Principal Scientist

2 days ago


RAHWAY NJ, United States Merck Sharp & Dohme (MSD) Full time

Job DescriptionThe Sterile and Specialty Products (SSP) group is responsible for developing non-oral dosage forms (injections, implants, inhaled, ocular) for small, intermediate, and large molecules from preclinical toxicology studies to commercialization. Our development teams ensure robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization such that the process is scalable without compromising stability, safety, efficacy, and delivery. During development, we leverage smart experimental design, cutting edge analytical tools, and predictive approaches to inform molecule, formulation and process selection. In summary, our team enables the translation of preclinical candidates into non-oral drug products. Our team is looking for a strong candidate for the position of Principal Scientist (R5) within the Biologics product development group. Primary duties:Be a seasoned biologics product developer responsible for designing and developing sterile products for injectable, ophthalmic, and inhaled routes of administration. Support both early and late-stage development candidates that will include ensuring screening and development of robust drug product composition, scalable process, primary packaging, compatibility characterization for processing and administration, and supporting regulatory filings. Have deep fundamental knowledge around large molecule drug product development and have management responsibilities for a small group of scientists during product development to ensure completion of key milestones and laboratory / regulatory documentation. Active strategic and technical leadership on program development teams, interfacing with key stakeholders, and collaborating across functions to drive defined milestones will be required.Responsible for ideating, leading, and championing organizational strategic and innovation objectives aligned with organizational goals. Has prior experience with process scale up, modeling, regulatory filings and/or driving key capability evaluation/ build  Be willing to take initiative, motivated to excel, have a strong technical background, have excellent communication and interpersonal skills, ability to multi-task, mentor scientists, and a strong desire to learn and contribute.Proven demonstration of leadership behaviors​Education Minimum Requirement:  Masters with a minimum of 12 years or Ph.D. with a minimum of 8 years of industry experience and a Degree in Chemical/ Biomedical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry or related field. Required Experience and Skills: The candidate should have a strong track record in biologics product development/ regulatory filing/ drug delivery/ complex formulation and process development (including mAbs, ADCs, fusion proteins, combinations such as doublet or triplet co-formulations and drying technologies such as lyophilization) reflected through industry experience and external publications and patents.The candidate should have experience in designing and executing appropriate DOE studies to inform on biologic drug product risks such as oxidation or light exposure  The candidate should be well-versed in QbD principles and have experience applying the QbD tools and principles to drug products in developmentThe candidate should have experience authoring regulatory filings for sterile dosage forms especially biologics (liquid/ lyophilized/ complex systems).The candidate should have experience with technology transfer to facilitate scale-up of early phase and late phase biologic drug product manufacturing processes to GMP production facilitiesThe candidate should have strong familiarity with relevant biologic analytical methods and specifications for drug products as well as drug substance downstream formulation considerationsThe candidate should have experience in developing combination products for biologic therapeuticsThe candidate should have experience, desire and a track record of effective mentorship of junior scientists towards timebound goals.The candidate should demonstrate scientific leadership in the field of biologics product developmentPreferred Experience and Skills:Experience in pharmaceutical sciences, physical pharmacy, physiology, pharmacokinetics, biochemistry, protein sciences, chemical kinetics or transport phenomenon is highly desirable.Experience in biologics process development and process characterization to enable efficient tech transfer to manufacturing sites.Experience in modeling such as Monte Carlo simulations to predict manufacturing successExperience in formulation/process, definition of critical attributes for process scale-up, analytical development and experience with Biologics License Application filing for non-conventional sterile dosage forms including ocular dosage forms or peptide therapeutics, and/or alternate delivery technologies (e.g. high concentration, hydrogels, emulsions, suspensions, injectable depot) is a plus.#EligibleforERPNOTICEFORINTERNALAPPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.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.We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:EEOC Know Your RightsEEOC GINA Supplement​Pay Transparency NondiscriminationWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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 ActsU.S. Hybrid Work ModelEffective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.Expected US salary range:$149,400.00 - $235,100.00Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.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:DomesticVISA Sponsorship:YesTravel Requirements:10%Flexible Work Arrangements:Not ApplicableShift:Not IndicatedValid Driving License:NoHazardous Material(s):n/aJob Posting End Date:01/31/2025*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



  • Rahway, United States Merck & Company, Inc. Full time

    The Biologics Analytical Research & Development department of our company's Research Laboratories Division is seeking applicants for a Principal Scientist position available at our company's research facility. The Principal Scientist is a senior scie Scientist, Analytical, R&D, Analytical Chemist, Principal, Chemistry, Technology


  • Rahway, New Jersey, United States MSD Malaysia Full time

    About the RoleAs 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...


  • Rahway, United States MSD Malaysia Full time

    Senior Principal Scientist, Upstream Biologics Process R&DSenior Principal Scientist, Upstream Biologics Process R&DApply remote type Not Applicable locations USA - New Jersey - Rahway time type Full time posted on Posted 4 Days Ago time left to apply End Date: January 17, 2025 (27 days left to apply) job requisition id R327660Job DescriptionOur Scientists...


  • Rahway, United States Merck Sharp & Dohme Full time

    Job Description The Principal Scientist-Team Lead is responsible for providing direct technical leadership and management for a team of scientists (3-5) that are embedded with the chemical biotechnologies group within the Process Research and Development, Enabling Technologies Organization. The team provides analytical expertise that ranges from high...


  • Rahway, United States MSD Malaysia Full time

    Principal Scientist, Bio Process Principal Scientist, Bio Process Apply remote type Not Applicable locations USA - New Jersey - Rahway time type Full time posted on Posted 2 Days Ago time left to apply End Date: February 7, 2025 (28 days left to apply) job requisition id R328501 Job Description The Biologics Process Research & Development organization within...


  • Rahway, New Jersey, United States Merck & Company, Inc. Full time

    Job Summary">We are seeking an experienced Associate Principal Scientist to lead our Device Technology Assessment and Early Development initiatives.">Responsibilities">This role will be responsible for evaluating the feasibility of emerging technologies, assessing their potential impact on medical device development, and identifying areas for further...


  • Rahway, United States Merck & Company, Inc. Full time

    The Associate Principal Scientist of Device Technology Assessment and Early Development will spearhead early-stage device technology evaluation and feasibility initiatives. This role will focus on front-end development, emphasizing the exploration an Technology, Development, Assessment, Device, Scientist, Associate


  • Rahway, United States Merck & Company, Inc. Full time

    Our company in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Today, we are building a new kind of healthcare company one that is ready to h Clinical Research, Clinical, Research, Scientist, Hematology, Principal, Healthcare


  • Rahway, New Jersey, United States Merck Sharp & Dohme Full time

    Company Overview:Merck Sharp & Dohme is a global leader in healthcare, with a diverse portfolio of medicines, vaccines, and animal health products. We strive to create an environment of mutual respect, encouragement, and teamwork, where our employees can develop and expand their careers. As part of our global team, you'll have the opportunity to collaborate...


  • Rahway, United States MSD Malaysia Full time

    Principal Scientist Medicinal Chemistry, London Discovery Our company has a rapidly growing interdisciplinary team of scientists in London and exciting plans to expand our London presence, initially at the Francis Crick Institute as part of our ‘Skylab’ expansion, and from 2027 in our new ‘state of the art’ London Discovery and UK headquarters at the...


  • Rahway, United States Merck & Company, Inc. Full time

    As the Director/ Principal Scientist in Devices and Drug-Device Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. You will spearhead regulatory Regulatory Affairs, Director, Chemistry, Controls, Manufacturing, Regulatory


  • RAHWAY, NJ, United States Merck Sharp & Dohme (MSD) Full time

    Job DescriptionThe Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical and Early Development to rapidly develop manufacturing processes for diverse...


  • Rahway, United States Merck Sharp & Dohme (MSD) Full time

    Job DescriptionThe Principal Scientist-Team Lead is responsible for providing direct technical leadership and management for a team of scientists (3-5) that are embedded with the chemical biotechnologies group within the Process Research and Development, Enabling Technologies Organization. The team provides analytical expertise that ranges from high...


  • Rahway, United States Merck Sharp & Dohme Full time

    Job Description The Biologics Analytical Research & Development department of our company's Research Laboratories Division is seeking applicants for a Principal Scientist position available at our company's research facility. The Principal Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and...


  • RAHWAY, NJ, United States Merck Sharp & Dohme (MSD) Full time

    Job DescriptionOur Scientists are our Inventors. We deliver robust scientific data and interpretation that drives the commercialization of breakthrough therapeutics using innovative thinking, state-of-the-art facilities and modern equipment. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like...


  • RAHWAY, NJ, United States Merck Sharp & Dohme (MSD) Full time

    Job DescriptionPosition Description:Senior Principal Scientist, Biostatistics (Hybrid)In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company’s renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies...


  • Rahway, United States Merck & Company, Inc. Full time

    The Clinical Director (Principal Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology. With a focus on late-stage development, the Clinical Direc Clinical Research, Clinical Director, Clinical, Research, Scientist, Clinic, Healthcare


  • Rahway, New Jersey, United States Merck Sharp & Dohme Full time

    Job Description: We are seeking a highly skilled Principal Scientist to join our Biologics Analytical Research & Development department. As a key member of our team, you will be responsible for leading a group of scientists in solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines.


  • Rahway, New Jersey, United States Merck & Company, Inc. Full time

    Job SummaryThe Principal Scientist, Clinical Research will be responsible for leading clinical research activities involving investigational compounds in Immunology.


  • Rahway, New Jersey, United States MSD Malaysia Full time

    Job Description">The Associate Principal Scientist, Health Economics will be responsible for developing and refining the integrated value evidence strategy and evidence generation across all phases of product development. This involves working closely with cross-functional teams to identify opportunities to demonstrate the value of our company's products to...