Thermo Fisher Scientific Manager, Drug Substance Engineering in Cambridge, Massachusetts
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
How will you make an impact?
The Engineering Drug Substance Manager will manage the overall strategy of the site Drug Substance engineering team, ensuring that the process and utility engineering groups are properly supported as well as being a key figure in driving tech transfers and site projects. The Manager will provide engineering leadership, guidance, support the VVS network and will work closely with the Validation and Manufacturing teams.
What will you do?
Ensure safety of mechanical and utility areas and work practices in partnership with EHS standards.
Ensure all equipment and system design documentation is organized and meets cGMP regulatory standards.
Provide leadership, guidance, and direction to staff in alignment site goals, requirements and directives.
Establish and maintain key performance indicators in alignment with department and product supply goals, maintain and report applicable area or organizational metrics.
Proactively identify and escalate key risks and issues to system owners
Organize and lead ad hoc cross functional teams to manage investigations and implementation of changes.
Drive continuous improvement and operational excellence through correcting processes and systems and instilling strong ownership and accountability.
Ensure high levels of communication with team
Drive technical leadership, program management and clients to implement product / process improvements; participates and/or may lead cross functional projects.
Acts as Facility and Engineering subject matter expert for assessments for change controls, validation protocols, and document changes.
How will you get here?
- Bachelor's degree in Engineering or related field - required. Master's degree or PhD - desired.
B.S. with 8+ years' experience, or Master's degree with 6+ years' experience, or PhD with 4+ years' experience.
2+ years project or team management experience - required Preferred experience working in 2 or more functional areas.
Knowledge, Skills, Abilities
Demonstrated ability to manage cross-functional teams and collaborate across the business.
Strong analytical and problem-solving skills; great attention to detail and excellent decision making process.
Expertise in managing technical projects.
Demonstrated ability to present ideas and negotiate effectively.
Excellent written and oral communication skills both internal and external.
Ability to aseptically gown and/or sterile gown as needed.
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.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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