Process Development Scientist

The Process Development Scientist conceives, designs, implements, and executes scientific experiments that support project and organizational goals. Working under general guidance, this role contributes to process development, data generation, troubleshooting, and technical support for manufacturing operations, including formulation and aseptic filling.

FUNCTIONS

• Conceive, design, execute, evaluate, and interpret experimental strategies.
• Develop and implement new or novel protocols to address specific technical issues.
• Ensure studies are conducted in compliance with protocols, guidelines, and applicable regulations.
• Provide input to new processes to ensure robust and reliable data generation.
• Introduce advanced scientific methods when appropriate.
• Stay current with scientific literature, technology developments, and trends relevant to the function.
• Perform data analysis, interpretation, and assess impact on project objectives.
• Independently author scientific reports, summary documents, regulatory documents, invention disclosures, and patents.
• Support process monitoring, data trending, and statistical analysis (e.g., JMP).
• Prepare documentation suitable for regulatory audits and technical reviews.
• Represent the department on project teams under supervision of senior scientific staff.
• Initiate productive collaborations within and outside the department.
• Provide guidance to others in experimental design, data interpretation, and troubleshooting.
• Support deviations, investigations, root cause analysis, and product impact assessments.
• Provide real‑time manufacturing floor support in fast‑paced, 24/7 operations, including formulation and aseptic filling.
• Participate in external scientific community activities.
• May lead department-wide initiatives such as safety, recruiting, or committees.
• May develop supervisory and mentoring skills.
• Develop and follow timelines for project deliverables.

COMPETENCIES & SKILLS

• Advanced scientific analysis, troubleshooting, and laboratory skills.
• Strong knowledge of cGMP and application of scientific theory.
• Creative experimental design and interpretation of results.
• Understanding of protein science, formulation, and aseptic filling processes.
• Experience in drug product manufacturing and process validation.
• Proficiency in Windows environment (Word, Excel, PowerPoint).
• Experience with statistical tools (e.g., JMP) and data trending.
• Ability to analyze complex datasets and communicate findings clearly.
• Strong verbal and written communication skills, including technical writing.
• Negotiation, conflict resolution, analytical problem‑solving, and project management skills.
• Ability to motivate or supervise others.
• Fully bilingual (English/Spanish).

EDUCATION REQUIREMENTS

• Doctorate OR
• Master’s + 2 years of scientific experience OR
• Bachelor’s + 4 years of scientific experience

Preferred:

• Chemical Engineering, Mechanical Engineering, Biology, Chemistry, or related scientific discipline.

PREFERRED QUALIFICATIONS

• Experience in commercial biopharmaceutical manufacturing, especially formulation and aseptic filling.
• Strong background in deviations, investigations, and root cause analysis.
• Experience writing technical protocols, reports, and regulatory documentation.
• Ability to provide real‑time support on the manufacturing floor in a 24/7 operation.
• Excellent communication, presentation, problem‑solving, and cross‑functional collaboration skills.

• Administrative Shift
• 6- month contract with possible extension