Compliance Specialist III

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

Vantagens oferecidas por esta oferta de emprego

Medical & dental plans

Employee assistance programs

Paid time off & holidays

401(k) retirement plan

ESPP stock purchase

Resumo da oferta

Thermo Fisher Scientific in Massachusetts is seeking a Scientist III in Formulation to contribute to developing and manufacturing biopharmaceutical products. You’ll apply your technical expertise to ensure the highest quality standards while working with cross-functional teams to deliver therapies that help improve global health and environmental sustainability.

You will manage technical projects, provide manufacturing support, and resolve complex process challenges.

Qualificações

• Advanced degree (MS/PhD) with 3+ years in biopharma manufacturing or related field
• Bachelor's degree with 5+ years in biopharma manufacturing or related field
• Certification in Production and Inventory Management (CPIM) beneficial
• Strong understanding of GMP regulations and quality systems
• Experience with 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
• Excellent project management and organizational skills
• Outstanding written and verbal communication abilities
• Ability to work effectively in a matrix environment with cross-functional teams
• Proficiency in English; other language skills beneficial
• Experience with SAP, LIMS, or similar systems
• Willingness for on-call duties and flexible scheduling
• Knowledge of Lean Manufacturing and Six Sigma methodologies

Responsabilidades

• Manage technical projects in formulation and biopharma manufacturing
• Provide manufacturing support and resolve complex process challenges
• Develop and optimize formulation processes and conduct validation studies
• Collaborate with clients and internal teams to deliver results
• Lead technology transfer and scale-up efforts
• Ensure GMP compliance and quality documentation
• Mentor and coach junior staff
• Apply Lean/Six Sigma principles to processes

Conhecimentos

Analytical thinking

Problem solving

Project management

Cross-functional collaboration

Communication

Leadership & mentoring

Lean Six Sigma

English proficiency

Matrix environment

Formação académica

Advanced degree (MS/PhD) + 3 years experience

Bachelor's degree + 5 years experience

CPIM certification (beneficial)

Ferramentas

SAP

LIMS

Descrição da oferta de emprego

Work Schedule

First Shift (Days)

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.