Job Description
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 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 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
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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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\EEOC\KnowYourRights\10\20.pdf)
EEOC GINA Supplement?
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
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.
Expected US salary range:
$187,000.00 - $294,400.00
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 (https://www.benefitsatmerck.com/) .
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
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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Biological Manufacturing, Biological Manufacturing, Biopharmaceutics, Bioprocess Engineering, Business, Cell Cultures, Cell Line Development, Cell Line Engineering, Clinical Judgment, Communication, Flux Analysis, Human Health Risk Assessment, Innovative Thinking, Interpersonal Relationships, Mammalian Cell Culture, Manufacturing Processes, Mentorship, Metabolomics, Molecular Biology, Omics Technologies, Process Characterization, Project Leadership, Project Management, Proteomics, Scientific Leadership {+ 3 more}
Preferred Skills:
Job Posting End Date:
07/4/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R351123