Clinical Research Associate
Behavioral Health Market Context
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Qualifications
- •Title - Sr Research Associate I with experience in protein purification process development and process characterization mandatory
- •Experience level - 4 to 10 years
- •Able to work with highly potent compounds upon training
- •Prior experience in biologics purification, with an emphasis on conjugation, tangential flow filtration (UF/DF), and filtration
- •Prior experience in analytical operations: SEC/HPLC, CE (R/NR), HCP testing is beneficial, but not required
- •Knowledge of cGMPs, technology transfer, and scaling up bioprocesses
- •Must be able to work effectively in cross-functional teams
- •Must demonstrate excellent technical writing skills
- •Working understanding of downstream process development including centrifugation, normal and tangential flow filtration, chromatography operations, and virus clearance
- •The ability to demonstrate hands on experience in several of these areas is expected
- •Ability to work effectively within the purification team to help design and execute experiments supporting process definition, optimization, and characterization with an increasing level of independence
- •Ability to effectively communicate ideas, project goals and results and should have the ability to proactively identify issues and suggest solutions in a collaborative, multidisciplinary environment
- •This is a highly collaborative environment where willingness and ability to communicate and work effectively with individuals across various teams is essential
- •Self-motivated, organized, and enjoy scientific investigation and thinking
- •11 more items(s)
Responsibilities
- •Plan and execute assigned experiments on-site that support Process Development activities and project goals
- •Select appropriate methods and techniques for performing experiments
- •Develop skills in data analysis and interpreting experiment outcomes including the ability to evaluate data quality and recognize anomalous results
- •Recommend alternatives, research new methods and techniques and proactively seek out senior personnel to discuss potential solutions to problems
- •Participate in group meetings and present results, data interpretation and conclusions
- •Demonstrate strong verbal communication and interpersonal skills including the ability to explain processes used to achieve results of assigned tasks
- •Work with team oriented, collaborative and problem-solving mindset
- •Always work with safety in mind
- •Ability to collaborate with Technical Operations during technology transfer from process development to GMP manufacturing, including serving as a process development representative during purification operations, providing technical troubleshooting and identifying opportunities for future process and equipment improvements
- •The candidate will also contribute to the preparation of regulatory filings and process validation and characterization reports
- •The candidate will monitor and contribute to external literature and scientific conferences
- •8 more items(s)
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