Manufacturing Production Planning Manager
4 weeks ago
Abzena Inc. is seeking a highly experienced Manufacturing Production Planning Manager to lead and oversee day-to-day manufacturing operations. The successful candidate will ensure the timely production of high-quality products while adhering to cGMP, FDA, and other regulatory requirements.
Key Responsibilities- Oversee all manufacturing activities, ensuring that production schedules are met in compliance with quality, regulatory, and safety standards.
- Manage and mentor a team of manufacturing supervisors and associates.
- Track performance to provide Supervisors with career growth and development opportunities.
- Ensure optimal resource allocation to meet project timelines and customer requirements.
- Assist with technical and compliance investigations, inspections, and audits.
- Manage the timely review of GMP records for completeness, accuracy, and compliance in conformance with regulatory requirements.
- Draft, revise, and review manufacturing SOPs, master batch records, specifications, and other applicable cGMP documentation, as needed.
Ensure that all operations are in strict compliance with cGMP, FDA, and other regulatory requirements.
- Lead investigations, corrective actions, and preventative actions associated with process deviations/non-conformances, adapting strategies as needed to maintain high standards of quality and compliance.
- Identify, assess, and mitigate risks to ensure the safety, purity, quality, and effectiveness of manufactured products, developing contingencies to address potential challenges.
Collaborate with the MSAT team to transfer processes and technologies into manufacturing, ensuring a smooth transition by identifying potential risk and developing mitigation strategies.
- Lead and manage manufacturing projects from inception through completion, ensuring alignment with business objectives, timelines, and quality standards.
Ensure ongoing training and development of manufacturing staff on new technologies, SOPs, and regulatory guidelines.
- Ensure an adequate number of personnel with appropriate education, experience, and training in accordance with cGMP requirements.
Abzena Inc. is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
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