GMP Compliance Scientist III – Formulation

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

Benefits offered by this job

Medical & dental plans

Employee assistance programs

Paid time off & holidays

401(k) retirement plan

ESPP stock purchase

Job summary

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.

Qualifications

• 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

Responsibilities

• 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

Skills

Analytical thinking

Problem solving

Project management

Cross-functional collaboration

Communication

Leadership & mentoring

Lean Six Sigma

English proficiency

Matrix environment

Education

Advanced degree (MS/PhD) + 3 years experience

Bachelor's degree + 5 years experience

CPIM certification (beneficial)

Tools

SAP

LIMS

Job description

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.