Merck & Co, Inc

Associate Principal Scientist, Vaccine Drug Product Development

Merck & Co, Inc$142K — $224K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Ph.D. in a relevant field with 6 years of experience; or an M.S. with 8 years; or a B.S. with 10 years of experience.
  • Proven written and verbal communication skills.
  • Ability to prioritize and execute tasks with limited guidance.
  • Experience with vaccine adjuvant or biologics drug product development.
  • Strong facilitative leadership and teamwork skills.
  • Hands-on laboratory experience in process development.
  • Experience with statistical methods for process robustness.

Responsibilities

  • Design and execute experiments for stable formulations and scalable manufacturing processes.
  • Collaborate with cross-functional teams and external partners in a dynamic lab environment.
  • Lead technical programs and demonstrate strategic leadership in project development.
  • Communicate data and findings effectively through reports and presentations.
  • Support innovation and process improvements in drug product development.
  • Mentor less experienced scientists and foster a culture of growth.
  • Advance technical capability in clinical manufacturing processes.

Benefits

  • Opportunity to work in a cutting-edge research environment.
  • Engagement in meaningful projects that contribute to public health.
  • Collaborative team culture with a focus on mentorship and development.
  • Access to advanced analytical and experimental design tools.
  • Chance to influence the translation of scientific concepts into commercial products.
Full Job Description
Job Description

Vaccine Drug Product Development, a part of our company's Research Laboratories, is seeking an Associate Principal Scientist to join our department in West Point, PA. 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:
  • 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 support 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.
  • 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 minimum of 6 years of relevant industrial experience; an M.S. degree in a similar field with minimum of 8 years of relevant industrial experience; or a B.S. degree in a similar field with minimum of 10 years of relevant industrial 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, vaccine drug product, and/or biologics drug product processes including advanced knowledge of key unit operations (freeze/thaw, formulation, mixing, filtration, filling, stoppering, etc.)
  • Understanding of sterile drug product quality attributes, specifications, characterization techniques, and product vulnerabilities and mitigation strategies
  • Track record of difficult technical problem solving
  • Ability to develop and implement new methods/processes
  • Experience with use of statistical principles to understand, predict, and communicate process robustness
  • Experience with root cause analysis and investigations (FMEA, fishbone, etc.)
  • 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, and experience with GMP manufacturing of clinical supplies
  • Experience with technical transfer of processes from lab to pilot plant and/or commercial sites including the use of risk assessment tools
  • Experience with engineering principles used in process development and process scale up/scale down
  • 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 liquid and lyophilized drug product formulation development
  • Experience authoring regulatory filings for sterile dosage forms (adjuvants and/or DP), and experience responding to regulatory questions related to drug products


#erp #PSCS #VDPD

Required Skills:
Biochemistry, Cell Line Development, Detail-Oriented, Downstream Process Development, Drug Delivery Technology, Drug Development, Expression Vectors, Facilitative Leadership, GMP Compliance, Interpersonal Relationships, Leading Project Teams, Mentorship, Molecular Biology, New Product Development, Pharmaceutical Formulations, Pharmaceutical Process Development, Physical Characterization, Process Scale Up, Risk Analysis, Risk Assessments, Stable Cell Lines

Preferred Skills:

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Current Contingent Workers apply HERE

Employee Status:
Regular

Relocation:
Domestic

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
08/5/2026
*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.

About Merck & Co, Inc

Schering-Plough Corporation is a major U.S.-based manufacturer of pharmaceuticals. It operates in three segments: Prescription Pharmaceuticals, Animal Health, and Consumer Health Care. Schering-Plough develops products targeting on allergy, cancer, hepatitis, cardiovascular, central nervous system, respiratory system, and more.  It was founded in 1851 by Ernst Christian Friedrich Schering as Schering AG in Germany. Schering-Plough manufactured several pharmaceutical drugs, the most well-known of which were the allergy drugs Claritin and Clarinex, an anti-cholesterol drug Vytorin, and a brain tumor drug Temodar. It also developed drugs targeting on central nervous system and the respiratory system. Schering Plough also owned and operated the major foot care brand name Dr. Scholl's and the skin care line Coppertone. These also became a part of the new company. Schering-Plough was a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA), a membership which is also maintained by the new Merck.

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Learn more about Merck & Co, Inc
Size
68,000 employees
Market Cap
$282.6 billion
Industry
Net Income
$7 billion
Founded
1668
5 Year Trend
+4.1%
Revenue
$47.9 billion
NASDAQ

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