Job Description

The 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

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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 development

• The 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 facilities

• The candidate should have strong familiarity with relevant biologic analytical methods and specifications for drug products as well as drug substance downstream formulation considerations

• The candidate should have experience in developing combination products for biologic therapeutics

• The 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 development

Preferred 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 success

Experience 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.

#EligibleforERP

NOTICE FOR INTERNAL APPLICANTS

In 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.

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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:

$149,400.00 - $235,100.00

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.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

10/23/2024

*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.

Requisition ID:R298071