Technical Manager (CMC) job in Maidenhead, England

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Genetics & Genomics

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

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

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