Sr. Supervisor, Manufacturing Fill Finish

Ajinomoto Bio-Pharma Services; San Diego (CA); On-site; USD 96,000 - 127,000; Full time

Job summary

Ajinomoto Bio-Pharma Services is seeking a Sr. Supervisor for Manufacturing Fill Finish in San Diego. This role involves overseeing daily operations, ensuring compliance with cGMP standards, and leading a manufacturing team. Candidates should have a Bachelor’s degree in Life Sciences and relevant experience, including leadership in manufacturing settings.

Qualifications

• At least 5 years of relevant experience, including 1 year in a leadership role.
• Knowledge of cGMPs and regulatory standards.
• Understanding of filling processes and manufacturing systems.

Responsibilities

• Oversee daily manufacturing operations including formulation, filtration, and filling.
• Review and generate batch records.
• Plan and coordinate production schedules and troubleshooting.

Skills

Knowledge of cGMPs

Understanding of chemistry

Leadership

Troubleshooting

Education

Bachelor’s degree in Life Sciences or related field

Tools

QAD

LIMS

RAM

Job description

Sr. Supervisor, Manufacturing Fill Finish

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Job Overview

The Sr. Supervisor, Manufacturing Fill Finish is responsible for overseeing daily operations including formulation, filtration, filling, troubleshooting, batch record review, and strategic planning within a cGMP environment. This role involves coordinating with various departments, participating in client interactions, managing investigations, and ensuring compliance with regulatory standards.

Key Responsibilities

1. Oversee daily manufacturing operations such as formulation, filtration, and filling.
2. Review and generate batch records.
3. Plan and coordinate production schedules and troubleshooting.
4. Participate in client meetings, audits, and regulatory inspections.
5. Manage investigations related to deviations, OOS, and product quality.
6. Plan facility activities including shutdowns, maintenance, and certifications.
7. Ensure compliance with SOPs and regulatory requirements.
8. Maintain professional and positive relationships with internal and external stakeholders.

Leadership Responsibilities

1. Lead and develop the manufacturing team, including recruiting and training.
2. Set performance standards and provide feedback and coaching.
3. Promote PCI’s cultural values and foster a collaborative environment.

Minimum Requirements

• Bachelor’s degree in Life Sciences or related field.
• At least 5 years of relevant experience, including 1 year in a leadership role.
• Knowledge of cGMPs and regulatory standards.
• Understanding of chemistry, filling processes, and manufacturing systems like QAD, LIMS, and RAM.

Additional Information

The salary range is $96,612.16 to $126,803.46 plus performance bonuses, determined by experience and qualifications.