Apply: Senior Manager, Downstream Process Development (Biologics)

Reference: BH-169385

Accountability
You will manage the collaboration with CDMOs with a focus on the downstream process development and manufacture of biologics drug substance. This position is integral to the advancement of the business growing portfolio of biopharmaceutical drug candidates and technology programs and will provide technical oversight and strategic input for downstream biologics drug substance development and manufacturing activities. The scope of the role spans from early stage process definition to late stage process characterization study. It extends further to the preparation of CMC content for regulatory submissions, technology transfer and manufacturing support.
  • Provide technical leadership, management and oversight for:
  • Development of robust purification processes utilizing multiple chromatography modes, filtration (normal and tangential flow) and clarification technologies.
  • Optimization and characterization of downstream manufacturing processes based upon quality by design (QbD) principles including linkage and worst-case studies.
  • Tech transfer, scale-up and manufacture of biologics drug substance to support nonclinical studies and clinical evaluation.
  • Interface with upstream, analytical, formulation, Regulatory, QA/QC groups to ensure alignment with overall program objectives.
  • Process Validation activities of biologics drug substance to support product commercialization.
  • Oversee phase appropriate viral clearance studies to enable regulatory submissions.
  • Prepare CMC documentation for regulatory and/or patent filings and prepare/reconcile responses for responsible topics.
  • Establish and maintain an understanding of current trends in purification technologies
  • Set clearly defined goals/objectives to ensure delivery of high-quality results.
  • Provide clear communication to CMC teams and functional line management regarding progress against technical objectives/milestones.
  • Ensure well-organized, clear and complete documentations of all activities across areas of responsibility.
 
Requirement
  • Master degree of doctorate degree of pharmaceutical sciences or related disciplines
  • Solid experience on biologics process development of downstream stage
  • Practical experience of managing and dealing with CDMOs
 
Singaporean, Singapore PR or EP holders only.

Reg No. R1109268
BeathChapman Pte Ltd
Licence no. 16S8112
Company Background:

Ethos BeathChapman is a global group of executive recruitment experts in Asia, Australia and EMEA, with a network beyond. We connect the world's exceptional companies to exceptional people.

Connect with us at www.ethosbc.com

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