Salary :
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BlueRock Therapeutics is seeking an External Manufacturing & Development Services, Senior Manager to support External Partners activities. The External Manufacturing & Development Services Senior Manager, is responsible for managing the operational relationship with BlueRock’s External Partners including Analytical Laboratories, Contract Manufacturing Organizations, and Medical Device Organizations (ExPs), and working cross functionally with peers in the BlueRock organization to support the manufacturing services and activities being performed or to be performed at the ExPs. Reporting to the Director, External Manufacturing & Development Services, this position will have accountability for all operational activities, owning the operational relationship with assigned ExPs, facilitating and driving discussions cross-functionally with ExPs to remediate quality or manufacturing constraints, and collaborating internally across Raw Materials Supply, Manufacturing, Quality Assurance, Project Management, CMC and GMP functions in BlueRock. In addition, the External Manufacturing & Development Services, Senior Manager, will collaborate with stakeholders within BlueRock to identify/track/measure KPIs and goals & objectives with ExPs, and own the Minutes and Action Item list with ExPs resulting from Operational and Joint Steering Team meetings.
This is an outstanding opportunity to contribute to bringing a new class of cell-based medicines to patients. Collaboration with a highly motivated, world-class team of scientists, engineers, and other professionals, and promises an exciting and engaging work environment for a motivated, self-starting candidate.
Responsibilities:
- Own the relationship with assigned ExP(s) and act as key point of contact for BlueRock.
- Responsible for overall ExP performance and project execution including budget and timeline adherence.
- Responsible for leading and actioning issue resolution to a mutually beneficial outcome.
- Own annual forecasting, planning, and resource allocation with ExPs in collaboration with BlueRock functional groups.
- Lead cross-functional operational meetings with assigned ExP(s) to drive improvements in ExP collaboration, quality, and performance.
- Act as escalation contact for performance remediation.
- Negotiate and manage ExP related contracts (MSA, SOWs, QAAs).
- Own risk management and continuous improvement activities within ExP network in collaboration with BlueRock QA and operational teams.
- Work closely with BlueRock workstream leads to identify ExP-specific constraints and negotiate resource allocation with ExPs to reduce risk.
- Own marketplace evaluation efforts (RFI, RFP) to ensure BlueRock’s ExP network is either aligned or leading industry standards for performance and efficiency.
- Maintain strong network awareness in all 3 categories (analytical QC, contract manufacturing, device development) to enable pivots when necessary and build network robustness.
- Process purchase requisitions, review open purchase orders, and follow up on status of placed orders as required.
- Support the Annual Budget process for all categories by aligning functional needs with ExP pricing and timing.
Minimum Requirements:
- Minimum of a Bachelor’s degree in business, scientific discipline or related field and 13+ years of experience in similar role where candidate was responsible for managing third-party relationships and operating in a matrixed environment OR a Master’s degree and 11+ years
- Highly functional in a fast-paced dynamic company with ability to prioritize issues under differing pressures and shifting timelines
- Demonstrated ability to be highly organized and proactive
- Demonstrated ability to view change or problems as an opportunity to learn and grow; adjusts easily to change
- Works well with others on both an individual level and in team environment
- Excellent written and verbal communication skills; ability to clearly communicate complex challenges and solutions internally and externally
- Experience with GxP guidelines/documentation and general GMP experience
- Experience in working with electronic systems such as ERP, Smartsheet, Oracle, Coupa, Microsoft Office Programs
- Ability to analyze and resolve abstract problems independently
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