BlueRock Therapeutics

Senior Manager, External Manufacturing & Development Services

BlueRock Therapeutics$145K — $171K *
Pharmaceuticals & Biotech
11 - 15 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in business or scientific discipline with 13+ years of relevant experience, or Master's degree with 11+ years.
  • Proven ability to manage third-party relationships in a matrixed environment.
  • Experience in a fast-paced dynamic environment with strong prioritization skills.
  • Organized and proactive, capable of adapting to change effectively.
  • Strong communication skills, both written and verbal, to convey complex solutions clearly.
  • Knowledge of GxP guidelines and GMP experience required.
  • Familiarity with ERP systems and Microsoft Office programs.

Responsibilities

  • Own the relationship and act as primary contact for assigned external partners (ExPs).
  • Oversee ExP performance, ensuring projects adhere to budgets and timelines.
  • Lead issue resolution discussions to achieve mutually beneficial outcomes.
  • Manage annual forecasting and resource allocation in collaboration with functional groups.
  • Facilitate cross-functional operational meetings to enhance ExP collaboration and performance.
  • Serve as escalation contact for performance-related issues.
  • Negotiate contracts and manage related agreements with ExPs.

Benefits

  • Opportunity to contribute to innovative cell-based medicine solutions.
  • Collaboration with a highly skilled, motivated team of professionals.
  • Engaging work environment designed for self-motivated individuals.
  • Involvement in operational improvements and strategic planning.
  • Potential for professional growth in a rapidly evolving industry.
Full Job Description
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 Salary Range: $145,000 - $171,500 #LI-AL1

About BlueRock Therapeutics

BlueRock Therapeutics is a biotechnology company that develops engineered cell therapies to cure diseases. The company's platform is based on induced pluripotent stem cells (iPSCs) and gene editing technologies. BlueRock Therapeutics is focused on developing therapies for diseases of the central nervous system, cardiovascular system, and immunology. The company was founded in 2016 and is headquartered in Cambridge, Massachusetts.
Learn more about BlueRock Therapeutics
Size
100 employees
Industry
Founded
2016

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