Associate Director - Manufacturing Operations & ValidationKaloBios Pharmaceuticals
THIS JOB HAS EXPIRED
The Associate Director - Manufacturing Operations & Validation will be responsible and accountable for oversight of global third-party manufacturing vendors. This position ensures consistency of production of drug substance to finished product as well as managing the relationship between the contract manufacturing organization (CMO) and KaloBios. CMO oversight will include start-up and on-going performance of CMO's ensuring implementation of strategic initiatives that meet KaloBios's requirements for quality, compliance, delivery and costs.
Responsible for managing technology transfer to contract manufacturers. This includes activities related to production of stability/clinical batches, scale-up, validation and commercial production.
Assist in the preparation of regulatory documentation for IND and NDA submissions.
Coordinate logistics of commercial production and shipping at contract manufacturing sites.
Plan and oversee all activities related to the GMP manufacture of KaloBios products.
Manage external contract relationships as they related to supply chain management, product manufacturing and product distribution.
Primary liaison for day-to-day decision making, evaluation and resolution of issues between KaloBios and the CMOs.
Oversee and provide guidance to CMOs to ensure quality of production.
Assist with negotiation of contracts and agreements, including development of performance indicators and compliance requirements.
Provide management with timely, reliable, and structured reports regarding CMO performance, variance analysis and contingency plans for corrective measures.
BS/MS in Chemical, Biochemical or Pharmaceutical science, or equivalent, and minimum of 10+ years relevant experience in the following areas:
5+ years management experience in a CMC discipline such as process development, formulations, etc. for biologics drugs
Good working knowledge of pharmaceutical cGMP's and quality systems (including international)
Good working knowledge of Quality by Design (QbD) principles and study conduct
Experience in validation of biologics drug substance and/or drug product manufacturing process
Contract manufacturing experience required, as well as demonstrated experience in establishing and maintaining supplier/contractor relationships
Knowledge and experience of cost of goods management and corresponding financial impact on business decisions.
Proven success in leading multi-disciplinary project teams with excellent communication, problem-solving and critical-thinking skills
Requires excellent written and oral communication skills
Must be willing to travel up to 25% time
Energetic person with ability to prioritize and work on multiple projects at the same time.
Must be highly organized, flexible, and a team player.
Computer proficiency, outstanding organizational, and analytical skills.