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Sciences - Process Development
•30 days ago
| Hours | Full-time |
|---|---|
| Location | Rockville, MD Rockville, Maryland |
About this job
We are seeking a highly motivated and experienced individual to play a significant role in our Downstream Process Development group. The candidate will also support development of virus-like particle (VLP), Respiratory Syncytial Virus (RSV) vaccine and other biologic product candidates, and, as needed, support cGMP manufacturing. This position requires hands-on execution of development, scale-up, and optimization of purification processes that can be transferred to the Manufacturing group and external partners and collaborators. This position will be located at our Rockville, MD facility.
Responsibilities include but are not limited to:
¿ Develop robust, high-producing, scalable and economically purification production processes for technology transfer up to the manufacturing scale for VLP and RSV-based vaccine and biologic product candidates. Evaluate optimal purification operational strategies to improve product yield, quality and purity.
¿ Execute Design of Experiment (DOE) studies to fully characterize processes. Support process validation studies and activities.
¿ Maintain and monitor process development equipment. Propose modifications to processes or equipment to deliver improvements.
¿ Participate in the technology transfer of processes to the Manufacturing group and external partners and collaborators. This may include training staff, providing recommendations for equipment to use for scale-up, and directing experiments to troubleshoot and/or support scale-up and cGMP operations.
¿ Perform critical operations as needed in our development and cGMP manufacturing facilities to deliver clinical materials.
¿ Generate, manage, evaluate, and maintain critical data and records of all process development operations in support of regulatory requirements.
¿ Collaborate and coordinate with colleagues from basic research, upstream cell culture, and analytical development.
¿ Author technical reports, data analysis summaries, and SOP’s as needed.
Present scientific findings at internal meetings.
¿ Discuss data, draw preliminary conclusions, and design next experiments in
conjunction with colleagues and managers.
Candidate must have Bachelors in Life Sciences with 5+ years experience or
Masters with 3+ years related industry experience
*For immediate consideration, please call Jeff Beckhorn at 301-315-1855*
About Aerotek Scientific:
Join Aerotek Scientific®LLC, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law.
Responsibilities include but are not limited to:
¿ Develop robust, high-producing, scalable and economically purification production processes for technology transfer up to the manufacturing scale for VLP and RSV-based vaccine and biologic product candidates. Evaluate optimal purification operational strategies to improve product yield, quality and purity.
¿ Execute Design of Experiment (DOE) studies to fully characterize processes. Support process validation studies and activities.
¿ Maintain and monitor process development equipment. Propose modifications to processes or equipment to deliver improvements.
¿ Participate in the technology transfer of processes to the Manufacturing group and external partners and collaborators. This may include training staff, providing recommendations for equipment to use for scale-up, and directing experiments to troubleshoot and/or support scale-up and cGMP operations.
¿ Perform critical operations as needed in our development and cGMP manufacturing facilities to deliver clinical materials.
¿ Generate, manage, evaluate, and maintain critical data and records of all process development operations in support of regulatory requirements.
¿ Collaborate and coordinate with colleagues from basic research, upstream cell culture, and analytical development.
¿ Author technical reports, data analysis summaries, and SOP’s as needed.
Present scientific findings at internal meetings.
¿ Discuss data, draw preliminary conclusions, and design next experiments in
conjunction with colleagues and managers.
Candidate must have Bachelors in Life Sciences with 5+ years experience or
Masters with 3+ years related industry experience
*For immediate consideration, please call Jeff Beckhorn at 301-315-1855*
About Aerotek Scientific:
Join Aerotek Scientific®LLC, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law.
Requirements
Uncategorized, PROCESS DEVELOPMENT SCALE-UPS, Downstream, DOE, GMP, AKTA
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