Sr Research Associate - Downstream Process Development in Oceanside, CA

100% on-site Oceanside (no hybrid/no )

Working Hours: Mon-Fri business hours (ie, 8am-5pm, 8:30am-5pm)

Reason for opening: critical business needs continue during non-FTE hiring period (multi-year site closure); this role specifically is not likely to extend; this role is not a consideration for FTE conversion in this location.

Summary:

• Sr Research Associate with experience in protein purification process development and process characterization to support our biologics development group (early and late stage development of our protein molecules).
• Focus: Downstream Process Development.

Top 3 Must Have:

• Skills in data analysis and interpreting experiment outcomes including the ability to evaluate data quality and recognize anomalous results
• Demonstrate strong verbal communication and interpersonal skills including the ability to explain processes used to achieve results of assigned tasks.
• 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.

Ideal Requirements (in addition to Must Have's):

• Experience in biologics purification, with an emphasis on conjugation, tangential flow filtration (UF/DF), and filtration.
• Knowledge of cGMPs, technology transfer, and scaling up bioprocesses
• Experience with multiple modalities - specifically mAbs and antibody drug conjugates

Essential Duties and Job Functions:

• Plan and execute assigned experiments on-site that support Process Development activities and project goals.
• Select appropriate methods and techniques for performing experiments.
• 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.
• 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:

• Experience in analytical operations: SEC/HPLC, CE (R/NR), HCP testing is beneficial, but not required.
• Must be able to work effectively in cross-functional teams.
• Must demonstrate excellent technical writing skills.
• 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.

Education/Qualifications –

• preferred degree in Chemical/Biochemical Engineering, Biochemistry, Chemistry or a related scientific discipline.
• BS degree in a relevant scientific discipline and 2+ years of relevant experience; OR
• MS degree in a relevant scientific discipline and 1-2+ years of relevant experience

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