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Project Manager

Thousand Oaks, CA
“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and puerto rico vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship this company, its operations, or its staff.”                                                        

Top 3 Must Have Skills        
    
    
  • Must have strong Combination Product project development (late stage and lifecycle management) and be savvy on using MS Project tool.
  • Human Factors experience.
  • Packaging and labeling development and FDA submission experience.
  • MS expierence

Business Intelligence
  • Project Management
  • E2E Implementation
  • The manager will not consider IT Project Managers or Construction Project Managers. This is a totally different area and out of their expertise.*

Day to Day Responsibilities:        
        
  • Support late stage activities including process validation and PAI preparations
  • Coordinate and document activities surrounding complaints, excursions, or deviations received from sites or vendors
  • Present metric updates to management and project stakeholders.
  • Participate in regularly scheduled meetings with partners and vendors
  • Participate in establishing/updating supply contracts with new vendors and current vendors
  • Participate on audits of third party suppliers
  • Handle confidential information and perform duties in strict confidence
  • Ability to multitask with varying priorities
  • Other Duties as assigned. •Masters Degree Preferred: Bachelor’s in Operations, Materials Management, Finance, Chemistry, Chemical Engineering or a related field. •3 -5 years pharmaceutical/biotech industry experience in manufacturing/supply chain management
  • Process chemistry and API manufacturing experience preferred if the focus is on API, or Formulation and Drug Product manufacturing experience if the focus is on Drug Product manufacturing
  • Previous supervisory skills are a plus (management of staff).
  • Manages staff in CMO’s
  • Functional/Technical Knowledge & Skills (including any required proficiency for particular computer programs or applications, if applicable):
  • Good knowledge and demonstrated practice of ICH/cGXP Guidelines
  • Experience with regulatory submissions is a plus
  • Proficient in Microsoft Outlook, Word & Excel
  • Prior commercial launch experience desirable
  • Prior experience with SOX Compliance desirable
  • Prior experience with use and implementation of ERP systems desirable
  • Up to 25% travel (including international) may be required
  • Ability to thrive in a small group setting with limited administrative support, developing and maintaining collaborative internal and external relationships.Good organizational,



"This posting is for Contingent Worker, not an FTE"
 

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