Role at a glance
- Salary
- Not Disclosed
- Location
- Florence, South Carolina, United States
- Work arrangement
- On-site
- Employment
- Full-time
- Experience
- Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in process development, scale-up, and manufacturing optimization required. Experience leading cross-functional teams and managing complex technical projects. Experience with quality systems and risk assessment methodologies. Experience developing and supporting team members.
- Education
- BS Degree Required. Preferred Fields of Study: Chemical Engineering, Chemistry, Polymer Chemistry, Process Engineering, or a similar...
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Role Summary
The Manufacturing Process Manager is an onsite role at the Florence, South Carolina site supporting the Drug Substance Division. The role provides technical leadership in developing, validating, and implementing manufacturing processes for active pharmaceutical ingredients, with a focus on process development, scale-up, and optimization.
What You'll Do
- Lead complex technical projects and provide manufacturing support.
- Conduct process improvements and drive technology transfer initiatives.
- Collaborate with R&D, Quality, Engineering, and Production on project goals and quality standards.
- Troubleshoot and optimize processes and implement data-driven solutions while ensuring regulatory compliance.
- Support the flawless import of materials and goods at the Florence locations.
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
BS degree required. Required experience is an advanced degree plus 6 years, or a bachelor's degree plus 8 years, in process development, scale-up, and manufacturing optimization. Also required: experience leading cross-functional teams and complex technical projects, working with quality systems and risk assessment, and developing and supporting team members. Qualifications include GMP and regulatory compliance knowledge; process development, scale-up, and optimization expertise; statistical analysis and DOE; troubleshooting and corrective actions; documentation, data analysis, process modeling, and trending; technical writing and presentation; stakeholder communication; cleanroom/GMP environment capability; and proficiency with statistical software and standard business applications.
Required
- Experience leading cross-functional teams and managing complex technical projects
- Experience with quality systems and risk assessment methodologies
- Experience developing and supporting team members
- Deep technical expertise in process development, scale-up, and manufacturing optimization
- Strong background in GMP manufacturing and regulatory compliance (FDA, EMA, ISO)
- Advanced analytical and problem-solving skills with expertise in statistical analysis and DOE
- Ability to troubleshoot complex process issues and implement corrective actions
- Strong documentation skills including SOPs, batch records, validation protocols and reports
Preferred
- Preferred fields of study: Chemical Engineering, Chemistry, Polymer Chemistry, Process Engineering, or a similar background
- Advanced degree
- Knowledge of Lean/Six Sigma methodologies
Original job description
Content provided by the employer
Original job description
Content provided by the employer
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materialsJob 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.
Division/Site Specific Information
Position will sit onsite at the Florence, SC site and will support the Drug Substance Division (DSD) at Thermo Fisher Scientific. This role, reporting to the Production Planning Manager, ensures the flawless import of materials and goods at our Florence, South Carolina locations.
Discover Impactful Work:
Join us as a Process Manager (Area Manager) in Manufacturing and contribute to excellence in process development and manufacturing optimization of active pharmaceutical ingredients. You'll provide technical leadership in developing, validating, and implementing robust manufacturing processes while collaborating across multiple departments to ensure successful scaling and optimization of new and existing processes. Make meaningful contributions to innovative solutions that help our customers make the world healthier, cleaner, and safer.
A Day in the Life:
As a key technical expert, you'll lead complex projects, provide manufacturing support, conduct process improvements, and drive technology transfer initiatives.
You'll collaborate with cross-functional teams including R&D, Quality, Engineering, and Production to achieve project goals and maintain high quality standards.
Your expertise will be essential in troubleshooting, optimizing processes, and implementing data-driven solutions while ensuring compliance with regulatory requirements.
Keys to Success:
Education
BS Degree Required. Preferred Fields of Study: Chemical Engineering, Chemistry, Polymer Chemistry, Process Engineering, or a similar background.
Advanced degree preferred.
Experience
Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in process development, scale-up, and manufacturing optimization required.
Experience leading cross-functional teams and managing complex technical projects.
Experience with quality systems and risk assessment methodologies.
Experience developing and supporting team members.
Knowledge, Skills, Abilities
Deep technical expertise in process development, scale-up, and manufacturing optimization
Strong background in GMP manufacturing and regulatory compliance (FDA, EMA, ISO)
Advanced analytical and problem-solving skills with expertise in statistical analysis and DOE
Proven ability to troubleshoot complex process issues and implement corrective actions
Strong documentation skills including SOPs, batch records, validation protocols and reports
Expertise in data analysis, process modeling, and trending
Excellence in technical writing and presentation skills
Strong interpersonal and communication abilities for collaborating with internal/external stakeholders
Ability to work in cleanroom/GMP manufacturing environments
Proficiency with statistical software and standard business applications
Travel may be required (<20%) to other sites
Knowledge of Lean/Six Sigma methodologies preferred
Benefits
We offer competitive remuneration, annual incentive plan bonus scheme, 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.
About the company
Thermo Fisher Scientific
Large Enterprise
Thermo Fisher Scientific is a global leader in serving science, providing a wide range of analytical instruments, reagents, and software solutions for healthcare, pharmaceuticals, and life sciences research. With a commitment to innovation and quality, the company enables customers to make significant advancements in scientific discovery and healthcare diagnostics. Thermo Fisher operates in more than 50 countries and employs over 80,000 people, fostering a collaborative environment aimed at enhancing global health and safety. Through its broad portfolio of brands and technologies, the company plays a vital role in accelerating life-changing research and improving patient outcomes worldwide.