Principal Scientist, Vaccine Drug Product Development

MSD Malaysia; Pennsylvania; Hybrid; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Principal Scientist to drive innovation in vaccine drug product development. This role involves designing and executing experiments to create robust formulations and manufacturing processes that enhance global health. The successful candidate will work in a dynamic laboratory, collaborating across functions and leading teams to advance scientific innovation. If you are passionate about vaccine development and eager to make a significant impact, this opportunity is for you. Join a team that values diversity and fosters an inclusive environment where your contributions can lead to groundbreaking advancements in healthcare.

Qualifications

• 8+ years of relevant industrial experience for Ph.D. holders.
• Proven ability to lead and mentor less experienced scientists.
• Experience with regulatory filings for sterile dosage forms.

Responsibilities

• Design and execute experiments for stable formulations.
• Lead program development teams with strategic leadership.
• Mentor less experienced scientists and manage stakeholder expectations.

Skills

Ph.D. in chemical/biochemical engineering

Proven written and verbal communication skills

Facilitative leadership

Hands-on laboratory skills

Experience with GMP manufacturing

Experience developing vaccine adjuvant processes

Technical problem solving

Education

Ph.D. in relevant field

M.S. in relevant field

B.S. in relevant field

Tools

Statistical principles

Risk assessment tools

Job description

Principal Scientist, Vaccine Drug Product Development page is loaded

Principal Scientist, Vaccine Drug Product Development

Apply remote type Not Applicable locations USA - Pennsylvania - West Point time type Full time posted on Posted 2 Days Ago time left to apply End Date: May 13, 2025 (8 days left to apply) job requisition id R337015

Job Description

Vaccine Drug Product Development, a part of our company's Research Laboratories, is seeking a Principal Scientist to join our department in West Point, PA. Our mission is to develop novel vaccine drug products that will profoundly improve global human health—directly building from our company's 50+ year legacy as pioneers in the discovery, development, and manufacturing of novel vaccines to eliminate disease. Our department is responsible for developing vaccine adjuvants and drug products from preclinical studies through Phase III clinical trials with line of sight to commercialization. We ensure robust composition, primary packaging, and process development through deep fundamental understanding and characterization such that the process is scalable without compromising safety, efficacy, or stability. During development, we leverage smart experimental design, cutting edge analytical tools, and statistical/predictive approaches to inform formulation and process development. Our team enables the translation of vaccine preclinical candidates from concepts into robust commercial drug products.

Primary responsibilities of the role include design, execution, and documentation of experiments to develop stable formulations and robust manufacturing processes for preclinical and clinical supply production and to scale-up these processes to the pilot plant and commercial space. The successful candidate will be expected to work independently in a hands-on, dynamic laboratory environment engaged in development activities while also working collaboratively within the group, across functional areas, and with external partners.

Active strategic and technical leadership on program development teams will be required. Strong communication skills are expected to clearly communicate data and conclusions verbally, through written documents and reports, and technical presentations. Proven facilitative leadership and communication skills are essential to effectively lead matrix teams and manage expectations of stakeholders as part of our stage-gate process used to manage the development of new products. The role will also entail supporting or leading teams to advance areas such as science and technology innovation, business process improvement, and clinical manufacturing capability build.

Successful candidates are motivated to excel, willing to take initiative, have a strong desire to learn and contribute, and actively mentor less experienced scientists. Senior colleagues in Vaccine Drug Product Development have strong external scientific networks to help us maintain an awareness of industry challenges, trends, and opportunities. Successful candidates will have a track record of external publication, patenting, and presentations.

Required Experience and Skills

• Ph.D. in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, or related discipline with 8 years of relevant industrial experience; an M.S. degree in a similar field with 10 years of relevant experience; or a B.S. degree in a similar field with 12 years of relevant experience.
• Proven written and verbal communication skills
• Ability to prioritize, plan, and execute work with limited guidance
• Ability to work in a dynamic and fast-paced team environment
• Demonstrated facilitative leadership and influencing skills
• Hands on laboratory skills
• Experience developing vaccine adjuvant and/or vaccine drug product processes, or significant nucleic acid and lipid nanoparticle experience, including advanced knowledge of key unit operations (freeze/thaw, formulation, mixing, filtration, filling, stoppering, etc.)
• Understanding of vaccine adjuvant and/or drug product quality attributes, specifications, characterization techniques, and product vulnerabilities and mitigation strategies
• 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
• Experience with GMP manufacturing of clinical supplies
• Experience with use of statistical principles to understand, predict, and communicate process robustness
• Experience with root cause analysis and investigations (FMEA, fishbone, etc.)
• Experience authoring regulatory filings for sterile dosage forms (adjuvants and/or DP)
• Experience responding to regulatory questions related to drug products
• Experience, desire, and a track record of effective mentorship of less experienced scientists towards timebound goals

Desired Experience and Skills

• Experience with sterile product manufacturing and aseptic technique
• Experience with colloidal systems and characterization of colloids including emulsions
• Familiar with ISO, CFR, ICH, and USP guidelines as they relate to sterile products
• Familiar with Quality by Design principles and have experience applying the Quality by Design tools and principles to products in development
• Experience with process modeling
• Experience with liquid and lyophilized drug product formulation development
• Understanding of compliance and regulatory issues for sterile injectable products manufactured by aseptic processing
• Experience with direct people management

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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

Current Employees apply HERE

Current Contingent Workers apply HERE

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 if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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

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”.

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

Search Firm Representatives Please Read Carefully
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/International

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:

05/13/2025

*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.

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Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.