Location

Lexington, MA

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases

How will you make an impact?

The Sr. Manufacturing Associate is a key assistant and adviser to the Manufacturing Lead and Supervisor and is a direct leader to the manufacturing technicians. In the absence of the Lead, the Sr. Associate will assume the role. Sr. Associates are responsible for daily activities required for the GMP manufacturing of clinical and commercial products.

What will you do?

Responsibilities

• Troubleshooting and operating bioprocess manufacturing equipment, aseptic processing, and completing or reviewing the associated documentation of those activities, and monitoring assigned processes using automated production systems and controls.
• Keeping the GMP manufacturing facility in a state of inspection readiness, using performance tools (Human Performance), and routine housekeeping activities.
• The Sr. Associate must be technically proficient with a thorough to extensive theoretical comprehension of general biopharmaceutical manufacturing equipment, principles and processes and have a strong understanding of current GMP and safety standards and be able to apply this knowledge independently in a GMP manufacturing environment.
• Be a role model and mentor for the manufacturing technicians.

ESSENTIAL JOB FUNCTIONS:

• Prepare and process equipment and materials for manufacturing use including performing equipment functional checks, start up, basic maintenance and operation of single use bioreactors, purification columns and skids.
• Perform equipment function checks, preventative maintenance, standardization and calibration, and testing of in-process samples using analytical equipment following written procedures. Clean production clean-rooms and remove waste materials.
• With minimal to no supervision navigate and use with a thorough understanding manufacturing systems for process operation and process performance. Sr. Associates must be able to independently train junior associates on Thermo Fisher policies, programs and procedures adequately using their experience and knowledge.
• Assess, author and revise departmental documentation (e.g., Standard Operating Procedures, PBR’s and Work Instructions), for GMP compliance, accuracy and completeness. Reviews data, and trends.
• Participates and runs PPI meetings. Provides input into the investigation of non-conformance's in compliance with procedures, policies and regulations. Write and investigate deviations.

How will you get here?

• Bachelor’s Degree in Life Sciences preferred
• 2-4 years’ industry related experience with a Bachelor’s Degree in Life Sciences
• 3-5 years’ industry related experience with a Associates Degree/certificate program
• 4-6 years industry related experience with a high school diploma
• Strong interpersonal and communications skills; written and oral.
• Solid understanding of applicable regulatory requirements

Experience

• Must be able to make process decisions impacting GMP manufacturing including process performance independently with minimal to no supervision. Ability to independently recognize, understand, assess, and resolve situations that require additional evaluation or analysis and report these events appropriately.
• Ability to provide effective written or verbal communication to peers, associates, area management and to all manufacturing support groups.
• Enforce the safe performance of activities and safely perform activities on the shift in order to prevent releases, accidents and injuries.

Knowledge, Skills, Abilities

• Ability to aseptically gown and/or sterile gown as needed
• Ability to work within environmental clean rooms
• Ability to function in a dynamic environment and balance multiple priorities simultaneously
• While performing the duties of this job, the employee is required to write, read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
• Is regularly required to talk and hear. The employee frequently is required to sit and stand for extended periods. The employee is occasionally required to lift, stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.

Work Hours: The position is a 12-hour nighttime rotation after on-boarding is complete.

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.