Principal Scientist- Drug Substance
Company: EPM Scientific - Phaidon International
Location: Thousand Oaks
Posted on: October 18, 2024
Job Description:
Title: Principal Scientist- Drug SubstanceSalary:
$120-130kCompany: 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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Keywords: EPM Scientific - Phaidon International, Burbank , Principal Scientist- Drug Substance, Other , Thousand Oaks, California
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