Process Development Scientist 3546379
Title: Process Development Scientist – 3546379
Location: Hybrid/Remote – Administrative Shift (Open to Puerto Rico Residents)
Contract Duration: Approximately 10 months
Open Positions: 1
Our client is seeking a highly motivated Process Development Scientist to support commercial biopharmaceutical manufacturing operations. This role requires the ability to provide hands-on manufacturing floor support in a fast-paced, 24/7 production environment, while also contributing to scientific strategy, data analysis, and cross-functional project execution.
Summary
Under general supervision, the Process Development Scientist will conceive, design, implement, and execute scientific experiments that contribute to the successful completion of project goals. The role involves providing technical expertise, interpreting data, ensuring compliance with regulatory requirements, and supporting manufacturing operations—particularly in formulation and aseptic filling processes.
Preferred Qualifications
- Academic background in Life Sciences or Engineering (e.g., Biochemistry, Chemical Engineering).
- Experience in a commercial biopharmaceutical manufacturing environment, preferably supporting formulation and aseptic filling operations.
- Strong understanding of protein science, formulation development, and filling processes.
- Experience with process monitoring, data trending, and statistical analysis tools (e.g., JMP).
- Experience supporting deviations, investigations, root cause analysis, and product impact assessments.
- Ability to provide manufacturing floor support in a fast-paced, 24/7 operation.
- Bilingual proficiency in English and Spanish (written and verbal).
- Strong technical writing skills, including preparation of documentation for regulatory audits.
- Excellent communication, presentation, problem-solving, project management, and cross-functional collaboration skills.
Key Responsibilities
- Conceive, design, execute, evaluate, and interpret experimental strategies.
- Provide technical input to develop robust and reliable processes.
- Ensure studies are conducted in compliance with approved protocols and applicable regulatory guidelines.
- Monitor, conduct, and analyze experimental strategies with general supervision.
- Perform data analysis, interpret findings, and assess project impact.
- Stay current with scientific literature, emerging technologies, and advancements relevant to the role.
- Develop and implement innovative protocols to address technical challenges.
- Author scientific reports, summary documents, and complex regulatory documentation independently.
- Support deviation investigations, technical assessments, and continuous improvement initiatives.
- Represent the department on cross-functional project teams as needed.
- Provide guidance on experimental design and data interpretation.
- Contribute to department-wide initiatives such as safety, recruiting, and committee participation.
- Develop project timelines and ensure timely completion of deliverables.
Education Requirements
- Doctorate degree; OR
- Master’s degree with a minimum of 2 years of scientific experience; OR
- Bachelor’s degree with a minimum of 4 years of scientific experience.
Core Competencies
- Advanced scientific analysis and troubleshooting capabilities.
- Strong laboratory and technical execution skills.
- Knowledge of cGMP regulations and regulatory compliance requirements.
- Excellent verbal and written communication skills, including technical writing.
- Analytical problem-solving and project management expertise.
- Ability to work effectively across departments in a dynamic environment.
- Organizational skills with the ability to manage multiple projects simultaneously.
- Flexibility and adaptability in managing change.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).
- Creative scientific thinking and application of theoretical knowledge to practical solutions.
- Fully bilingual (English/Spanish).
If you meet the qualifications and are interested in contributing your expertise to a dynamic biopharmaceutical manufacturing environment, we encourage you to apply through the job description link and submit your updated resume for consideration.