Biopharma Manufacturing Roles Degree Required

Job Description

Job Description

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

Experience

• Degree in Life Sciences or 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

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