Lee Richardson

Gmp Manufacturing Process Manager at Celonic Group

Based in Heidelberg, Germany

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Seniority

Other

Department

Other

Location

Heidelberg

Industry

Pharmaceutical Manufacturing

Company size

343

Contact information

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Email

1 credit

l•••••••@celonic.com

Phone

5 credits

+49 ••• •••• ••••

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Background

About Lee Richardson

My previous role as Principal Production Technologist in a mammalian cell culture facility involves line management responsibilities for fist line managers, as well as supporting the manufacture of GMP batches. To achieve this, I regularly plan for key operations as well as supervising and training members the department. I lead daily manufacturing updates and monitor performance to achieve manufacturing goals using relevant KPIs. I coordinate solutions in response to equipment failures and mistakes, liaising with other departments including QA, PD, QC and supply chain. I work in clean rooms graded from D-C, as well as grade A MSCs and laminar flow hoods. My line management responsibilities involve regular 1-1s, performance reviews, SMART objective setting, coaching, mentoring and general support in production matters, as well as providing help accessing HR support. I also lead investigations (HR and process related). I am responsible for raising and assessing PR events and deviations, and provide support to QA to facilitate the closing of these events. I am responsible for ensuring the facility meets Safety, Health and Environmental (SHE), Good Manufacturing Practice (GMP), Data Integrity (DI), quality and best practice requirements. I have worked up to this role over the course of 5 years, starting as Production Technologist. During that time I became competent in performing and trouble shooting all aspects of upstream and downstream manufacture, from vial thaw to pack off. Areas of expertise include:* Culture Seed Chain equipment set up, monitoring and transfer from Vial Thaw to reactors.* Harvest via Centrifugation, Lysis, Flocculation and Depth Filtration.* Chromatography * Viral Inactivation * Viral Filtration * Ultrafiltration/Diafiltration * Open and Enclosed Pack Off I achieved an MSc in industrial and commercial biotechnology and completed a research project in analysing actinomycete bacteria from the Atacama desert, and I am a co-author of a research paper: Hunting for cultivable Micromonospora strains in soils of the Atacama Desert https://link.springer.com/article/10.1007%2Fs10482-018-1049-1 I have a degree in Biology, during which I completed a research project entitled 'Investigating soil microbial communities using next generation DNA sequencing'. These projects required spending a lot of time performing techniques such as- Gel electrophoresis - PCR - Cell culturing - DNA extraction - Protein/DNA purification - Cell culture agar work - Blast searching I also have experience with a range of analytical software such as QIIME

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Lee Richardson Email & Phone Number @ Celonic Group | Kipplo Discover