of tasks, in line with SOPs, in the following area:
• Upstream Activities (e.g., solutions, media aliquot, and buffer preparation and autoclave materials for cell culture, staging of raw materials, seed train, bioreactor set up, fermentation monitoring and/or harvest).
• Follow instructions when performing planned manufacturing activities, in alignment with the batch record.
• Prepare, edit, and complete quality documents. Well-versed in applying GDP.
• Ensure data integrity - accurately document and review work prior to submission.
• Document, record, investigate, and report observed process variances/deviations, in real time.
• Follow instructions when operating equipment. Prepare, clean, and maintain equipment/tools.
• Troubleshoot routine issues, using root cause analysis.
• Propose and implement approved improvements.
• Create and implement safety practices, assist others, and report all incidents immediately.
• Adhere to safe working practices and comply with site-based guidelines by applying:
• Cleanroom and aseptic behaviors and procedures.
• Proper Personal Protective Equipment (PPE) and gowning requirements.
• Proper preparation, disinfection, sterilization, and sanitation methods/processes for equipment, etc.
• The safe handling, transport, storage, and disposal of biological specimen, chemical, and hazardous materials.
• An understanding of biosafety levels and applying specific controls.
• Universal precautions with respect to OSHA guidelines.
• Appropriate organization, sanitizing, and stocking of work area to avoid unsafe situations.
• May assist others.
• Ensure 100% on time completion of training plan.
• Be punctual and flexible with work schedule, tasks, etc. to support business demands.
• Perform other responsibilities as required.

Qualifications:

• HS Diploma/equivalent with high grades in science and 3 years of related experience, A.S. with 2.5 years or a B.S. in biology/life sciences, bioengineering, or related discipline with 1.5 years of experience. Prior cell/gene therapy experience in a technical role covering a range of tasks within a cGMP and/or biotech manufacturing environment or other related industry, etc. Willing to become a qualified LEAN trainer.
• Able to work in accordance with Values.
• Foster collaboration - is a team player, with a positive attitude, professional tone, and demeanor.
• Is accountable and delivers high quality work on time.
• Willing to continuously learn and improve.
• Strong attention to detail, can recognize deviations, and has solid GDP skills.
• Solid analytical, critical thinking, problem-solving and communication skills.
• Solid knowledge/application of Word, Excel, Teams, databases, etc. Willing to learn PowerPoint.
• Pass/maintain aseptic/gowning qualifications & media fill activities; work in a cleanroom at least 4 hours/day.
  Additional Requisition Requirements:
  Candidate will need demonstrated experience in Upstream cGMP operations.
  HS Diploma/equivalent with high grades in science and 3 years of related experience, A.S. with 2.5 years or a B.S. in biology/life sciences, bioengineering, or related discipline with 1.5 years of experience.
  Prior cell/gene therapy experience in a technical role covering a range of tasks within a cGMP and/or biotech manufacturing environment or other related industry, etc

Notes: Looking for good experience with Bioreactors