CMC Manufacturing Specialist

Contribute to Groundbreaking Manufacturing Projects in Biotech

Join a dynamic team at a leading biotech organization to contribute to cutting-edge solutions and groundbreaking manufacturing projects. As an on-site representative at contract manufacturing organizations (CMOs), you will provide 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.

Key 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.

Skills and 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.

Compensation

$135,000 to $140,000 per annum.