Vice President, Operations

Location
Northern Chicago, IL, United States
Posted
Apr 16, 2018
Ref
1080XX
Required Education
Bachelors Degree
Position Type
Full time
Act as global leader for overall Manufacturing and Technical Operations, managing a diverse team to plan and implement drug manufacturing (including vendor management and coordination across multiple third party contract manufacturers), engineering design and qualification, and technical operations strategies and tactics to meet clinical and commercial manufacturing needs for the organization. Builds and develops the Manufacturing Operations organization for the Company, ensuring that an efficient, on-time and on-budget, quality driven organization is in place to meet regulatory agency requirements and operational needs. Creates an internal environment of commitment to the program objectives, establishing a sense of urgency to meet timelines and program milestones.

Primary executive responsible for defining and managing the company's global operations strategy and directs the efforts of the following functions to achieve the objective of preparing the Company's lead product for NDA approval and commercial launch: scale-up and qualification of third party contract manufacturers; design, qualify and implement manufacturing automation; commercial manufacturing management and supply chain coordination through multiple third party suppliers; strategic planning for back-up suppliers and internal competency development, materials management and distribution/logistics. The scope is end to end, from preparing all qualification testing and processes for NDA submission on the front end, to receiving a booked order through customer delivery once commercial.

Responsible for planning and implementing activities of the purchasing, shipping, receiving and material handling groups as they relate to the timely, cost-effective procurement, inventory control, planning, and quality control of production materials. Develops, implements, and maintains policies, procedures, and material control systems to reduce cost, streamline procedures and implement solutions. Ensures that materials in the supply chain (both clinical and commercial) are available, as scheduled and inventory is maintained at minimum acceptable levels. Defines budgets, effectively resource programs/projects and deliver on defined objectives against approved budgets and timelines.

Responsible for company Project Management Office (PMO) with activities which include establishing and maintaining project management best practices; cross-functional project management for a range of programs (including life cycle management, product development program initiatives), acquisition integration teams and representation of the company in key strategic alliances.

Also responsible for companywide procurement covering all departments.

ESSENTIAL JOB FUNCTIONS
  • Responsible for development and execution of Manufacturing Operation strategies and annual plan and works collaboratively across a broad range of people, functions and disciplines to achieve strategic goals.
  • Responsible for the company's project management office and key strategic alliance relationship management.
  • Finalizes and qualifies all CMC and scale-up activities to establish a robust clinical and commercial manufacturing process, preparing for FDA audit and eventual commercial manufacturing to meet customer demand for our products.
  • Interacts with the Company's partners, third party contract manufacturers, suppliers and with regulatory agencies as appropriate including the need to interface with CMO's and the DEA as it relates to quota needs.
  • Provides leadership with regulatory compliance inspections. Ensures consistency and regulatory compliance of third party contract manufacturers with company policies and procedures.
  • Ensures all Manufacturing Operations follow all policies, procedures and documentation to ensure reproducible product quality and GXP compliance.
  • Works collaboratively across a broad range of locations of external vendors, functions and teams, developing and maintaining good working relationships to meet Company objectives.
  • Responsible for the efforts of the above functions to achieve the worldwide production plan at target cost, quality, and reliability levels.
  • Implements and manages appropriate policies, programs, and practices to meet department and product supply objectives.
  • Directs and coordinates the efforts of End-to-End Supply Chain Process to achieve the worldwide production plan at required cost, quality, and reliability levels.
  • Controls major policies, programs, and practices in the implementation of strategies to drive Operations towards world-class manufacturing.
  • Directs manufacturing resources to meet profit goals by orchestrating continuous improvement in manufacturing efficiencies as measured by the reduction in the cost of goods sold. Establishes and guides programs to maintain inventory goals consistent with manufacturing, marketing and distribution plans.
  • Collaborates with other members of the executive team to establish, implement, streamline, and revise strategic and operating objectives as necessary and appropriate.
  • Coordinates new product introductions with appropriate departments and ensure that the manufacturing and the materials functions support product roll out schedules.
  • Provides operational and strategic input in the management of the product development process (PDP).
  • Directs and controls the activities of the Purchasing, Shipping, Receiving and Material Management Departments through several department managers and leads. Has overall responsibility for planning, budgeting, implementing and maintaining cost, methods, and employees.
  • Responsible for sourcing and supplying raw materials, utilities, outside services, and coordinating global procurement efforts, overall supply chain management.
  • Works with customers in auditing customer inventory levels and with internal and external vendors to comply with inventory policies.
  • Leads third party manufacturing vendor and supplier negotiations by developing the Company's negotiation position, conducting contract negotiations and executing on completed contracts.
  • Supports procurement actions by evaluating complex proposals from suppliers; participating in source selection surveys and source selection; preparing reports on supplier financial capability and adequacy of accounting; estimating systems; and assisting suppliers in developing cost collection and financial accounting systems, as required.
  • Ability to travel nationally and internationally, with extensive interaction with external contract manufacturers.


ADDITIONAL RESPONSIBILITIES/DUTIES
  • Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people.
  • Ensures budgets and schedules meet corporate requirements.
  • Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major customers.
  • Serves as an external spokesperson for the organization.


Requirements

EDUCATION AND EXPERIENCE

Education:
  • BS/BA degree in related discipline and fourteen years of related experience; or,
  • MS/MA degree in related discipline and twelve years of related experience; or,
  • PhD in related discipline and nine years of related experience, or;
  • Equivalent combination of education and experience.
  • May require certification in assigned area.


Experience:
  • Typically requires a minimum of eighteen years of related experience and/or combination of experience and education/training.
  • BS in Engineering, Operations Management, Supply Chain, Business is required. MBA is preferred.
  • Minimum fifteen years of increasingly complex professional experience in commercial manufacturing scale-up, implementation and management.
  • Experience in Pharmaceutical industry preferred.


SKILLS AND ABILITIES
  • Requires in-depth and contemporary knowledge of, and experience in, technically sophisticated and organizationally complex device and drug manufacturing environments, including global supply chain management with external contract manufacturers.
  • Demonstrates working knowledge of the following but not limited to SAP, GMP, ISO9000, MRP, JIT/TQC, DFT, DFM, AGILE, Six Sigma and other manufacturing methods.
  • Possess the ability to analyze complex situations and make timely policy decisions.
  • Demonstrates mature interpersonal and communication skills and otherwise have relative and comprehensive management experience, including demonstrated vendor negotiations and management skills.
  • Should have accounting, industrial engineering, planning and manufacturing shop experience.
  • Possesses well-developed interpersonal skills to participate extensively in meetings and exchanges with management and technical personnel and with customers or subcontractors/suppliers.
  • Able to direct and review the work of direct reports, plan activities within guidelines provided by more advanced levels of management, and conduct management briefings and reviews.
  • Proven track record of excellent negotiating and decision-making skills involving high dollar contracts.
  • Possesses working knowledge of manufacturing and warehouse business systems including MRP, master scheduling, production control, purchasing, inventory control, manufacturing, store rooms, shipping, receiving, traffic, material handling and service.
  • Demonstrates ability to manage the big picture while also focusing, both directly and through managing others, on the small details and tactics. Demonstrates preference to effectively and successfully manage many separate yet interrelated activities simultaneously.
  • Strong proven leadership skills with demonstrated ability to lead and set vision while operating in a cross functional and matrixed team environment.
  • Projects timeline and budget management focus.
  • Proven track record to work independently, while achieving aggressive individual objectives. Highly motivated, "can do" and hands-on attitude with strong influence management skills.
  • Ability to effectively communicate (written and verbal) at all levels within an organization and across diverse groups.
  • Proven track record of good judgment. Demonstrated integrity and respect of peers.
  • Demonstrates knowledge of business planning assessment and financial planning analysis tools including return on investment, net present value cash flow, etc.
  • Identifies issues and addresses proactively.
  • Consistently works with abstract ideas or situations across functional areas of the business. Through the assessment of intangible variables, identifies and evaluates fundamental issues, providing strategy and direction for major functional areas.
  • Has an in-depth knowledge of the functional area, business strategies and the company's goals.
  • Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.


DEPOMED COMPETENCIES INCLUDE
  • Integrity
  • Decisions & Judgment : Ownership & Initiative
  • Adaptability & Change Readiness
  • Teamwork & Collaboration


PHYSICAL/MENTAL DEMANDS
  • Sitting - 80%
  • Standing/ walking - 20%
  • Travel 25%, domestic and international
  • Must be able to enter clean room environments and manufacturing areas, and to follow gowning procedures
  • Repetitive motion: Substantial movements of the wrists, hands, and or fingers for sustained periods of time. Approximately 6-hours of keyboarding per day.
  • Visual Requirements: Able to see and read PC screens and read fine print.
  • Comprehension: Ability to understand opposing points of view on highly complex issues and to negotiate and integrate different viewpoints.
  • Decision Making: Ability to make decisions which have impact on the department's credibility, operations, and services.
  • Communication: Ability to formulate complex and comprehensive materials such as legal documents, authoritative reports, official publications of major scope and impact, etc. and to make formal presentations.
  • Mathematics: Ability to compute, analyze, and interpret numerical data for reporting purposes.


About Us

THE COMPANY

Depomed is a leading specialty pharmaceutical company committed to putting the Patient First in everything we do; with a focus on enhancing the lives of patients, families, physicians, providers and in payors through commercialization of products in the areas of pain and neurology, and developing drugs in areas of unmet medical needs.

Depomed currently markets three medicines focused on neuropathic pain and migraine through its Neurology and Pain Business and has an emerging Specialty Business focused on orphan drug indications and areas of unmet medical need.

Depomed has a clear THREE PILLAR strategy for growth:

MAINTAIN a strong/profitable NUCYNTA franchise through a commercialization agreement with Collegium, GROW the Neurology and Pain Business and BUILD a new Specialty Business through a recent Cosyntropin transaction. The company's strategy is to continue to identify, license and develop new products-that offer enhanced therapeutic options to patient populations that may be underserved by existing therapies.

As part of the transformation strategy, Depomed will be relocating its headquarters to northern Chicago, Illinois. Additional information about location will be shared during the interview process.

Depomed is an AA/EEO/Veterans/Disabled employer