Endo International Senior Director, Technical Operations - Internal/External in Chestnut Ridge, New York

Job Description

Job Title

Senior Director, Technical Operations – Internal/External

Company

Par Pharmaceutical

Function

Scale-up/Process Validation

Location(s)

Chestnut Ridge, NY

Department

Process Development

Direct Reports (list)

Reports to (title)

Vice President, Technical Operations

Date Submitted

7/17/2017

To be completed by Corporate Compensation:

Job Summary - a concise overview of the job

This position has responsibility for directing activities for new product introduction and marketed product support across the Endo/Par Network, including contract manufacturers. Responsibilities include ensuring successful transfer of new products from R&D into commercial manufacturing as well process optimization activities for marketed products. The incumbent will foster effective cross-functional working relationships with internal and external groups. Experience with formulation and process development of oral solid-dosage, liquid, creams, ointments and other dosage forms is required. The incumbent will apply innovative manufacturing technology and quality-by-design principles and execute on key strategic operations projects to achieve business objectives. The incumbent will provide support to contract manufacturers as well as sites within the Endo/Par network for scale-up, process validation, and continuous process monitoring for marketed products. The incumbent will support on the floor manufacturing activities, deviation, change control and CAPA, as well as support regulatory submissions. This position requires working closely with Business Development, Research & Development, Manufacturing, Engineering, Regulatory Affairs and Quality Assurance teams. The incumbent is expected to make efficient and effective use of resources and be an effective collaborator with internal/external customers, contract manufacturers and supporting departments. This role will require a minimum of 50% travel both domestic and international.

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

  • This position reports to the Vice President, Technical Operations and may supervise technical staff members.

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Leadership

  • Provides direction to technical teams

  • Acts as liaison between R&D and Commercial Operations to ensure new products are launched on time and ensuring adherence to corporate objectives and goals

  • Provides technical guidance to troubleshoot manufacturing processes

  • Collaborates with formulation scientists and scale-up teams to ensure optimal process development and application of QbD principles

  • Harmonize business processes across the technical organization implementing best practices accordingly

  • Identify and execute on manufacturing improvement/COGs reduction projects

  • Responsible to ensure that plant objectives are aligned with both Quality, Supply Chain, and the Generics Business Unit objectives

  • Remain current with regulatory requirements that impact study design, execution, analysis , etc.

  • Stays current with emerging technology within industry

30%

Issue Resolution

  • Communicate with senior management and site leaders to identify and resolve any technical issues.

20%

Financial

  • Accountable for managing site specific financial plan for technical operations department.

10%

Safety and Compliance

  • Ensures adherence to cGMP’s, standard operating procedures, safety practices and manufacturing protocols. Ensures the safety of all Manufacturing Operations employees through compliance with all company policies, procedures, safety rules, and regulations

  • Accountable for ensuring that standard operating procedures are established and executed in accordance with all regulatory requirements and best practices

10%

Continuous Improvement

  • Accountable for leading Continuous Improvement initiatives, utilizing expert resources to reduce overall cost of goods, manufacturing cycle times, and all forms of waste. Applies Process Excellence methodologies (6 S, Lean Manufacturing, and Six Sigma) to improvement initiatives

10%

Regulatory Compliance

  • Provides guidance in regulatory and internal audits and inspections. Ensures team members respond to audit observations and make timely and appropriate corrective actions

10%

Talent Management

  • Responsible for ensuring that training and development programs for staff members are in place to meet future objectives of the business. Participates in Talent Management, succession planning, and talent acquisition.

10%

Total

100%

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

  • Minimum of a Bachelor's degree in Business, Engineering, Life Sciences or related field from accredited university (Master’s Degree Preferred)

  • Minimum of 15 years of manufacturing process development experience in regulated environment, with no less than 5 years in successfully managing teams.

Knowledge

Proficiency in a body of information required for the job

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

  • Must possess knowledge of cGMPs and SOPs applicable to position. 21CFR Part 210 and 211 and Part 11

  • Strong knowledge, understanding and demonstrated experience in Supply Chain Operations, including inventory management, planning, scheduling and all associated measures and metrics

  • Knowledge and understanding of pharmaceutical manufacturing, compounding, production processes, and packaging operations, equipment and facilities

  • Knowledge of Standard Work Principles and demonstrate the ability to implement standard work in a visual factory environment

  • Knowledge of statistical and mathematical principles

  • Knowledge and demonstrated application of Process Excellence tools(6S, Visual Factory, Lean Manufacturing and Six Sigma) and methodologies

  • Basic knowledge of computer programs. Background knowledge in pharmaceutical science or engineering is advantageous.

Skills

&

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.

  • Must possess good interpersonal skills,

  • Demonstrate strong collaboration capability

  • Effective verbal and written communication skills

  • Must demonstrate the ability to multi task by performing multiple projects and tasks simultaneously

Physical Requirements

Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

  • GMP/Manufacturing Environment

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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Customer Focus – Results Driven – Leadership – Teamwork – Innovation and Continuous Improvement

Endo Job Description Template - Revised July 2014