Process Development Sr. Scientist

*Summary* We are seeking a highly motivated and technically strong *Process Development Sr. Scientist* to support process development, characterization, and manufacturing operations within a fast-paced pharmaceutical environment. The ideal candidate is a *hands-on technical problem solver* who can independently lead activities on the manufacturing floor, analyze process data, identify root causes, and develop practical solutions with limited direction. This role requires strong ownership, critical thinking, technical judgment, and the ability to take a problem from identification through resolution. The successful candidate will work closely with cross-functional teams and manufacturing operations to support process characterization, process improvements, troubleshooting, technical documentation, and execution of development activities. *Responsibilities* * Lead and execute process development and characterization activities in an operational/manufacturing environment. * Provide technical support directly on the manufacturing floor and independently troubleshoot process issues. * Analyze process and manufacturing data to identify trends, potential issues, and root causes. * Develop and implement technical solutions to complex process problems. * Take ownership of assigned activities and drive them from initiation through completion with limited supervision. * Support process characterization and development activities, including development or optimization of processes from the ground up. * Generate and review technical documentation, reports, protocols, and other process-related documentation. * Collaborate with Manufacturing, Engineering, Quality, Validation, and other cross-functional teams. * Make timely, data-driven decisions in a fast-paced operational environment. * Communicate technical findings and recommendations effectively to both technical and non-technical stakeholders. * Identify opportunities for process improvement and proactively recommend solutions. * Support manufacturing operations by providing technical expertise and resolving issues in real time. *Required Qualifications* * Doctorate (PhD, PharmD, or MD) with relevant postdoctoral experience where applicable; or Master's degree with 3+ years of relevant scientific experience; or Bachelor's degree with 5+ years of relevant scientific experience. * A degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Bioprocess Engineering, Pharmaceutical Sciences, Biotechnology, Biology, Microbiology, or a related scientific discipline is highly preferred. * Relevant experience in *process development, process characterization, manufacturing science, or a similar technical role* within the pharmaceutical, biotechnology, or manufacturing industry. * Demonstrated experience independently troubleshooting technical/process problems. * Strong analytical and critical-thinking skills with the ability to analyze data and determine root causes. * Demonstrated ability to take ownership of technical activities and drive them to completion with limited supervision. * Experience working in an operational or manufacturing environment. * Strong technical writing and communication skills. * Ability to work effectively in a fast-paced environment and make decisions in a timely manner. * Experience with *vial filling or aseptic filling operations*. * Experience supporting pharmaceutical manufacturing operations. * Experience performing process characterization and developing or optimizing processes from the ground up. * Experience with manufacturing troubleshooting and root-cause analysis. * Experience analyzing process data and using data to support technical decisions. * Experience generating technical documentation related to process development or characterization. * Experience working in a GMP-regulated pharmaceutical manufacturing environment. *What We Are Looking For* The ideal candidate is not simply someone who can execute a protocol or follow an established procedure. We are looking for a *technical owner and high performer* who can independently assess a situation, understand the problem, analyze the available data, determine the appropriate course of action, and drive the solution forward. Successful candidates should be able to demonstrate examples of: * Taking ownership of complex technical problems. * Leading activities with minimal direction. * Developing or improving a process rather than simply executing an established process. * Troubleshooting issues directly in a manufacturing environment. * Using data and scientific/engineering principles to identify root causes. * Making technical decisions and recommending solutions. * Successfully leading an activity from *problem identification through resolution*. *Experience in filling operations is highly preferred but not mandatory. Candidates with strong process development, technical problem-solving, and manufacturing experience will also be considered.* Job Type: Full-time Pay: $55.00 - $60.00 per hour Education: * Bachelor's (Preferred) Experience: * developing or optimizing processes: 5 years (Preferred) * process development: 5 years (Preferred) * process characterization: 5 years (Preferred) * manufacturing science: 5 years (Preferred) * troubleshooting technical/process problems: 5 years (Preferred) * analyze data and determine root causes: 5 years (Preferred) * operational or manufacturing environment: 5 years (Preferred) * vial filling: 5 years (Preferred) * aseptic filling operations: 5 years (Preferred) * supporting pharmaceutical manufacturing operations: 5 years (Preferred) Work Location: In person