The Manufacturing Associate – Buffer Preparation supports cGMP manufacturing operations by preparing buffers and solutions used in upstream and downstream bioprocessing. This role is critical to ensuring timely, accurate, and compliant production activities within a biotech CDMO environment supporting multiple client programs. The ideal candidate has hands-on buffer preparation experience and a strong understanding of cGMP principles, documentation, and safety requirements.
Key Responsibilities
Prepare buffers, media, and process solutions according to batch records, SOPs, and cGMP requirementsPerform weighing, mixing, pH adjustment, filtration, and transfer of buffers at various scalesOperate and clean buffer preparation equipment, including tanks, mixers, pumps, and filtration systemsExecute and document manufacturing activities in batch production records (BPRs) accurately and contemporaneouslyPerform equipment setup, operation, and teardown in classified cleanroom environmentsAdhere to gowning, aseptic techniques, and contamination control proceduresPerform line clearances, material verification, and inventory transactions as requiredSupport buffer hold studies, labeling, storage, and lifecycle managementIdentify and report deviations, discrepancies, or safety concerns promptlyParticipate in continuous improvement initiatives and lean manufacturing effortsSupport client audits, regulatory inspections, and internal audits as neededQualifications
Education
Associate’s or Bachelor’s degree in Biotechnology, Biology, Chemistry, or a related scientific field preferredEquivalent industry experience will be consideredExperience
1–3 years of experience in cGMP manufacturing within biotech, biopharmaceutical, or CDMO environmentsHands-on experience with buffer and solution preparation requiredFamiliarity with upstream and/or downstream manufacturing processes preferredTechnical Skills
Knowledge of cGMP regulations and documentation practicesExperience with buffer prep equipment, pH meters, balances, and filtration systemsAbility to follow complex batch records and SOPsBasic understanding of cleanroom operations and aseptic techniqueProficiency with electronic batch records (EBR) and manufacturing systems a plusSoft Skills & Competencies
Job Title: Manufacturing Associate – Buffer Preparation
Location: [Location]
Department: Manufacturing / Operations
Reports To: Manufacturing Supervisor / Manager
Position Summary
The Manufacturing Associate – Buffer Preparation supports cGMP manufacturing operations by preparing buffers and solutions used in upstream and downstream bioprocessing. This role is critical to ensuring timely, accurate, and compliant production activities within a biotech CDMO environment supporting multiple client programs. The ideal candidate has hands-on buffer preparation experience and a strong understanding of cGMP principles, documentation, and safety requirements.
Key Responsibilities
Prepare buffers, media, and process solutions according to batch records, SOPs, and cGMP requirementsPerform weighing, mixing, pH adjustment, filtration, and transfer of buffers at various scalesOperate and clean buffer preparation equipment, including tanks, mixers, pumps, and filtration systemsExecute and document manufacturing activities in batch production records (BPRs) accurately and contemporaneouslyPerform equipment setup, operation, and teardown in classified cleanroom environmentsAdhere to gowning, aseptic techniques, and contamination control proceduresPerform line clearances, material verification, and inventory transactions as requiredSupport buffer hold studies, labeling, storage, and lifecycle managementIdentify and report deviations, discrepancies, or safety concerns promptlyParticipate in continuous improvement initiatives and lean manufacturing effortsSupport client audits, regulatory inspections, and internal audits as neededQualifications
Education
Associate’s or Bachelor’s degree in Biotechnology, Biology, Chemistry, or a related scientific field preferredEquivalent industry experience will be consideredExperience
1–3 years of experience in cGMP manufacturing within biotech, biopharmaceutical, or CDMO environmentsHands-on experience with buffer and solution preparation requiredFamiliarity with upstream and/or downstream manufacturing processes preferredTechnical Skills
Knowledge of cGMP regulations and documentation practicesExperience with buffer prep equipment, pH meters, balances, and filtration systemsAbility to follow complex batch records and SOPsBasic understanding of cleanroom operations and aseptic techniqueProficiency with electronic batch records (EBR) and manufacturing systems a plusSoft Skills & Competencies
Strong attention to detail and data integrityAbility to work effectively in a fast-paced, multi-client environmentGood communication and teamwork skillsStrong organizational and time-management abilitiesWillingness to work flexible schedules, including weekends or shifts, as requiredStrong attention to detail and data integrityAbility to work effectively in a fast-paced, multi-client environmentGood communication and teamwork skillsStrong organizational and time-management abilitiesWillingness to work flexible schedules, including weekends or shifts, as required Read Less