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Supervisor, Manufacturing Upstream - Nights
Company: Thermo Fisher Scientific
Location: Lexington, MA
Employment Type: Full Time
Date Posted: 01/08/2021
Expire Date: 03/05/2021
Job Categories: Arts, Entertainment, and Media, Biotechnology and Pharmaceutical, Healthcare, Other, Information Technology, Manufacturing and Production, Purchasing, Quality Control, Research & Development, Medical
Job Description
Supervisor, Manufacturing Upstream - Nights

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 CDMO 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
Nights 7P – 7A 2/2/3

How will you make an impact?
The supervisor in this role will be part of a cohesive team responsible for upstream manufacturing operations at the Thermo Fisher Scientific Lexington gene therapy manufacturing site. Upstream operations include but are not limited to adherent and suspension cell expansion through bioreactor, clarification and tangential flow filtration. The manufacturing supervisor will support equipment, documentation, investigations and improvement initiatives within the manufacturing operations. Works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.

What will you do?
• Practices and promotes safe work habits and adheres to safety procedures and guidelines
• Team with Engineering to ensure equipment readiness for campaign start
• Team with facilities and Quality to ensure suite readiness from a change in and compliance stand point
• Utilizes manufacturing process knowledge and investigation skills to identify and resolve manufacturing issues and drive continuous improvement in process operations
• Proactively directs and delegates staff to ensure the execution of the daily manufacturing schedule
• Supervises team responsible for seed train, bioreactor, transfection, clarification, and hTFF activities.
• Understands small scale cell culture work utilizing aseptic technique in a biological safety cabinet including media preparation, cell passaging and cell counting.
• Performs batch record review, procedure revisions, and work order generation
• Supports equipment, documentation, investigations and improvement initiatives within manufacturing operations
• Support and develop consistent manufacturing standards for controlled documents used within cGMP manufacturing
• Conducts complex document revisions and/or document management including batch production records and manufacturing procedures
• Performs training with staff on the floor, as needed
• Supports cross-functional company goals
• Builds cross-functional relationships and enhances relationships with team members
• Works cooperatively with others to meet group and organizational goals
• Meet with operators regularly to discuss goals, planning, and progress.
• Continuously builds a high-performance diverse team of people to achieve objectives
• Develops self and others to improve performance in current role and to prepare for future roles
• Seeks and welcomes feedback and responds to coaching
• Provides frequent feedback and coaching to others on ways to improve performance
• Recognizes and celebrates successes
• Establishes and maintains a culture in line with company values
• Participates in initiatives to support, innovation and continuous improvement activities and improved compliance with quality procedures, policies and regulations.
• Participate in client and planning meetings as requested

How will you get here?
Education

• Bachelor’s in Life Sciences, Engineering or related field – preferred. A combination of experience and education will be considered. HS Diploma or equivalent – required.

Experience
• 3+ years’ experience in the bio/pharma industry and aseptic processing - required.
• 2+ years of management and people leadership experience - preferred.

Knowledge, Skills, Abilities
• Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously
• Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
• Ability to make decisions and work with minimal to moderate supervision.
• Able to provide effective written or verbal communication to peers, senior associates, and area management within their operational groups
• Demonstrated ability to motivate exempt and non-exempt employees and demonstrated management skills, (i.e., business knowledge, leadership, communication, ability to analyze technical issues, conflict resolution). Thorough knowledge of cGMPs.
• Strong planning, organization and multitasking skills
• Solid understanding of applicable regulatory requirements.
• Strong understanding of aseptic principles
• Experience with adherent and/or suspension cell lines
• Experience with tissue flasks and cell factories
• Ability to lift at least 30lbs


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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