Senior Consultant, CMC
Type of Job
About the job
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.
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.
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