Process Development Scientist - Manufacturing at BioPharma Consulting JAD Group

Juncos, , Puerto Rico -

Full Time

Start Date

Immediate

Expiry Date

05 Oct, 26

Salary

0.0

Posted On

07 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Development, GMP Regulations, Statistical Analysis, Technical Writing, Experimental Design, Troubleshooting, Project Management, Data Interpretation, Aseptic Filling, Root Cause Analysis, Process Optimization, Technology Transfer, Protein Science, Formulation Development, JMP Software, Cross-functional Collaboration

Industry

Biotechnology Research

Description

The Process Development Scientist is responsible for designing, executing, and interpreting scientific studies that support process development, manufacturing operations, and continuous improvement initiatives within a regulated environment. This role applies scientific expertise to process optimization, troubleshooting, investigations, and data analysis while collaborating with cross-functional teams to ensure robust manufacturing processes, product quality, and regulatory compliance. Key Responsibilities Design, execute, monitor, and interpret scientific studies to support process development and manufacturing operations. Develop experimental strategies that generate robust, reliable, and scientifically sound data. Evaluate scientific results and provide technical recommendations based on data analysis. Support process characterization, optimization, and technology transfer activities. Develop and implement new methodologies, protocols, and experimental approaches to improve manufacturing processes and resolve technical challenges. Stay current with scientific literature, industry trends, and emerging technologies relevant to process development. Provide scientific support for commercial manufacturing operations, including formulation and aseptic filling processes. Collaborate with Manufacturing, Quality, Engineering, Validation, and Process Development teams to resolve technical issues. Support manufacturing floor activities by providing process expertise in a fast-paced production environment. Monitor process performance through data trending and statistical analysis. Identify opportunities for process optimization and continuous improvement. Support deviations, investigations, root cause analyses, and product impact assessments. Ensure scientific studies and process development activities comply with GMP requirements and applicable regulatory guidelines. Prepare scientific reports, technical summaries, protocols, validation documentation, and regulatory support documents. Participate in audit readiness activities and provide technical support during regulatory inspections. Analyze manufacturing and experimental data using statistical tools to identify trends and improve process performance. Interpret results and communicate findings to project teams and leadership. Author technical reports, scientific documentation, protocols, and presentations. Present scientific findings to cross-functional teams and management. Participate on multidisciplinary teams supporting process development, technology transfer, manufacturing, and continuous improvement initiatives. Collaborate with internal and external stakeholders to achieve project objectives. Mentor junior scientists and provide technical guidance as appropriate. Support departmental initiatives related to safety, operational excellence, and knowledge sharing. Manage project timelines and ensure timely completion of assigned deliverables. Skills Strong understanding of process development principles and experimental design. Knowledge of GMP regulations and regulated manufacturing environments. Excellent analytical, laboratory, troubleshooting, and problem-solving skills. Strong statistical analysis and data interpretation capabilities. Excellent technical writing, documentation, and presentation skills. Strong verbal and written communication skills. Effective project management and organizational skills. Ability to manage multiple priorities in a fast-paced environment. Proficiency with Microsoft Office applications (Word, Excel, PowerPoint). Strong collaboration skills and the ability to work effectively across cross-functional teams. Qualifications Doctorate degree, OR Master's degree with 2+ years of scientific experience, OR Bachelor's degree with 4+ years of scientific experience. Preferred Qualifications Degree in Life Sciences, Biochemistry, Chemical Engineering, Biotechnology, Biology, Pharmaceutical Sciences, or a related scientific discipline. Experience supporting process development or commercial biotechnology/pharmaceutical manufacturing. Understanding of protein science, formulation development, and aseptic manufacturing processes. Experience with process monitoring, statistical analysis, and data trending. Experience using statistical software such as JMP or similar analytical tools. Experience supporting deviations, investigations, root cause analysis, and product impact assessments. Strong technical writing skills with experience preparing scientific, validation, or regulatory documentation. Bilingual proficiency in English and Spanish. 6-month contract with possible extension Administrative Shift

Responsibilities

The role involves designing and executing scientific studies to optimize manufacturing processes and ensure regulatory compliance. It also requires collaborating with cross-functional teams to resolve technical issues and support commercial manufacturing operations.