Director: Vaccine Drug Product Development (mRNA & Delivery Technologies)

Job Description

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century. Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Our company is on a quest for cures and is committed to be the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Our company's Research Laboratories is a true scientific research facility of tomorrow and will take our company's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

Our company is seeking a highly motivated candidate for the position of Director, mRNA and Delivery within Vaccine Drug Product Development (VDPD). The successful candidate will be expected to work as part of a team that is focused on the development of various innovative technology platforms and mRNA drug products. The main responsibilities include the design and execution of experiments to support process development and Front-End Loading (FEL) activities for improvements associated with Innovative Drying technology platform, Drug Delivery platforms and other capital projects that require complex problem analysis and solutions. The successful candidate will be responsible for strategic planning, coordinating, and execution of VDPD initiatives in our company's portfolio from discovery to launch. The successful candidate will have to collaborate with key stakeholders across the organizations (Research Division/Manufacturing Division) to champion novel technologies and ensure the DP images are in alignment with business needs.

The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. The incumbent will drive disruptive innovation technologies while developing new ways of working to meet aggressive timeline requirements and integrate within the portfolio, where appropriate. The incumbent will also have to demonstrate and collaborate effectively multiple partnerships with other stakeholders across both our Research Division and our Manufacturing Division in particular Discovery (ID/VAX), Analytical Research and Development (AR&D), Vaccine Process Research and Development (VPR&D), and Sterile Drug Product Commercialization (SDPC/ Manufacturing Division) in the identification of new vaccine programs/adjuvants and the development of robust and scalable processes for commercial products. The applicant will also have a developed external network both across industry and academia and have multiple presentations and publications at conferences associated with vaccine development to show their leadership in the field. Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders in development.

The Director will report to the Executive Director of Vaccine Drug Product Development, have 3 – 5 direct reports and will be responsible for a team of 10-20 senior and associate level scientists. The successful candidate will be key in implementing strategy, conducting scientific research from the laboratory to commercial scale, step across boundaries and implement novel innovations into the DP space to afford world class vaccine processes for human health while ensuing a phase appropriate approach and adhering to the highest scientific standard.

The incumbent will be responsible for the recruiting, appraisal, and development of personnel under her/his supervision. The Director selects, trains, and effectively recommends transfers, merit increases, promotions, and closures of personnel under her/his direction within the framework of Company policy. The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate will also have a proven track record of developing talent and building high performing teams from a diverse scientific background and will have the ability to advance our company's commitment to a diverse and inclusive work environment.

Responsibilities for the Director Include:

• mRNA / LNP development and strategic direction for product development

• New vaccine manufacturing and delivery technology evaluation, development, and application to our company's pipeline

• Fill/finish process scale-up, drug delivery and/or technology transfer including the use of gap analysis and risk assessment tools

• Recruit, select, develop, and mentor talent

• Develop the departmental budget and meeting the agreed upon spend

• Implementation of VDPD strategy and vision to future vaccine programs for human health

• Collaborates and builds strong relationships with upper management and other disciplines to select and qualify new CMOs/CROs/CDMOs

• Build collaborations across internal company departments and key stakeholders

• Lead and champion organizational structure and be a change agent when necessary

Minimum Qualifications Include:

• An advanced degree (Ph.D. with minimum of 8+ years, or M.S. with minimum 10+ years) in pharmaceutical sciences, pharmaceutics, biochemical / biomedical engineering, chemical engineering, biology, virology, or relevant field.

• A minimum of 8+ years of relevant experience in pharmaceutical development with exposure to all stages and aspects of development (pre-clinical, clinical, and commercial) and cGMP industrial background.

• A minimum of 5+ years managing a team of three or more direct reports

• Experience in developing liquid, lyophilized, injectable drug product formulations and/or Drug Delivery and Technology initiatives.

• Experience with sterile unit operations and knowledgeable of the sterile standards and equipment design standards

• Experience with GMP manufacture of mRNA/LNP for clinical supplies

• Experience evaluating external mRNA/LNP opportunities

• Experience integrating novel devices into product development

• Participated on a large capital project teams

• Exposure to project / engineering work process and deliverables (e.g., equipment fabrication, FAT, SAT, Validation etc.)

• Must be innovative and drive new ideas, but also have pragmatic approach to technology selection and development

• Demonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC. Strong experience in safety and environmental knowledge.

• Candidate should have solid understanding of integration and partnering for Pharmaceutical development/CMC with Quality, Regulatory, Operations, Non-clinical, Clinical, and other functional areas

• Excellent verbal and written communication skills, demonstrated creativity, strong interpersonal and collaboration skills.

• A strong track record of publications in parenteral drug product development and/or delivery

• Demonstrated ability to lead cross-functional teams with proven talent development skillsets.

• Demonstrated strength in delivering results on firm deadlines in support of product discovery, process development and commercial filings for biopharmaceuticals or vaccine products.

Preferred Experience and Skills:

• Expertise in biological and/or vaccine clinical and commercial manufacturing would be ideal

• Strong process development (including upstream and downstream) and technology transfer experience is sought.

• Experience in regulatory compliance expectations across all phases of product development to commercialization.

• Experience with regulatory submissions for international agencies is desired. Experience in writing / review of regulatory filings including INDs and BLAs.

• Demonstrated leadership skills and organization design (i.e. building high performing teams, building talent, and shown to be able to motivate, influence scientific team; lead by example through past scientific / technical expertise).

• Experience in budget planning & management, establishing development strategies, and managing scientific staff from a budgetary and personnel decisions standpoint.

• Experience with process design and/or scale-up in the clinical or commercial space, including process flow diagrams & engineering drawings

• Experience in equipment Fabrication, FAT/SAT, start-up, qualification and/or validation is preferred

• Fill/finish process scale-up, Drug Delivery and/or technology transfer experience including the use of gap analysis and risk assessment tools

• Highly motivated, flexible, a change agent, and ability to work in a fast-paced environment.

• Willing to implement novel and innovative technologies into vaccine programs. Ability to provide novel and creative solutions to challenges and pinch points in vaccine development. Encourages innovative thinking / risk-taking and eliminates obstacles / barriers to implement change

• Ability to present clear and compelling quality and business cases. Ability to engage and align other stakeholders outside the project team.

• Ability to apply and promote a growth mindset with teams and partnerships

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., Rahway, 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.

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

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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.

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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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Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:R185118