Job Description

Role: Sr. Biomanufacturing associate (downstream)

**Location:

5 Research Court, Rockville, MD, USA, 20850

Pay rate:

$31.50

/hr. on W2

Duration: 6+ months contract (Possibly convert into full-time)

Shift timings:

8:00 am - 4:30 pm (Monday to Friday)

Position Summary:

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The Sr. Biomanufacturing Associate plays a key 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 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.

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**Key Responsibilities and Duties:

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• 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:

• 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.

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**Qualifications:

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• 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 Values.

• 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.

You should be proficient in:

• Bachelor's Degree
• Continuous Improvement
• Cell Culture
• Standard Operating Procedures (SOPs)
• Lean Manufacturing Principles
• Good Manufacturing Practices (GMP)
• High School / GED