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Upper Gwynedd Township, Pennsylvania, United States
Onsite
Available
Job Description
Vaccine Drug Product Development (VDPD), 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:
Lead a matrixed team in the 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 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 minimum of 8 years of relevant industrial experience; an M.S. degree in a similar field with minimum of 10 years of relevant industrial experience; or a B.S. degree in a similar field with minimum of 12 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 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
#erp #PSCS #VDPD
Required Skills:
Adaptability, Adaptability, Biochemistry, Business Processes, Business Process Improvements, Business Process Modeling, Cell Culture Process Development, Cell Line Development, Combination Products, Data Analysis, Facilitative Leadership, Finite Element Analysis (FEA), GMP Compliance, Innovative Thinking, Leadership Mentoring, Mentorship, New Product Development, Pharmaceutical Process Development, Pharmaceutical Sciences, Professional Collaboration, Professional Networking, Quality by Design, Regulatory Filings, Risk Assessments, Strategic Thinking {+ 2 more}Preferred Skills:
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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:
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.
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The salary range for this role is
$173,200.00 - $272,600.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
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:
RegularRelocation:
DomesticVISA Sponsorship:
YesTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
08/17/2026*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.