Firmenlogo

Senior Manager, Raw Materials - MSAT na Bluerocktx

Bluerocktx · Toronto, Canadá · Hybrid

Microsoft Excel

Candidatar-se agora

Description

Who is BlueRock?

BlueRock Therapeutics LP is a clinical stage cell therapy 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.

Based in Toronto, Ontario or Cambridge, MA, USA, the Senior Manager of Raw Materials will lead the technical oversight and lifecycle management of raw materials used in our internal and externally partnered pipeline programs. This role ensures materials are fit‑for‑purpose, phase appropriate, and consistently available to support research, process development, and clinical cell therapy operations.
 
As a technical SME, the manager will own the characterization, qualification, and ongoing performance monitoring of raw materials—such as cytokines, serum, media, viral vectors, reagents, and single‑use consumables—used throughout our cell therapy processes. The SME will also be accountable for supporting clinical operations with deviation investigations, OOS/OOT assessments and CAPA implementation. The role is responsible for authoring BlueRock’s raw material business process and overall raw material control strategy.
 
As a well-structured leader, the manager will chair the internal Raw Material Review Committee, partner cross functionally to influence raw material selection, partner with Supply Chain to steer key vendors and lead internal & externals resources to perform life cycle management on raw materials and drive targeted continuous improvements. The leader will be responsible for onboarding contract staff to support peak workloads (i.e. new tech transfers).
 
The position reports to the VP Engineering & MSAT.
 
The Senior Manager must excel in fast-paced environment, be able to execute on functional builds relevant to the raw material business process while executing on deliverables to progress pipeline assets. This leader will engage with all technical (Research, Process Development, Manufacturing, MSAT, TDT Leads) and non-technical departments (Supply Chain, Procurement) as it relates to raw materials. 

Responsibilities:

  • Represent the MSAT function in cross-functional teams as a materials science SME for single-use systems, cell culture media, cytokines, and/or small/large molecule raw materials.
  • Support creation and maintenance of the raw material lifecycle management process for CGMP operations.
  • Provide technical input into raw material change controls and deviations to ensure strong scientific and compliance decision‑making.
  • Lead root cause analyses and corrective/preventive actions for raw material deviations or performance inconsistencies.
  • Serve as the SME for raw materials used in cell therapy manufacturing, including qualification, characterization, risk assessment, and lifecycle management.
  • Develop and maintain raw material specifications and testing strategies aligned with regulatory expectations for advanced therapies.
  • Drive raw material control strategies, focusing on biological variability, contamination risks, and general process criticality.
  • Own the risk management framework for raw materials, including contamination control, variability mitigation, and tiered supplier oversight strategies.
  • Support new material introductions, ensuring technical assessment, validation readiness, and compliance with CGMP requirements.
  • Partner with Supply Chain and Quality to qualify suppliers, including technical evaluations, supplier capability assessments, and Material Qualification (MQ) activities.
  • Lead technical interactions with suppliers, including troubleshooting, raw material investigations, and support of supplier‑driven changes.
  • Evaluate and qualify alternate suppliers in partnership with users as appropriate.
  • Partner with Process Development to ensure materials selected in development are robust for planned scale‑ups.
  • Collaborate with Quality Control to develop or refine raw material testing methods, including methods for biologically complex inputs.
  • Provide regulatory support for IND/BLA submissions, specifically around raw material control strategies, supplier qualification, and risk management.
  • Establish workflows, prioritization strategies, and performance metrics for raw material lifecycle management.
  • Foster a culture of scientific rigor, operational excellence, and proactive risk identification.

    • Qualifications:

  • Bachelor’s degree or higher in life sciences field with 13+ years of experience including 11+ years in a biopharma setting required.
  • Advanced degree (MS/ Ph.D./ Eng Doc) in Science/Engineering is preferred.
  • Deep knowledge of cell culture media formulations and manufacturing, single-use-systems, and small/large molecule and CGT materials.
  • Extensive experience with cell and gene and biologics process development and cGMP manufacturing.
  • Experience with cGMP regulations/guidance and regulatory agency inspections.
  • Experience with continuous improvement, proficiency with operational excellence preferred.
  • Strong interpersonal skills to effectively communicate with a diverse wide customer base.
  • Strong planning and organizational skills.
  • Good oral and written communication skills.
  • High level of urgency and is able quickly adapt to changing priorities.


  •  Target Base Salary: $149,000 - $175,800

    • Additional Information

    #LI-AL1

    BlueRock Therapeutics Company Culture Highlights
    Winner of Boston Business Journal's Best Places to Work (Mid-size Company) 2023
    Winner of Comparably's Award for Best Company for Diversity 2022
    Winner of Comparably's Award for Best Company for Women 2022
    Winner of Comparably's Award for Best CEO 2022
    BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably.
    Engineering Department is ranked in the top 5% of companies for Overall Culture on Comparably.

    Check us out on Comparably: https://www.comparably.com/companies/bluerock-therapeutics
    Follow us on Linkedin: https://www.linkedin.com/company/bluerocktx/

    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.
    Candidatar-se agora

    Outros empregos

    Firmenlogo

    Scientist II, MSAT

    Bluerocktx · Toronto,

    Firmenlogo

    Staff Software Engineer - Cloud Services

    Agiloft · Canada,

    Firmenlogo

    Truck Shop Helper

    Premiertruck · Oshawa,