Production Coach

Bachem AG•Vista, CA

12d

About The Position

The Production Coach provides daily leadership, technical guidance, and operational support to an assigned manufacturing team. This role oversees all activities within the work area to ensure production schedules, performance targets, and project deadlines are met in full compliance with cGMP standards. Responsibilities include training team members on equipment operation, applying chemistry expertise to troubleshoot issues, and reviewing documentation for accuracy and adherence to policies and procedures, including timekeeping, EHS requirements, and 5S practices. The Production Coach ensures effective communication across shifts, maintains consistent operational handoffs, and drives continuous improvement initiatives to reduce waste and enhance efficiency.

Requirements

Bachelor's degree in chemistry, biochemistry or related field
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.
Thorough understanding of all manufacturing stages and in-process analytical methods
Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods. Knowledge of solvent, waste and materials flow is required.
Familiar with and fully capable of operating and training on scientific manufacturing equipment and utilities
Experience working safely with hazardous materials and hazardous waste.
Advanced computer knowledge, including Microsoft Office applications
Ability to commit to a 4 day per week, 10 hour per day schedule that includes a rotating early morning shift (5am start ) and evening shifts (3pm start), as well as one weekend day every week

Nice To Haves

Master's degree (preferred)
4-6 years pharmaceutical manufacturing (preferred)
SAP experience (preferred)

Responsibilities

Execute and support assigned production stages such as 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, BPR, SOPs, STMs, utilization, Safety standards, 5S standards, compliance, etc. 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.
Ensure operations are running efficiently, and safety & compliance requirements are met through active monitoring of operations in the suites.
Provide and ensure safe & efficient use of 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 and coaching to their team members regarding 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.
Regularly identify improvement initiatives and involve team members in ongoing improvement activities.