Principal Scientist, Mixed Modality Product Development – Inhalation Full-time

Principal Scientist

The Mixed Modalities team is responsible for drug product development small, intermediate, and large molecules from preclinical toxicology studies to commercialization for parenteral and inhaled dosage forms. 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.

We are seeking a highly motivated candidate for the position of Principal Scientist with deep subject-matter expertise to lead the design and development of integrated (single-entity) and non-integrated (co-packaged/cross-labelled) inhalation products (i.e. DPIs, MDIs, nebulizers, nasal sprays, etc.). The successful candidate must be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.

Primary Duties

• Be a seasoned formulation scientist responsible for the design and development of inhaled dosage forms.
• Provide active strategic and technical leadership on program development teams, interfacing with key stakeholders, and collaborating across functions to drive defined milestones.
• Support both early and late-stage development candidates, including screening and development of robust drug product composition, combination product development, scalable process, primary packaging, compatibility characterization for processing and administration, and supporting regulatory filings.
• Collaborate with key stakeholders across the organizations (Research Division / Manufacturing Division) to drive key capability evaluations / builds and champion strategic and innovation objectives aligned with organizational goals.
• Maintain a strong network internally and across the external academic and regulatory community and build collaborations across internal company departments and key stakeholders.
• Mentor and/or supervise a small group of scientists to perform the above duties and to develop the above capabilities.

Minimum Education Requirements

• Ph.D. with 8+ years industry experience, M.S. with 10+ years, or B.S. with 14+ years with a degree in Chemical / Biochemical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry or related discipline

Required Experience and Skills

• Deep technical expertise in inhalation dosage forms (dry powder inhalers, metered dose inhalers, soft-mist inhalers, and/or nebulized formulations), including formulation, device interaction, and performance drivers.
• Proven experience in formulation development for pulmonary delivery: particle engineering, aerosol performance optimization, dispersion, and stability of respirable particles
• Hands-on knowledge of aerosol characterization methods and instruments: cascade impactors (NGI, ACI), aerodynamic particle size distribution (APSD), laser diffraction, Next Generation Impactor (NGI) operation and data interpretation
• Proficiency with device development and device/formulation compatibility testing, including dose delivery metrics, emitted dose, fine particle fraction, and device performance troubleshooting.
• Strong understanding of inhalation pharmacokinetics and lung deposition principles; experience with in vitro–in vivo correlation (IVIVC) and translating in vitro performance to clinical outcomes.
• Experience with regulatory expectations and dossier preparation for inhalation products (CMC sections for NDAs/BLAs/MAAs), including familiarity with ICH, FDA, and EMA guidance relevant to inhalation products.
• Practical knowledge of manufacturing and scale-up for inhalation products, including process development, technology transfer, and GMP considerations for device assembly and aseptic/non-aseptic steps where applicable.
• Experience, desire, and a track record of effective mentorship of junior scientists towards timebound goals.
• Strong knowledge of QbD principles and experience applying the QbD tools to drug product development, and experience in designing appropriate DOE studies to inform on risks.
• Demonstrated experience leading cross-functional teams and driving key capability evaluations and technology selection / builds.
• Excellent verbal and written communication skills, demonstrated initiative, strong interpersonal and collaboration skills, and a strong desire to learn and contribute.

Preferred Experience and Skills

• Experience with modeling and simulation tools for aerosol deposition or PK modeling (e.g., CFD, physiologically based PK models) is advantageous.
• Experience influencing regulatory strategies and a track record of supporting global filings.
• Prior experience working with biologic/large-molecule inhalation formulations is a plus.

Required Skills: Biopharmaceuticals, Chemical Engineering, Combination Products, Data Analysis, Dry Powder Inhalers (DPI), GMP Compliance, Innovative Thinking, Leadership Mentoring, Medicinal Chemistry, Mentorship, Pharmaceutical Process Development, Professional Collaboration, Professional Networking, Quality by Design, Regulatory Filings, Stakeholder Engagement, Strategic Thinking, Technology Transfer

Preferred Skills:

The salary range for this role is $173,200.00 – $272,600.00

This 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.