Analytical Development Lead – Antibodies – Reading
A unique and exciting opportunity has arisen for an Analytical Development Lead to join an international biopharmaceutical company who have recently opened a brand new state-of-the-art manufacturing process development facility in Reading. As an organisation they are entering into a significant period of growth and investment to support the next phase of development for their innovative R&D pipeline.
The main responsibility of the role is to lead the internal technology transfer of analytical methods, establishing them at the UK site and subsequently transferring them to a 3rd party. The role is predominantly lab based and will also involve directing the work of 1-2 analytical scientists in the early years. As the laboratory is newly established, there will be some involvement in setting up lab system and procedures, equipment commissioning, preparing documentation, training others and cross training in upstream and purification procedures to support the broader team.
*Lead technology transfer of in-process Analytical Methods for bio-therapeutic products
and later externally to 3rd party contract manufacturers
* Oversee the analytical activities related to the running of a small antibody process
*Transfer, establish, develop and qualify in-process analytical methods spanning
UPLC/HPLC (IgG concentration, aggregation/fragment and charge variant analysis),
ELISA (PnA ligand, HCP), PCR (DNA), ceSDS (Purity)
*Establish systems and coordinate/perform routine analytical tests as required to
ensure operational demands are met.
*Train and direct others in executing routine analytical activities, acting as subject
*Author and review Study Protocols and Reports prepared to GLP standards
*Perform data analysis, interpretation, delivering internal, external presentations and reports.
*Provide technical support across sites and to 3rd party CMO’s.
*General housekeeping, stock taking, ordering, laboratory cleaning, reagent/buffer prep.
* PhD/MSc in Biological or Bio-Engineering discipline with 5+ years of industry related
*Knowledge and practical experience establishing, developing, qualifying, and transferring
in-process analytical methods between sites.
*Experience validating analytical methods in line with ICH guidelines
*Practical experience operating & maintaining some of UPLC, ceSDS, ceIEF, gel based
SDS/IEF, densitometers, plate readers, PCR systems and performing/analysing results
from associated analytical methods for antibodies.
*Experience undertaking technology transfer into/out of companies.
Experience working with CMOs
*Proven ability to methodically plan own and direct others’ work
This is a fantastic opportunity to be involved in the set-up of a brand new facility and to really have an impact on the science, technical capabilities and laboratory output from the beginning. In return the company are offering a very competitive salary and benefits package. For further information on this superb opportunity please feel free to contact myself, Lauren Gripton of Paramount Recruitment, firstname.lastname@example.org
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Job Reference: Lg65647_1548065261
Broadcast As: 196
Salary To: Negotiable
Job Type: Full Time
Job Term: Permanent
Job Industry: Biotech
Job Specialism: Science R and D
Recruitment Consultant: Lauren Gripton