"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.
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:
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 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.
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Merck & Co., Inc.