Operations Product Leader III

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc… allowed, Office

Job Description

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.

The OPL (Operations Product Leader) position will be site based in Plainville, MA and will support our Viral Vector Services (VVS Plainville) business unit of Thermo Fisher Scientific. At VVS Plainville, we deliver process development through commercial supply and offer the expertise and resources vital to help clients deliver innovative gene therapies.

Pharma Services / Viral Vectors / 5 Commerce Drive, Plainville, MA / 100% Onsite Discover Impactful Work:

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.

A day in the Life:

· 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, Solution Prep) 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.

· Facilitation of on site client visits for MFG operation observations

· Lead tier meetings within department and communicate issues when appropriate.

Keys to Success:
Education

· Bachelor’s Degree in sciences, biotech, pharma, or related field required.

· 4+ years of relevant experience within biotech, or regulated industry (manufacturing, tech transfer, NPI, process development, project management).

· Experience with client communication and interaction preferred.

· Experience with working in clean or sterile environments, clean rooms preferred.

· 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,…