On-Site CMC Manufacturing Specialist – GMP & Tech Transfer

Proclinical; New Jersey; On-site; USD 135,000 - 140,000; Full time

Job summary

Proclinical is seeking a CMC Manufacturing Specialist to serve as an on-site representative at U.S. CMOs, leading GMP campaigns with hands-on technical support and quality oversight.

You will collaborate with CMO teams to ensure compliance, optimize processes, drive CAPAs, and support equipment qualification and technology transfer. The role requires on-site work across multiple U.S. CMOs and strong problem-solving and communication skills.

Qualifications

• Bachelor’s degree in pharmaceutical sciences, chemistry, chemical engineering or related field.
• Hands-on GMP manufacturing experience including batch record review, IPC monitoring and CAPA processes.
• Familiarity with dosage form manufacturing processes (fill-finish, spray-drying, powder processing, inhalation).
• Experience with equipment qualification (IQ/OQ/PQ) and technology transfer at CMOs.
• Knowledge of analytical methods (HPLC, dissolution, Karl Fischer) and method validation/transfer.
• Understanding of regulatory guidelines (21 CFR 211/820, ICH Q7/Q8/Q10, EU GMP).
• Ability to work on-site at multiple U.S. CMO locations regularly.

Responsibilities

• Provide technical support during GMP and non-GMP manufacturing campaigns, ensuring adherence to batch records and GMP requirements.
• Observe and support critical process steps, IPCs, and troubleshooting during production runs.
• Drive process improvement initiatives, including yield optimization and cycle time reduction.
• Manage deviation investigations, OOS results, CAPAs, and other quality events; ensure timely resolution.
• Review GMP documentation, including batch records, SOPs, and specifications.
• Identify risks in manufacturing processes and implement preventive actions.
• Support equipment qualification activities (IQ/OQ/PQ) and technology transfer for new products.
• Oversee labeling and packaging activities at CMOs and third parties.
• Assist with supplier qualification and audits at CMO sites.
• Facilitate development and analytical improvement activities (DOE, method optimization).
• Provide oversight for drug substance/API manufacturing, including batch observation and quality event management.
• Deliver regular reporting on batch status, quality events, and process performance trends.
• Build deep product/process knowledge to support decision-making as sponsor and legal manufacturer.
• Ensure effective communication between CMOs and internal development teams.

Skills

GMP manufacturing

Batch record review

IPC monitoring

CAPA processes

Regulatory compliance

21 CFR 211/820, ICH Q7/8/10, EU GMP

On-site collaboration

Quality oversight

Education

Bachelor's degree in Pharmaceutical Sciences, Chemistry, or Chemical Engineering

Tools

IQ/OQ/PQ

Technology transfer at CMOs

HPLC, Dissolution, Karl Fischer

Job description

Proclinical is seeking a CMC Manufacturing Specialist to serve as an on-site representative at U.S. CMOs, leading GMP campaigns with hands-on technical support and quality oversight.

You will collaborate with CMO teams to ensure compliance, optimize processes, drive CAPAs, and support equipment qualification and technology transfer. The role requires on-site work across multiple U.S. CMOs and strong problem-solving and communication skills.