Associate Director, Manufacturing Outsourcing - Germantown , Maryland, United States, 20876

Position

The Associate Director, Manufacturing Outsourcing, is responsible for the outsourcing strategy and activities for all Neuraly pipeline products. These activities include, but not limited to, establishing CMO/CRO/supplier network, selecting / contracting CMOs, coordinating tech transfer, managing drug substance & drug product manufacturing & release, and clinical supply chain. The candidate will coordinate with external and internal stakeholders to ensure the quality and compliance of clinical trial materials in established timeline and budget.



Responsibilities

  • Establish a network of CMOs/CROs/suppliers partners for Neuraly pipeline products (peptides, biologics, and small molecules).
  • Author RFPs, select CROs/CMOs, negotiate contracts, manage tech transfer and cGMP drug substance/API and drug product manufacturing.
  • Manage raw materials, components, and clinical material supply, including demand assessment, inventory tracking, clinical labeling/packaging and distribution.
  • Contribute to process and product specification, change control, and investigation as needed.
  • Establish best practice and maintain traceable documentation for raw materials, components, process and product records.
  • Document decisions & lessons learned. Champion knowledge management & Operation Excellence.
  • Assist preparation for regulatory filing (IND / IMPD) and due diligence.
  • Serve as a CMC leader; proactively identify and communicate progress, issues, risks and mitigation plans to broader team and management.


Experience & Education

  • Broad understanding of CMC approaches, requirements and relevant regulatory guidelines in Pharmaceutical Development and cGMP manufacturing operations. Late stage development and product registration experience preferred.
  • Experience in managing manufacturing operation, outsourcing and supply chain
  • Experience in supporting IND filing and partnering due diligence
  • Excellent communication and person skills
  • Passionate to work in a people orientated, start-up environment.
  • Ability to independently and rapidly evaluate impact of new information, anticipate solutions, identify the need for decisions, frame issues, inform impacted stakeholders and drive resolution using inclusive, collaborative approach and sound judgement
  • B.S. or advanced degree in Chemistry, Engineering or Biology with at least 15 years relevant industry experience. Level of position may be adjusted based on level of competency and years of experience.