Proclinical are recruiting a Lead Associate, Molecular Biology for a biotech establishment. This role is on a permanent basis and is located in Cambridge. The client is focused on engineering precise genetic medicine for rare illnesses.
* Write evolvement documents, study protocols, and pre-validation documents.
* Evolve and sustain clear and concise lab archives and papers.
* Perform qPCR, ddPCR based test approaches and any other molecular biology linked test approaches in the AD laboratory in assistance of liberating AAV based gene therapy products.
* Support further evolvement, qualification and validation actions linked to viral test tactics for AAV based gene therapy products planned for clinical and commercial stage programs.
* You will train new personnel to the laboratory on these techniques and offer supervision when necessary.
* When required, analyse test outcomes produced in-house or at the CRO/CMO for outcomes acceptance.
* Act as the subject matter expert on the qPCR and ddPCR test method based molecular biology test methods for AAV based products planned for early and late stage clinical trials.
* The ideal candidate will evolve workflow methods to develop the success of these sensitive test tactics.
* Perform stage suitable validation and transfer of these methods to laboratories in the US and EU on an external level and handle the lifecycle of these tactics.
* Serve as a company mediator with CMOs to organise in tactic improvement and tactic transfer across multiple CMO/CRO sites.
* Other duties may be assigned to this role.
*Skills & Requirements:*
* Educated to an advanced degree in molecular biology, microbiology, biology, chemistry or similar discipline with at least 5+ years of experience.
* Familiarity within quantitative qPCR and ddPCR.
* Prior involvement operating in a cGMP setting as well as in writing laboratory processes.
* Communication skills both verbally and written.
* Work well in a team environment.
* Able to support lab associates in offering an operational, safe work setting while maximising laboratory effectiveness.
If you are having difficulty in applying or if you have any questions, please contact Danielle Bahnasy at (+1) .
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.