Senior Principal Scientist – Process Development

About the Role

We are seeking a Senior Principal Scientist for our Process Development Sciences team in Singapore, based at our Tuas location. This position offers an office-centric setup, mainly onsite, with the flexibility to work remotely up to one day per week. The selected candidate will champion scientific initiatives in biologics process development, focusing heavily on process characterization and validation to support commercial readiness and regulatory compliance.

Responsibilities

• Lead the scientific implementation and advancement of mammalian cell culture processes for therapeutic protein production.
• Guide late-phase process characterization, establish validation strategies, and drive continued process verification, ensuring robust and compliant processes suited for Biologics License Application (BLA) submissions.
• Apply data-driven methodologies such as Root Cause Analysis (RCA), Design of Experiments (DoE), multivariate statistics, and risk assessments (e.g., FMEA) to create effective studies and resolve complex development challenges.
• Oversee end-to-end process development activities including the transfer and scale-up of clinical processes to cGMP manufacturing, ensuring commercial readiness, and lifecycle management.
• Act as a subject matter expert, upholding rigorous scientific and documentation standards, while ensuring alignment with global regulatory requirements.
• Partner with multidisciplinary teams in Manufacturing, R&D, MSAT, and Quality to integrate process improvements and adopt new technologies.
• Provide technical leadership and mentorship to both internal teams and external stakeholders, maintaining scientific excellence and compliance.
• Stay abreast of—and share insights on—emerging industry trends and scientific advances in process validation and biologics production.
• Represent the team in technical discussions with clients, delivering impactful presentations and contributing to strategic project planning.

Requirements

• PhD in a relevant scientific discipline or equivalent deep practical experience.
• At least 10 years' hands-on experience advancing biologics process development, with a strong record in leading late-stage process characterization and validation for clinical and commercial programs.
• Solid expertise in BLA-supporting studies, regulatory frameworks, modern process validation strategies, Quality by Design (QbD), and continued process verification.
• Substantial technical proficiency in process characterization and validation for both upstream and downstream processing, utilizing DoE and risk-based approaches.
• Proven track record leading global, cross-functional scientific projects and teams.
• Highly developed communication, presentation, and stakeholder management skills.

Perks & Benefits

• Progressive, agile career opportunities within a dynamic workplace.
• Commitment to inclusivity and ethical business practices.
• Performance-based reward and recognition programs.
• Company bus service from nearby MRT stations to the Tuas campus and back.
• Comprehensive company-paid medical insurance, with subsidized coverage available for family members.

Additional Information

At Lonza, we foster a culture driven by our core values of collaboration, accountability, excellence, passion, and integrity. We believe diverse ideas and perspectives drive innovation and are committed to maintaining an inclusive environment where everyone’s contributions matter.

Reference ID: R77186