Downstream Biomanufacturing Associate

Job Title: Sr. BMA Downstream

Job Location: Rockville, MD

Job Duration: 6 months (There is a possibility of extension or conversion at end of 6 months)

Schedule: 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.

Position Summary:

The Sr. Biomanufacturing Associate plays a key role within Client’s 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 independently and effectively apply experience and in-depth technical knowledge across a range of floor-level tasks (from start to finish), some of which are complex, requiring independent action and initiative when executing manufacturing protocols.

Key Responsibilities and Duties:

• Apply and adhere to SOPs, cGMP, GLP, Quality, and Safety requirements.
• Independently execute floor-level tasks, in line with SOPs in one or more areas:
• Downstream Activities
• Fill-Finish Activities
• Assist in coordinating and executing floor activities, in alignment with the batch record.
• Apply advanced GDP when preparing, editing, reviewing, and implementing Quality documents.
• Perform daily BPR reviews to ensure completion.
• Participate in/co-lead GMP audits and investigations.
• Ensure high data integrity when accurately documenting, analyzing, and reviewing work.
• Prepare, clean, maintain, inspect, and operate equipment; assist with calibrations.
• Troubleshoot routine to moderately complex issues, using root cause analysis.
• Co-lead health and safety prevention initiatives to reduce risk.
• Comply with safety regulations and site-based guidelines by applying:
• Cleanroom and aseptic behaviors and procedures.
• 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.
• Understanding of biosafety levels and applying specific controls.
• Universal precautions/OSHA guidelines.
• Assistance in training others to avoid accidents or other unsafe situations.
• Assist in mentoring and training others; share knowledge and best practices.
• Provide recommendations and implement Continuous Improvement/LEAN solutions to create efficiencies.
• Ensure 100% on time completion of own/others training plans; ensure they are maintained and up to date.
• Be punctual and flexible with work schedule, tasks, etc. to support business demands.
• Perform other responsibilities as required.

Qualifications:

• HS Diploma/equivalent and 6 years of related experience, A.S. with 5 years, or a B.S. in biology/life sciences, bioengineering, or related discipline with 3 years of related experience.
• Prior cell/gene therapy experience in a highly technical role, covering a wide range of tasks, within a cGMP/biotech manufacturing environment or related industry/role.
• Informal coaching or project management experience is desirable.
• Qualified as a LEAN trainer or willing to become qualified.

Other:

• Able to work in accordance with and role model the client.
• Foster collaboration – a team player, with a positive attitude, professional tone, and demeanor.
• Able to plan, coordinate, and execute multiple projects simultaneously and deliver on time.
• Able to engage, inspire, assist, and mentor others.
• Demonstrate an operations and customer-focused mindset.
• Willing to continuously learn and improve.
• Strong attention to detail and excellent GDP skills.
• Advanced analytical, critical thinking, and problem-solving skills.
• Takes pride in own work – high quality, delivered on time, requiring limited rework.
• Strong listening, clear written, and verbal communication skills.
• In-depth knowledge/application of MS Word, Excel, PowerPoint, Teams, databases, etc.
• Pass/maintain aseptic/gowning qualifications & media fill activities; work in a cleanroom at least 4 hours/day.