Associate Principal Scientist, Sterile Product Development

MSD Malaysia; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Job summary

Merck in the United States is seeking an Associate Principal Scientist focused on developing parenteral drug products across modalities. You will lead internal and external programs, drive robust formulation and manufacturing processes, and work within a multidisciplinary team to meet milestones.

The role requires deep expertise in biologics formulation, process development, and regulatory strategy, with a proven track record in late-stage development and technology transfer.

Qualifications

• Experienced in biologics process development and characterization, especially for late-stage programs.
• Able to lead formulation development activities in matrix team environments to define robust formulations and manufacturing processes.
• Recognized as a technical expert with a track record of innovative ideas and external publications/patents.

Responsibilities

• Lead/contribute towards innovative approaches for biologics sterile product development through experimental designs and data analysis.
• Support both early and late-stage development candidates, including screening and development of robust drug product composition and scalable processes.
• Build deep fundamental knowledge around the drug product to ensure milestone completion and regulatory documentation.
• Provide strategic and technical leadership on program development teams and interface with stakeholders across functions to drive milestones.
• Lead and champion organizational strategic and innovation objectives aligned with company goals.
• Take initiative, excel, mentor scientists, and contribute to learning and knowledge sharing.
• Lead project activities at external manufacturing sites including technology transfers.
• Enhance Merck's professional image through patents, presentations, and publications.

Skills

Biologics process development

Formulation development

Regulatory filings

Complex formulation

Team leadership

Strong communication

Interdisciplinary collaboration

Education

PhD in Chemical Engineering

BS/MS in Engineering or related

Job description

Job Description

The Mixed Modalities team within Sterile Product Development is responsible for developing parenteral dosage forms (injections, implants, inhaled, ocular) for small, intermediate, and large molecules from preclinical toxicology studies to commercialization. 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 Associate Principal Scientist focused on developing parenteral drug products across a range of modalities (small molecule, peptides, proteins, antibody-drug conjugates, and biologics). The successful candidate must be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.

Primary duties

Lead/ contribute towards the new, innovative approaches for biologics sterile product development through the generation of experimental designs, execution of experimental plans and data analysis

Support both early and late-stage development candidates, including screening and development of robust drug product composition, scalable process, primary packaging, compatibility characterization for processing and administration, and supporting regulatory filings.

Build deep fundamental knowledge around the drug product to ensure completion of key milestones and laboratory / regulatory documentation.

Active strategic and technical leadership on program development teams, interfacing with key stakeholders, and collaborating across functions to drive defined milestones will be required.

Responsible for leading and championing organizational strategic and innovation objectives aligned with organizational goals.

Be willing to take initiative, motivated to excel, have a strong technical background, have excellent communication and interpersonal skills, ability to multi-task, mentor scientists, and a strong desire to learn and contribute.

Leads project activities at external manufacturing sites including tech transfers

Enhance our Company's professional image and competitive advantage through patents, presentations, publications and professional activities and advance areas such as science and technology development, technical and business strategic improvements, business process innovations

Maintain awareness of relevant new and current technologies, capabilities, and effectively share this knowledge with others

Education

Minimum Requirement: Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 4 years relevant industry experience. B.S. or M.S. degree in Engineering, Pharmaceutical Sciences or related discipline with minimum of 8 years relevant industrial experience.

Required Experience and Skills

Experienced in biologics process development and characterization particularly for late-stage programs Capable of leading formulation development activities in matrix team environments to define a robust formulation and manufacturing process Recognized as a technical expert and scientific contributor with proven ability to identify and develop innovative ideas Has broad knowledge of formulation science and in depth-knowledge in multiple areas, including core understanding of the drug development process Track record of working effectively with team-members of skill sets and backgrounds Strong verbal and written communication skills The candidate should have a strong track record in product development/ regulatory filing/ drug delivery/ complex formulation and process development/ characterization reflected through industry experience and external publications/ patent

Preferred Experience and Skills

Deep understanding of one or more of the following: surface science, colloid science, particle engineering and/or high concentration formulations Prior experience leading development projects at an enterprise level Capable of mentoring individuals in a peer-to-peer fashion and as a technical mentor Recognized as a subject matter expert in at least one drug delivery and/or manufacturing technology Demonstrated ability to identify, fundamentally characterize and address manufacturing challenges through the development and optimization of novel production technologies. Desire to build new capabilities through the evaluation of new technologies and hands‑on optimization of existing technologies. Prior experience with process scale up, modeling, regulatory filings and/or driving key capability evaluation/ build would be highly preferred

Required Skills

Antibody Drug Conjugates (ADC), Antibody Drug Conjugates (ADC), Biomedical Engineering, Cell Line Development, Competitive Advantages, Detail-Oriented, Development Projects, Downstream Process Development, Drug Delivery Technology, Drug Development, Expression Vectors, Interpersonal Relationships, Leading Project Teams, Molecular Biology, Multitasking, Particle Physics, Peer Mentoring, Pharmaceutical Biology, Pharmaceutical Formulations, Pharmaceutical Process Development, Pharmaceutical Sciences, Physical Characterization, Process Scale Up, Stable Cell Lines, Stakeholder Engagement {+ 1 more}

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

US and Puerto Rico Residents Only

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

The salary range for this role is $142,400.00 - $224,100.00 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

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

Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a

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.