Job Title: Manager Manufacturing Bulk Drug Substance
Requisition ID: 117041BR
When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.
Location/Division Specific Information
Cambridge, MA - Requires overtime to work evenings, weekends or holidays, as required to meet project timelines.
How will you make an impact?
As part of the VVS gene therapy manufacturing organization, the Manufacturing Manager-Bulk Drug Substance is responsible for leading the manufacturing team through production campaigns, owning the production suites and be accountable for schedule adherence. The Manufacturing Manager-Bulk Drug Substance reports into the head of manufacturing. He/she provides the cross functional leadership, operations acumen, and results focus to reliably meet timelines and due dates. This position requires an individual capable of partnering across the site to ensure sharing of best practices and learning opportunities, building robust business processes to drive sustainable performance and support the release of product in a fast-paced production environment.
What will you do?
• Ensure safety of manufacturing area and work practices in partnership with site EHS standards.
• Provide leadership, guidance, and direction to staff in alignment cGMP requirements and site 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 manufacturing line and manufacturing leadership team. Organize and lead ad hoc cross functional teams to manage investigations and implementation of changes.
• Drive continuous improvement and operational excellence culture thru self-detecting and self-correcting processes and systems and instilling strong ownership and accountability.
• Ensure high levels of communication with team, support resources and management regarding issue identification and resolution; develop formal communication protocols and tools including progress tracking systems, dashboards, and management reports, and any other product specific information as needed.
• Partner with technical leadership, program management and clients to implement product / process improvements; participates and/or may lead cross functional projects. Acts as manufacturing subject matter expert for assessments for change controls, validation protocols, and document changes.
How will you get here?
• BS - Engineering, Biological Sciences or related field desired. A combination of education and experience will be considered.
• Expertise in managing small and medium technical and/or capital projects.
• Minimum of 5 years in management / leadership positions. Preferred experience working in 2 or more functional areas.
• 3+ years leading cGMP operations teams in fast paced production environment.
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.
• Demonstrated ability to present ideas persuasively and negotiate effectively.
• Excellent written and oral communication skills both internal and external.
• Ability to aseptically gown and/or sterile gown as needed.
• 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.
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.