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Manufacturing Operations Manager
2 months ago
Position: Supervisor, Manufacturing Operations (Injectable)
Location: Chicagoland area
Shift: 1st shift 8:30 - 5:00 with occasional OT on weekends.
Salary: $80K - $100K + Benefits
The Supervisor, Manufacturing Operations (Injectable) is a critical leadership role within the manufacturing team. In this leadership position, you will oversee operations related to Fill Finish manufacturing, visual inspection, and finished product production. You will ensure that high-quality products are produced in compliance with regulatory standards and company policies.
We are seeking a highly skilled and experienced professional to lead our manufacturing operations team. The ideal candidate will have a strong background in aseptic processing and manual visual inspection experience with pre-filled syringes (PFS). Additionally, experience with Finished Product packaging, including Serialization, is an advantage.
The successful candidate will have a thorough knowledge of FDA cGMPs and regulatory compliance. They will also possess strong communication, leadership, and problem-solving skills. Experience in planning, documentation, and professional development of others is also required.
Responsibilities:
- Oversee operations related to Fill Finish manufacturing, visual inspection, and finished product production.
- Ensure high-quality products are produced in compliance with regulatory standards and company policies.
- Lead the manufacturing operations team to achieve production targets.
- Develop and implement process improvements to increase efficiency and productivity.
- Collaborate with cross-functional teams to ensure smooth operations.
- Ensure compliance with FDA cGMPs and regulatory requirements.
Requirements:
- Bachelor of Science degree in Engineering, Pharmaceutical Sciences, or a related Life Science field with at least 5 years of experience or a Master of Science degree in Engineering, Pharmaceutical Sciences, or a related Life Science field with at least 2 years of experience.
- Experience with aseptic processing preferred.
- Manual visual inspection experience with pre-filled syringes (PFS) preferred.
- Experience with Finished Product packaging, including Serialization, is an advantage.
- Strong experience in aseptic process execution and supervision.
- Biotechnology experience in a pharmaceutical environment is preferred.
- Thorough knowledge of FDA cGMPs and regulatory compliance.
- Strong communication, leadership, and problem-solving skills.
- Technical writing skills, with experience authoring SOPs and handling deviations.
- Proven ability to lead operational teams and participate in cross-functional teams.
- Proficient in MS Office Applications.
- Knowledge of the current Code of Federal Regulations (CFRs) and cGMPs.
- Experience in planning, documentation, and professional development of others.
Equal Employment Opportunity: Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.
