Head of Drug Substance Manufacturing

Company: Thermo Fisher Scientific
Location: Cambridge
Posted on: January 11, 2021

Job Description:

location Cambridge, Massachusetts, US Job ID: 136729BR 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 . GROUP/DIVISION SUMMARY The Head of Drug Substance Manufacturing reports into the Viral Vector Services Group at Thermo Fisher Scientific. This position will based in the Cambridge, MA office. POSITION SUMMARY This position is responsible for leading the Viral Vector Services' Cambridge site's Drug Substance (DS) Manufacturing operation inclusive of cell banking, host cell inoculation, viral vector production, buffer/ media prep, and equipment prep as well as indirect operational / suite support activities including production scheduling, deviation investigation, change management, document management, and training all according to current good manufacturing practices (cGMP) in support of late stage clinical and commercial production. Reporting to the GM, he/she provides the leadership, strategic thinking, and results focus to reliably meet and/or exceed the site's production targets while achieving high levels of quality and driving a strong safety culture. The DS Manufacturing head will define and deploy operational excellence tools and systems that empower cross functional production flow / value stream teams. This position requires an individual capable of partnering across the organization to manage a fast-paced production environment and deliver exceptional service to our clients Key Responsibilities:

• Ensure the safety of assigned areas and work practices in accordance with site and company EHS programs.
• Provide daily management oversight for all DS production activities at Cambridge site ensuring processes and practices are compliant with global current good manufacturing practices (cGMP).
• Partner with clients, manufacturing sciences, and program managers to facilitate technical transfer of client processes to manufacturing including management of change controls, development / revision of batch records and procedures, and establishing process and equipment training programs.
• Recruit and develop staff to execute department functions; ensure effective utilization of resources through strong people leadership including consistent performance management, robust employee development and routine rewards and recognition practices.
• Establish department / individual goals and key performance indicators in alignment with company and operational goals; maintain and report applicable department and delivery metrics.
• Drive continuous improvement and Operational Excellence culture thru self-detecting and self-correcting processes and systems and instilling strong ownership and accountability.
• Develop and manage department's annual operating budgets; partner with Finance to analyze variances and implement adjustments.
• Proactively identify, assess, and mitigate quality, operational, and organizational risks; escalate key risks and issues. Qualifications:
  • Bachelor's degree and 10-15 years of related work experience or Master's degree and 8-10 years of work experience.
  • Minimum of 10 years in management / leadership positions-preferred
  • Minimum of 8 years leading cGMP manufacturing / operations teams in fast paced production environment-preferred
  • Expertise in GMP facilities and equipment design / engineering concepts 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.
    • Excellent written and oral communication skills both internal and external. At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer. To access this job later or share with a friend, please enter Name and Email Address below. Your Name Get notified for similar jobs Sign up and receive similar job alerts to your email Enter Email address Get customized job recommendations based on your career area of interest. Location Cambridge, Massachusetts, US Operations Location Franklin, Massachusetts, US Operations Location Franklin, Massachusetts, US Operations Location Franklin, Massachusetts, US Operations Location Cambridge, Massachusetts, US Operations How would you rate your experience popup 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.

Keywords: Thermo Fisher Scientific, Cambridge , Head of Drug Substance Manufacturing, Accounting, Auditing , Cambridge, Massachusetts