Hiring: Principal Scientist/Director (Downstream), Biologics Drug Substance Commercialization (BDSC) Company: Merck Location: West Point, PA Job Posted Time: 2026-09-12 13:15:55 Employment Type: Contract Target Skills & Keywords : Workday About the job Required Skills: •Reporting to the Director of BDSC-Downstream, the Principal Scientist (Director) will manage a team of downstream scientists and serve as a key technical leader and collaborator across Manufacturing, Quality, Regulatory, and external partners. •Lead downstream and/or integrated drug substance teams supporting late-stage clinical and commercial programs, with clear line of sight to licensure and commercialization. •Provide technical leadership for laboratory scale and manufacturing scale studies supporting process characterization, validation, investigations, and continued process verification. •Serve as a downstream subject matter expert across core unit operations, with a strong understanding of upstream, analytical, and GMP manufacturing interdependencies. •Ensure process and product knowledge are developed, documented, and transferred in alignment with company standards and regulatory expectations. •Support technology transfer activities to internal and external manufacturing sites, including scale-up, process validation, and manufacturing readiness. •Contribute to manufacturing investigations and lifecycle management activities for commercial processes. •Author and review technical and regulatory documentation, including sections supporting regulatory submissions. Qualifications: •BS, MS, or PhD in Chemical Engineering, Biological Engineering, Chemistry, or a related discipline. •Minimum Years of experience: Fourteen (14) years (BS), Twelve (12) years (MS), or Six (6) years (PhD) of required industry experience. •Deep technical expertise in downstream processing of biologics. •Demonstrated ability to independently design, direct, execute, analyze, and document all stages of process development. •Proven ability to prioritize and deliver complex objectives in fast-paced, dynamic environments. •Strong leadership and collaboration skills within cross-functional, matrixed organizations. •Action-oriented, problem-solving mindset with a track record of innovation and continuous improvement. •Demonstrated commitment to coaching and mentoring scientific staff. •Excellent written and verbal communication skills, with the ability to clearly articulate process science and influence technical decision-making. •Leadership experience on drug substance working groups or program teams. Compensation: •$173,200 - $272,600 / year •The successful candidate will be eligible for annual bonus and long-term incentive, if applicable Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!