Cell Culture Manufacturing/Technology Special Acceleron Pharma
THIS JOB HAS EXPIRED About Acceleron:
Acceleron is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel protein therapeutics for cancer and rare diseases. The company is a leader in understanding the biology of the Transforming Growth Factor-Beta protein superfamily, a large and diverse group of molecules that regulate the growth and repair of tissues throughout the human body, and in targeting these pathways to development important new medicines. Acceleron has built a highly productive R & D platform that has generated numerous innovative biologic therapies with novel mechanisms of action. These differentiated biologic candidates have the potential to significantly improve clinical outcomes for patients with cancer and rare diseases. The investors in Acceleron have included: Advanced Technology Ventures, Alkermes, Avalon Ventures, Bessemer Ventures, Celgene, Flagship Ventures, MPM BioEquities, OrbiMed Advisors, Polaris Ventures, QVT Financial, Sutter Hill Ventures, and Venrock. For further information on Acceleron, please visit www.acceleronpharma.com.
Acceleron Pharma has a position in our Manufacturing Science and Technology Group reporting to the Senior Manager, Manufacturing. Acceleron operates a single-use manufacturing facility, and this position will be directly involved in the GMP Cell Culture of drug substance which will be used in human clinical trials. Candidates will be involved in transferring internally developed processes to both internal and external manufacturing environments. Qualified individuals will have experience scaling up robust protein production processes, providing technical solutions for potential process issues, and writing and reviewing all aspects of GMP documentation.
Will assist management with GMP and training of manufacturing and process development staff on changes in manufacturing operations and procedures as required
Will work with process development to transfer production projects into GMP
Author, execute, and review GMP documentation including batch records, SOPs, change controls, deviations, risk assessments, and technical reports according to GMP and site quality standards
Supports Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment
Supports QA during audits and regulatory inspections
Takes a lead role in troubleshooting process and equipment problems
Will attend local scientific meetings and national training courses.
Will be member of cross-functional project teams (internal and partnered programs)
Bachelor?s degree with 5-10 years of GMP cell culture experience
Candidates must have demonstrated cell culture experience working in a Good Manufacturing Practices environment
Has excellent understanding and knowledge of cell culture techniques and processes
Experience operating relevant manufacturing equipment such as: incubators, single-use bioreactors (WAVE and stirred tank), depth filtration skids, and in process analytical equipment such as VCedex or Nova BioProfile analyzer
Experience with transferring cell culture process to contract manufacturing organizations
This person must possess solid communication skills, be hands-on and hard-working, self-motivated and is able to work in a team oriented and dynamic environment.
Works under general supervision, and will be a main point of contact during operation of GMP cell culture activities
Demonstrates, understands and adheres to emergent policies, GMP standards and safety procedures
||149 Sidney Street |
Cambridge, MA 02139
THIS JOB HAS EXPIRED