Senior Biomanufacturing Associate - Upstream & Compliance

Job Summary

The Senior Biomanufacturing Associate – Upstream & Compliance will report to the Associate Director Manufacturing and will work with team members performing Upstream GMP manufacturing in support of client production. 

This role will independently and effectively apply experience and in-depth technical knowledge across a range of floor-level tasks (when needed), some of which are complex, requiring independent action and initiative when executing manufacturing protocols. The role will also require extensive firsthand experience with TrackWise (or similar quality system) in order to author deviations, risk/impact assessments, CAPAs, and change controls.  

Key Responsibilities and Duties:

•    Apply and adhere to SOPs, cGMP, GLP, Quality, and Safety requirements. 
•    Apply process knowledge in investigating, authoring, and completing manufacturing deviations, risk/impact assessments, CAPAs, and change controls in TrackWise.  
•    Work with quality assurance to track all manufacturing quality records to ensure timely closures. 
•    Independently execute floor-level tasks (as needed), in line with SOPs in one or more areas:
    o    Upstream Activities 
    o    Fill-Finish Activities 
•    Assist in coordinating, scheduling, and executing floor activities, in alignment with the batch record and production schedule.
•    Apply advanced GDP when preparing, editing, reviewing, and implementing production documents. 
•    Perform daily BPR reviews to ensure completion. 
•    Participate in/co-lead GMP audits and investigations.
•    Troubleshoot routine to moderately complex issues, using root cause analysis. 
•    Comply with safety regulations and site-based guidelines by applying: 
    o    Cleanroom and aseptic behaviors and procedures. 
    o    PPE and gowning requirements. 
    o    Proper preparation, disinfection, sterilization, and sanitation methods/processes for equipment, etc. 
    o    The safe handling, transport, storage, and disposal of biological specimen, chemical, and hazardous materials.
    o    Understanding of biosafety levels and applying specific controls.
    o    Universal precautions/OSHA guidelines. 
    o    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. 
•    Be punctual and flexible with work schedule, tasks, etc. to support business demands. 
•    Perform other responsibilities as required. 

Job 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. 
•    Extensive experience with TrackWise or similar quality systems, specifically with authoring deviations, risk/impact assessments, CAPAs, and change controls is required. 
Other:
•    Able to work in accordance with and role model the Charles River 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.

Compensation Data

The pay range for this position is $34.00 - $36.00. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.