Process Development Scientist -05
About The Position
The Process Development Scientist will provide scientist services in the Process Development: Inspection Projects area. The role involves developing and conducting experimental strategies, producing reliable data, and supporting process development and inspection projects in a regulated pharmaceutical environment. The scientist will analyze and interpret data, assess its impact on projects, and ensure studies follow protocols and applicable guidelines and regulations. The position calls for experience with automated and manual visual inspection of finished drug products; incoming quality inspection of primary packaging components; GMP packaging line clearance, verification, and in-process controls; and laboratory sample testing and data collection. The role also includes scientific reporting, collaboration, project teamwork, and potentially representing the department on project teams under senior scientific staff supervision. The shift is administrative and may vary according to business needs.
Requirements
- Bachelor's degree.
- Four years of experience as a Scientist within the pharmaceutical or regulated industry.
- Bilingual in English and Spanish.
- Project management skills.
- Experience with automated and manual visual inspection of finished drug products.
- Experience with incoming quality inspection of primary packaging components, including vials, stoppers, caps, and syringes.
- Experience with GMP packaging line clearance, verification, and in-process controls.
- Experience with process development laboratory sample testing and data collection.
Responsibilities
- Conceive, design, execute, evaluate, and interpret experimental strategies.
- Provide input to new processes to generate robust and reliable data.
- Ensure studies are conducted in compliance with their protocols and applicable guidelines and regulations.
- Design, monitor, or conduct experimental strategies with general guidance from the supervisor.
- Analyze and interpret data and assess its impact on the project.
- Stay current in the field of scientific expertise and other areas relevant to the role.
- Monitor relevant literature and technology developments and communicate observations.
- Introduce advanced scientific methods when appropriate.
- Develop and implement new protocols to address specific issues.
- Represent the department on project teams under the supervision of a senior scientific staff member, when appropriate.
- Initiate productive collaborations within and outside the department or company, when appropriate.
- Advise or assist others with experimental design or data interpretation and diagnosis, and implement innovative remedies.
- Independently author scientific reports, summary documents, complex regulatory documents, invention disclosures, and/or patents.
- Participate in the external scientific community.
- Potentially take a lead role in department-wide support efforts, such as safety, recruiting, and committees.
- Develop supervisory and mentoring skills.
- Develop and follow timelines for completing project teamwork.
Benefits
- The company describes itself as flexible and family-oriented, with a focus on employee well-being.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
