3rd shift Production Manager-Aseptic Job at Pharmaceutics International Inc in H

Job Overview:

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 daily management to Aseptic Manufacturing Associates of various levels. Responsibilities include interviewing, managing, motivating, coaching, and mentoring.
• Ensure oversight of daily Aseptic Manufacturing operations across assigned shift and support management of other shifts, as requested.,
• Serve as a working manager on weekends, as needed.
• Oversee and ensure the completion of internal batch record review.
• Participate in and/or contribute to internal and external client meetings, as requested.
• Assist with the authoring and implementation of manufacturing procedures and batch records.
• Manage daily routine manufacturing activities, including day to day scheduling and raw materials.
• Management of materials/consumables to ensure daily scheduled adherence occur to achieve OTIF.
• Accurately document data and complete batch records as needed.
• Train and Lead operators in various manufacturing tasks, including, but not limited to: Component Preparation, Formulation Operations, Lyophilization Processes, Product Accountability, and Sterile Filling.
• Partner with the Production Supervisor to ensure personnel are trained on all applicable procedures and master batch records prior to execution.
• Follow all current and revised cGMP procedures, and master batch records.
• Manage the daily scheduling and performance of routine maintenance and calibration of production equipment.
• Provide support to Senior management in client communications by effective problem solving, schedule development, and project status updates.
• Provide support to Senior management with client and regulatory audits.
• Perform other duties as assigned.

Qualifications:

• Bachelor’s degree in Life Sciences or a related field and/or a minimum of 4-6+ years related work experience, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
• 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.
• Successfully complete and maintain aseptic gowning and media fill qualification program.
• 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.
• Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.
• Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
• Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
• Must be able to comprehend and follow all applicable SOPs.
• Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
• Demonstrate solid understanding on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
• Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
• Demonstrate the ability to portray the appropriate level of integrity and professionalism.
• Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
• Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
• Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
• Energetic, execution-focused, self-motivated, and 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.
• Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
• Demonstrate the ability to work well in a cross-functional team environment.
• Must communicate fluently in English and have legible handwriting.

Physical Demands:

• Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
• Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
• Ability to lift up to 40 pounds on occasion.
• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).