Director, Vaccine Process Development

Job Description

At our Company, we are inspired by a shared mission and vision to save and improve lives worldwide. We are committed to being the premier, research-intensive biopharmaceutical company and are dedicated to providing leading innovations and solutions for today and the future. For over a century, our Company has been engaged in the development, manufacture, and distribution of vaccines. We continue that legacy in conducting cutting edge research programs that develop new vaccines to meet an unmet medical need.

Our team in West Point, Pennsylvania, is seeking a highly motivated candidate for the position of Director within the Vaccine Process Development organization. The ideal candidate should be passionate about leading scientists in developing and delivering robust manufacturing processes for our Company's pipeline and have a proven track record of developing talent and high performing teams from a diverse scientific background.

The Director will partner with cross-functional and cross-divisional teams to enable rapid and disciplined pipeline decisions, support tech transfer and commercialization of new products, and assist in trouble shooting and implementation strategies. The post holder will work in close partnership with other stakeholders across the DSCS, specifically Vaccine Analytical Research and Development, through which close co-ordination of resource planning will occur to support pipeline products. Vaccine pipeline candidates span various modalities, the ideal candidate will have experience in designing, developing, and troubleshooting both upstream and downstream vaccine drug substance manufacturing processes, and understand the analytical tools used to measure and monitor process performance. In this role, the candidate will oversee an organization of 20-25 upstream and downstream scientists tasked with supporting both pipeline programs and platform development initiatives. The successful candidate will be a member of the Vaccine Process Development leadership team and will contribute to the development and implementation of the organization’s strategy, including advancing innovation for the current and future pipeline, enhancing internal and external collaborations, and fostering high performing teams.

Specific responsibilities include:

• Recruit, select, mentor, develop talent across all levels of the organization

• Interface with Discovery, Regulatory, and Clinical colleagues to help manage early stage programs

• Partner with the Manufacturing division on planning and implementing innovative and transformative manufacturing process strategies

• Process development for programs and support of tech transfer and scale up at both internal manufacturing sites and external Contract Manufacturing Organizations (CMOs)

• Cross functional collaboration to prepare INDs and other submissions to health agencies

• Partner with VPR&D extended leadership team to develop a vaccine technology strategy; direct the organization to action the strategy

• Ability to lead organizational change

Education Requirement:

• BS in biochemical engineering, molecular biology, cell biology, virology, or related field with at least 15 years of experience or MS with a minimum of 8 years’ experience or PhD with 5 years of relevant biopharmaceutical experience

Required Experience and Skills:

• Proven track record of recruiting, maintaining, mentoring, and developing scientists across all levels of the organization

• Experience in developing and characterizing upstream and downstream processes for vaccine or biological processes and tech transfer to commercialization

• Demonstrated working knowledge of FDA, ICH, and other regulatory requirements; experience with regulatory submissions for international agencies is desired

• Proven track record of partnering and collaborating across various biopharmaceutical development/CMC boundaries (Quality, Regulatory, Operations, Non-Clinical, Clinical, etc.)

• Proven leadership ability to align, motivate, and empower team members

• Demonstrated ability for critical thinking and innovation with effective communication, partnership and negotiation

• Ability to understand and communicate risks as well as developing and executing contingency plans for development programs

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

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.

Invent. Impact. Inspire.

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.

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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Relocation:

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Requisition ID:R117855