Operations Process Leader

ThermoFisher Scientific; Plainville (MA); Presencial; USD 83 000 - 125 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Annual bonus

Healthcare

PTO 120 hours

Paid holidays

Parental leave

401(k) plan

ESPP

Resumo da oferta

Thermo Fisher Scientific seeks a Scientist III in Formulation to develop and manufacture biopharmaceutical products, applying advanced technical expertise to uphold high quality standards, GMP compliance, and robust processes.

You will lead formulation development, validation studies, and collaborate with clients and internal teams to deliver optimized results, contributing to global health and environmental sustainability. Strong project mgmt and communication are essential.

Qualificações

• - Advanced Degree plus 3 years of experience in biopharmaceutical manufacturing or related industry (per listing).
• - Bachelor's Degree plus 5 years of experience in biopharmaceutical manufacturing or related industry.
• - Certifications in Production and Inventory Management (CPIM) or related areas are beneficial.
• - Strong understanding of GMP regulations and quality systems.
• - Expertise in process validation, risk assessments, and process control strategies.
• - Proficiency with manufacturing documentation systems and batch record review.
• - Experience with technology transfer and scale-up processes.
• - Strong analytical and problem-solving abilities.
• - Excellent project management and organizational skills.
• - Outstanding written and verbal communication capabilities.
• - Ability to work in a matrix environment with cross-functional teams.
• - Proficiency in English; additional languages beneficial.
• - Experience with SAP, LIMS, etc.
• - Availability for flexible scheduling including on-call duties.
• - Leadership abilities and mentoring skills.
• - Knowledge of Lean Manufacturing and Six Sigma methodologies.
• - Strong attention to detail and commitment to quality standards.

Responsabilidades

• Develop and optimize formulation processes for biopharmaceutical products.
• Manage technical projects and provide manufacturing support.
• Resolve complex process challenges and ensure GMP compliance.
• Conduct validation studies and work with cross-functional teams and clients.
• Support technology transfer and scale-up activities.
• Contribute to process improvements and document control.

Conhecimentos

GMP compliance

Process validation

Risk assessment

Documentation

Project management

Leadership

Cross-functional teamwork

Communication

Lean Six Sigma

On-call readiness

Formação académica

Advanced degree in chemistry/biochemistry/biology/biotechnology/chemical engineering

Bachelor's degree in a related scientific field

CPIM certification

Ferramentas

SAP

LIMS

Descrição da oferta de emprego

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.

DESCRIPTION:

At Thermo Fisher Scientific, join our collaborative team as a Scientist III in Formulation, where you'll contribute to developing and manufacturing biopharmaceutical products. You'll apply your technical expertise to ensure the highest quality standards while working with advanced technologies and processes. This position offers the opportunity to work with cross-functional teams, enhance processes, and contribute to therapies that help improve global health and environmental sustainability.

You will manage technical projects, provide manufacturing support, and resolve complex process challenges while ensuring compliance with GMP regulations. Your role will involve developing and optimizing formulation processes, conducting validation studies, and working closely with clients and internal teams to deliver excellent results. This position offers professional development opportunities within our organization that values integrity, dedication, collaboration, and innovation.

REQUIREMENTS

• Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in biopharmaceutical manufacturing or related industry
• Preferred Fields of Study: Chemistry, Biochemistry, Biology, Biotechnology, Chemical Engineering, or related scientific field
• Additional certifications in Production and Inventory Management (CPIM) or related areas are beneficial
• Strong understanding of GMP regulations and quality systems
• Expertise in process validation, risk assessments, and process control strategies
• Proficiency in manufacturing documentation systems and batch record review
• Experience with technology transfer and scale-up processes
• Strong analytical and problem-solving abilities
• Excellent project management and organizational skills
• Outstanding written and verbal communication capabilities
• Ability to work effectively in a matrix environment with cross-functional teams
• Proficiency in English required; additional language skills beneficial
• Experience with relevant software systems (SAP, LIMS, etc.)
• Availability for flexible scheduling including on-call duties when required
• Demonstrated leadership abilities and mentoring skills
• Knowledge of Lean Manufacturing and Six Sigma methodologies
• Strong attention to detail and commitment to quality standards

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.