Principal Scientist, Upstream Process Development Group Lead
$173.2k - $272.6kMerck Sharp & Dohme (MSD)
Job DescriptionJob 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 reportsMentor and actively share expertise across teams; guide career development within and outside the group; build strong, collaborative connections in matrix teamsMinimum 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 fieldExpertise in independently conducting and directing the design, execution, analysis, and documentation of all stages of cell-culture process developmentTrack 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.Required 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 TransferPreferred Skills: Current Employees apply HERECurrent Contingent Workers apply HEREUS 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 RightsEEOC GINA SupplementWe 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 ActsThe salary range for this role is$173,200.00 - $272,600.00This 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 .You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance OrdinanceLos 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 OrdinanceSearch 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. Employee Status: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:Not ApplicableShift:Valid Driving License:Hazardous Material(s):Job Posting End Date:10/10/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. SummaryLocation: USA - New Jersey - RahwayType: Full time
$190.8k - $300.3k
...Description:Our Scientists are our Inventors... ...to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within... ...to design upstream, cell-culture processes... ...environment.Lead the development of... ...growth of a cohesive group and direct...PrincipalFull timeFor contractorsLocal areaVisa sponsorshipFlexible hours$190.8k - $300.3k
...Description: Our Scientists are our Inventors... ...join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist. BPR... ...to design upstream, cell-culture processes... ...environment. Lead the development of... ...growth of a cohesive group and direct...PrincipalFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$173.2k - $272.6k
...Description The Biologics Process Research & Development organization within our... ...to join our team as a Principal Scientist. In this role, the successful candidate will lead cross-functional teams to... ...include: Leading biologic upstream process development for...PrincipalFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$142.4k - $224.1k
...Description The Biologics Process Research & Development organization within our... ...our team as an Associate Principal Scientist.- In this role, a... ...Scientists and Engineers in the Upstream Process Development area... ...Participates in and/or leads upstream process development...PrincipalFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$173.2k - $272.6k
...Description The Biologics Process Research & Development organization within our Company... ...individual to join our Upstream Development Department as a Principal Scientist. In this role, the successful... ...mentoring junior scientist, leading projects, and strong external...PrincipalFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$282.2k
...career. The Senior Director (Sr. Principal Scientist) has primary responsibility... ...span all phases of clinical development (pre-clinical to post-... ...closely with a cross-functional group of experts in... ...candidates can engage in a hiring process that exhibits their true capabilities...PrincipalFull timeFor contractorsLocal areaFlexible hours$87.3k - $137.4k
...Description Our Research Scientists are our Inventors.- Using... .... Biologics Process Research & Development (BPR&D) within our Research... ...Process Cell Sciences (PCS), Upstream Process, and Downstream Process... ...Process Development (PD) group that works on both the early...Full timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$190.8k - $300.3k
...and highly motivated Principal Scientist to provide strategic... ...portfolios.This role will lead the design, execution... ...late clinical development.The successful candidate... ...functional teams, governance groups, and key stakeholders... ...engage in a hiring process that exhibits their...PrincipalFull timeFor contractorsLocal areaFlexible hours$173.2k - $272.6k
...'s renowned Research and Development division, quantitative scientists, in partnership with other... ...standards. Actively leads and contributes to the department... ...functional stakeholder groups in BARDS, GCD, and our... ...deliverable quality and process compliance.Strategic thinking...PrincipalFull timeFor contractorsLocal areaFlexible hours$142.4k - $224.1k
...DescriptionThe Sterile Product Development (SPD) group is responsible for... ...primary packaging/device, and process selection through deep... ...the position of Associate Principal Scientist (R4) supporting the Biologics... ...Development. Primary duties: Lead/ contribute towards the...PrincipalFull timeFor contractorsLocal areaFlexible hours$260.3k - $409.7k
...opportunity for a physician-scientist to join our group as a Principal Scientist (Clinical... ...Medicine/Early Clinical Development in the Infectious Diseases... ...development strategyTaking a lead role in developing and... ...through the regulatory filing process including preparation of...PrincipalFull timeFor contractorsLocal areaWorldwideFlexible hours$260.3k - $409.7k
...responsible for early clinical development of novel therapeutics... ...conditions. The Principal Scientist (Clinical Director)... ...of the people in the group. To this end, we... ...biomarker plans for Lead Optimization programs... ...can engage in a hiring process that exhibits their true...PrincipalFull timeFor contractorsLocal areaWorldwideFlexible hours$142.4k - $224.1k
...DescriptionAssociate Principal Scientist, Regulatory CMC - Biologics... ...will assist in the development and the... ...in the authorization process to prioritize submissions... ...continued product supply.Lead authoring of clear, concise... ...with partner groups in the authoring and...PrincipalFull timeFor contractorsLocal areaVisa sponsorshipFlexible hours$255.8k - $402.7k
...DescriptionThe Clinical Director (Principal Scientist) has primary... ...focus on late-stage development, the Clinical... ...with a cross-functional group of experts in commercialization... ...Development Team Lead in ensuring that... ...can engage in a hiring process that exhibits their...PrincipalFull timeFor contractorsLocal areaFlexible hours$173.2k - $272.6k
...Description Position Title: Principal Scientist, Early Development Center of Excellence Our... ...device, and manufacturing process. Driving drug product... ...of a Drug Product working group tasked with initiating Commercial... ...will be responsible for leading a team of formulators...PrincipalLocal areaRelocationVisa sponsorshipFlexible hoursShift work$173.2k - $272.6k
...Description - The Biocatalysis group within the Small Molecule Process Research & Development (SMPR&D) Department in Rahway, New Jersey is seeking a Principal Scientist to expand and deepen our... ...biocatalysis challenges.- ~ Lead development and implementation...PrincipalFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$190.8k - $300.3k
...’s renowned Research and Development division, quantitative scientists, in partnership with other... ...Safety Statistics (CSS) group develop strategic and statistical... ...for this Position: Lead safety monitoring and... .... ~ Develop processes, job aids, statistical methods...PrincipalFull timeFor contractorsWork experience placementLocal areaRelocationVisa sponsorshipFlexible hoursShift work$173.2k - $272.6k
...Job Description Principal Scientist Job Description: Our company... ..., and manufacturing process. Driving drug product... ...be responsible for leading CMC project teams and the formulation development of new chemical entities... ...physical characterization groups ~ Leads project...PrincipalFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$145.48k - $224.1k
...-stage drug/vaccine clinical development projects. ~ Develop and execute... ...support multiple stakeholder groups which include clinical... ...procedures, SAS/MACRO, SAS/GRAPH; leading large and/or complex... ...data management systems and processes; CDISC and ADaM standards;...PrincipalFull timeFor contractorsLocal areaRemote workWorldwideRelocationVisa sponsorshipFlexible hoursShift work$173.2k - $272.6k
...animals. We are seeking a Principal Scientist to join our Analytical... ...Technology (ACT) group within Analytical Chemistry in Development and Supply (ACDS) at our... ...exciting opportunity to lead a highly collaborative... ...product and manufacturing process characterization, drug...PrincipalFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$156.9k - $247k
...pivotal role in combination product development (both design and process), commercialization, and... ...management. This person will lead several Human Factors scientists to perform and manage human factors... ...and Activities:The Principal Scientist is responsible for managing...PrincipalFull timeFor contractorsLocal areaFlexible hours- ...Associate Principal Scientist, Regulatory Affairs Department: Global Regulatory... ...role and metrics development. Competencies Required: Hands... ...development pharmaceutics, process technology, analytical method... ...with the respective CORA and lead the answer team of cross-functional...PrincipalShift work
$142.4k - $224.1k
...and review of information required for development of regulatory Chemistry, Manufacturing and... ...We are an international network on the leading-edge of healthcare breakthroughs that help... ...Regulatory Compliance, Pharmaceutical Process Development, Regulatory Affairs Management...PrincipalFull timeContract workFor contractorsLocal area$190.8k - $300.3k
...as an industry leader in drug development, product registration, and... ...Leaders, Compound Leaders, and scientists across NDS and/or Preclinical... ...collaborations, and proactively lead internal cross-departmental... ...experience with regulatory processes, nonclinical risk assessments...PrincipalFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$127.08k - $179.4k
...currently recruiting for a:Principal Scientist, Consumer Science... ...to support the development of products for the category... ...ZARBEES® as well as upstream innovation. You will... .... Experienced in leading consumer research in... ...recruitment & hiring process. Kenvue is proud to...PrincipalFull timeWork experience placement$169.7k - $267.2k
...Global Animal Health Research & Development (R&D) division is a pioneer... ...skilled and motivated Principal Scientist to join our R&D team.Purpose... ...advance novel targets and will lead these research programs from... ...research work (Medicinal and Process Chemistry, in vitro...PrincipalFull timeFor contractorsLocal areaFlexible hours$142.4k - $224.1k
...Job Description: Associate Principal Scientist, Biomarker Operations Role... ...operational partner to Biomarker Leads, helping implement... ...handling, shipping, storage, and processing requirements aligned to the... ...Skills: Biobank, Biomarker Development, Biomarker Discovery,...PrincipalFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$145.48k - $224.1k
...-stage drug/vaccine clinical development projects. ~ Develop and execute... ...support multiple stakeholder groups which include clinical... ...procedures, SAS/MACRO, SAS/GRAPH; leading large and/or complex... ...data management systems and processes; CDISC and ADaM standards;...PrincipalFull timeFor contractorsLocal areaRemote workWorldwideRelocationVisa sponsorshipFlexible hoursShift work$156.9k - $247k
...Job Description We are seeking a Principal Scientist to join our Separations Sciences team, within... ...capabilities supporting the development pipeline programs across multiple modalities... ...and partnership with colleagues across process chemistry, discovery process chemistry...PrincipalFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$142.4k - $224.1k
...'s renowned Research and Development division, quantitative scientists, in partnership with other... ...health. This position leads the statistical... ...support multiple stakeholder groups which include clinical development... ...Experience ensuring process compliance and deliverable...PrincipalFull timeFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work
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