Shenandoah Biotechnology, Inc., a FUJIFILM Irvine Scientific company, is a leading manufacturer of recombinant proteins. Our vision is to provide a superior and affordable source of recombinant proteins to the academic and industrial scientific research communities. Our team are a passionate group from diverse backgrounds. Our headquarters and state-of-the-art, manufacturing facility is located in Warminster, Pennsylvania. Founded in April 2006, we joined Fujifilm Group in March 2022 and are rapidly expanding our operations.
We are hiring an Operations Manager. The Operations Manager will be responsible for managing facility operational duties to include overseeing the various teams to ensure the maintenance of the QMS and compliance processes associated with day-to-day manufacturing processes and filling operations.
- Responsibilities include overall business operations from product design, development, and production through delivery of the purified recombinant proteins globally to the various markets served
- Manage and lead cross functional teams working in the various departments to establish ensure maximum production capacity
- Manage the Quality Team to ensure the establishment and maintenance of the site QMS compliance related to manufacturing and packaging operations to enable the development and reliable supply of finished product
- Responsible for overseeing the production teams and ensuring operational compliance while looking at continual process improvement opportunities within the confines of the Shenandoah Quality Management System
- Communicate with project owners to assist with managing project timelines and budgets while ensuring workflows are effectively executed and prioritize items when required
- Oversee Quality Assurance to ensure that all operational aspects of the handling, manufacturing, and distribution of Shenandoah products comply relevant cGMP regulatory requirements
- Oversee Facilities and Purchasing to identify cost savings opportunities, budgetary needs, and ongoing production demands/constraints are addressed to ensure facilities are 100% operationally capable
- Manage Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment
- Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions
- Promote a quality mindset and quality excellence approach to all activities
- Promote a safety mindset and focus on safety for all operations activities
- Bachelor’s degree in a scientific discipline
- Minimum of 8 years Quality/CGMP management experience in the pharmaceutical industry
- Experience in production operations and sterile manufacturing Project management
- Manufacturing operations in a cGMP regulated environment
- Ability to speak, write and read English fluently
- Good oral and written communication skills
Principals only. No recruiters please.
Shenandoah Biotechnology, Inc., a FUJIFILM Irvine Scientific company is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.