Process Development Sr Scientist

Job Description

Job Description

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.

Requirements

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.

Benefits

• 6-month contract with possible extension
• Administrative shift