Principal Scientist- Drug Substance

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
• Prepare, approve, and execute study and validation reports and protocols along with lead Quality by Design exercise and documents (process, FMEA's, risk assessment)
• Contribute 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, give technical input for SOP's and production records, and troubleshooting GMP equipment and processes
• Work alongside Global partners to support similar strategies and initiatives. Be the subject matter expert for audits, regulatory submissions, and change controls.
• Assist & own 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 the basic chemical and biological safety procedures, regulatory agency requirements and submission write up for the bio pharma, industry, experience participating in regulatory compliance audits
• Adept expertise understanding results of experiments and making recommendations for process improvements that reflect comprehension of regulatory requirements, business objectives, and cost ramifications. Success leading projects, tech transfer, and people to help manufacturing activities.
• Adept expertise performing Product Impact Assessments to support process deviations, creating risk assessment to support change controls and qualification activities, be able to prepare and execute study protocols to design and initiate quality scientific experimentation for purpose of 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, 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 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.