Supervisor, Manufacturing Fill Finish - 2nd Shift

Ajinomoto Bio-Pharma Services; San Diego (CA); On-site; USD 87,000 - 115,000; Full time

Job summary

Ajinomoto Bio-Pharma Services is seeking a Supervisor for Manufacturing Fill Finish on the 2nd Shift. This role involves overseeing production operations in a cGMP environment, ensuring compliance with regulatory standards, and leading a team to achieve operational excellence. Candidates should possess a Bachelor’s degree in life sciences and relevant experience in manufacturing processes.

Qualifications

• At least 5 years of relevant technical experience.
• Minimum 1 year of leadership experience.
• Strong understanding of filling processes.

Responsibilities

• Oversee daily operations including formulation and filling.
• Conduct internal investigations related to deviations.
• Plan facility activities such as maintenance and audits.

Skills

Leadership

Knowledge of cGMPs

Chemistry understanding

Education

Bachelor’s degree in life sciences or related field

Tools

QAD

ACE

LIMS

RAM

Job description

Supervisor, Manufacturing Fill Finish - 2nd Shift

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Job Overview

The Drug Product Manufacturing Supervisor – 2nd Shift is responsible for implementing all production and manufacturing procedures to optimize processes and meet regulatory requirements. This role involves coordinating with other departments to plan, schedule, and execute production operations in a validated cGMP environment.

Responsibilities

• Oversee daily operations including formulation, filtration, filling, and troubleshooting.
• Review and generate batch records.
• Plan strategically with drug product manufacturing and internal teams, including scheduling, preparation, and troubleshooting.
• Participate in client calls, meetings, and site tours, and resolve operational or quality issues.
• Conduct internal investigations related to deviations, CAPAs, and product quality reviews.
• Plan facility activities such as shutdowns, maintenance, HEPA certifications, and media fills.
• Prepare audit responses for client, QP, and regulatory inspections, including SOP and batch record revisions.
• Collaborate with Quality on investigations and deviations.
• Maintain reliable attendance and professional conduct.
• Uphold PCI’s cultural values and align actions with department and company goals.

Leadership Responsibilities

• Lead and provide expertise in drug product manufacturing operations.
• Recruit, retain, and develop top talent.
• Promote PCI’s culture and empower employees.
• Mentor, coach, and support team development and onboarding.
• Set performance standards, provide feedback, and manage performance.
• Ensure transparent communication within the team.
• Guide employees in accordance with company policies.

Minimum Requirements

• Bachelor’s degree in life sciences or related field.
• At least 5 years of relevant technical experience.
• Minimum 1 year of leadership experience.
• Knowledge of cGMPs and regulatory standards.
• Strong understanding of chemistry, filling processes, and relevant systems (QAD, ACE, LIMS, RAM).

The salary range is $87,473 to $114,808 plus performance bonuses, based on experience and other factors.

Additional Information

PCI is an Equal Opportunity Employer committed to diversity and inclusion. We foster an inclusive environment where everyone can belong and grow.