Associate Principal Scientist, Sterile Product Development

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, enabling scalable processes that meet stability, safety, efficacy, and delivery requirements. The team leverages smart experimental design, cutting‑edge analytical tools, and predictive approaches to inform molecule, formulation, and process selection, ultimately translating preclinical candidates into non‑oral drug products.

• Lead and contribute to innovative approaches for biologics sterile product development through experimental design, execution, and data analysis.
• Support early and late‑stage development candidates, including screening and development of robust drug product composition, scalable processes, primary packaging, processing compatibility, and regulatory filings.
• Build deep fundamental knowledge of the drug product to ensure milestone completion and regulatory documentation.
• Provide active strategic and technical leadership on program teams, interfacing with stakeholders and collaborating across functions.
• Lead and champion organizational strategic and innovation objectives aligned with organizational goals.
• Take initiative, demonstrate strong technical background, excellent communication and interpersonal skills, ability to multi‑task, mentor scientists, and a strong desire to learn and contribute.
• Lead project activities at external manufacturing sites, including technology transfer.
• Enhance the company’s professional image and competitive advantage through patents, presentations, publications, and professional activities.
• Maintain awareness of relevant new and current technologies and share knowledge with others.

• 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. in Engineering, Pharmaceutical Sciences or related discipline with a minimum of 8 years relevant industry experience.

• Experience in biologics process development and characterization, particularly for late‑stage programs.
• Ability to lead formulation development activities in matrix team environments to define robust formulations and manufacturing processes.
• Technical expert with proven ability to generate innovative ideas and solutions.
• 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 multidisciplinary team members.
• Strong verbal and written communication skills.
• Strong track record in product development, regulatory filing, drug delivery, complex formulation, and process development/characterization, reflected through industry experience and external publications or patents.

• Deep understanding of surface science, colloid science, particle engineering, or high concentration formulations.
• Prior experience leading enterprise‑level development projects.
• Capability to mentor peers and serve as a technical mentor.
• Subject matter expertise in at least one drug delivery or manufacturing technology.
• Demonstrated ability to address manufacturing challenges through innovative production technologies.
• Desire to build new capabilities via new technology evaluation and optimization of existing technologies.
• Experience with process scale‑up, modeling, regulatory filings, and key capability evaluation/​build preferred.

Salary range: $ – $. The successful candidate may also be eligible for annual bonus and long‑term incentive, if applicable. 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.

• Visa sponsorship:
  Yes
• Travel requirement: 10%
• Relocation:
  Domestic

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 any other legally protected characteristic. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.