Principal Scientist, Upstream Process Development

Job Description The Biologics Process Research & Development organization within our Research & Development Division is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical and Early Development to rapidly develop manufacturing processes for diverse biotherapeutics, and efficiently manufacture material to supply clinical trials. We are also responsible for late-stage process development and process characterization to prepare for commercial manufacturing. We work with our partners in our Company Manufacturing Division to commercialize and launch new products. We are seeking a highly motivated and experienced individual to join our team as a Principal Scientist. In this role, the successful candidate will lead cross-functional teams to develop CMC packages for our pipeline assets. The successful candidate will also collaborate with fellow Bioprocess Development colleagues to develop and refine technical strategy related to next generation processing for assets in early- and late-stage clinical development. Applicants must have effective organizational and multi-tasking skills, demonstrated excellent scientific leadership, and superior written and oral communications abilities. A track record of leveraging data science and digital tools for delivering impactful solutions to complex problems is distinguishing. Evidence of strong cross-functional collaboration, experience successfully mentoring junior scientist, leading projects, and strong external presence through scientific excellence are expected. Job Responsibilities JOB RESPONSIBILITIES: The successful candidate will contribute to CMC development of our Company's pipeline, playing an active role in development of cell culture processes and transfer to clinical and commercial manufacturing sites. They will also develop strategies for process and pipeline-facing innovation. Leading biologic upstream process development for first-in-human and commercial processes by efficiently developing high yield, robust and scalable cell culture processes. Providing technical direction for process development, characterization, commercialization, and regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for our company pipeline. Advancing upstream platform process technical strategy and championing creative process improvement initiatives. Initiating new collaborations to assess new technologies and industry strategies with relevance to our Company. Collaborating with academia, industry partners, and vendors to drive development, innovation and adoption of new process technologies with broad impact to projects or platform. Keeping current with the external patent and literature environment; actively presents and publishes externally and pursues patenting strategies. Mentoring and educating junior scientists. Minimum education required Ph.D. with 6+ years of industry experience or Master with 8+ years industry experience in Chemical Engineering, Bioengineering, Biochemistry or a related field. Required experience and skills Proven record of accomplishments in upstream process and technology development with a strong scientific publication and presentation track record. Experience in CHO fed-batch cell culture and a working understanding of downstream & analytics. Understanding and hands-on experience on cell culture bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors, and scaleup/tech transfer activities. Working knowledge of cell culture media, CHO cell biology and metabolism, DOE statistics and computational fluid dynamics. Ability to direct the planning, execution, analysis, and documentation of all stages of cell culture process development. Ability to work in a matrixed team environment and collaborate with both internal and external partners including vendors. Knowledge of biologics CMC development cycle. Experience with late-stage commercial process development, technology transfer, scale-down model qualification and process characterization. Demonstrated ability for taking initiative, creativity, and innovation in problem solving. Demonstrated ability to develop staff to maximize utilization of talent and actively guides career development; builds strong and collaborative teams. Preferred experience and skills Experience with state-of-the-art cell culture processes including intensified inoculum and perfusion process development. Experience with high throughput microbioreactor systems, and advanced in situ analytics for process monitoring and control. Expertise in media development, media/solution chemistry. Background in data science approaches related to cell culture and predictive modeling e.g., metabolic flux analysis (MFA), omics, machine learning; experience integrating PAT efforts) and computational fluid dynamics (CFD). Experience leading cross functional, program development teams. Required Skills Adaptability Cell Culture Process Development Cell Line Development Combination Products Data Analysis Finite Element Analysis (FEA) Innovative Thinking Leadership Mentoring Pharmaceutical Process Development Professional Collaboration Professional Networking Quality by Design Regulatory Filings Strategic Thinking Technology Transfer 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. 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 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. Equal Employment Opportunity 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. Salary The salary range for this role is $173,200.00 - $272,600.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. Benefits medical, dental, vision healthcare and other insurance benefits (for employee and family) retirement benefits, including 401(k) paid holidays vacation compassionate and sick days 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 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. Employee & Work Details Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a About Us Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. #J-18808-Ljbffr MSD Malaysia