CMC Manufacturing Specialist / CMC Manufacturing Specialistess

CMC Manufacturing Specialist - Permanent - New Jersey

Join a dynamic team at a leading biotech company and contribute to groundbreaking manufacturing projects and innovative 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.

Responsibilities

• 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 interested in applying to this exciting opportunity, please apply online using the form below. Please note that only applications matching the job profile will be considered.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.