Sr. Manufacturing Associate

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Job Description

Job Title: Sr. Manufacturing Associate

Location: Thousand Oaks, CA

About the role:

As the Sr. Manufacturing Associate, you will execute all processes in the production area while strictly adhering to CGMP, environmental health and safety guidelines and any other related regulations under the direction of the Supervisor. You will report to the Supervisor, Manufacturing.

How you will contribute:

• Support Cell Culture/Purification operations to produce a bulk drug substance product.

• Prepare media and buffer solution. Perform sampling using aseptic techniques.

• Clean, set up, operate, and teardown of equipment such as tanks, filtration systems, carton assembler, bioreactors, and production lines.

• Gain qualification to perform CIP, SIP autoclave, small parts preparation.

• Operate general production equipment (such as pH and conductivity meters, autoclave, portable mixers).

• Perform routine maintenance and cleaning of production equipment to maintain equipment in GMP fashion. Perform moderate troubleshooting. Monitor and record critical process parameters.

• Identify processing gaps and help implement new technologies.

• Receive and distribute supplies into production area.

• Complete relevant paperwork following GDP/GMP guidelines. Rewrite complex procedures or initiate new procedures as applicable. Develop training modules for new and current process lines.

• Draft complex DCRs and complete moderate NCR investigations.

• Demonstrate technical and administrative competence to organize and lead production activities, including leadership in state-of-the-art cGMP compliance and EHS skills.

• Proficient in JDE and understand how to issue materials to Manufacturing Work Orders, and account for the digital inventory of materials and review batch records.

• Understand scheduled operations for up to one month in advance. Provide insight to potential barriers and provide feedback to remove barriers.

• Lead the department through the manufacture of a product campaign.

What you bring to Takeda:

• High school diploma required; Bachelor's Degree preferred.

• 2- 4 years of related work experience

• Knowledge of cGMP manufacturing, SOPs (standard operating procedures), regulatory regulations and requirements.

• Proficient at troubleshooting moderate to complex problems.

• Experience elevating issues and applying appropriate corrections.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Professional training and development opportunities

• Tuition reimbursement

Important Considerations:

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. In this role, you may:

• The overall physical exertion of this position requires medium to heavy work.

• May be required to gown frequently and balance when gowning into clean areas.

• May require the use of special visual or auditory protective equipment.

• May be required to work at heights above floor level.

• May be required to sit between 1-2 hours.

• May be required to climb (use step stools and ladders) or kneel up to 1 hour.

• Requires repetitive use of both right and left hands and arms up to 3-4 hours.

• May be required to walk or stand between 3-4 hours.

• May be required to bend at the neck/waist or squat for up to 1 hour.

• May be required to reach above/below the shoulder between 1-2 hours.

• May be required to twist at the waist up/twist at the neck up to 1 hour.

• May be required to lift up to 75lbs; Lifts per shift up to 14 times.

• May be required to carry up to 25lbs; Carry distance of up to 30ft; Carries per shift up to 6 times.

• May require simple grasping/power grasping and fine manipulation up to 1 hour.

• May require pushing/pulling with hands/arms between 1-2 hours.

• May require office work activities with hands/arms up to 1 hour.

• May work and have exposure to hot, cold, wet environment/conditions.

• May be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes which may require respiratory protection.

• May work in confined areas.

• May work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.

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

• May work in a cold, hot or wet environment.

• May be required to manage hazardous waste in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.

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

• Required to work an alternate work schedule (10-hour shift / 4 days a week) including weekends and possibly holidays.

• May require overtime and/or assignment to different shift as needed.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

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.

Base Salary Range: $43,000.00 to $53,000.00 . Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program, and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors, including, but not limited to, location, skills, education, and experience.

#GMSGQ #ZR1

EEO Statement

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.

Locations

USA - CA - Thousand Oaks - Rancho Conejo

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time