Katalyst CRO · 1 month ago
Biotechnologist Associate
Katalyst CRO is focused on producing therapeutic proteins, and they are seeking a Biotechnologist Associate to execute manufacturing processes under cGMP conditions. The role involves operating production equipment, performing laboratory tasks, and maintaining a compliant manufacturing environment.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Execute manufacturing processes according to SOPs and process recipes under cGMP guidelines
Operate and monitor production equipment, including Clean-in-Place (CIP) and Steam-in-Place (SIP) systems
Perform basic laboratory tasks such as pH and conductivity measurements, sampling, and documentation
Maintain facility and equipment cleanliness through routine sanitization and support 6S programs
Accurately document all activities in compliance with Good Documentation Practices (GDP)
Handle material movements: transfer raw materials and chemicals within production areas
Participate in administrative tasks such as shift exchanges, meetings, and project work
Work in a cleanroom environment with proper gowning and aseptic techniques
Perform other duties as assigned
Qualification
Required
Execute manufacturing processes according to SOPs and process recipes under cGMP guidelines
Operate and monitor production equipment, including Clean-in-Place (CIP) and Steam-in-Place (SIP) systems
Perform basic laboratory tasks such as pH and conductivity measurements, sampling, and documentation
Maintain facility and equipment cleanliness through routine sanitization and support 6S programs
Accurately document all activities in compliance with Good Documentation Practices (GDP)
Handle material movements: transfer raw materials and chemicals within production areas
Participate in administrative tasks such as shift exchanges, meetings, and project work
Work in a cleanroom environment with proper gowning and aseptic techniques
Perform other duties as assigned
Basic understanding of cGMP compliance and aseptic techniques
Ability to follow written procedures and maintain accurate documentation
Mechanical aptitude and comfort with automated systems
Strong computer skills for operating automated equipment
Attention to detail and ability to work in a regulated environment
Willingness to work in cleanroom conditions and wear appropriate gowning
Preferred
Bachelor's degree in Life Sciences, Biotechnology, Chemistry, or related field preferred
Associate degree or relevant technical certification considered
Prior experience in manufacturing, pharmaceutical, or biotech industry preferred
Candidates from the following backgrounds have shown success: Food service/cooks (recipe following), Pharmacy technicians, EMTs, nurses/nurse aides, Mechanical/technical roles (robotics, tech support), Security guards, Roles requiring SOP adherence and regulatory compliance
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
H1B Sponsorship
Katalyst CRO 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 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageRecent News
2024-04-07
Company data provided by crunchbase