Principal Scientist, Downstream Process Development Full-time

Principal Scientist

BPR&D within our Company's Research Laboratories is on a mission to rapidly deliver biotherapeutics to patients by efficiently developing innovative, robust manufacturing processes and technologies. To achieve this, we work closely with colleagues in Discovery, Pre-clinical, Early Development, Analytical, Formulation, and Commercial Manufacturing while providing an inclusive environment for all. Beyond process development for pipeline biologics, we innovate and build next generation biomanufacturing technologies. Examples include investments for development of 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 Principal Scientist you will have the opportunity to influence the future direction of our Company's Downstream Processing of Biologics. You will work with an immensely creative and collaborative team of scientists and engineers to design purification processes while developing technical strategies related to downstream processing for drug candidates in early- and late-stage development.

Responsibilities include but are not limited to:

• As an impactful contributor, shape and realize innovation across the Biologics' pipeline, strategy, and science
• Advance the pipeline by collaborating with cross-functional teams, from Research & Manufacturing, in a fast-paced, multidisciplinary environment
• Participate in or lead 1) development of robust and scalable purification processes for biologics in different stages of clinical development, 2) process characterization and regulatory filings for successful commercialization
• Advance downstream processes by improving efficiency and cost effectiveness through research and innovation, while assessing technologies and industry best practices
• Collaborate with academia, industry, and vendors to drive development and early adoption of novel process technologies
• Contribute to strategic initiatives; partner with senior leaders to set overall project strategy, and guide teams towards its execution
• Conceptualize, plan, and execute projects with effective organizational, prioritization and problem-solving skills
• Stay abreast of scientific and regulatory landscape; actively present (premier conferences), publish (peer-reviewed journals) and patent
• Represent BPR&D as a downstream bioprocess expert in internal, cross-functional project teams and external conferences/consortia
• Mentor and actively share expertise; guide career development; build strong, collaborative teams
• Champion compliance and safety; promote a culture of inclusion

MINIMUM EDUCATION REQUIREMENTS:

Ph.D. with 6+ years, MS with 8+ years, or BS with 10+ years of industry experience and background in Chemical/Biochemical engineering, or a related field

REQUIRED EXPERIENCE, SKILLS, AND COMPETENCIES

Strong fundamental knowledge and subject matter expertise in downstream processing of biologics, recent advances, and challenges in the field

Expertise in independently conducting and directing the design, execution, analysis, and documentation of all stages of purification process development

Track record of accomplishments in downstream bioprocessing with a history of peer-reviewed publications and presentations

Knowledge of biologics CMC development

Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment

Experience and aptitude to lead, work, and collaborate in internal and external cross-functional, matrixed teams

Action-oriented, mindset for creativity; ability to take initiative, innovate, iterate and problem-solve

Demonstrated commitment to coach and mentor staff to maximize talent development and utilization

Excellent interpersonal and communication skills

PREFERRED EXPERIENCE & SKILLS:

Leadership of CMC development teams

Continuous biomanufacturing integrated with process-analytical technologies

High-throughput experimentation, automation, and process control

Knowledge of protein expression, analytics, conjugation chemistry and formulation

Biophysical, mechanistic and facility modeling; statistical analysis, data-science, machine learning, artificial intelligence

Required Skills: Adaptability, Artificial Intelligence (AI), Biomanufacturing, Bioprocess Engineering, Career Development, Cell Culture Process Development, Cell Line Development, Combination Products, Data Analysis, Finite Element Analysis (FEA), Innovation, Innovative Thinking, Leadership Mentoring, Manufacturing Operations, Pharmaceutical Process Development, Prioritization, Process Characterization, Professional Collaboration, Professional Networking, Protein Expression, Publishing, Quality by Design, Regulatory Filings, Strategic Initiative {+ 2 more}

Preferred Skills:

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. Available benefits include 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. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.