Senior Scientist, Sterile and Speciality Products

Job Description

Sterile Product Development (SPD) 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.

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 late-stage 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

• Masters degree with four years or Ph.D. Degree in Chemical/ Biochemical/ Biomedical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry or related field (with expected completion by May 2025).

Required 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 scale-up, analytical development and Chemistry, Manufacturing and Control filing for sterile dosage forms including ocular dosage forms, peptide therapeutics, and non-conventional drug delivery technologies (e.g. emulsions, suspensions, injectable depot)

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U.S. Hybrid Work Model

Effective 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:

Available 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 pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

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