Process Development Sr Scientist

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