Executive Director, Biologics Process Development

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.

In this role you will be responsible 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.

Nature and Scope of Position:

The Executive Director reports to the head of Biologics Process, Research & Development (BPR&D). As a member of the BPR&D Leadership team, the process development department head contributes to strategic planning in the development of BPR&D goals and objectives and works with the other directors in providing leadership to the organization. Participates in network wide activities within BPR&D for setting strategic direction, prioritizing allocation of resources and managing budgets to align actions with strategy.

• 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 their direction within the framework of Company policy.
• Supervises 4-5 Director and Senior Director level leaders and through them, approximately 80 biologists and engineers responsible for developing end-to-end integrated drug substance process development for biologics pipeline programs.
• Lead the designing, executing, and optimizing cell culture and purification processes using high-throughput microscale and benchtop bioreactors, with the goal of developing scalable and robust processes for production of proteins.
• Provide technical and managerial leadership to develop world class continuous and fedbatch processes.
• Serve as a technical and scientific resource for the entire BPR&D organization.
• Identify opportunities for process improvements and champion their successful implementation.
• The position will ensure that development activities are well aligned with manufacturing needs, experiments are appropriately designed, and that results are effectively communicated to key stakeholders.
• Accountable for driving innovations in developing exceptional mammalian and microbial bioprocess platforms for diverse therapeutic modalities.
• Responsible for developing priorities, project plans and schedules for implementation of continuous manufacturing (CM) process.
• In-depth knowledge in perfusion cell culture process development, cell culture media development, bioreactor development, to support bioprocess platform and technology innovation.
• Drive technology development for process intensification and continuous manufacturing to reduce manufacturing costs and footprint.
• Collaborate with the Automation and Software teams to develop automated systems for coordinating bioreactor runs and integrating process data into our computational platform.
• Collaborate with the Enabling Technology Modeling team to develop in silico predictive models of cell culture performance and apply them to process optimization.
• Act as an internal technical resource for Manufacturing and Process Design, as well as a resource and subject matter expert for external clients and collaborators.
• Communicate ideas, data, and strategy with other technical members, executives, and commercial partners.
• Lead the cross functional effort to develop and incorporate Process Analytical Technologies for enhanced process monitoring and control in support of CM introduction.
• Coordinate and track progress of creation of new automation programming and reports in support of CM implementation.
• Interface with pilot scale and commercial production facilities to ensure effective technology transfer and regulatory filings.
• Collaborate across the organization to speed time to clinic while reducing development costs.
• 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.
• Work cross functionally and cross organizationally to own the effort to implement continuous manufacturing.
• 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.

Desired Skills:

• A successful incumbent will excel in collaborating with partner groups within Process R&D, our 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.
• Lead by influence to advance program strategy and objectives.
• Collaborates and influences both technically and strategically the capabilities of the DS network inside the company and with key partners.
• Proactively manage priorities, resources, and investments aligned with organizational strategy.
• Strong partnering skills and ability to identify and capitalize on synergies across organizational or functional interfaces.
• Ability to formulate and apply enterprise-wide thinking to process development endeavors.
• Establishes, recommends, and maintains for R&D outside 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:

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

Required Experience and Skills:

• 10+ years drug substance experience and demonstrated proven track record of sustained success in people management, scientific mentorship, and project or scientific initiative leadership.
• Strong knowledge and experience in bioprocess development, scale-up, technology transfer, and process characterization for diverse therapeutic modalities
• In-depth knowledge in perfusion cell culture process development, process intensification and continuous manufacturing to reduce manufacturing costs and footprint, cell culture media development, bioreactor development, purification development to support bioprocess platform and technology innovation
• Able to develop in silico predictive models of cell culture performance and apply them to process optimization
• Experience with single use bioreactor systems and associated in-process analytical equipment
• Have the knowledge and experience in designing, executing, and optimizing cell culture processes using high-throughput microscale and benchtop bioreactors, with the goal of developing scalable and robust processes for production of proteins
• Work experiences with increasing responsibilities in more than two or three leading biopharmaceutical companies
• Demonstrated leadership in driving scientific excellence; translating breakthroughs in fundamental science to afford world class biologics manufacturing processes
• Ability to perform short and long-term project planning in terms of the generation of scope of work documents and project plans, resource demands, timelines, and budget forecasting
• Ability to prioritize multiple tasks, work under various timeline pressures, and drive tasks to completion
• Strong collaboration, team-building, communication and organizational skills required.
• Must be recognized in the pharmaceutical industry, through publications/presentations, for subject matter expertise.
• Demonstrated leadership in driving scientific excellence; translating breakthroughs in fundamental science to afford world class biologics manufacturing processes

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, Washington State and California State 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:
$213,280.00 - $335,700.00
For Washington State Jobs, a summary of benefits is listed here.

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:

Shift:

Valid Driving License:

Hazardous Material(s):