Job Title: Aseptic Manufacturing Manager
Hours: 3rd shift - Sunday-Thursday 11 PM-8 AM
Job Type: Full time, direct hire position with benefits
Location: Hunt Valley, MD
Job Responsibilities:
- Provide leadership to Aseptic Manufacturing Associates which includes hiring, managing, motivating, coaching, and mentoring.
- Support Aseptic Manufacturing operations across all shifts, including weekend support as needed.
- Completion of internal batch record review.
- Client support/interaction related to these processes.
- Assist with the authoring and implementation of manufacturing procedures and batch records.
- Accurately document data and complete batch records as needed.
- Successfully complete the facility’s gowning and media fill qualification program.
- Perform and train other employees in various manufacturing tasks, including, but not limited to: Component Preparation, Formulation Operations, Lyophilization Processes, Product Accountability, and Sterile Filling.
- Operate and assist with the maintenance of production equipment.
- Perform duties in cleanroom areas and help to maintain those areas.
- Ensure personnel is trained on all applicable procedures and master batch records prior to execution.
- Initiate revisions to cGMP procedures, and master batch records.
- Assist in the scheduling and performance of routine maintenance and calibration of production equipment.
- Participate in client communications, including problem-solving, schedule development, and project status updates.
- Interface with auditors, including client representatives and regulatory agencies.
- Perform Manufacturing review and approval of cGMP documentation in support of continuous improvements, including: Procedures, Master Batch Records, Standard Work Instructions, Risk Assessment Reports, Training Curricula
- Support Agency, customer, and vendor audit as needed.
- Exhibit professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Perform all other tasks, projects, and duties as assigned.
Requirements:
- Minimum of 8 years of related work experience
- Ability to be a hands-on leader of a team of cGMP associates in a controlled environment.
- Ability to continually identify and close cGMP gaps in an interdisciplinary team setting.
- A thorough understanding of cGMP, FDA guidelines, and multinational regulatory standards is required; experience and expertise in aseptic manufacturing of regulated products is preferred.
- Ability to interpret and relate Quality standards for implementation and review.
- Knowledge of Quality principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
- Accountable fo the compliance of the department, managing training, deviation closure, CAPA closure, CCR closure all in in effort to ensure quality product is produced and in reducing errors through process improvements.
- Department owner of the safety program.
- Ability to always portray an appropriate level of integrity and professionalism.
- Ability to communicate effectively with management, staff, regulators, and client representatives, in both written and verbal forms.
- Ability to complete tasks accurately and according to established timelines.
- Demonstrated management ability with a proven track record of leading teams to meet objectives.
- Ability to make sound decisions about scheduling, allocation of resources, and managing priorities.
- Proficiency in both written and verbal communication and presentations
- Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Results oriented and efficient.
- Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
- Ability to work closely with a diverse customer and employee base (internally and externally).
- Ability to work well in a cross-functional team environment.
- Must have proficient computer skills in Microsoft Word, Excel, and Outlook.
