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Sr.Manager/Associate Director, External Manufacturing/Contract Laboratory Management

Metagenomi
Emeryville, CA
  • Posted: over a month ago
  • Full-Time
Job Description
Salary:

At Metagenomi, we are accelerating innovation in cell and gene therapy with a wave of proprietary CRISPR-based systems to accurately edit DNA where current technologies cannot. Our metagenomics-powered discovery platform and analytical expertise reveal novel cellular machinery sourced from otherwise unknown organisms. We adapt and forge these naturally evolved systems into powerful therapeutic tools that can be leveraged by partners and fuel our own pipeline of potentially curative medicines. Our goal is to revolutionize gene editing and unlock its power for the benefit of patients around the world.


About the Role:


This is a matrix leadership role that collaborates across multiple functions to arrive at and execute upon a comprehensive CMC development plan. This is a highly visible and influential role in the organization that will interact extensively with line function heads and team members within Technical Operations, Program Team members, and Metagenomi leadership.


Senior Manager / Associate Director, External Manufacturing


At Metagenomi, we are accelerating innovation in cell and gene therapy with a wave of proprietary CRISPR-based systems to accurately edit DNA where current technologies cannot. Our metagenomics-powered discovery platform and analytical expertise reveal novel cellular machinery sourced from otherwise unknown organisms. We adapt and forge these naturally evolved systems into powerful therapeutic tools that can be leveraged by partners and fuel our own pipeline of potentially curative medicines. Our goal is to revolutionize gene editing and unlock its power for the benefit of patients around the world.


About the Role

Reporting to the VP, Program Management and Business Operations, the Associate Director/Sr.Manager, External Manufacturing will be responsible for leading projects at contract manufacturers including cell banking and pDNA, gRNA, mRNA, LNP/DP, viral vectors and/or recombinant nuclease. In addition to external manufacturing responsibilities outlined below, the role will have auxiliary responsibilities for supporting the Technical Operations department with project management..  


We are looking for a candidate with strong interpersonal skills and technical experience to support Metagenomi's pipeline of gene editing therapeutic development programs.


External Manufacturing Responsibilities:

  • Perform due diligence and contracting with CDMOs and/or contracted testing labs (CTL)
  • Manage CDMO/CTL contracts and performance with defined metrics, KPIs
  • Provide leadership building productive collaboration with CDMOs/CTLs
  • Lead cross-functional team members in developing and executing an engagement model for effective oversight of CDMO/CTL operations
  • Manage RFP with potential CDMO/CTL partners and due diligence, and in partnership with legal department to coordinate and lead contract negotiation 
  • Coordinate with internal technical teams to define technical, service, and supply requirements, and ensure requirements are well understood by CDMO/CTLs and translated to deliverables with clear timelines.
  • Manage supply plans to determine material needs and budgets
  • Use project management tools, e.g. smartsheet, MS Project preferred to track deliverables and spend against plans and budget
  • Knowledgeable about  multiple phases of product development lifecycle (e.g. new product introduction, IND enabling, early clinical, pivotal/late phase, commercial) to anticipate technical and development and supply needs
  • Experience with QBD methodology, performing risk assessments and managing CMC changes preferred
  • Monitor and communicate new developments on CDMO landscape to keep the team and management informed about outsourcing capabilities in the industry
  • In partnership with QA and Technical Operations,, ensure manufacturing in compliance with GMP standards where applicable.


Technical Operations Project Management Responsibilities:

Support technical operations group, as defined from time to time by management team, with project management activities including but not limited to:

  • Using project management tools to facilitate key project portfolio management
  • Facilitating pre-clinical/clinical product and critical material supply planning
  • Training technical operations personnel on project management tools and best practices
  • Other responsibilities may include assisting in budgeting and goal setting processes


Relevant experience and mindset:

  • BS in a scientific or related field, MS preferred
  • At least 10 years of experience in a biotechnology or pharmaceutical company (position level dependent on candidate experience)
  • Experience managing external contract manufacturing organizations
  • Experience in cell and gene therapy preferred
  • Working knowledge of ICH regulatoration governing GMP



Why work at Metagenomi?


  • We are passionate about developing technologies of the future with a focus on unlocking the potential of microbial products for use in therapies, industry, and biotechnology
  • We value teamwork, quality, agility, independent thinking, and excitement
  • Competitive salary and annual target bonus, and comprehensive benefits plan, including matching 401(k) retirement safe harbor plan and perks
  • Stock options in an early-stage startup


We care about our people as they are the key to our success. Metagenomi provides an open, collegial, and friendly work environment where we empower people and provide them with opportunities to develop their long-term career. We are an equal opportunity employer and believe in and value diversity and inclusion. All employment is decided on the basis of qualifications, merit, and business need. 

 

If you need assistance or an accommodation due to a disability, you may contact us at hr@metagenomi.co.

Metagenomi

Address

Emeryville, CA
94608 USA

Industry

Retail

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