Lead Scientist, Process Development
PRIMARY PURPOSE OF THIS POSITION:
The Process Development Scientist will be a part of a process development team responsible for development of manufacturing processes for the production of human cell and tissue products (HCT/Ps) compliant with current regulatory requirements, perform process optimization and troubleshooting, and technical transfer of developed processes for internal manufacturing and external manufacturing at contract manufacturing organizations (CMOs). The candidate will design experiments, workflows, collect, and record and interpret data appropriately. Data will be presented in internal and external meetings. The candidate will train other personnel on techniques and equipment. The process development scientist will report to the process development group leader.
The specific duties and responsibilities for this position include but are not limited to the following:
- Design, conduct and analyze experiments to define the process, critical parameters to enable robust performance of manufacturing processes and support regulatory filings (INDs)
- Collaborate closely with R&D, manufacturing, and other departments to implement successful strategy for development and technical transfer
- Prepare process descriptions, reports
- Prepare documentation including but not limited to process descriptions, protocols, technical reports, SOPs, production batch records, etc. and communicate findings internally and externally as appropriate
- Perform process risk assessments, process validations and qualifications
- Perform process risk assessments, process validations and qualifications.
- Perform technical transfers to internal manufacturing and external CMOs
- Oversees and troubleshooting manufacturing processes performed by CMOs
- Follows company safety policies & other safety precautions within work area
- Regular attendance and timeliness is essential
- BS or MS with 5 or more years or a PhD with 2 years of experience in Biopharmaceutical industry
- A strong understanding and experience in the application of various GXP concepts (GMP, GLP, Good Documentation Practices)
- Experience in Formulation of biopharmaceutical product and lyophilization cycle optimization is a plus.
- Successfully have designed and performed product characterization/optimization experiments to identify critical process parameters.
- Experience working in a manufacturing pilot plant preferred.
- Experience with process validation preferred
- Strong knowledge and experience of technology transfer and scale-up/down processes preferred
- Experience writing and reviewing scientific protocols, reports, standard operating procedures and batch production records
- Ability to work independently and demonstrate a high degree of personal & professional initiative
- Problem solving ability - able to develop creative, practical solutions that meet business objectives
- Strong project management skills ability to create, adapt and follow work plans
- Ability to work in a collaborative team environment
- Good organization and time management skills, able to manage multiple competing priority
- Excellent verbal and written communication skills
- Experience in training internal team members. Training of external clients preferred.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Osiris Therapeutics, Inc. is an Equal Opportunity Employer with a commitment to diversity. Applicants are considered on the basis of individual merit without regard to race, color, national or ethnic origin, gender, gender identity, sexual orientation, marital status, veteran status, pregnancy, age, religion, disability, genetic information, or any other characteristic protected by law.