Principal Scientist, Upstream Process Development Group Lead

MSD Malaysia; Rahway (NJ); On-site; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement plan

Paid holidays

Vacation

Job summary

MSD Malaysia is seeking a Senior Principal Scientist to lead upstream bioprocess development for biologics, guiding internal teams and collaborating with external partners. You will drive strategy, process scale-up, and regulatory readiness across development stages.

Ideal candidates have a Ph.D. in chemical/biochemical engineering with extensive industry experience and a proven track record in leadership, publications, and innovative process technologies.

Qualifications

• Ph.D. with extensive industry experience in biologics or related field is required.
• Deep expertise in cell-culture process development for biologics and scale-up.
• Strong publication/presentation record and leadership experience in matrix teams.

Responsibilities

• Lead the design and development of upstream bioprocesses for biologics across development stages.
• Guide cross-functional projects and mentor scientists in a matrix environment.
• Drive process characterization, regulatory filings, and tech strategies.
• Collaborate with academia, industry, and vendors to adopt novel technologies.
• Represent BPR&D as a bioprocess expert in internal teams and external projects.

Skills

Cell culture

Upstream bioprocessing

Process scaling

Leadership

Project management

Cross-functional collaboration

Regulatory awareness

Education

Ph.D. in Chemical/Biochemical Engineering

Tools

Process Analytical Technology (PAT)

Bioreactor scale-up

Job description

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. 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.

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.
• 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.

Minimum Education Requirements:

• Ph.D. with 10+ years, MS with 12+ years, or BS with 14+ and Ph.D. with 6+ years, MS with 8+ years, or BS with 10+years of industry experience in Chemical/Biochemical Engineering or a related field for Senior Principal Scientist position and Principal Scientist position, respectively.

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 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.
• 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.

Preferred Skills:

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.

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.

We offer a comprehensive package of 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.

Employee Status: Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements: Not Applicable

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