Manager, Aseptic Operations

Manager, Aseptic Operations

BASIC FUNCTION :

Provides direction and leadership to the Company's operations with oversight of Aseptic Manufacturing (formulation and filling) operations.

This position works closely with all levels of Operations (Manufacturing and Finishing), Quality Assurance, Technical Services, Validation, QC (Microbiology and Analytical Chemistry), Business and Finance teams.

RESPONSIBILITIES :

• Provide leadership to Aseptic Manufacturing Associates of various levels. Responsibilities include hiring, managing, motivating, coaching, and mentoring.
• Ensure oversight of Aseptic Manufacturing operations across shifts, including weekend support as needed.
• Completion of internal batch record review.
• Assist with the authoring and implementation of manufacturing procedures and batch records.
• Lead routine manufacturing activities, including day to day scheduling and raw materials / consumables management.
• Provide leadership when performing component and equipment preparation, bulk drug formulation, and aseptic filling duties.
• Accurately document data and complete batch records as needed.
• Successfully complete 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 on shift are 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 Record
• Standard Work Instructions
• Risk Assessment Reports
• Training Curricula
• Support Agency, customer and vendor audits 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 practice.

Perform all other tasks, projects, and duties as assigned.

REQUIREMENTS :

• 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 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.
• 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.
• 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.

QUALIFICATIONS :

• A thorough understanding of cGMP, FDA guidelines, and multinational regulatory standards is required; experience and expertise in aseptic manufacturing of regulated products is preferred.
• At least 2 years of prior management / leadership experience required.
• Minimum of 4 years Aseptic Production experience
• Prior experience interacting with regulatory authorities is preferred.
• The level of knowledge required to successfully perform these duties is normally acquired through completion of a bachelor’s degree in Life Sciences or a related field and / or a minimum of 4-6+ years related work experience.
30+ days ago