At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases. Viral Vector Services is an experienced viral vector CDMO supporting gene and cell therapies, and is focused on process and analytical development, and clinical and commercial supply. With more than a decade of experience, our 500-strong, highly skilled team has managed over 100 client projects delivering first-in-human clinical materials to accelerate our client’s products from the laboratory to patients in need. We work in close collaboration with each client’s team to deliver successful programs. Through this, we enable the delivery of novel medicines to improve patient health with the potential to cure diseases.
Together with the acquisition of approximately 600 new VVS colleagues based in Massachusetts and Florida, we’ll enable breakthroughs in science that improve patients’ lives and bring hope for a healthier world!
How will you make an impact?
The Lead Specialist in this role will be part of a cohesive team responsible for suite readiness, as well as owning/supporting Deviations, CAPAs, and Change Controls for all phases of manufacturing. The Lead Specialist uses expert knowledge of cGMP regulations and project management to support manufacturing. The incumbent will support equipment, documentation, training, and improvement initiatives within manufacturing operations.
What will you do?
- Team with Engineering and Facilities to schedule and maintain equipment readiness through each process
- Create and maintain materials used on the manufacturing floor, utilizing SAP when required
- Create, assign, perform, and maintain training for manufacturing staff while continuously tracking gap reports as required
- Edit cGMP documents and process through workflow for the creation of quality approved documentation. Cross-functional collaboration with document control and other supporting groups is required.
- Ownership and support of deviations, change controls, and corrective and preventative actions (CAPA’s). Lead manufacturing investigations as needed.
- Utilizes manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement in process operations
- Support manufacturing internal and external observations
- Practice and promote safe work habits while adhering to safety procedures and guidelines
- Leads cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology
- Support and develop consistent manufacturing standards for controlled documents used within cGMP manufacturing.
- Support and develop consistent manufacturing/quality standards and/or process for Deviations, Change Controls, and CAPAs in new Quality System
- Conduct complex document revisions and/or document management including batch production records and manufacturing procedures
- Own and maintain tracking systems of manufacturing priorities
- Works cooperatively with others to meet group and organizational goals.
- Participates in initiatives to support innovation and continuous improvement activities
- Improve compliance within quality procedures, policies, and regulations
- Participate in client and planning meetings as requested. Including but not limited to presentation and document preparation
How will you get here?
- Bachelor’s in Life Sciences, Engineering or Masters preferred
- Minimum of 5 years’ experience in pharmaceuticals manufacturing
- Minimum 2 years specialist experience preferred
- Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously
- Strong planning, organization and multitasking skills
- 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
- Solid understanding of applicable regulatory requirements.
- Gown aseptically and/or sterile gown as needed.
- 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.
- Regularly required to talk and hear. The employee frequently is required to sit and stand for extended periods.
- The employee is occasionally required to lift, stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.
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.