Job Description

　　Operations Product Leader II

　　Job DescriptionT

　　As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

　　Location/Division Specific Information

　　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 vital to help clients deliver innovative gene therapies. Placed in the forefront of our leading- and innovative Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

　　Location: 5 Commerce Boulevard Plainville, MA

　　Schedule: 8am - 4:30pm, Mon-Fri

　　How will you make an impact?

　　In this role, you will be responsible for the leadership and execution of operations deliverables for our clients. You will act as the liaison between manufacturing and the client to pro-actively communicate status of manufacturing documentation, performance of the run, and escalation of any risks to the process. You will also provide daily direction to the RSO specialists that are responsible for drafting batch records, SOPs, OJTs in order to prioritize needs for the client. This candidate will partner with technical leadership, program management, and clients to implement product and process improvements.

　　Responsibilities

　　Lead operational production readiness for late clinical stage and commercial manufacturing of new products ensuring robust implementation of new production capabilities that reliably and sustainably meet and/or exceed operational, quality, and cost targets.Manufacturing lead (Upstream, Downstream, Drug Product) for New Product Introduction and technical transfer team, communicating with client throughout product lifecycle.Manager to RSO/Specialist team's workload and priority of batch record, SOP, and work instruction creation to support program run readiness.Provide daily strategic direction of product's production flow / value stream ensuring end to end internal supply chain delivers product on-time and in-full.Proactively identify and escalate key risks and issues to manufacturing line and site leadership team.Coordinate and lead ad hoc cross-functional teams to develop risk mitigation plans and/or manage complex operational issues.Partner with technical leadership, program management, and clients to implement product / process improvements.Act as Manufacturing subject matter expert for assessments for change controls, validation protocols, and document changes.Engage in proactive relationships with client including acting as key client interface representing Thermo Fisher Scientific operational interests in both tactical and strategic meetings.Lead tier meetings within department and communicate issues when appropriate.

　　Education/Experience

　　Bachelor's Degree in Science, Engineering, Manufacturing, or related field required.4-5 years of relevant experience within biotech industry (manufacturing, tech transfer, NPI, process development, project management), or regulated industry.Experience with client communication and interaction preferred.Experience with working in clean or sterile environments, cleanrooms preferred.

　　Knowledge/Skill/Abilities

　　Strong interpersonal and communication skills (both verbal and written).Strong attention to detail and strive to accomplish the job timely, accurately, and safely the first time is required.Will be regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; sit and to talk or hear.Will be required to walk and stoop, or kneel, crouch.Will be expected to meet the specific vision abilities required by this job which include close vision and ability to adjust focus with tasks.Based on manufacturing process, there may be occasional requirements to work off shift/weekends.

　　We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

　　Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.

　　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 EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.