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 requirements
- Perform weighing, mixing, pH adjustment, filtration, and transfer of buffers at various scales
- Operate and clean buffer preparation equipment, including tanks, mixers, pumps, and filtration systems
- Execute and document manufacturing activities in batch production records (BPRs) accurately and contemporaneously
- Perform equipment setup, operation, and teardown in classified cleanroom environments
- Adhere to gowning, aseptic techniques, and contamination control procedures
- Perform line clearances, material verification, and inventory transactions as required
- Support buffer hold studies, labeling, storage, and lifecycle management
- Identify and report deviations, discrepancies, or safety concerns promptly
- Participate in continuous improvement initiatives and lean manufacturing efforts
- Support client audits, regulatory inspections, and internal audits as needed
Qualifications
Education
- Associate’s or Bachelor’s degree in Biotechnology, Biology, Chemistry, or a related scientific field preferred
- Equivalent industry experience will be considered
Experience
- 1–3 years of experience in cGMP manufacturing within biotech, biopharmaceutical, or CDMO environments
- Hands-on experience with buffer and solution preparation required
- Familiarity with upstream and/or downstream manufacturing processes preferred
Technical Skills
- Knowledge of cGMP regulations and documentation practices
- Experience with buffer prep equipment, pH meters, balances, and filtration systems
- Ability to follow complex batch records and SOPs
- Basic understanding of cleanroom operations and aseptic technique
- Proficiency with electronic batch records (EBR) and manufacturing systems a plus
Soft 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 requirements
- Perform weighing, mixing, pH adjustment, filtration, and transfer of buffers at various scales
- Operate and clean buffer preparation equipment, including tanks, mixers, pumps, and filtration systems
- Execute and document manufacturing activities in batch production records (BPRs) accurately and contemporaneously
- Perform equipment setup, operation, and teardown in classified cleanroom environments
- Adhere to gowning, aseptic techniques, and contamination control procedures
- Perform line clearances, material verification, and inventory transactions as required
- Support buffer hold studies, labeling, storage, and lifecycle management
- Identify and report deviations, discrepancies, or safety concerns promptly
- Participate in continuous improvement initiatives and lean manufacturing efforts
- Support client audits, regulatory inspections, and internal audits as needed
Qualifications
Education
- Associate’s or Bachelor’s degree in Biotechnology, Biology, Chemistry, or a related scientific field preferred
- Equivalent industry experience will be considered
Experience
- 1–3 years of experience in cGMP manufacturing within biotech, biopharmaceutical, or CDMO environments
- Hands-on experience with buffer and solution preparation required
- Familiarity with upstream and/or downstream manufacturing processes preferred
Technical Skills
- Knowledge of cGMP regulations and documentation practices
- Experience with buffer prep equipment, pH meters, balances, and filtration systems
- Ability to follow complex batch records and SOPs
- Basic understanding of cleanroom operations and aseptic technique
- Proficiency with electronic batch records (EBR) and manufacturing systems a plus
Soft Skills & Competencies
- Strong attention to detail and data integrity
- Ability to work effectively in a fast-paced, multi-client environment
- Good communication and teamwork skills
- Strong organizational and time-management abilities
- Willingness to work flexible schedules, including weekends or shifts, as required
- Strong attention to detail and data integrity
- Ability to work effectively in a fast-paced, multi-client environment
- Good communication and teamwork skills
- Strong organizational and time-management abilities
- Willingness to work flexible schedules, including weekends or shifts, as required