Small Molecule Manufacturing Expert

Responsibilities:

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

Qualifications:

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

Working condition details:

Part-time, no limitations on geographical location, salary range (depending on experience and suitability for role): $250-750/hour