Principal Scientist- Drug Substance
1 month ago
Principal Scientist- Drug Substance
Job Summary:
We are seeking a highly skilled Principal Scientist to join our Manufacturing Sciences Department. The successful candidate will be responsible for leading cross-functional teams to perform process optimization, technology transfer, and investigations. The ideal candidate will have a strong understanding of basic chemical and biological safety procedures, regulatory agency requirements, and submission write-up for the bio-pharma industry.
Key Responsibilities:
• Lead cross-functional teams to perform process optimization, technology transfer, and investigations.
• Prepare, approve, and execute study and validation reports and protocols, and lead Quality by Design exercises and documents.
• Contribute to Subject Matter Expert manufacturing investigations, monitoring of process performance, and providing technical input for SOPs and production records.
• Work alongside Global partners to support similar strategies and initiatives.
• Be the subject matter expert for audits, regulatory submissions, and change controls.
• Assist and own Validation Master Plans, Process Validation, and Material qualification activities to support process improvement, capital projects, technology transfer, and changes in material.
• Perform other duties as assigned.
Requirements:
• Bachelor's degree in a scientific discipline with a minimum of 10 years' experience, MS with at least 8 years, or PhD with at least 4 to 6 years of relevant experience.
• Strong understanding of basic chemical and biological safety procedures, regulatory agency requirements, and submission write-up for the bio-pharma industry.
• Adept expertise in understanding results of experiments and making recommendations for process improvements that reflect comprehension of regulatory requirements, business objectives, and cost ramifications.
• Success in leading projects, tech transfer, and people to help manufacturing activities.
• Proficient in statistical analysis and experimental design, with knowledge of laboratory and pharmaceutical production equipment including bioreactors, chromatography processes, ultrafiltration, diafiltration, sterile filtration, process tanks, and CIP/SIP systems.
Work Environment Considerations:
• Could require availability outside of business hours.
• Work around specific chemicals such as alcohol, buffers, and celite that may require respiratory protection.
• Cold, hot, or wet work environment.
• Remove all make-up, jewelry, contact lenses, nail polish, and/or artificial fingernails while in manufacturing environment.
• Environments may require special gowning and protective clothing over the head, face, hands, feet, and body. Could include additional hearing protection for loud areas.
• Fast pace and job demands may be high.
• Regular office environment.
• May be required to lift up to 35 pounds when handling samples.
• Overall physical exertion of this position is medium work.
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