Rangam · 17 hours ago
RCI-GILD-16822 Sr Research Associate - Downstream Process Development (AKTA/ TFF)
Oceanside, CA
Contract
Onsite
Mid, Senior Level
$38/hr - $42/hr
1+ years expRangam is seeking a Senior Research Associate for their Downstream Process Development team. The role involves contributing to purification process development and characterization for biologics entities during pivotal and commercial development phases, while also mentoring junior team members and ensuring compliance with GMP standards.
ConsultingInformation TechnologySoftwareStaffing Agency
Hiring Manager
Rajguru Azad
Responsibilities
Contribute to experimental design. Plan and execute assigned purification process development laboratory studies. Support process scaleup and implementation in internal and external GMP facilities
Collect and analyze data from laboratory experiments in compliance with data integrity policy. Author experimental protocols and reports
Support process transfer to internal and contract manufacturing facilities to produce GMP and non GMP drug substances on time and with high success rate
Provide technical support for manufacturing atypical event investigations
Ensure high-quality documentation in electronic laboratory notebooks, protocols and reports
Mentor junior team members on purification process development strategies, experimental design and execution as well as process transfer
Help to establish and maintain a state-of-the-art purification lab
Execute purification platform development and new technology/innovation evaluation and implementation to enable pivotal clinical trials
Participate in cross functional initiatives as needed
Adhere to department budget and all training, compliance and safety requirements
Qualification
Required
M.S. with 1+ years or B.S. with 2+ years in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering)
Hands-on laboratory operations experience with purification process operations including centrifugation, normal flow filtration, chromatography operations, tangential flow filtration, and virus inactivation/removal is required
Experience with AKTA chromatography systems and UNICORN software is required
Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities
Excellent communication, technical writing, and presentation skills and aptitude for creative problem solving
Demonstrated ability to collaborate and influence cross-functionally
Experience in statistics, design-of-experiments, and data analysis (e.g. JMP, Spotfire)
Plan and execute assigned purification process development laboratory studies
Collect and analyze data from laboratory experiments in compliance with data integrity policy
Author experimental protocols and reports
Preferred
Antibody drug conjugate experience is a plus
Experience writing CMC sections of commercial regulatory filings (BLA, MAA) and post approval change filings is a plus
Working knowledge of lab automation, data management, data science, knowledge management and data protection is a plus
AKTA operation
TFF Filtration/Viral Clearance
Hamilton purification/High-throughput system operation
Company
Rangam
Rangam is a global, innovative, Total Talent management firm with the mission of accelerating meaningful employment for everyone! We are a minority-, woman-, and disability-owned firm with over 25 years of experience promoting sustainable and inclusive talent programs within our communities and employers.
501-1000 employees
H1B Sponsorship
Rangam has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (2)
2023 (4)
2022 (5)
2021 (4)
2020 (9)
Funding
Current Stage
Late StageLeadership Team
Nish Parikh
Co-founder & CEO
Hetal Parikh
Co-Founder & President
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