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MSAT Associate Principal Scientist - Purification

External
Lonza logoLonza · Us - Vacaville, CA
Full-timeOn-site2w ago
Compliance
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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.

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.
  • About Lonza

Benefits

Health insuranceDental insuranceVision insurance401(k)Performance bonus

Additional Information

Location: Vacaville, California 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. 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). What you will get: The full-time base annual salary for this position is expected to range between $130,500 to $ 217,500. In addition, below you will find a comprehensive summary of the benefits package we offer: 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


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