Executive Director, Bio Process

Job Description

“As a science-based healthcare company with a longstanding commitment to inventing and providing important medicines and vaccines, subject to local law, we will require all U.S. and Puerto Rico based employees to be vaccinated by November 1, 2021, unless they have an approved medical or religious exemption or accommodation. We are committed to supporting our employees during this process as we work to ensure a safe and healthy work environment.”

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.

Our Development team ensure production can be scaled up whilst remaining stable, effective, deliverable and safe. Following formulation, cutting edge computer modelling techniques are used to simulate outcomes and, if successful, PKPD and toxicity studies bring the science one step closer to giving hope to patients.

The Biologics Process Research & Development (BPR&D) organization within our Company's Research Laboratories is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline, including cell line, upstream and downstream process development. We work closely with colleagues in Discovery, Analytical Research & Development and Pharmaceutical Sciences and Clinical Supplies to rapidly develop manufacturing processes for diverse biotherapeutics, and we efficiently produce drug substance to supply clinical trials. We are also responsible for late stage/commercial process development and development of new manufacturing technologies. We work with our partners in the Manufacturing Division to commercialize and launch new products.

The Executive Director of Process Cell Sciences (PCS) leads a business unit within BPR&D, which is responsible for delivering cell-based technologies. PCS partners early with Discovery Biologics, leveraging our manufacturing platform cell lines and molecular biology tools to enable molecule design, conducting developability assessments, and ensuring seamless transition of programs from Discovery into Development. Upon candidate selection, PCS is responsible for developing production cell lines, including single cell cloning and cell banking. PCS is also responsible for development of cell-based therapies. The Executive Director of PCS will operate under the general scientific and administrative direction of the Associate Vice President, working with internal and external partners. This leader will demonstrate a deep scientific understanding of cellular and molecular biology, and they will have experience-based skillsets in process and technology development.

The primary activities include but are not limited to the following:

Leadership:

• Sets performance targets of the PCS in line with business priorities and develops long-term plans for the unit in line with BPR&D strategy
• Works and co-ordinates with partners at the Discovery group interface to help develop new products, modalities, and processes that allow for new products to be designed at speed.
• Develops the organization and culture (empowerment, cultural change, values and behaviors) in order to increase the unit performance against current and future business priorities
• Drives a talent agenda: Leads people processes through recruitment, training, coaching and performance to meet all operational requirements sustaining both global and local competitiveness and diversity
• Sustains robust succession plans for PCS. Drives actively talent retention. Creates environment of accountability ownership, trust, assures clarity and open two-way communication, and fosters a speak-up mentality
• Builds and sustains strong network in and outside the organization
• Develops staff to maximize utilization of talent and work effectively in cross-functional team settings.

Key Responsibilities:

• Provides scientific and strategic leadership for development of cell-based technologies to support Phase I/II/III clinical and commercial manufacturing.
• Partners with colleagues in Discovery, Upstream Process Development, Downstream Process Development, Analytical Sciences and Manufacturing to develop integrated manufacturing solutions that achieve quality by design targets with robust control strategies.
• Drives and delivers continuous improvement in cell-based technologies including cloning, expression vectors, host cell lines, process-relevant biomarker identification, transfection, cryopreservation, primary cell culture, etc.
• Identifies and implements continuous improvement initiatives
• Networks with academic, industry and regulatory agency thought leaders and leads development and implementation of cell-based process technologies.

Education:

• PhD is preferred but not required; MD or other advanced degrees will be considered
• 8+ years’ experience in Biological Science, specifically in a cell line engineering role for biologic products.

Required:

• Successful track record of leading cell line development in support of GMP production of recombinant proteins.
• Subject matter expertise in molecular and cellular biology
• Working knowledge of cell culture and/or fermentation, purification & analytics for recombinant protein production.
• Strong technical, business & financial skills, ability to manage multiple programs in a matrix environment, strong collaborative skills; ability to work strategically as well as in a detail-oriented framework.
• Demonstrated ability to develop talent and manage people across multiple sites
• Excellent oral and verbal communication skills.

Preferred:

• Successful track record of introducing new technologies into GMP manufacturing.
• Experience with cell therapy and/or immunology.
• Experience leading cross-functional, highly complex project teams.
• Proven ability to translate organizational objectives into actionable strategies.
• Recognized as an expert in the field with experience managing external collaborations.
• Ability to lead global functions
• Excellent external networks in both industry and academia

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.

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.

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.

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R145415