Manufacturing Associate II

Proclinical Staffing; Bristol Township (Bucks County); On-site; USD 60,000 - 78,000; Full time

Job summary

Proclinical Staffing is seeking a Manufacturing Associate II in Bristol, PA to support cGMP bioconjugation and gene therapy manufacturing. The role involves performing large-scale manufacturing activities in a GMP environment, documenting batches, sampling materials, and assisting with quality systems.

The ideal candidate has a chemistry/biology/engineering background and hands-on experience with chromatography systems, UF-DF, and TFF skids.

Qualifications

• Bachelor's degree in chemistry, biology, or engineering.
• Experience in a GMP pharmaceutical environment.
• Knowledge of cGMP manufacturing operations and GxP principles.
• Familiarity with UF-DF and preparative chromatography systems.

Responsibilities

• Operate in a GMP-compliant environment adhering to regulatory standards.
• Perform manufacturing activities including batch documentation, material sampling, staging, dispensing, and returns.
• Set up, operate, and clean equipment and rooms per procedures.
• Conduct in-process inspections and sampling.
• Support quality systems and CAPA activities.
• Assist with maintenance, troubleshooting, and repair of equipment.
• Write and review SOPs and other cGMP documentation.
• Maintain accurate equipment logs and batch records.

Education

Bachelor's degree (Chemistry/Biology/Engineering)

Tools

AKTA Pilot

AKTA Ready

UF-DF

TFF skids

Job description

Manufacturing Associate II - Permanent - Bristol, PA

Join a team transforming the future of medicine through cutting-edge bioconjugation and gene therapy manufacturing.

Proclinical is seeking a Manufacturing Associate II to join a team in the US.

Primary Responsibilities:

The successful candidate will perform large-scale bioconjugation processes for cGMP manufacturing projects. You will be responsible for ensuring compliance with Good Manufacturing Practices (GMP), maintaining production quality, and meeting delivery timelines. This position involves collaboration across various teams and offers an opportunity to contribute to the development and processing of drug substances in the gene therapy space.

Skills & Requirements:

• Bachelor's degree in chemistry, biology, or engineering.
• Experience in a GMP pharmaceutical environment.
• Familiarity with normal flow filtrations and tangential flow filtrations (UF-DF).
• Hands-on experience with preparative chromatography systems (e.g., AKTA Pilot, AKTA Ready) and manual or automated TFF skids.
• Knowledge of cGMP manufacturing operations and GxP principles.
• Understanding of bioprocess optimization.

The Manufacturing Associate II's responsibilities will be:

• Operate in a GMP-compliant environment, ensuring adherence to regulatory standards.
• Perform manufacturing activities, including batch documentation, material sampling, staging, dispensing, and returns.
• Set up, operate, and clean equipment and rooms as per procedures.
• Conduct in-process inspections and sampling.
• Support investigational and quality systems activities.
• Assist with preventative maintenance, troubleshooting, and repair of equipment.
• Participate in continuous improvement initiatives.
• Collaborate with process development, Quality Control, and Quality Assurance teams.
• Initiate deviations, assess product quality impacts, and propose corrective and preventive actions (CAPAs).
• Write and review SOPs and other cGMP documentation.
• Ensure proper execution of Master Batch Records, SOPs, and validation protocols.
• Maintain accurate equipment logs and batch records.
• Train on and adhere to all policies, procedures, and safety standards.
• Communicate effectively with clients, supervisors, and colleagues.
• Perform other duties as assigned.