Technical Manager (CMC)

Highly Competitive
  1. Permanent
  2. Genetics & Genomics
  3. United Kingdom
Maidenhead, England
Posting date: 12 Jan 2021

A life changing opportunity has arisen for a Technical Manager with an interest in CMC for Gene Therapy. In this role you will be expected to identify scientific documents to facilitate regulatory filings.

Job Responsibilities

  • Provide technical review and approval for process and analytical protocols, reports and other source documentation as required.
  • Generate required CMC technical reports and technical documentation to facilitate regulatory filings and support technical, regulatory and quality requirements.
  • Support third party vendors contracted to perform GT manufacturing or testing with expert technical knowledge to support the cGMP manufacture and testing of clinical supplies and commercial product.
  • Partner with Gene Therapy External Manufacturing, CMC Quality and CMC Regulatory colleagues to support timely, value-added, stage appropriate, fit-for-purpose reporting documentation in our Gene Therapy drug development processes.
  • Provide technical support for cGMP audits and batch disposition reviews of Gene Therapy facilities and products.

Skills and Requirements

  • University degree or the equivalent combination of education and experience required; advanced/graduate degree preferred
  • Typically requires 5 to 8 years of relevant industrial experience.
  • 3-5 years of experience working with biopharmaceuticals required.
  • Experience working with Advanced Therapy Medicinal Products (ATMPs), especially[D6] viral gene therapy, highly desirable.
  • Excellent process development scientist, good tech knowledge and process characterisation plus QbD
  • GT experience and some biologicals, worked in process development of ATMP or protiens/antibodies no small molecule please
  • Ideally 8-10 years expertise and can talk fluently about the different process steps cell lines to purification
  • Gone through Biological process development and validation

To Apply

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.