MSAT Associate Principal Scientist - Purification

Lonza•Vacaville, CA

1d•Onsite

About The Position

This is a fully site‑based role in Vacaville, California. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. The role will be a recognized process expert in purification operations (Downstream DSP, chromatography, viral filtration, ultrafiltration/diafiltration). Supporting multiple customer project teams to transfer manufacturing processes into the Vacaville site as well as maintaining and improving existing commercial processes. This role has the opportunity to develop extensive internal and external networks while 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 or advanced degree in scientific/engineering field with minimum 8 years biotech experience.
Experience supporting large-scale biologics manufacturing (mammalian preferred); strong knowledge of cGMP and US/EU regulations.
Proven ability to analyze data identify issues, and drive process improvements, completes quality tasks (e.g. deviations, CAPAs).
Experience with technology transfer in highly automated commercial facilities.
Strong collaboration and communication skills; ability to work with cross-functional teams and customers.
Experience interacting with health authorities and supporting regulatory responses.
Strong task planning and time management; adaptable to fast-paced environments; willingness for on-call manufacturing support.

Responsibilities

Provide technical oversight of commercial purification processes; ensure batches are delivered on time and in full.
Support process transfer and lifecycle activities; develop process understanding, perform gap analysis/FMEA, and author/review process documents (Batch Records, Process Descriptions, deviations, change controls).
Manage technical risks during process and raw material changes; ensure timely cross-functional communication of critical information.
Analyze complex data to enhance process understanding; perform quality activities including deviations, CAPAs, and campaign summary reporting.
Monitor manufacturing systems to ensure compliance with Continuous Process Verification (CPV) requirements.
Partner with SMEs to expand process knowledge; mentor junior staff and drive continuous improvement in GMP operations.
Lead technology transfer and customer projects; conduct lab experiments for optimization/troubleshooting and support product licensure with health authorities.