Senior Research Associate 1 - United States
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- Our Romany is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- Our company's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain our company's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
- Come join our team and make a meaningful impact on patients’ lives.
- Our company leads the biotechnology industry in delivering therapies for chronic and degenerative genetic conditions that reduce patients' quality of life and shorten life spans. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- Our company will continue to focus on advancing therapies that are the first or best of their kind and make a big difference in improving patients' lives.
- This position will utilize scientific and engineering principles to develop cell culture processes for gene therapy vector production.
- The individual will be focusing on small-scale cell culture activities in the laboratory, developing processes in shake flasks and bench-top bioreactors as well as larger scale activities that involve process transfer to the manufacturing site.
- The candidate will have experience in bioprocessing, and more specifically, with stirred-tank bioreactor processes (fed-batch and perfusion) and initial harvest recovery and purification, ideally involving gene therapy.
- This individual must be competent with analysis and interpretation of data and will ideally have experience with plate-based and qPCR assays.
- The candidate will present data to collaborators and will assist in writing memos, protocols, and reports by organizing data and observations.
- This individual will also work with vendors to install, maintain, and troubleshoot laboratory equipment.
- Design and execute mammalian cell culture process development experiments, perform analytical testing, analyze data, interpret and present results.
- Perform initial recovery & purification of harvest material, including filtration or chromatography.
- Solve moderately complex issues independently.
- Excellent verbal and written communication skills.
- Handle multiple tasks with good organizational skills.
- Collaborate with cross-functional team to achieve project milestones.
- Set-up and maintenance of multiple pieces of process development laboratory equipment: e.g. bioreactors, analyzers, and chromatography or harvest skids.
- Provide quantitative analysis of data and limited interpretation of results.
- Write reports and present to group of >20 people
- Evaluate moderately complex lab equipment; recommend purchase.
- Relate literature to current experimental work.May attend external training or seminars.Work on a wide range of processes of diverse scope.
Bachelor’s or Master’s Degree in Biochemistry, Biology, Chemical/Bioengineering or other related scientific discipline.
- Mammalian cell culture - (fed-batch and perfusion)
- qPCR and plate-based assay experience
- Some molecular biology skills, especially plasmid production and purification
- Downstream processing: harvest filtration and chromatography
- cGMP experience a plus
Viral vector production/processing experience
- Process Development Department: Cell Culture and Purification
- Assay Development
- Analytical Chemistry
- Vendors or Outside Collaborators
- Senior Research Associate 2 - Bachelor’s degree with at least 8 years experience; Master's degree with at least 6 years experience.
- Expert knowledge of GMP manufacturing and process transfer. Ability to resolve the most complex process development issues.
- Ability to take a leadership role in groups and to influence others effectively. Exercise significant technical discretion in the design and execution of a wide variety of complex experiments including quantitative data analysis and interpretation of results. Use results to design new experiments.
- Write complex protocols and technical reports. Evaluate very complex methods and technologies. Routinely identify new areas requiring evaluation.
- Exercise significant discretion in adapting complex processes and developing new processes.
- Identify and troubleshoot complex manufacturing problems.
- May lead process transfer and process validation activities. Evaluate complex lab equipment.
- Under direction, manage external contractors to develop processes or equipment.
- Make contributions to scientific publications and regulatory submissions.
- Participate in external seminars and conferences. Normally receives little supervision
- The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell.
- The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
- We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.