Head of Pharmaceutical Sterile Filling Operations

Job Description

Korn Ferry has partnered with our client on their search for the role, Head of Pharmaceutical Sterile Filling Operations.

The Company

Endo Inc. [$2B; 3K FTEs], is a global specialty pharmaceutical company that develops and sells various pharmaceutical products worldwide. The company is recognized for its diverse portfolio comprised of Branded Pharmaceuticals, Generic Pharmaceuticals, and Sterile Injectables encompassing therapeutics for Pain Management, Urology, Endocrinology, CNS, Immunosuppression, Oncology, Cardiovascular, and Women's Health.

The Branded and Generic Pharmaceuticals segment provides products with dosage forms to include solid oral extended-release, solid oral immediate release, liquids, semi-solids, patches, powders, gels, ophthalmics, and sprays amongst others. The Sterile Injectable segment offers ADRENALIN for emergency treatment of certain allergic reactions including anaphylaxis and VASOSTRICT which increases blood pressure in adults with vasodilatory shock.

The International Pharmaceuticals segment sells a range of specialty pharmaceutical products primarily to customers in Canada. Its principal products serve various therapeutic areas, including attention deficit hyperactivity disorder, pain, women’s health, oncology, transplantation, and over-the-counter products.

Endo places a strong emphasis on research and development (R&D) as a cornerstone of its operations. With state-of-the-art facilities and a team of skilled scientists, the company invests heavily in advancing therapies that address critical gaps in healthcare. Its R&D pipeline focuses on enhancing drug formulations, developing novel delivery methods, and exploring new therapeutic areas.

Endo is now looking ahead to capitalize on its strategic growth initiatives by expanding its global presence and continuing to address the evolving needs of patients. The company’s strategic focus includes strengthening its core therapeutic areas, exploring emerging markets, and leveraging advancements in biotechnology. By combining its expertise with a patient-centric approach, Endo strives to enhance lives worldwide to solidify its position as a trusted leader in the pharmaceutical industry.

The company has global headquarters in Dublin, Ireland and its U.S. corporate office in Malvern, Pennsylvania.

Position Overview

The Director, Head of Filling Operations will oversee the establishment, implementation, maintenance, and execution of cleaning, sanitization, and / or sterilization of production equipment and facilities at the Rochester, MI site. These responsibilities include but are not limited to raw material sampling, dispensing, product formulation, and aseptic / sterile primary packaging of liquid, suspension, or lyophilized products in plastic bottles, vials or syringes with oversight for inspection, secondary labelling, and packaging of the finished product.

The Director, Head of Filling Operations must bring proven team management and leadership development experiences at similar scope / scale to the position being able to demonstrate clear communication and collaboration skillsets. This individual will work extensively with direct staff members and cross-functional teams to accomplish overall organizational objectives that includes sustaining the site’s positive performance record associated with Quality Management System (QMS), cGMP and EHS compliance.

The Director, Head of Filling Operations will have significant budgetary management responsibilities and lead a direct team of 6-8 FTEs with 15 indirect FTEs. In addition, this individual will have broader managerial oversight for more than 150 hourly employees. In partnering with and reporting directly to the General Manager of Site Operations, this executive must coordinate work between teams and functions to ensure alignment with the Rochester site’s overall Vision, Mission and Execution Strategy.

Key Responsibilities

Operations and Compliance :

• Oversees execution of commercial production to meet patient, quality, business, and financial objectives as well as supporting developmental and technical transfer production activities across three shifts.
• Directs production in Sanitation, Preparation Services, Drug & Chemical Dispensing, Bulk Manufacturing, Sterile Filling, Inspection & Packaging.
• Establishes and drives expectations for production schedules & reducing non-value-added waste while meeting weekly delivery schedule and financial objectives
• Provides management reporting through development and use of department metrics aligned with Site Objectives and Scorecards.
• Sets priorities to meet internal cycle times and delivery schedules. Maintains proper staffing and training levels to meet requirements.
• Participates and develops long-term strategies and risk management programs that increase the compliance, efficiency and effectiveness of operations. Assures adequate maintenance of department machinery and supplies.
• Develops and maintains a safe manufacturing environment in accordance with plant and corporate policies in addition to local, state, and federal EHS regulations. Participates in safety meetings, investigates accidents, ensures proper PPE and industrial hygiene controls, and takes appropriate corrective actions to eliminate hazardous conditions.
• Promotes a quality and compliance focused culture which embraces RFT (right first time) and CI (continuous improvement) methodologies.
• Performs site performance assessments and risk assessments based on business development and new product / process / technical transfer activities associated with employee operations, GMP Compliance, and safety.
• Directs change controls related to processes, equipment, documentation and safety practices in accordance with Quality System requirements.
• Manage audits and inspections by regulators, corporate office and contract customers by escorting and facilitating information sharing, document review and response commitments. Assures cGMP compliance with regulatory agencies (FDA, EMA, etc.)
• Lead initiatives for root cause analysis to implement effective corrective actions, reducing the potential for deviations related to human error.

Budgetary Management & Delivery Performance :

Team Supervisory & Development :

Team & Cultural Leadership :

The Candidate

Experience and Professional Qualifications