Senior Consultant, CMC

Job Location

Seattle or Remote

Type of Job

Full Time

Job Description

Pluristyx is seeking an enthusiastic and self-driven individual to join our team in the role of a Senior Consultant, CMC. The position will primarily support Pluristyx’s consulting services by providing technical and project leadership to client companies that are developing cell and gene therapy products. The successful candidate is expected to be a subject matter expert in elements concerning the development, manufacturing, and analytical testing of cell therapy products. Since it is not possible for a single individual to be an expert in every element of such a diverse field, the individual should also have the maturity, experience, and motivation to apply their expertise to new concepts, proactively identify issues, and work with project teams to recommend/implement solutions. The candidate should also be experienced in writing/reviewing technical documents that include, for example, IND/BLA submissions, batch records, validation/qualification protocols, and technical development reports. The candidate should have demonstrated experience leading multi-disciplinary teams and driving projects to completion.

Requirements

Education & Experience

  • Advanced degree in a technical discipline and 10+ years experience in the biotech industry.

  • Experience related to the development, manufacture, and testing of biotech products within a GMP environment, especially with cell and gene therapy products

  • Experience in CMC project management and leading teams in the translation of development projects into clinical manufacturing and supplying drug product to clinical sites; experience with the regulatory submissions and the generation of CMC IND content.


Primary Responsibilities

The position will have responsibilities that include:

  • Work with external clients in support of consulting projects; this will include acting as a subject matter expert in areas that may include the procurement of starting tissues, the isolation of cell types, the genetic modification of cells, cell culture (batch, fed-batch, perfusion), cryopreservation, and the use of analytical methods for in-process, release, and stability testing.

  • Provide CMC project management leadership to clients in moving forward CMC development and manufacturing activities

  • Give technical presentations/workshops in  public forums (e.g. conferences) and teaching technical topics in a classroom (including virtual classroom) setting

  • Business Development activities in identifying clients, participating in business meetings with clients, and drafting work statements

  • Occasional travel for client projects and conferences

  • Other duties as assigned

Other Skills & Abilities

  • Excellent verbal and written communication skills with an ability to effectively interact with other technical professionals

  • Good technical writing skills in writing/editing reports and regulatory documents

  • Strong written and oral communication skills

  • Good organizational skills and detail-oriented

  • Ability to work independently and in a team environment

  • Relevant computer skills and familiarity with common business software