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Job Details


Merck & Co, Inc

Executive Director, Biologics Process Development

Executive

Executive Director

No

Rahway, New Jersey, United States

Job Description

In April 2020, our Company announced plans to consolidate our New Jersey campuses into a single New Jersey headquarters location in Rahway, NJ by 2023. Therefore, the NJ work location for this role will be temporarily based and the exact timing of the departmental move to Rahway, NJ will be communicated at a future date.

The Executive Director, Biologics Process Development is accountable for driving industry-leading innovations in bioprocess that are implemented to enable world class commercial processes for new products at first filing. The scope of this operation includes laboratory-based bioprocess innovation through prep-lab and pilot plant demonstration and partnering across Development Sciences and Clinical Supply (DSCS) and our Manufacturing Division colleagues to complete process characterization, technology transfer to commercial manufacturing sites and authoring of regulatory filing submissions.


Primary Responsibilities:


Reports to the head of Biologics Process, Research and Development (BPR&D). The department head participates in network wide activities within BPR&D for setting strategic direction, prioritizing allocation of resources and managing budgets to align actions with strategy.


Supervises 3 - 4 leaders and through them, approximately 35 biologists and engineers who work closely within multidisciplinary teams. Responsible for the appraisal and development of personnel under their supervision. Selects, trains, and effectively recommends transfers, merit increases, promotions, and closures of personnel under thier direction within the framework of Company policy.


Accountable for driving innovations in drug substance process development for biologics pipeline programs. Strong capabilities in managing progressive timelines, program risks and mitigation strategy. Strong knowledge and experience in bioprocess development, scale-up, technology transfer, and process characterization. In-depth knowledge in upstream cell culture process development, to support bioprocess platform and technology development. The incumbent must excel in leading the conduct of scientific research, both at laboratory and plant scale; translating breakthroughs in fundamental science to afford world class process for biopharmaceuticals. Oversight of the non-clinical drug substance budget as well as any internal activities related to supply of GMP DS for the support of early clinical and preclinical development.

A successful incumbent will excel in collaborating with partner groups within Process R&D, Manufacturing Division, and Regulatory CMC, to ensure new commercial manufacturing processes successfully transfer to manufacturing sites in preparation for first commercial filing and assist in the authoring of regulatory filing submissions for commercial products. Collaborates and influences both technically and strategically the capabilities of the DS network inside the company and with key partners.

Directs the preparation of and approves disclosures prepared within their department to be used as the basis for patent applications.

Establishes, recommends, and maintains for R&D external contracts, including grants, fellowships, and consultants in expressed fields of activity. Is expected to cultivate strong relationships with key opinion leaders and top academics in their field.

Education:

  • Ph.D. in biology, biochemistry, chemical engineering or related pharmaceutical science is required.

Required Experience and Skills:

  • 10+ years drug substance experience and demonstrated ability in leading a research team.

  • Demonstrated leadership in driving scientific excellence; translating breakthroughs in fundamental science to afford world class biologics manufacturing processes

  • Must have excellent interpersonal, communication, and collaboration skills and strength in delivering results on firm deadlines.

  • Must be recognized in the pharmaceutical industry, through publications/presentations, for subject matter expertise.

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.

For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

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 Know Your Rights

EEOC GINA 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.

Under New York City law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$191,700.00 - $326,000.00

Learn more about your rights, including under California, Colorado and other US State Acts

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.

Employee Status:

Regular

Relocation:

Domestic/International

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Specified

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R210717