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Downstream Manufacturing Sr. Associate
Company: Thermo Fisher Scientific
Location: Lexington, MA
Employment Type: Full Time
Date Posted: 01/19/2021
Expire Date: 03/06/2021
Job Categories: Biotechnology and Pharmaceutical, Customer Service and Call Center, Healthcare, Other, Information Technology, Manufacturing and Production, Purchasing, Quality Control, Research & Development, Medical
Job Description
Downstream Manufacturing Sr. Associate

Job Title: Sr. Associate, Downstream Manufacturing - Days
Requisition ID: 115591BR

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of more than $24 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Viral Vector Services is a dynamic gene and cell therapy contract development and manufacturing organization that is looking for leaders to bring the highest quality processes, products and testing to our clients. Our staff members are committed to making a difference in our organization, for our client partners and the patients we serve. We seek individuals with proven competencies and strong character to help lead our organization now and into the future.

Location/Division Specific Information
Lexington, MA 12 hour shift – 7A- 7P – 2/2/3

How will you make an impact?
Responsible for cGMP manufacturing operations at the Thermo Fisher Lexington site Downstream Operations.

What will you do?
• Executing aseptic operations within Biosafety cabinet and cleanroom environment.
• Preparation of buffers to support downstream purification activities.
• Performing critical downstream activities through Chromatography, TFF, Viral Filtration, and Final Formulation.
• 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 Record’s, SOP’s 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.

How will you get here?
• BS – Chemistry, Biology or related field – desired. A combination of education and industry experience will be considered
• 4+ years of industry related experience on the floor leadership or "subject matter expertise" in cGMP manufacturing.
Knowledge, Skills, Abilities
• Qualify to work in aseptic environments to complete required production activities.
• 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.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

Contact Information
Company Name: Thermo Fisher Scientific
Website: https://thermofisher.contacthr.com/...
Company Description:

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