Sr Manufacturing Technical Specialist

Lonza; Vacaville (CA); On-site; Confidential; Full time

Benefits offered by this job

Medical, dental and vision insurance

401(k) matching

Life insurance

Disability insurance

Employee assistance programs

Paid Time Off

Job summary

Lonza in Vacaville seeks a Senior MSAT Purification Specialist to provide scientific leadership and drive purification decisions for drug substance manufacturing. You will collaborate with Manufacturing, Process Development, Quality, and other teams to ensure robust, compliant processes and technology transfer excellence.

The role emphasizes mentoring, process optimization, and support for regulatory submissions within a cGMP framework at a fully site-based facility.

Qualifications

• Bachelor's degree in life sciences/engineering; advanced degree preferred.
• 10+ years in pharmaceutical industry specializing in purification of drug substance protein therapeutics, with cross-discipline experience.
• Experience with technology transfers, process validation, regulatory submissions, Health Authority interactions, inspections, and resolution of quality investigations.
• Expert in purification and separation sciences of drug substance protein therapeutic.
• Strong knowledge of cGMPs, Health Authority regulations, and Quality Systems.
• Desirable knowledge of OSI PI, R, SAS JMP, SQL and Tableau.

Responsibilities

• Technical lead/SME providing scientific expertise and driving complex purification process decisions across projects.
• Partner with site and network stakeholders to ensure effective technical knowledge transfer and long-term commercial product support.
• Drive technical decisions by balancing business, product, quality, and manufacturing operational needs.
• Maintain cGMP compliance and ensure purification process specifications meet regulatory and business requirements.
• Lead process optimization, troubleshooting, and new process evaluations through laboratory studies and data-driven analysis.
• Support regulatory submissions, inspections, change management, and resolution of significant manufacturing or quality issues.
• Mentor junior team members and drive continuous process improvement, process monitoring, and product/process health management.

Skills

Scientific leadership

Cross-functional collaboration

Process optimization

Regulatory knowledge

Mentoring

Education

Bachelor's degree in life sciences/engineering

Advanced degree in life sciences/engineering

Tools

OSI PI

R

SAS JMP

SQL

Tableau

Job description

Location: Vacaville, CA

This is a fully site based role. Working together in person supports close, real time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

Senior MSAT Purification Specialist provides scientific and technical support to drug substance manufacturing / production operations to ensure efficient and safe drug substance manufacturing processes at Vacaville. Works in collaboration with Manufacturing, Process Development, Quality, and other technical and business functions by specifying process requirements, driving for process optimization, maintaining the validated state of manufacturing process, and introducing new processes and new technologies in accordance with current Good Manufacturing Practices (cGMP) requirements and corporate standards. Lead complex projects, act as a lead Vacaville MSAT representative to other site and network teams, coach other team members as well as, when assigned, oversee, review and approve the work of other team members.

What you will get:

• The full-time base annual salary for this position is expected to range between $130,500 and $217,500.
• Performance-related bonus
• Medical, dental and vision insurance
• 401(k) matching plan
• Life insurance, as well as short-term and long-term disability insurance
• Employee assistance programs
• Paid Time Off

What you will do:

• Technical lead/SME providing scientific expertise and driving complex purification process decisions across projects.
• Partner with site and network stakeholders to ensure effective technical knowledge transfer and long-term commercial product support.
• Drive technical decisions by balancing business, product, quality, and manufacturing operational needs.
• Maintain cGMP compliance and ensure purification process specifications meet regulatory and business requirements.
• Lead process optimization, troubleshooting, and new process evaluations through laboratory studies and data-driven analysis.
• Support regulatory submissions, inspections, change management, and resolution of significant manufacturing or quality issues.
• Mentor junior team members and drive continuous process improvement, process monitoring, and product/process health management.

What we are looking for:

• Bachelor's degree in life sciences/engineering required, advanced degree in life sciences/engineering preferred.
• 10 or more years of experience (including advanced degree) in pharmaceutical industry specializing in purification of drug substance protein therapeutic; including experience across various disciplines in local or global roles.
• Experienced with technology transfers, process validation, authoring regulatory submissions, Health Authority interactions, inspections, and resolution of product/process quality investigations.
• Expert in purification and separation sciences of drug substance protein therapeutic.
• Strong knowledge of cGMPs, Health Authority regulations, and Quality Systems.
• Knowledge of the following software is desirable: OSI PI (and associated client tools), R,SAS JMP, SQL, Tableau.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table.

At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law.

Ready to shape the future of life sciences?