Director, Technical Product Steward | Antibody Drug Conjugate

Job Description

Job Description

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, in accordance with applicable law.

GBSO Global Technical Operations is seeking a highly motivated individual for the role of Director, Technical Product Steward | Antibody Drug Conjugates. This role will provide end-to-end support of manufacturing science and technology for key pipeline biologics in the antibody drug conjugates (ADCs) portfolio.

The ADC Technical Product Steward will provide strategic technical direction and leadership through cross-functional partnerships with key business units and customers (e.g., Process Development, External Manufacturing Operations & Technology, Quality, Regulatory-CMC). The incumbent will join the commercialization team and support the tech transfer, licensure, and launch of the product(s). Specific focus will be placed on building the foundation for long-term robust manufacturing to achieve the goals for safety, compliance, supply, and productivity. The end-to-end scope includes Drug Substance, Drug Product, and Analytics; collaborations will include USA and International colleagues. This role is critical to the company’s ability to support new and in-line transfers with a key focus on antibody drug conjugates product portfolio.

Responsibilities

• Collaborate with research, process development, and internal/external manufacturing sites to support New Product Introduction, enabling on-time, right-first-time ADC technology transfers
• Represent GBSO GTO on the Development Commercialization teams (DCTs) and appropriate working groups
• Prepare for the post-launch transition from DCT to Value Chain Management Team (VCMT), specifically through planning to assume the leadership of the cross-functional Technical Product Council (TPC) which will manage all technical aspects of product lifecycle management (issue resolution, process & analytical risks and continuous improvement)
• Responsible for deep understanding of technical aspects of all process unit operations | Support Knowledge Management and Product/Process Data Management efforts
• Lead above-site technical projects through all phases | Project Planning | Project Management Implementation
• Provide support for site technical operations teams: technical reports, data analysis, process monitoring, site comparisons and technical risk assessments
• Build and maintain strong and trusting relationships with site leaders, functional management, and other stakeholders to ensure effective communication of plans and issues
• Influence, motivate, and energize individuals at all levels in the organization

Education Requirements

• B.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with 15 years of relevant experience OR Master's degree with 10 years of relevant experience OR Ph.D. with 5 years of relevant experience

Experience and Skills

Required

• Strategic, principled and strong Facilitative Leadership skills and ability to be agile and adaptive to support growing ADC portfolio
• Demonstrated problem solving, effective verbal and written communication, and people management skills
• External Manufacturing
• Principled and strong scientific understanding of small molecule API and biologic products and processes and their effective integration with relevant regulatory/GMP requirements
• Ability to collaborate effectively, across functional boundaries, to align stakeholders and sponsors on technical strategies
• Proficiency with pharmaceutical industry technical business processes | Change Control Deviation Management | Technical Protocols/Reports | BLA/MAA Regulatory License Documents

Preferred

• Site Technical Operations department, supporting commercial API and biologics production and drug conjugates
• ADC experience/expertise with DS and DP

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.

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 ...

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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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.

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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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Requisition ID:R137876