Process Cell Culture Development Scientist

Acambis is a leading vaccine company developing novel vaccines that address significant unmet medical needs or substantially improve standards of care. ChimeriVax™-JE, Acambis’ most advanced product in its development-stage pipeline, has to date shown an excellent safety and efficacy profile following pivotal Phase 3 trials. It is currently undergoing paediatric trials in the endemic region and is partnered with Sanofi Pasteur. Acambis’ proprietary ChimeriVax™ technology, developed in association with St Louis University, has also been used to develop ChimeriVax™-West Nile, which is undergoing Phase 2 clinical testing, making it the most advanced investigational vaccine against the West Nile virus. Acambis has established a global collaboration with Sanofi Pasteur for further development and commercialisation of the vaccine. ChimeriVax™ has also been applied to development of Sanofi Pasteur’s tetravalent dengue vaccine, which has successfully demonstrated proof-of-concept in a Phase 2 trial by generating 100% seroconversion to all four dengue virus serotypes.

 

Acambis’ ACAM-CDIFF™ is the only vaccine in development against Clostridium difficile bacteria, a leading cause of hospital-acquired infections. C. difficile is estimated to cause at least 360,000 cases of C. difficile-associated disease in the US alone, and annual costs to US and European healthcare systems are estimated to be in excess of $7bn a year. Acambis’ influenza programme aims to develop a universal vaccine against influenza, for which a universal ‘A’ strain vaccine, ACAM-FLU-A™, was recently tested in a Phase 1 trial and pre-clinical challenge study. Acambis is currently undertaking pre-clinical testing of a vaccine candidate, dl5-29, against genital herpes.

 

Acambis is recognised internationally as the leading producer of smallpox vaccines for emergency-use stockpiles held by the US Government and several other governments around the world. Acambis developed its ACAM2000â„¢ smallpox vaccine under contracts with the US Government.

 

Acambis is based in Cambridge, UK and Cambridge, Massachusetts, US, and is listed on the London Stock Exchange (ACM). More information is available at www.acambis.com.

 

A Process Development Scientist 2/3 is needed to develop cell culture processes for the manufacture of viruses and proteins for use in various vaccines under development. This individual will: interface with Research personnel to develop early-phase production methods, scale-up bioreactor and primary recovery operations, and fully define and characterize late-stage manufacturing processes for commercialization. As also manager of the Process Cell Culture laboratory, expertise with bench-scale bioreactors and a strong commitment to laboratory research is required.

 

 Job Responsibilities:Cell culture process development, optimization, characterization, and technology transfer. Uses scientific and engineering concepts to solve a wide range of difficult problems in imaginative and practical ways. Supervise and/or provide guidance to associate-level staff; manage performance. Assist with the professional development efforts of the Process Development group.Laboratory management and maintenance of equipment and standard methods.Cell bank creation and documentationGeneration of all necessary process development documentation and reports including specification of production procedures and equipment requirements.  Review and editing of master Manufacturing batch production recordsTechnical support of process validation activities.  Maintains substantial knowledge of state-of-the-art principles and theories and contributes to scientific literature and conferences. Knowledge of regulatory compliance requirements Participate in developing budget and objectives for the group.Ensuring safe lab practices and BSL requirements while working with live microbes and microbial products.Understanding and using control and data acquisition and storage systems.

 

 

The right individual needs a PhD in a scientific discipline and at least 2 years experience or a MS with approximately 7 years of experience in development of processes based on protein expression or production of other biologicals through mammalian cell culture or microbial fermentation. Demonstrated success in technical proficiency, bioreactor operation, scientific creativity, collaboration with others and independent thought is necessary. Strong written and oral communication skills are critically important to manage and mentor Development Associates, to plan and document experimental work and to construct process specifications to support technology transfer. Familiarity with QbD concepts and GXP requirements is highly desirable in order to contribute to the authorship of regulatory filings.

 

 

 

CONTACT INFO:

 

Human Resources

Acambis Inc.

38 Sidney Street

Cambridge, MA  02139

E-mail:  careers@acambis.com

Interested applicants must apply on-line attaching a word document to your email submission

 

Acambis Inc. provides a competitive salary and a full range of benefits.

We are proud to be an equal opportunity employer, dedicated to promoting a culturally diverse workplace.