Genetic Toxicology Testing

Responsible for Science, Quality and new product development at a company producing reagents and kits for genetic toxicology and microbiology testing, specialist and to-order.

Safety assessment of pharmaceuticals, medical devices etc. Monitor non-clinical studies. Prepare and support nonclinical regulatory submissions worldwide.

Advised on potential genotoxicity issues on chemicals, pharmaceuticals and qualification of drug impurities.

> Established a completely new FDA/OECD GLP compliant capability; produced business plan, designed labs, trained staff, main client contact.> Introduced screening & GLP in vivo and in vitro tests together with a comprehensive training program. > Ensured continual growth and high profitability. > Acted as study director and trained new study directors during periods of acute staff shortage, maintaining or exceeding targets> Peer-reviewed all reports ensuring… Show more > Established a completely new FDA/OECD GLP compliant capability; produced business plan, designed labs, trained staff, main client contact.> Introduced screening & GLP in vivo and in vitro tests together with a comprehensive training program. > Ensured continual growth and high profitability. > Acted as study director and trained new study directors during periods of acute staff shortage, maintaining or exceeding targets> Peer-reviewed all reports ensuring accuracy, clarity and correctness of conclusions; ensured reports were >99% on time or early> Introduced electronic mailing and filing of documents at the corporate level resulting in substantial cost and time savings.> Developed new markets by introducing special methods> Liaised with clients to deal with compound-specific issues (e.g. formaldehyde-releasing prodrug); ensured study designs met corporate and regulatory requirements.> The quality of the work done and timeliness frequently lead to further more long-term studies in other areas; regular clients included many large pharma. Show less

Reviewed formal documents for all in vitro and in vivo studies including PK, mass balance and QWBA. Improved clarity of protocols and reports; reflected by significant business growth during this period - their most successful year ever.

Performed, supervised and directed a very wide range of in vitro and in vivo studies: Ames, rodent micronucleus, cytogenetics (germ cell, gut, bone marrow, in vitro), mammalian cell mutation, liver UDS, histological examination for target organ genotoxicity. Directed up to 70 in vivo micronucleus and 20 in vivo UDS studies per year. Assisted in the international validation of the rat acute and sub-acute micronucleus tests.Techniques: all aspects Responsibilities: oversaw all in… Show more Performed, supervised and directed a very wide range of in vitro and in vivo studies: Ames, rodent micronucleus, cytogenetics (germ cell, gut, bone marrow, in vitro), mammalian cell mutation, liver UDS, histological examination for target organ genotoxicity. Directed up to 70 in vivo micronucleus and 20 in vivo UDS studies per year. Assisted in the international validation of the rat acute and sub-acute micronucleus tests.Techniques: all aspects Responsibilities: oversaw all in vivo genotoxicity testingMain accomplishment: introduced practical improvements resulting in improved quality and efficiency in all areas. Show less

Research DNA turnover in lymphocytes

Plant tissue culture