Production Coach

A brief overview

The individual in this role utilizes their experience and education to provide day-to-day guidance, direction, support, and technical development and leadership to an assigned manufacturing team. Activities include implementing and monitoring all activities in the assigned work area to ensure production schedules, manufacturing goals and project deadlines are met while maintaining compliance with current good manufacturing practices (cGMPs). Additionally, this individual is responsible for training team members in the technical aspects of equipment use and applying chemistry expertise to troubleshooting activities.

This individual reviews documentation, and ensures compliance with policies and procedures, including, but not limited to timekeeping, meal and rest periods, environmental health and safety (EHS), and 5S guidelines. The individual in this role ensures seamless transfer of information and responsibilities across shifts and between areas, and identifies and leads continuous improvement efforts that reduce waste and increase operational efficiency.

• Execute and support all production stages which include but are not limited to; synthesis, cleavage, cyclization, conjugation, purification, reconstitution, lyophilization and in-process analytics. Sign off on steps requiring supervision, diagnose and troubleshoot equipment issues, make data-based decisions and escalate to appropriate parties when necessary.

• Provide technical training and guidance on equipment, SOPs, and chemistry processes to support the ongoing development of each member of the team. Ensures that all team member Master Control requirements are met in a timely manner. Maintains training and certification records for team members, as needed.

• Install, operate and maintain equipment for production and in-process testing. The equipment includes but is not limited to analytical HPLC/UPLC, prep. HPLC systems, lyophilizes, balances, reactors, HF cleavage equipment, diafiltration systems, water purification systems, ovens, washing systems and others used in manufacturing.

• Schedule work assignments and ensure team members are able to take timely rest breaks and meal periods and that all applicable hours are accurately captured on work orders. Stand in for team members to cover breaks or lunches to ensure that a process continues, as needed.

• Actively present in the labs to ensure that operations are running smoothly, and safety and compliance requirements are met. Ensure operators are trained properly on the required standards of operations; BPR, SOPs, STMs, utilization, Safety standards, 5S standards, compliance, etc. Approaches daily activities with a continuous improvement mindset. Regularly identifies improvement initiatives and involves team members in ongoing improvement activities.

• Ensure availability and safe, efficient use of the instruments, raw materials and other resources while scheduling production activities and communicating with all responsible departments involved.

• Review BPRs, logbooks, other quality documents, as needed, but at least once daily. Act as a witness to procedures as required. Provide constructive feedback to Managers regarding team members performance.

• Initiate, investigate and close quality events (Deviation, CAPA, etc.) in a timely manner. Support investigations and implementation of corrective actions with technical knowledge.

• Ensure seamless transfer of information and responsibilities across shifts and between areas. Plan, attend and lead production huddles meetings representing production team, bringing knowledge of processes, equipment and schedule, as needed.

• Ability to work late shifts on a continuous basis and be flexible of wrokgin hours based on business needs which may include some nights and weekends.

• Bachelor's Degree Organic Chemistry, Biochemistry, or the equivalent

• Master's Degree Organic Chemistry, Biochemistry, or the equivalent (preferred)

• 1-3 years experience in cGMP manufacturing and the related documentation standards, including safety, health and compliance regulations as specified by federal, state and local governments.

• 4-6 years…