Senior Principal Scientist, Preclinical Development

$164,800 - $259,400/Yr

Merck KGaA Darmstadt Germany - Rahway, NJ

Full-time - Senior

Onsite - Rahway, NJ

Chemical Manufacturing

About the position

The Senior Principal Scientist in Biologics Process Research & Development (BPR D) is a scientific leader responsible for driving innovation and developing robust manufacturing processes for biologics. This role involves collaboration with various teams to enhance downstream processing, ensuring efficient and effective purification processes for drug candidates. The position emphasizes strategic initiatives, scientific leadership, and compliance within a diverse and inclusive environment.

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 purification processes for biologics in various stages of clinical development, as well as process characterization and regulatory filings for successful commercialization.
• Improve downstream 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 downstream 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.

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.
• In-depth knowledge and expertise in downstream processing of biologics, biologics CMC development, and the associated challenges.
• Extensive experience in conducting and directing the design, execution, analysis, and documentation of purification process development.
• Proven track record of accomplishments in downstream bioprocessing, including peer-reviewed publications and presentations.
• 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 and coach scientists to maximize talent development and utilization.
• Excellent interpersonal and communication skills.

Nice-to-haves

• Leadership of CMC development teams.
• Experience with continuous biomanufacturing integrated with process-analytical technologies.
• High-throughput methodologies.
• Experimentation, automation, and process control.
• Knowledge of protein expression, analytics, conjugation chemistry, and formulation.
• Skills with biophysical, mechanistic, and facility modeling; statistical analysis, digitalization, machine learning, and artificial intelligence.

Benefits

• Bonus eligibility
• Long term incentive if applicable
• Health care and other insurance benefits (for employee and family)
• Retirement benefits
• Paid holidays
• Vacation
• Sick days