: Associate Project Manager - Biopharma (JP8128)
: 14 months with likely extensions
Job posting date
Remote until COVID-19 restrictions are lifted.
3 Key Consulting is hiring an Associate Project Manager
for a consulting engagement with our client, a leading global bio-pharmaceutical company.
The External Process Development organization is seeking a highly qualified candidate to support synthetic-related outsourcing associated with execution of external development and clinical supply. The position will have a focus in synthetic drug substance/process chemistry and serve as a key enabling role in a high-performing cross-functional organization. Individual projects may span development, sourcing (e.g., requests for proposal and site selection), supplier on-boarding, and manufacturing activities for both non-GMP and GMP/clinical deliverables.
The External Process Development group develops and implements Process Development sourcing strategy to optimize utilization of Process Development’s internal and external capabilities and capacity through external execution. External Process Development is part of the Integrated Portfolio Advancement organization which is responsible for partnering with our Product Delivery Teams across all stages of commercialization to drive and optimize the pipeline in alignment with company’s goals and streamline the path to the patient.
Bachelor's Degree in Chemistry/Biology or related field & 3 years of Industry experience
Top Must have Skill Sets:
- General knowledge of synthetic drug development and manufacture
- a. Experience interfacing and managing CRO and CMO relationships
- b. Understanding of tech transfer activities to enable external manufacture.
- c. Strong understanding of cGMP and Regulatory/CMC policies to support clinical manufacture.
- d. Understanding of drug development and commercialization of synthetic therapeutics
- e. Understanding of legal obligations to protect intellectual property.
- f. Understanding of international import/export policies
- Experience working in cross-functional settings
- a. Experience as a team member or leader of cross-functional or matrix team
- b. Strong communication skills both written and verbal
- Experience with overseeing investigations and deviations relating to manufacturing campaigns.
Experiences with CRO & CMP
Strong interpersonal and communication skills
Strong ability to multitask while delivering quality results
Day-to-day oversight for external synthetic/process chemistry-related projects:
Employee Value Proposition:
- Overseeing ongoing activities at contract development and manufacturing sites along with any subcontracted sites to ensure project
deliverables, including compliance, timelines, product quality, and cost
- Working closely with the External Process Development team and internal stakeholders to support sourcing activities, including managing
scope of work (SoW) and quotation request documents
- Meeting management, including capturing meeting minutes, and action item follow-up
- 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
Exposed to an array of development.
Phone and Webex Interviews
We invite qualified candidates to send your resume to email@example.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.