Company
Manufacturing & Supply Chain
CDMOManager,ExternalManufacturing(Contract)
“CDMO Manager, External Manufacturing (Contract). Skills: External Manufacturing, Process Management, Quality Compliance. Oversee day-to-day operations at contract manufacturing sites. Serve as secondary point of contact between Adverum and CMO(s)”
What You'll Achieve.
ensure production targets are met; quality standards are maintained; products are manufactured on time and within budget; compliance with company specifications, regulatory requirements, and industry standards; prevent stock-outs or excess stock; alignment with budgetary goals; enhance product quality, production efficiency, and operational effectiveness; continuity of supply
Industry & Context.
working with contract manufacturers to develop and implement solutions; Identify opportunities for cost savings and efficiency improvements; Identify and mitigate risks; Develop contingency plans
30% (or more depending on needs) travel to CDMO(s), Ability to gown into and work in clean rooms
What They're Looking For.
Must Have
Bachelor's degree in scientific or engineering discipline, Minimum of 8 years of experience in manufacturing management, Drug Substance Viral Vector/AAV or biologics experience in either upstream or downstream operations, understanding of relevant manufacturing processes, aseptic processing, quality control, and regulatory compliance in the industry, Proven track record of managing external manufacturing partners and driving operational excellence, Excellent leadership, communication, and negotiation skills, Ability to manage multiple projects and priorities in a fast-paced environment, Ability to gown into and work in clean rooms
Nice to Have
Knowledge of Lean Manufacturing, Six Sigma, or other process improvement methodologies, Process Validation / PPQ experience / Commercial Manufacturing Drug Product experience, Master's degree or Phd
What You'll Do.
Oversee day-to-day operations at contract manufacturing sites
Serve as secondary point of contact between Adverum and CMO(s)
Monitor and assess performance of contract manufacturing partners
Coordinate with contract manufacturers to schedule production runs
Monitor production processes for compliance
Address and escalate production issues or delays
Review and approval of manufacturing documentation
Ensure products meet Adverum’s quality standards
Collaborate with Quality Assurance teams to schedule audits
Monitor corrective and preventive actions (CAPA)
Manage flow of materials and finished products
Ensure contract manufacturers have necessary resources
Monitor inventory levels at contract sites
Monitor and manage production costs
Identify opportunities for cost savings
Ensure manufacturing activities comply with regulations
Maintain up-to-date knowledge of regulatory requirements
Lead efforts to implement and maintain compliance programs
Drive continuous improvement initiatives
Collaborate with cross-functional teams to identify improvements
Track and report on key performance indicators (KPIs)
Identify and mitigate risks associated with contract manufacturing
Develop contingency plans
How You'll Work.
Team & Collaboration
Serve as the secondary point of contact between Adverum and CMO (s); Collaborate with Quality Assurance teams; Work closely with the Supply Chain team; Collaborate with cross-functional teams
Communication Scope
Excellent communication skills
Process & Methodology
Ability to manage multiple projects and priorities
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