Operations Process Leader

ThermoFisher Scientific; Plainville (MA); On-site; USD 83,000 - 125,000; Full time

Benefits offered by this job

Total Rewards package

Stock Purchase Plan (ESPP)

401(k) retirement savings plan

Paid time off & holidays

Job summary

Thermo Fisher Scientific in Plainville, MA is seeking an OPL to lead operations deliverables for viral vector services. You will liaise between manufacturing and clients, directing RSO specialists, drafting batch records, SOPs, and work instructions, and partnering with technical leads to implement improvements.

The role requires 5–7 years in biotech or regulated manufacturing, with strong communication skills and experience in cleanrooms.

Qualifications

• Bachelor's Degree in sciences, biotech, pharma, or related field required.
• 5-7 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, cleanrooms preferred.

Responsibilities

• Lead operational production readiness for late clinical stage and commercial manufacturing of new products.
• 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 elevate 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.

Education

Bachelor's Degree in sciences, biotech, pharma, or related field

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

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.

Location/Division Specific Information

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

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 elevate 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.
• 5-7 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, cleanrooms preferred.

Qualifications

• 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.
• Based on manufacturing process, there may be occasional requirements to work off shift/weekends.

Benefits

We offer competitive remuneration, annual incentive plan bonus, 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!

Other

Relocation assistance is not provided.

Must be legally authorized to work in the United States now and in the future, without sponsorship.

Must be able to pass a comprehensive background check, which includes a drug screening.

Compensation and Benefits

The salary range estimated for this position based in Massachusetts is $83,300.00–$125,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

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.