Senior Principal Scientist, Upstream Biologics Process R&D

Job Description

Our Scientists are our Inventors. Through innovative thinking, state-of-the-art facilities, cutting-edge science, and technology, we collaborate to deliver the next medical breakthroughs. We are looking for a collaborative, self-motivated  scientific leader with expertise in downstream bioprocessing to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.

BPR&D within our Company Research Laboratories is committed to rapidly delivering diverse biotherapeutics to patients by efficiently developing innovative and robust manufacturing processes and technologies. To achieve our goals, we work closely with colleagues in Discovery, Pre-clinical, Early Development, Analytical, Formulation, and Commercial Manufacturing, all within a diverse and inclusive environment. In addition to process development for pipeline biologics, we are focused on innovating and building next-generation biomanufacturing technologies. This includes investments in continuous manufacturing, green and sustainable processes, and proprietary technology platforms. We actively publish and engage with the scientific community to influence the field.

As a Senior Principal Scientist, you will drive various strategic initiatives and translate strategies into  implementation for our Company’s Biologics platform. You will collaborate with an immensely creative and collaborative team of scientists and engineers to design upstream, cell-culture processes while developing technical strategies related to upstream processing and recombinant expression of drug candidates in early- and late-stage development.

Responsibilities include, but are not limited to:

• Serve as a scientific leader to shape and drive innovation across the Biologics pipeline, strategy, and science.

• Anticipate and solve scientific and technical challenges across projects and functional teams, in a fast-paced, multidisciplinary environment.

• Lead the development of robust and scalable upstream processes for biologics in various stages of clinical development, as well as process characterization and regulatory filings for successful commercialization.

• Improve upstream processes by increasing efficiency and cost-effectiveness through research and innovation, while evaluating technologies and industry best practices.

• Collaborate with academia, industry, and vendors to facilitate the development and early adoption of novel process technologies.

• Contribute to strategic initiatives; work with senior leaders to establish overall project strategy and guide teams in its execution.

• Conceptualize, plan, and execute projects using effective organizational, prioritization, and problem-solving skills.

• Stay updated on the scientific and regulatory landscape; contribute scientifically and build your reputation through conference participation.

• Represent BPR&D as a upstream bioprocess expert/co-leader in internal and cross-functional project teams.

• Supervise, coach, and develop talent within the functional area; guide career development; build strong, collaborative teams.

• Champion compliance and safety while promoting a culture of diversity, equity, and inclusion.

Minimum Education Requirements:

• Ph.D. with 10+ years, MS with 12+ years, or BS with 14+ years of industry experience in Chemical/Biochemical Engineering or a related field.

Required Experience, Skills, and Competencies:

• Strong fundamental knowledge and subject matter expertise in cell-culture process development for biologics, fed-batch cell culture, bioreactor scale-up and scale-down, as well as recent advances, and challenges in the field

• Expertise in independently conducting and directing the design, execution, analysis, and documentation of all stages of cell-culture process development

• Track record of accomplishments in upstream bioprocessing with a history of peer-reviewed publications and presentations. Strong understanding of cell metabolism and biochemical pathways relevant to bioprocessing.

• Knowledge of biologics CMC development

• Ability to adapt to and prioritize complex objectives under tight timelines in a rapidly changing environment.

• Experience leading internal and external cross-functional, matrixed teams.

• Demonstrated scientific leadership with significant, measurable project impacts across a diverse set of programs.

• Action-oriented mindset with a capacity for creativity; ability to take initiative, innovate, iterate, and solve problems.

• Supervise, coach and mentor scientists to maximize talent development and utilization.

• Excellent interpersonal and communication skills.

Preferred Experience & Skills:

• Leadership of CMC development teams.

• Experience with continuous biomanufacturing integrated with process-analytical technologies.

• Intensified inoculum and perfusion process development

• Expertise in media/solution development and chemistry

• High-throughput experimentation, automation, and process control.

• Knowledge of microbial fermentation

• Cell culture predictive modeling (omics (transcriptomics, metabolomics, or/and proteomics), metabolic flux analysis); statistics, data-science, machine learning, artificial intelligence

#BPRD #PRD

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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.

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Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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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. 

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