Responsibilities:

• Work closely with the research and development team in: designing experiments for polymer synthesis and characterization, formulation, and characterization parenteral polymer-, or lipid-based drug delivery systems and polymer-drug or polymer-protein bioconjugates;
• Create and implement high-level strategies including budgeting and oversight outsourced manufacturing of polymer- and lipid-based drug delivery systems for pharmaceutical products including polymer-drug conjugation;
• Hands on guidance from preclinical development through cGMP manufacturing of polymer- and lipid-based drug delivery systems;
• Provide scientific and strategic leadership for polymer-drug formulation, and drug product development;
• Ensure that manufacturing strategies and processes are in place to meet business objectives and needs;
• Ensure that production, performance, and quality standards of manufacturing products are met;
• Evaluate the risks,challenges and mitigation action;
• Proactively communicate and negotiate with external clients and CDMOs;
• Review manufacturing and quality control reports and delivery goals;
• Support the creation and expansion of the company's intellectual property;
• Provide regular updates to management;
• Perform other duties as assigned.

Qualifications:

• PhD in Chemistry (Organic, Polymer, or Medicinal Chemistry focus), Industrial Pharmacy, Pharmaceutical Sciences, Chemical or Biomaterials Engineering,
• Scientific expert in polymer synthesis, modification, and chemical and biophysical characterization (specifically PEG-poly(amino acid) synthesis through NCA polymerization)
• Experience in formulation and characterization parenteral polymer-, or lipid-based drug delivery systems and polymer-drug or polymer-protein bioconjugates
• Experience with developability assessment of polymer-drug to support early CMC development
• Knowledgeable in design-of-experiments (DOE) and quality-based-design (QbD)
• At least 5 years of relevant experience in formulation and cGMP polymer-drug manufacturing
• Thorough understanding of the policies and practices used in the cGMP-manufacturing field
• Strong strategic and analytical thinking capability
• Ability to work effectively with people from different cultures to accomplish business objectives
• Excellent leadership, organizational and managerial skills

Infrahire is an Equal Opportunity Employer