Manufacturing Science and Technology Specialist IV, GMP Cell Culture
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
*Recruiters - please do not send unsolicited resumes to this posting.
FOR IMMEDIATE CONSIDERATION PLEASE VISIT OUR WEBSITE AT: