Senior Scientist, Preclinical Development
Senior Scientist, Preclinical Development
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$ 114700 - 180500
1 Vacancy
Job Description
Job Description
Sterile Product Development (SPD) group is responsible for developing nonoral 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 nonoral drug products.
Primary Responsibilities
Designing and developing sterile products for biologics small molecule peptide and oligonucleotide drugs for injectable and ophthalmic routes of administration
Support both early and latestage development candidates will include screening and developing robust drug product composition developing scalable process and defining primary packaging
Coordinate good practice (GxP) manufacture activities and appropriate compatibility characterization to enable processing of drug product and dosage administration in toxicology and clinical study
Build deep fundamental knowledge around the drug product and document experimental findings and conclusions in formulation development reports and regulatory filings
Active participation and leadership on formulation development teams and interfacing and collaborating with key stakeholders to drive project milestones
Take initiative motivated to excel have a strong technical background have excellent communication and interpersonal skills
Education Requirements
Bachelors degree with 4 years of experience or masters degree with 2 years or experience or Ph.D. Degree in Chemical/ Biochemical/ Biomedical Engineering Pharmaceutics Pharmaceutical Chemistry Pharmaceutical Sciences Chemistry Biochemistry or related field.
Experience and Skills
Experience and/or knowledge in one or more of the following:
Biologic molecule design
Formulation screening
Characterization
Process development or process modeling
Stability predictive modeling
Basic understanding of sterile product development and parenteral drug delivery
Preferred
Course work in physiology pharmacokinetics biochemistry protein sciences chemical kinetics Transport phenomenon polymer chemistry physical pharmacy is highly desirable.
Biologics formulation design/process development alternative processing approaches definition of critical attributes for process scaleup analytical development and Chemistry Manufacturing and Control filing for sterile dosage forms including ocular dosage forms peptide therapeutics and nonconventional drug delivery technologies (e.g. emulsions suspensions injectable depot)
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
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U.S. Hybrid Work Model
Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining 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 candidates relevant skills experience and education.
Expected US salary range:
$114700.00 $180500.00Available 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 Ordinance
Los 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 Ordinance
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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 preexisting 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/ARequired Skills:
Adaptability Adaptability Analytical Chemistry Bioanalysis Biochemistry Biomedical Engineering Biopharmaceuticals Bioprocessing Business Chemical Analysis Chemical Biology Clinical Physiology Communication CrossFunctional Teamwork Data Analysis Dosage Forms Drug Delivery Technology Environmental Toxicology Flow Cytometry Forensic Toxicology HighThroughput Screening Immunochemistry Innovative Thinking Interpersonal Relationships Management Process 19 morePreferred Skills:
Job Posting End Date:
05/16/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Senior IC
Employment Type
Full-Time
