Principal Scientist, Upstream Process Development Group Lead

MSD • Rahway, NJ

3d

About The Position

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. As a Senior Principal Scientist/Principal Scientist, you will drive various strategic initiatives and translate strategies into implementation for our Company 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.

Requirements

• 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 bioproprocessing.
• 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 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.
• Biologics
• Bioprocess Engineering
• Bioreactors
• Cell Culture Process Development
• Cell Culture Techniques
• Cell Line Development
• Chemistry
• Combination Products
• Commercialization
• Downstream Processing
• Finite Element Analysis (FEA)
• Matrix Management
• Pharmaceutical Process Development
• Process Development (PD)
• Process Implementations
• Quality by Design
• Regulatory Filings
• Scientific Presentations
• Technical Evaluation
• Technology Development
• Technology Transfer

Nice To Haves

• Leadership of CMC development teams.
• Experience with continuous biomanufacturing integrated with process-analytical technologies.
• Knowhow of intensified inoculum and perfusion process development.
• Expertise in media/feed development and relevant 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.
• Process characterization and validation, CDMO supervision, commercialization of biologics.
• 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.
• 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. Learn more about your rights, including under California, Colorado and other US State Acts
• 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.

Responsibilities

• 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.
• Direct supervision of 3-5 scientists, accountable for development and growth of a cohesive group and direct reports
• Mentor and actively share expertise across teams; guide career development within and outside the group; build strong, collaborative connections in matrix teams

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays, vacation, and compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree