Title: Principal Scientist- Drug Substance
Salary: $120-130k
Company: One of the largest award-winning Global Pharmaceutical companies in the world. Has been consistently recognized and Certified as a Global Top Employer.
Role Description: The Principal Scientist will assist the Manufacturing Sciences (MS) Department with its manufacturing procedures, particularly those related to cell culture and purification. In a multi-product manufacturing plant, you will be in charge of MS daily production support, inter-facility, and global process alignments/improvements activities of the commercial and clinical manufacturing operations. Technical transfers and process enhancements for manufacturing operations will receive your direct support. The Head of Manufacturing Sciences is the person to whom the Principal Scientist reports.
The Principal Scientist will be responsible for:
- Leading cross-functional teams to perform process optimization, technology transfer, as well as investigations.
- Preparing, approving, and executing study and validation reports and protocols along with leading Quality by Design exercises and documents (process, FMEA's, risk assessment).
- Contributing to Subject Matter Expert manufacturing investigations, monitoring of process performance (Lifestyle Process Validation Stage 3 Continuous Process Verification) to meet quality, yield, capacity, and timelines, providing technical input for SOPs and production records, and troubleshooting GMP equipment and processes.
- Working alongside Global partners to support similar strategies and initiatives. Being the subject matter expert for audits, regulatory submissions, and change controls.
- Assisting & owning Validation Master Plans, Process Validation and Material qualification activities to support process improvement, capital projects, technology transfer, and changes in material.
- Able to perform other duties that are assigned.
The Principal Scientist should have the following qualifications:
- Understanding of basic chemical and biological safety procedures, regulatory agency requirements, and submission write-up for the bio pharma industry, with experience participating in regulatory compliance audits.
- 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.
- Adept expertise in performing Product Impact Assessments to support process deviations, creating risk assessments to support change controls and qualification activities, and preparing and executing study protocols to design and initiate quality scientific experimentation for troubleshooting, scale-up, or process optimization.
- Knowledge of cell culture, purification, process scale-up, troubleshooting, and process technical evaluations. 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.
- 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.
Important 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.
If you are interested in the Principal Scientist role, then please don't wait to apply.
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