Process Development Sr Scientist

The Process Development Senior Scientist independently designs, executes, and advances scientific studies that support drug product development, aseptic filling operations, and commercial manufacturing readiness. This role serves as a key technical resource and project leader, generating robust data, interpreting complex results, and driving strategic decisions. The Senior Scientist introduces new technologies, authors technical documentation, and collaborates cross‑functionally to ensure process reliability, compliance, and continuous improvement.

KEY RESPONSIBILITIES

• Independently plan, conduct, and monitor experiments, studies, and multi‑stage investigations to advance process development and manufacturing technologies.
• Perform advanced data analysis and interpretation; assess impact on project objectives and recommend scientifically sound actions.
• Expand scientific knowledge beyond core expertise to support innovation and technical problem‑solving.
• Identify and evaluate relevant external scientific and competitive insights.
• Develop novel protocols, experimental designs, and characterization strategies.
• Serve as a key contributor and technical leader within independent research or project teams.
• Initiate and maintain productive collaborations across departments and external partners.
• Introduce new technologies, concepts, and process improvements to enhance operational efficiency.
• Author and lead complex technical documents, including validation protocols, characterization studies, technical reports, investigations, and change controls.
• Lead department‑wide initiatives such as safety programs, recruiting efforts, and committee participation.
• Mentor junior staff and develop supervisory capabilities.
• Make proactive, data‑driven decisions that support project milestones and manufacturing timelines.
• Plan detailed project procedures, including timelines, resource needs, methodologies, and expected outcomes.

COMPETENCIES

• Strong leadership skills with the ability to motivate, supervise, and guide others.
• Ability to develop realistic project timelines and manage multiple priorities.
• Advanced problem‑solving skills grounded in scientific theory and experimental design.
• Independent development of scientific analyses, solutions, and technical strategies.
• High degree of autonomy in determining scientific objectives and approaches.
• Strong laboratory execution, project management, and organizational skills.
• Creativity in hypothesis generation and experimental innovation.
• Critical evaluation and detailed interpretation of scientific results.
• Deep understanding of scientific relevance and regulatory expectations for targeted work.

• Doctorate (PhD, PharmD, or MD) with relevant postdoctoral experience, OR
• Master’s degree with 3+ years of scientific experience, OR
• Bachelor’s degree with 5+ years of scientific experience.

Preferred academic disciplines: Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Bioprocess Engineering, Pharmaceutical Sciences, Biotechnology, Biology, Microbiology, or related scientific fields.

Technical Requirements:

• Proficiency in Microsoft Office (Excel, Word, PowerPoint).
• Experience with statistical software such as JMP or Minitab.
• Familiarity with Sample Management Systems (LIMS, HLEE).
• Bilingual (English and Spanish).

PREFERRED QUALIFICATIONS

• Experience supporting sterile drug product manufacturing in pharmaceutical or biotechnology environments.
• Hands‑on experience with aseptic filling operations, process characterization, PPQ, technology transfer, and commercial manufacturing support.
• Demonstrated ability to author and execute validation protocols, characterization studies, technical reports, investigations, and change controls.
• Strong knowledge of GMP, aseptic processing principles, contamination control strategy, and pharmaceutical quality systems.
• Experience applying statistical analysis (JMP/Minitab) to drive process optimization and data‑driven decision‑making.
• Ability to analyze manufacturing data, identify trends, and recommend scientifically sound improvements.
• Proven success working with Manufacturing, Quality, Engineering, Regulatory, and Technical Services teams.
• Exceptional technical writing, communication, presentation, and project management skills.
• Ability to independently manage multiple projects in a fast‑paced, highly regulated environment.
• Experience with single‑use technologies, filling equipment, and sterile manufacturing operations.

• 6-month contract with possible extension
• Administrative shiff