The Process Development Sr Scientist independently conceives, designs, implements, and advances scientific experiments that drive process understanding, technology development, and manufacturing support. This role serves as a key scientific and technical resource, contributing to project leadership, data-driven decision-making, and continuous improvement of sterile drug product operations. The scientist applies deep technical expertise, introduces innovative methodologies, and collaborates cross-functionally to ensure robust, compliant, and efficient processes.
FUNCTIONS & RESPONSIBILITIES
- Independently design, execute, monitor, and interpret complex experiments or series of studies to advance process development and manufacturing technologies.
- Prepare novel protocols and experimental designs that address technical challenges and enhance process robustness.
- Introduce new scientific concepts, advanced technologies, and innovative approaches to strengthen process understanding.
- Expand knowledge beyond core expertise and proactively identify relevant external scientific or competitive advancements.
- Perform advanced data analysis using statistical tools (e.g., JMP, Minitab) to identify trends, characterize processes, and support data-driven decision-making.
- Assess the impact of experimental results on project objectives and recommend scientifically sound actions.
- Author high-quality scientific documentation, including technical reports, characterization studies, validation protocols, investigations, and change controls.
- Contribute as lead author to scientific journal articles or complex technical documents when applicable.
- Provide hands-on support to sterile drug product manufacturing, including formulation, aseptic filling, and commercial process readiness.
- Support process characterization, technology transfer, PPQ/validation activities, and continuous improvement initiatives.
- Analyze manufacturing data to identify process trends, deviations, and opportunities for optimization.
- Apply contamination control principles, aseptic processing knowledge, and GMP requirements to ensure compliant operations.
- Serve as a key contributor or project leader within independent research or technical teams.
- Initiate productive collaborations with Manufacturing, Quality, Engineering, Regulatory, and Technical Services.
- Mentor junior staff and develop supervisory capabilities.
- Lead department-wide initiatives such as safety programs, recruiting efforts, and technical committees.
- Make proactive decisions that support milestone achievement and project success.
- Plan detailed procedures for assigned projects, including timelines, milestones, methodologies, expected outcomes, and resource needs.
- Manage multiple projects simultaneously in a fast-paced environment while maintaining high scientific rigor and documentation quality.
COMPETENCIES & SKILLS
- Strong foundation in sterile drug product manufacturing, aseptic processing, and contamination control strategy.
- Ability to solve complex problems using scientific theory and critical thinking.
- Demonstrated capability to independently develop scientific analyses, hypotheses, and solutions.
- Strong laboratory skills and experience with process characterization and validation.
- Proficiency with Microsoft Office (Excel, Word, PowerPoint).
- Experience with statistical software such as JMP or Minitab.
- Familiarity with sample management systems (LIMS, HLEE).
- Ability to interpret large datasets and communicate findings clearly.
- Ability to motivate, lead, and supervise others.
- Strong project management skills and ability to develop realistic timelines.
- Excellent technical writing, communication, and presentation skills.
- Fully bilingual in English and Spanish.
EDUCATION REQUIREMENTS
- Doctorate (PhD, PharmD, MD) with relevant postdoctoral experience where applicable OR
- Master’s degree + 3 years of scientific experience OR
- Bachelor’s degree + 5 years of scientific experience
Highly Preferred Disciplines: Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Bioprocess Engineering, Pharmaceutical Sciences, Biotechnology, Biology, Microbiology, or related scientific fields.
PREFERRED QUALIFICATIONS
- Experience supporting sterile drug product manufacturing in pharmaceutical or biotechnology environments.
- Hands-on experience with aseptic filling equipment, single-use technologies, and commercial manufacturing operations.
- Strong background in process validation (PPQ), technology transfer, and characterization studies.
- Demonstrated ability to author and execute validation protocols, technical reports, investigations, and change controls.
- Proven success analyzing manufacturing data, identifying trends, and recommending scientifically sound improvements.
- Experience working in cross-functional teams and supporting fast-paced, 24/7 operations.
- Ability to manage multiple complex projects while maintaining high quality and compliance standards.
- 6-month contract with possible extension
- Administrative shift