MSAT Senior Scientist

Lonza•Vacaville, CA

3d•Onsite

About The Position

MSAT Senior Scientist will independently lead the technical transfer of multiple concurrent manufacturing processes (Upstream - USP) from Process Development, Pilot Scale and other sites of manufacture to GMP operations. The role will be a recognized process expert. Supporting multiple customer project teams to deliver manufacturing processes in negotiation with external customers as well as other internal cross-functional teams. This role has the opportunity to develop an extensive internal network. Building influence and credibility in the industry. In addition, the role will act as a coach/mentor to more junior team members and cross functionally as a Subject Matter Expert (SME).

Requirements

Bachelor’s degree in life sciences or relevant field.
Strong technical writing, collaboration with customers and teams
A deep understanding of biologics processes and manufacturing
Strong analytical skills to identify issues, assess data, and propose solutions.
Effective communication
Ability to evaluate data and drive process improvements.
Adaptable to fast-paced environments, shifting workloads, and timelines.

Responsibilities

Lead and represent MSAT on customer-facing project teams, ensuring successful transfer of new and existing upstream processes into GMP manufacturing using standardized technology transfer methodologies.
Drive the introduction, qualification, and implementation of new upstream process technologies in cGMP manufacturing through effective cross-functional leadership and technical oversight.
Provide scientific leadership and technical expertise to evaluate, champion, and implement innovative manufacturing technologies while continuously improving existing processes.
Lead complex investigations and Root Cause Analysis (RCA) to resolve manufacturing process challenges and drive continuous improvement, compliance, and operational excellence.
Direct multidisciplinary teams and manage major technical projects, including the introduction of new processes, equipment, and technologies, while ensuring delivery of project objectives.
Design and implement manufacturing control strategies and Continuous Process Verification (CPV) systems to maintain process robustness, product quality, and regulatory compliance for commercial products.
Serve as a key technical SME for regulatory inspections, audits, customer interactions, and business development activities, including technical document review, proposal support, and representation of Lonza in customer meetings.