Senior Manager, External Manufacturing and Development Services

BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company pioneering a new generation of cellular medicines. Utilizing our proprietary CELL+GENE platform, we direct cellular differentiation and genetically engineer cells to create transformative therapies for patients suffering from neurological and ophthalmological diseases.

Founded in 2016, BlueRock is at the forefront of the convergence of cell biology and genetic engineering. Our mission is to harness pluripotent stem cell technology and gene editing to deliver authentic, functional cell therapies that address the root causes of disease and offer hope to millions of patients worldwide.

What Are We Doing?

Our foundational science enables the generation and directed differentiation of universal pluripotent stem cells into authentic, functional cells for allogeneic cellular therapies.

We are passionate about realizing the promise of cell and gene therapy, shaping the future of regenerative medicine, and delivering new therapies to patients with limited or no treatment options.

Who is BlueRock?

BlueRock Therapeutics LP is a clinical stage cell therapy company harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson’s disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves.

What Are We Doing?

Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit.

We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options.

We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients’ lives.

Description of Position:

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

The estimated compensation range for this position is $ 145,000.00 - $ 154,350.00 per year.

Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace.  Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.