Biopharma Formulation Process Leader

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

Benefits offered by this job

Annual bonus

Healthcare

PTO 120 hours

Paid holidays

Parental leave

401(k) plan

ESPP

Job summary

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.

Qualifications

• - 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.

Responsibilities

• 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.

Skills

GMP compliance

Process validation

Risk assessment

Documentation

Project management

Leadership

Cross-functional teamwork

Communication

Lean Six Sigma

On-call readiness

Education

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

Bachelor's degree in a related scientific field

CPIM certification

Tools

SAP

LIMS

Job description

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.