Job Description

Job Title: Manufacturing Senior Associate

Location: Lexington MA

How will you make an impact?

Thermo Fisher Scientific-Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.

Position Description/Summary

What will you do?

* Responsible for cGMP manufacturing operations at the VVS Lexington site Upstream Operations.
* Performing basic to complex activities in seed train, bioreactor, transfection and clarification.
* Executing aseptic operations within Biosafety cabinet and cleanroom environment.
* Performing pipetting, pouring, seeding and harvesting of adherent cell lines using tissue flasks and cell stacks.
* Preparation of growth and production media.
* Performing critical upstream activities utilizing iCELLis bioreactor platform.
* Documentation of all activities in Batch Records, Logbooks, Forms, Etc.
* Follows verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.
* Identifies, escalates and documents events and subtle variances that deviate from normal operation; participate as needed in investigations.
* Monitor processes using automated production systems and controls with limited supervision.
* Equipment preparation, sanitation and disinfection.
* Demonstrates ability to troubleshoot basic mechanical operations.
* Conducts training for less experienced personnel.
* Work in accordance with site and company EHS programs.
* Work in accordance with regulations, detailed protocols, Batch Record2019s, SOP2019s and Work Instructions.
* Fulfills role of lead trainer on numerous operations and is an area SME.
* Fulfills the role of Team Lead in the absence of the team supervisor. Responsible for assignment of duties to all team members, ensuring execution of duties, communicating at daily scheduling meetings, and providing technical support as needed.

The position is a 12-hour day time rotation and may require overtime to work evenings, weekends or holidays, as required to meet project timelines.

How will you get here?

* Effectively utilizes Microsoft office applications.
* Must be able to work in a fast-paced environment.
* A strong attention to detail through a 12-hour shift.
* Solid understanding of aseptic principles.
* Work towards solutions to given problems and operate under cGMP requirements.
* Work cross-functionally with support groups such as Facilities, Engineering, Contamination Control, MST, Quality Control and Quality Assurance.
* Qualify to work in aseptic environments to complete required production activities.
* Maintain facility and room inspection readiness.
* Ability to lift at least 50lbs.
* Ability to aseptically gown and/or sterile gown as needed.

200BEducation

High School Diploma required; Bachelor's in STEM field preferred

Experience

2+ years of related experience preferred; 5+ years preferred

On-the-floor leadership or 'subject matter expertise' in cGMP manufacturing.