Manager - Operations - III*
Manager - Operations - III*
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Location: Foster City Hybrid
Job Description:
Responsible within Global External Manufacturing to support the oversight of Client Contract Manufacturers of Biologics Drug Substances and Drug Products for commercial and clinical programs.
Proactively and effectively work with other Client functions (Quality Assurance Quality Control Strategic Sourcing Supply Chain Regulatory Portfolio Management) to execute on manufacturing strategy.
Executes the regular tactical management of CMOs to ensure Clients products are manufactured in accordance with the registered process and approved Master Production Record
Enables timely resolution of complex issues associated with manufacturing and/or compliance including handling of deviations complaints out-of-specification investigations Material Review Board associated investigations finished product trending and change control
Fosters and facilitates continuous improvement of production and business processes to reduce cost improve quality increase efficiency and ensure sustainability.
Required Years of Experience: 15
Top 3 Required Skill Sets: GMP Manufacturing expertise in commercial Biologics Drug Substance Communication (written and verbal) Decision making (prioritization risk evaluation)
Top 3 Nice to Have Skill Sets: Drug Product expertise Technology Transfers Clinical product manufacturing
Unique Selling Point of this role: Highly impactful role contributing to the advancement of innovative and transformative therapies.
Required Degree or Certification 4 year college (BS/BA in Science field)
Any Disqualifiers Must be flexible with work hours to support global network either early morning (7 am) or evening (6pm) calls are frequent.
Additional Details
- Onsite Offsite : Onsite
Employment Type
Remote
Company Industry
Key Skills
- Six Sigma
- Lean
- Management Experience
- Process Improvement
- Microsoft Outlook
- Analysis Skills
- Warehouse Management System
- Operations Management
- Kaizen
- Leadership Experience
- Supervising Experience
- Retail Management
