Production Coach

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.

Qualifications

• Bachelor's degree in chemistry, biochemistry or related field
• Master's degree (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 pharmaceutical manufacturing (preferred)
• 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
• SAP experience (preferred)
• Ability to commit to a 3-4 day per week, 10 hour per day schedule that includes rotating Wednesday-Saturday one week, Thursday-Saturday the next, schedule 3pm-1:30am

Pay

Base Salary Range: $77,756.00-$97,195.00
Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.

Total Rewards

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

Corporate Social Responsibility

Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.

Benefits

• Comprehensive Medical/Dental/Vision coverage
• 401(k) plan with employer contribution
• Paid vacation, personal and sick days

Equal Opportunity Employer

Bachem Americas is an Equal Opportunity Employer. We celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.