Scientific Applications Scientist - Thousand Oaks, CA, United States - Takeda Pharmaceutical Company Limited

Description

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The Principal Scientist will support the Manufacturing Sciences (MS) Department specifically in Cell Culture and Purification manufacturing processes.

You will oversee MS daily manufacturing support, inter-facility, and global process alignments/improvements initiatives of commercial and clinical manufacturing operations of a multi-product manufacturing plant.

You will directly support manufacturing operation process improvements and technical transfers.
This is an on-site role that reports to the Head of Manufacturing Sciences.
Lead Quality by Design exercise and documents, (i.e. process FMEAs, risk assessments) as well as prepare, approve, and execute study and validation protocols and reports.

Support as Subject Matter Expert manufacturing investigations, monitoring of process performance (Lifecycle Process Validation Stage 3 Continuous Process Verification) to meet quality, yield, capacity, and timelines, troubleshooting GMP equipment and processes, providing technical input for SOPs and production records.

Be the subject matter expert for audits, change controls, and regulatory submissions.

Assist and own Validation Master Plans, Process Validation and Material qualification activities to support capital projects, process improvement, technology transfer, and material changes.

Bachelor's degree in a scientific discipline with at least 10 years of relevant experience, MS with at least 8 years, or PhD with at least 4 to 6 years of relevant experience.

Proficiency 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.

Proficient expertise performing Product Impact Assessments to support process deviations, generating risk assessment to support change controls and qualification activities, preparing and executing study protocols to design and undertake quality scientific experimentation for purpose of troubleshooting, scale-up, or process optimization.

Proficient expertise interpreting results of experiments and making recommendations for process improvements that reflect understanding of regulatory requirements, business objectives, and cost implications.

Proficiency leading projects, tech transfer, and people to support manufacturing activities.

Knowledge of basic chemical and biological safety procedures, regulatory agency requirements and submission write up for the bio pharma industry, experience participating in regulatory compliance audits.

At Takeda, our patients rely on us to deliver quality products.

As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product.

Normal office environment.

Will need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.

We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

#The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
S. based employees may be eligible for short-term and/ or long-term incentives. S.

based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Full time
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