Clinical Research Associate

Hi,

Greetings from NexInfo!

We are hiring Sr Research Associate I with experience in protein purification process development and process characterization with one of our pharma client based in Oceanside, CA for the onsite work agreement. Good fit can share your resume to ***email_hidden***.

Title - Sr Research Associate I with experience in protein purification process development and process characterization mandatory.

Experience level - 4 to 10 years

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. Able to work with highly potent compounds upon training.

Knowledge, Experience and Skills:

Preferred degree in Chemical/Biochemical Engineering, Biochemistry, Chemistry or a related scientific discipline.

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. Experience with multiple modalities (mAbs, bispecifics, fusion and antibody drug conjugates, virus particles) produced in microbial and mammalian expression systems is a plus.

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 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.

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. The candidate will monitor and contribute to external literature and scientific conferences.

Best Regards,

Vijayakumar