Job Title: Associate Project Management (JP9832) Location: Cambridge, Massachusetts 02138 Employment Type: Contract Duration: 12 months with likely extensions Job posting date2/23/2022 Note: Remote until COVID restrictions are lifted
3 Key Consulting is hiring an Associate Project Managementfor 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) Manager is available immediately to start interviewing
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.