Director of Manufacturing

Essential Job Function:

To ensure that each and every product manufactured by Pharmaceutical Services meets customer expectations and FDA regulations by following and enforcing current good manufacturing practices(cGMP). Continuously monitor and improve production output, procedures, methods and techniques to consistently and reproducibly assure all quality standards are achieved. Develop, establish and implement metrics to routinely monitor and measure Pharmaceutical Services’ performance while maintaining the highest level of customer care, support and product quality.

Responsible for Manufacturing Operations, Development Operations, and Manufacturing Compliance.

Qualifications:

• Minimum 10 years’ experience in the pharmaceutical industry, including direct experience in the industry’s service provider sector.
• Fiscal acumen required. Must be a confident, self-motivated and consummate professional with a proven industry track record.
• BS or BE degree in Pharmaceutical Sciences, Chemical Engineering, Mechanical Engineering or Chemistry preferred or relevant combination of experience.
• Must have excellent decision making, reasoning skills and common sense.
• Must have excellent written and oral communication skills. Must be organized, thorough and self-motivated.

SCOPE OF WORK:

Accomplish Manufacturing Operations and Human Resources strategies by determining personal accountabilities; communicating and enforcing values, ethics, policies, and procedures; implementing recruitment, selection, orientation, training, coaching, counseling, disciplinary, and communication programs; planning, monitoring, appraising, and reviewing job contributions; planning and reviewing compensation strategies and overall Pharmaceutical Services operations and compliance.

Produce products that meet customer expectations by adhering to and enforcing current good manufacturing practices; developing and improving production, procedures, methods, and techniques; enhancing the application of staff; designing optimal manufacturing campaigns, production planning through schedule adherence and control systems and procedures; developing and enforcing inspection and quality assurance standards, procedures and methods.

Meets capacity requirements by identifying need for additional capacity and/or equipment by identifying and evaluating options; contracting with other manufacturers; recommending expansion of current facilities or addition of new facilities.

Develop, set, communicate and track metrics (KPIs) to measure the department’s performance while maintaining a high level of quality compliance and customer support. Monitoring achievements and reporting results to continuously bolster the improvements

Accomplish manufacturing operations’ goals and organization mission by completing established goals as requested.

Routinely cooperate and communicate with the Processing Technology Pharma, Pharmaceutical Development, Business Development and other Glatt Group companies as needed to support business growth across the Glatt Group

Accountable for weekly/daily manufacturing schedule adherence. Ensure adherence or note misses as applicable.

Continuously improve job knowledge by participating in educational opportunities, where applicable, reading technical and professional publications, maintaining personal networks and participating in professional organizations.

Operations

Directly responsible for all Contract Manufacturing and commercial product operations and equipment. Responsible for all Pharmaceutical Process Equipment inventory including R/D’s equipment

Oversees Development Operations’ activities including scale-up activities and validation.

Interacts with Regulatory and Quality Assurance/Quality Control groups of clients, as well as governing agencies such as, but not limited to, the FDA, DEA, NJDEP, OSHA and the NJ Board of Health, when and if deemed necessary.

Serves on Action Committees to review and continuously improve the operations. These include, but are not limited to, the Safety Committee, Technical Steering Committee and New Product Review Committee.

Review and approval of all Change Requests, SOPs, MBRs, Protocols, Reports and Deviations that pertain to processing and/or equipment.

Serve as clients’ main point of contact for Commercial Manufacturing and establish relationships with Clients. Routinely meet with clients to discuss client demand, performance and on-going improvements.

Oversee Batch Record Review and monitor order fulfillment. Strive for on-time in full.

Personnel

Continuously motivates the staff to perform on a daily basis.

Hires new employees into the department when applicable

Handles disciplinary issues within the department and along with HR.

Formally evaluates direct reports bi-annually. Reviews performance evaluations of indirect reports. Tracks personal progress against goals.

Accountable for training and qualification of Manufacturing and Development Operations personnel along with Glatt designated trainers for pharmaceutical processing.