Director of Vaccines Process Development & Commercialization Downstream Teams

Job Description

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

Our Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. We are on of the few companies that remains dedicated to the complex business of researching and producing vaccines. We are making investments in our pipeline and manufacturing capability to help protect billions of lives.

Our ability to excel relies on the integrity, knowledge, imagination, skill, diversity, and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you'll have the opportunity to partner with talented and dedicated colleagues while developing and expanding your career.

The Vaccine Process Development and Commercialization (VPDC) group within the Our Manufacturing Division focuses on late stage process development and characterization, technology transfer, and in-line promotion of vaccine products (live-attenuated vaccines, inactivated vaccines, subunit, recombinant, polysaccharide, and conjugate vaccines).

We are dedicated to keeping pace with the ever-evolving infectious disease landscape by developing vaccine candidates for important diseases. We are also developing promising new therapeutic approaches for cancer treatment, including gene and oncolytic virus therapies, which maybe the next breakthrough in cancer treatment.

We seek an energetic, people-oriented director with strong scientific and technical skills. They will direct the development and commercialization activities assisting downstream focused teams in sponsorship of inline and pipeline vaccine programs. The ideal candidate should have extensive knowledge in either Downstream Process Development or Downstream Technical Operations. In this role, you will be accountable for:

• Direct technical teams in developing and executing vaccine process development & commercialization, life cycle management of the existing vaccines programs, and commercial product investigations.

• Interface closely with technical operations, upstream and downstream teams, formulation, analytical, manufacturing operations, quality, and regulatory groups to develop and execute on long-term strategies and product trajectories.

• Collaborating with commercial manufacturing teams to promote facility start-up activities for drug substance manufacturing, both within our Company network and at contract manufacturing organizations (CMOs).

• Direct program objectives against critical-path program timelines.

• Manage relationships with senior management, outsourced organizations, and health authorities on strategic and technical objectives.

• Provides timely and accurate information and status updates to functional principals.

• Provides technical mentorship and situational coaching to coworkers and members of the team which may include dotted-line reporting relationships and non-our Company personal.

• Expand our culture of continuous learning and technical improvement through collaborations with research organizations and vendors.

• Recognized as a subject matter expert in large molecule process development and laboratory operations.

• Direct and/or matrix management of a team of scientists and engineers.

Education:

B.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 12 years of relevant knowledge; or Master's degree with 10 years of relevant knowledge; or Ph.D. with 7 years of relevant knowledge.

Skills:

• Large molecule process development knowledge or tech transfer of a large molecule drug substance processes or technical operations knowledge in promotion of large molecule drug substance manufacture.

• Downstream processing at different scales.

• Statistical data analysis and presentation of results/conclusions.

• Authoring technical documentation.

• Outstanding communication and people skills.

• Ability to foster a collective work environment focused on mentorship, coaching, and learning.

• Ability to work objectively and as part of a team and execute against key commitments.

• Project planning and management.

Preferred Knowledge and Skills:

• Knowledgeable in Drug Substance, end-to-end process development, including microbial, live virus vaccine, gene therapy, or oncolytic virus processes.

• Upstream and downstream unit operation mathematical modeling, theoretical scaling calculations, computational fluid dynamics (CFD) modeling.

• Quality by Design (QbD) and Lean Six Sigma standards

• Strong cross-functional background, enabling teams to reach peak performance.

• Ability to provide scientific mentorship and guidance to technical coworkers

• Aiding/writing regulatory filings (IND, MAA, BLA) and sponsoring inspections with multiple agencies (FDA, EMA, JNDA, TGA)

• On-the-floor GMP manufacturing

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed 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 …

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.

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.

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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.

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:

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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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R124427