“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"