Company Overview

Prime Medicine was founded to bring the promise of gene editing to patients. We use Prime Editing, a next-generation technology that can “search and replace” to restore normal genetic function almost anywhere in the genome. Prime Editing searches to find the precise place in the genome to edit and replaces the segment of faulty DNA with a correct copy of DNA.  A single Prime Editor can correct the individual mutations found across patients, meaning Prime Editing can potentially address more than 90 percent of known disease-causing genetic mutations.  

We envision a world where this technology can cure, halt, and ultimately prevent genetic diseases, providing lifelong benefit to patients.  Prime Medicine offers the opportunity to shape the future of gene editing and transform how medicines are used to treat disease. Realizing the promise of Prime Editing requires a talented team with diversity of viewpoints and expertise. We’re building a group of dedicated, scientifically curious individuals who are passionate about helping patients live longer, healthier lives.

Position Overview

 We are seeking a Senior Manager, External Manufacturing responsible for establishing and managing production and relations at External Manufacturing CDMOs along with support of key Supply Chain initiatives. This is a key role that requires excellent organizational and collaboration skills experience dealing with internal and external partners and technical skills required to manage a cross-functional team overseeing the sourcing, selection and production / testing of gene editing components. Areas of focus will include development of fit for purpose processes for supplier management and their governance establishing and driving cadence for supplier dashboards / budgeting / risk identification and management, organizing ways of working both internally and cross-functionally, organizing and deploying tools to manage information, aligning with internal stakeholders (Process Development, Analytics, QA, CMC, Asset Teams, etc.), support the design and rollout of supply planning and supplier/raw materials management, organize product and sample shipping logistics, invoicing and POs, etc. Ideally, the incumbent will have the necessary skills / experience and ultimately the desire to quickly advance into either a CDMO Site Manager or Supply / Material Planning leadership role.

 

Responsibilities

  • Provide oversight of CDMO operations including supply planning and production plans, management of manufacturing vendor change notifications; lead or assist with manufacturing deviations, customer complaints, and product failure investigations.
  • Organizes proposal responses, establish data repository and supports the development of outsourcing models, vendor evaluation, and CMO selection in close collaboration with key internal stakeholders.
  • Project Management of CDMO’s and critical suppliers; including driving cadences for budget planning & tracking, contracts, and manufacturing tactical execution.
  • Establish and foster strong collaborative relationships with external manufacturing counterparts & partners and service providers.
  • Establish and maintain detailed project plans, drive risk management program cadence.
  • Support supply planning by driving cadence, collecting and organizing data into meaningful output
  • Resource planning, generating metrics/ KPIs, and presentation of materials for internal stakeholder review.
  • Travel for in-person interactions with multiple contract manufacturing entities to ensure production is on plan and to foster good relations.
  • Perform other related duties and ad hoc projects as required by position and in support of the Head Supply Chain and External Manufacturing.

Qualifications:

  • Bachelor of Science and 7+ years’ experience in project management / biologics manufacturing required; C&GT preferred.
  • Understanding of external manufacturing operations and quality systems required.
  • Experience or understanding of supply chain planning, raw material supply.
  • Knowledge of cGMP requirements is a must.
  • Leadership skills with a PM track record of delivering on established goals & objectives
  • Strong communication skills (written and verbal), including experience presenting in front of multidisciplinary stakeholders and senior management.

Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.

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