Primary responsibilities include leading drug product development teams, technical mentorship of less experienced scientists, providing strategic and technical guidance to drug product development teams, and establishing capabilities at our Company to enable our current and future vaccine drug product pipeline. The successful candidate will be a recognized scientific leader able to work independently on challenging scientific problems, possess a strong external network, and be able to technically influence and lead our most complex drug product development programs and initiatives. Senior Principal Scientists are continual learners that promote and foster an environment of continual learning-challenging our collective group to advance our fundamental understanding of our products and how they work and how we can ensure their continued performance.

Exceptional communication skills are required to effectively communicate with stakeholders and scientists across all levels in our organization. The successful candidate will be able to distill complex strategic and technical challenges into clear and easy to understand messages to guide teams and our broader organization toward our goal of positively impacting global human health.

Required Experience and Skills

• Ph.D. in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, or related discipline with 12 years of relevant industrial experience; an M.S. degree in a similar field with 18 years of relevant experience; or a B.S. degree in a similar field with 20 years of relevant experience.
• Proven written and verbal communication skills
• Demonstrated ability to prioritize, plan, and execute work with limited guidance on technically and strategically complex projects
• Demonstrated ability and strong desire to teach and mentor peers and less experienced staff
• Subject matter expertise with drug product process scale-up, modeling, and/or regulatory filings
• Subject matter expertise in virology, stability of biologics, biophysical characterization, adjuvant science, and/or infectious diseases
• Subject matter expertise in unit operations commonly used to manufacture vaccine drug products (lyophilization, sterile filtration, vial filling, etc.)
• Subject matter expertise with the design of stable drug products in complex modalities (lipid nanoparticles, adjuvant systems, live virus, protein conjugates, and/or combinations of these modalities)
• Familiarity with common analytical techniques associated with vaccine drug product development
• Ability to identify critical quality attributes associated with complex drug products and translation of these CQAs to practical control strategy elements and robust capable formulations and processes
• Ability to work in a dynamic and fast-paced team environment
• Demonstrated facilitative leadership and influencing skills
• Experience with engineering principles used in process development and process scale up/scale down
• Experience with technical transfer of processes from lab to pilot plant and/or commercial sites including the use of risk assessment tools
• Track record of difficult technical problem solving
• Ability to develop and implement new methods, processes, and/or technologies
• Experience with GMP manufacturing of sterile drug products
• Experience with use of statistical principles to understand, predict, and communicate process robustness
• Experience with root cause analysis and investigations (FMEA, fishbone, etc.)
• Familiar with ISO, CFR, ICH, and USP guidelines as they relate to sterile products
• Experience authoring regulatory filings for sterile dosage forms (adjuvants and/or DP)
• Experience responding to regulatory questions related to drug products
• Strong external presence including publications, invited presentations, and patents

Desired Experience and Skills

• Experience with drug-device combination product development like pre-filled syringes
• Experience with the commercialization of novel vaccine drug products and adjuvant systems
• Experience with process modeling
• Understanding of compliance and regulatory issues for sterile injectable products manufactured by aseptic processing
• Experience with direct people management
• Familiarity with disease areas commonly associated with new vaccine drug products

#PSCS

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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".

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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:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
11/9/2024
*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:R316115