Executive Director, Chemical Technical Operations

Merck & Co., Inc. West Point , PA 19486

Posted 3 weeks ago

Job Description:

"If this position will be based in the US or Puerto Rico (not applicable to positions based outside of US or Puerto Rico): Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law."

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

The Executive Director (ED), Chemical Technical Operations (CTO), leads global teams of engineers and scientists, and reports to Vice President, Global Pharmaceutical Operations Science & Technology. The regional teams oversee more than 50 contract manufacturers across the Americas, Europe, and Asia. CTO supports the manufacturing of Active Pharmaceutical Ingredients (API) during the commercialization of new products at external contract manufacturing (CMO) facilities globally, as well as provide technical support to our Company's internal API manufacturing sites. This role holds technical oversight for external API manufacturing and has significant impact on the success of the manufacturing division.

Responsibilities include:

  • Be a member of the Science and Technology (S&T) leadership team

  • Be a key member of the External Manufacturing API Platform leadership team

  • Partner with colleagues across External Manufacturing API Operations and External Quality Assurance, Business Development, Supply Chain Management, Global Procurement and other groups within the S&T organization to support the development and execution of our supply chain design and long-term strategy for life cycle management of the API supply chain, including intermediates in the areas of COGs (Cost of Goods) reduction, risk management, and sourcing postures

  • Lead the technical efforts required for enhancing competitiveness through process optimization of the COGs structure

  • Through a dotted line management relationship with the Director, API Supply Analytical Sciences, ensure that the combined organizational capabilities are aligned

  • Ensure technical excellence in routine supply support to contract manufacturers and internal sites

  • Implement proactive programs and controls that enable robust manufacturing operations

  • Implement data analytics to enable early detection of process issues

  • Promote ongoing use of risk assessments and mitigation tools and the use of pre-campaign checklists and walkdowns

  • Implement after action reviews and share best practices

  • Ensure technical skill and capability building of both internal and external staff

  • Create a robust technical network of internal and external resources, rapidly deployable to solve complex problems in a cross functional manner

  • Provide advanced technical tools, a strong knowledge management infrastructure, and extensive use of communities of practice

  • Works closely with Research & Development and Commercialization partners to ensure readiness for new products and technologies

  • Key activities in support of supply include:

  • Resolution of deviations, Management of process / analytical changes, Process optimization

  • Regulatory compliance support including inspections and CAPA remediation activities

  • Establish and maintain close liaison with industry peers to keep apprised of the latest developments in science, technology, and business globally; communicate these continuously within the department

  • In support of new product commercialization, partner with Operations and Quality Assurance to establish compliant and robust manufacturing capabilities for the launched supply chain

  • Steer oversight of process scale-up and optimization, technical aspects of pre-approval inspection readiness, development of validation protocols, and execution of process validation (Process Performance Qualification) at external suppliers in the launched supply chain

In this role you must be able to lead several technical teams in the areas of development, commercialization/technical transfers/site operations and supply of API product in cGMP environment. The ED must ensure strong technical capability is developed for new products as part of acquisition and commercialization, and an appropriate control strategy is implemented. The ED will partner with colleagues within and outside of Global Pharmaceutical Operations S&T to rapidly and expertly resolve highly complex technical issues that could impact the continuity of supply and launch supply. The ED will lead teams to support the achievement of reliable supply and compliance of all applicable government and company quality, safety, and trade compliance requirements.

Education Minimum Requirement:

  • BS/ MS / Ph.D. in in chemical/biochemical engineering, pharmaceutical science or chemistry or related fields

Preferred:

  • Greater than 15 years of experience in process development or manufacturing or operations

  • Management experience in site-based manufacturing operations, managerial roles, experience at multiple sites and functions.

  • Deep expertise in process development and manufacturing operations with a holistic view of end to end supply chain

  • Multi-site, managerial experience in manufacturing operations

  • Strong analytical and problem-solving skills

  • Working knowledge of GMP (Good Manufacturing Practice) operations

  • Strengths in effective and efficient decision-making

  • Ability to navigate through change with ease

  • Proven skills in budget and large group management with a strong focus on operational excellence

  • A global mindset with the ability to partner across functions and geographies

  • Strong stakeholder management skills; build bridges across technical, quality, and operations within the internal and external network

  • Build a high-performing, integrated technology operations function

Who we are

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Remote Work

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

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Executive Director, Chemical Technical Operations

Merck & Co., Inc.