Job DescriptionSenior Scientist – Biologics Development and BiopharmaceuticsJob DescriptionThe Biologics Development & Biopharmaceutics (BDB) team is an integrated team responsible for the development and successful registration of new drug products. Formulation activities focus on the development of non-oral dosage forms spanning preclinical toxicology studies through commercialization. We 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. Biopharmaceutics scientists proactively develop and execute a comprehensive biopharmaceutics strategy that leverages cutting edge in vitro, in vivo and in silico Physiologically Based Pharmacokinetics (PBPK) and PK modeling tools, while advancing the underlying biopharmaceutics science within the organization and the external scientific community.Our team is looking for a strong candidate for the position of Senior Scientist to support biopharmaceutics assessment across delivery of small molecule, peptides and biologic modalities. The successful candidate will be responsible for representing the biopharmaceutics team in drug product development teams, driving the biopharmaceutics strategy, while helping to develop the next generation of physiologically-based modeling and simulation tools.Primary Responsibilities:
Proactively identify key biopharmaceutics risks at each stage of drug product development for biologics and/or small molecules, conducting hypothesis-based assessment employing an integrated approach, driving the development of in vitro-in vivo relationships and preclinical-to-clinical translation in bioperformance of formulations.
Develop diverse, parenterally administered biologic modalities and protein therapeutics considering absorption kinetics, stability and immunogenicity
Develop physiologically-based pharmacokinetic (PBPK) models to facilitate decisions in areas including formulation development, food effect evaluation, in vitro-in vivo correlations and dissolution specification setting.
Lead and participate in both internal and external innovation in the fields of biopharmaceutics and modeling.
The position is a blend of wet lab-based responsibilities and modeling and simulation activities.
Desired Qualifications:
PhD in Pharmaceutics, Pharmacokinetics or Pharmaceutical Sciences with zero to three years of experience
Masters in Pharmaceutics, Pharmacokinetics or Pharmaceutical Sciences with at least 5 years of industry experience.
Required Experience and Skills:
Advanced knowledge in pharmacokinetics and understanding of principles of physiologically-based pharmacokinetic modeling.
Familiarity with formulation development of small molecules, therapeutic proteins/biologic modalities
Strong influencing and communication skills and demonstrated ability and creativity in solving tough problems.
Demonstrated strong verbal as well as written communication skills and ability to work effectively with team-members of diverse skill sets and backgrounds
Demonstrated self-motivation to take ownership and accountability of issues and drive them to completion.
Strong collaboration skills to succeed in various team settings
A track record of scientific publications in the field.
Preferred Experience and Skills:
Hands-on experience with physiologically-based pharmacokinetics modeling software (e.g., Simcyp, GastroPlus, PK-Sim) is highly desired.
Experience with applying such models to specialized dosage forms (oral and non-oral extended release, inhaled, others)
Demonstrated proficiency in PK, PK/PD, PBPK/PD or popPK modeling e.g. MATLAB, Python, R, Phoenix
NOTICE FOR INTERNAL APPLICANTSIn 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. 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Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)US 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 (https://survey.sogosurvey.com/r/aCdfqL) 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 Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088EEOCKnowYourRights1020.pdf)EEOC GINA SupplementPay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.pdf)We 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 Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)U.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, generally Tuesday, Wednesday and either Monday or 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”.Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range:$111,400.00 - $175,300.00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here (https://www.benefitsatmerck.com/) .Search Firm Representatives Please Read CarefullyMerck & 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:1st - DayValid Driving License:NoHazardous Material(s):n/aRequisition ID: R281518