CMC Manufacturing Specialist

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

CMC Manufacturing Specialist - Permanent - New Jersey

Join a dynamic team at a leading biotech and contribute to groundbreaking manufacturing projects and cutting-edge solutions.

Proclinical is seeking a CMC Manufacturing Specialist to serve as an on-site representative at contract manufacturing organizations (CMOs).

Primary Responsibilities:

This role focuses on drug product manufacturing and provides hands-on technical support, quality oversight, and operational guidance during manufacturing campaigns. You will collaborate closely with CMO teams to ensure compliance, optimize processes, and drive continuous improvement initiatives.

Skills & Requirements:

• Background in pharmaceutical sciences, chemistry, chemical engineering, or a related field.
• Hands-on experience in GMP manufacturing, including batch record review, IPC monitoring, and CAPA processes.
• Familiarity with specialized dosage form manufacturing processes such as fill-finish, spray-drying, powder processing, or inhalation product manufacturing.
• Experience with equipment qualification (IQ/OQ/PQ) and technology transfer at CMOs.
• Knowledge of analytical methods (e.g., HPLC, dissolution, Karl Fischer) and method validation/transfer.
• Understanding of regulatory guidelines, including 21 CFR Parts 211 and 820, ICH Q7/Q8/Q10, and EU GMP requirements.
• Ability to work on-site at multiple U.S. CMO locations regularly.
• Strong problem-solving, critical thinking, and communication skills.
• Collaborative mindset with high personal integrity and accountability.

The Manufacturing Specialist's responsibilities will be:

• Provide technical support during GMP and non-GMP manufacturing campaigns, ensuring adherence to batch records, process parameters, and GMP requirements.
• Observe and support critical process steps, in-process controls (IPC), and troubleshooting during production runs.
• Drive process improvement initiatives, including yield optimization and cycle time reduction.
• Manage deviation investigations, out-of-specification (OOS) results, corrective actions (CAPAs), and other quality events, ensuring timely resolution.
• Review and provide input on GMP documentation, including batch records, SOPs, and specifications.
• Identify risks within manufacturing processes and implement preventative actions.
• Support equipment qualification activities (IQ/OQ/PQ) and technology transfer for new or transferred products.
• Oversee clinical labeling and packaging activities at CMOs and third-party vendors.
• Assist with supplier qualification and audit preparation at CMO sites.
• Facilitate pharmaceutical development and analytical improvement activities, including design of experiments (DOEs) and 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 and maintain deep product and process knowledge to support decision-making as a sponsor and legal manufacturer.
• Ensure effective communication between CMOs and internal development teams.

Compensation:

• $135,000 to $140,000 per annum.

If you are having difficulty in applying or if you have any questions, please contact Ed Little at [e-mail]

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