Manufacturing Support Manager Job in Seattle, Washington Us
Responsibilities:
- Manage and lead the Manufacturing Support Team. Leadership responsibilities include:
- Ability to develop a vision for growing the Manufacturing Support function and create an action plan (including goal and KPI setting) to drive the organization toward achieving the vision. This includes the ability to lead the group through a significant capacity increase while minimizing the increase in operating costs
- Ability to work in a fast-paced environment with the willingness to adapt quickly to change
- Provide mentorship and coaching to staff within the Manufacturing Support group
- Provide oversight and guidance to Manufacturing Support operations including dispensing, solution preparation, wash area operations and general operational support
- Work extensively with the Supply Chain Management group to ensure delivery of materials to Manufacturing
- Optimize operations related to support operations
- Serve as a member of the Manufacturing Management Team
- Ensure that the operation and staff follows cGMP guidelines
- Represent CMC and the Manufacturing operation during client visits, audits and regulatory inspections
Requirements
- Experience/Knowledge: BS in science, engineering or equivalent
- 8+ years of relevant industry experience including experience managing people
- Previous leadership role in technology transfer, process development or manufacturing
- Experience successfully managing multiple projects in parallel
- Communicate clearly, efficiently and accurately with internal and external customers
- Experience with and understanding of Good Manufacturing Practices (GMP) and applicable regulations (e.g., ICH Q7A, 21 CFR Part 211, etc.)
- Experience writing, reviewing and approving GMP batch records and SOPs
- Strong technical aptitude including the demonstrated experience of applying scientific reasoning to solve complex problems
- Ability to lead the development and implementation of new systems to facilitate the growth of the organization (e.g., supply chain management systems, electronic batch records, etc)
CMC ICOS Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. EOE
For immediate consideration please email your CV to Jobs@cmcbio.com highlighting the position in the subject line or apply directly at http://tbe.taleo.net/NA5/ats/careers/requisition.jsp?org=CMCICOScws=4rid=349
CMC ICOS Biologics is a contract development and manufacturing organization (CMO) and is the US division of CMC Biologics, a Danish CMO. The company manufactures protein-based biologics for human clinical trials under contract to small and large biopharmaceuticals companies and has plans to move into commercial manufacturing in the near future. CMC ICOS Biologics was created upon the acquisition of the biologics division of the former ICOS Corp., and hence retains many of the experienced staff from the former organization. We are currently seeking high-performing individuals to join this exciting new business.
