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Associate Project Management, Biopharma Drug Development - Remote (JP10005)

Cambridge, MA · Biotech/Pharmaceutical
Job Title: Associate Project Management, Biopharma Drug Development - Remote (JP10005)
Location: Cambridge, Massachusetts (Remote)
Employment Type: Contract

Business Unit: ACDM DS Synthetics Small Molecule
Duration: 14 months with likely extensions of conversion to FTE
Job posting date: 3/24/2022
Note: Remote until COVID restrictions are lifted

3 Key Consulting is hiring an Associate Project Management for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Summary:
  • The client Contract Development and Manufacturing team develops and implements the external sourcing strategy for client’s portfolio from early phase through commercial delivery.
  • This role will support engagement and oversight of client Contract Development and Manufacturing sites through executing activities according to Good Manufacturing Practices (cGMP) principles and the ACDM business practices.
     
Basic Qualifications:
  • Bachelor's Degree & 3 years of Industry experience
     
Preferred Qualifications:
  • General knowledge of synthetic drug development and manufacture
  • Experience interfacing and managing CRO and CMO relationships
  • Understanding of tech transfer activities to enable external manufacture
  • Strong understanding of cGMP and Regulatory/CMC policies to support clinical manufacture
  • Understanding of drug development and commercialization of synthetic therapeutics
  • Understanding of legal obligations to protect intellectual property
  • Understanding of international import/export policies
  • Experience working in cross-functional settings
  • Experience as a team member or leader of cross-functional or matrix team
  • Strong communication skills both written and verbal
  • Experience with overseeing investigations and deviations relating to manufacturing campaigns


Top Must have Skill Sets:
  • Degree in chemistry or chemical engineering required
  • General knowledge of synthetic drug development and manufacture
  • Experience interfacing and managing CRO and CMO relationships
  • Strong communication skills, both written and verbal, and interpersonal skills

Day-To-Day Responsibilities:
Day-to-day oversight for external synthetic/process chemistry-related projects:
  • Overseeing ongoing activities at selected sites along with any subcontracted sites to ensure project deliverables, including compliance, timelines, product quality, and cost
  • Working closely with the ACDM team and internal stakeholders to support sourcing activities, including managing scope of work (SoW) and quotation request documents
  • Coordinating requests for shipment of materials/samples between sites
  • Managing purchase orders and invoices
  • Overseeing investigations and deviations that occur
  • Performing other related duties and tasks as necessary or as assigned

Employee Value Proposition:
The person in this role will gain direct experience with drug development and cross functional experience.

Red Flags:
Less than 3 YOE
 
 
Interview Process:
A phone screen, followed by teleconference (or in-person if permitted)

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.

 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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