2299z SENIOR MANAGER PRODUCTION OPERATIONS

COMPANY OVERVIEW:

Our client is a global full service CDMO focusing on drug substance and drug product development and manufacturing (clinical and commercial).

This position is based out of their East Windsor, NJ site. This site is a well established facility with state of the art solid dose manufacturing capabilities with room to expand as the company grows.

JOB RESPONSIBILITIES:

• Responsible for all aspects of a commercial operation for the manufacture and packaging of pharmaceutical products according to Food and Drug Administration (FDA) guidelines and Good Manufacturing Practices (cGMP) for generic and branded products which includes planning, scheduling, and executing the commercial requirements.
• Manage raw material and component purchasing for production become expert in ERP system
• Responsible for directing the staff in the maintenance of production equipment and facility
• Prepare operation schedules and ensures production staffing is adequate to support the production schedule.
• Create and maintain all master documentation, SOP, MBR PM Calibrations etc
• Is responsible for managing and coordinating all activities and ensuring complete and accurate documentation.
• Is responsible for all safety incidents and quality deviations that occur during manufacturing and responsible for the thorough investigation and timely reporting of such.
• Troubleshoot production problems, document findings, and implement solutions while providing all information to Management for risk assessment
• Support product development group in activities required to support the introduction of new products.
• Writes, revises and trains on Standard Operating Procedures within the department.
• Collaborate with cross-functional leaders to support continuous improvement initiatives to drive operational excellence and maximize efficiency
• Organize and improve material storage and flow to eliminate losses and improve efficiencies
• Clearly communicates with subordinates and superiors any directions, issues, etc.
• Hires, trains, evaluate and disciplines personnel. Maintain training programs in compliance.
• Lead, coach and motivate manufacturing / packaging team
• Primary responsibility for all Serialization activities
• Complete other duties and tasks 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.

BENEFITS:

• Competive salary and annual incentivized target bonus
• Medical, dental, vision, life insurance, short and long term disability.
• 401k