Manufacturing Associate I at Baxalta U.S., Inc. in Thousand Oaks, California

Job Description:

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Manufacturing Associate I in our Thousand Oaks, CA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

Under the general direction of the Manufacturing Lead and overall direction of the Supervisor, the Manufacturing Associate I is responsible for executing all processes in the production area while strictly adhering to CGMP, environmental health and safety guidelines and any other related regulations.

Essential Duties and Responsibilities

Cell Culture/Purification:

• Support Cell Culture/Purification operations for the production of a bulk drug substance product.


• Prepare media and buffer solution.


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


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


• Monitor and record critical process parameters.


• Complete relevant paperwork following GDP/GMP guidelines.


• Perform routine maintenance and cleaning of production equipment to maintain equipment in GMP fashion.


• Manually clean portable equipment and small parts.


• Perform sampling using aseptic techniques.


• Participate on Continuous Improvement Teams.


• Receive and distribute supplies into production area as necessary.


• May perform other duties as assigned.

Formulation/Filling:

• Participate in bulk formulation, aseptic filling, Lyophilization, and capping operations


• Executes processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply


• Clean, Set up, operate, and teardown of equipment such as, tanks, filtration systems, filling lines, lyophilizers, etc.


• Operate general production equipment such as an autoclave, filter integrity testers, temperature probes, pH and conductivity meters, CIP skids, etc.


• Receive and distribute supplies into the manufacturing areas.


• May perform other duties as assigned.

All Areas

• Set up operations, daily maintenance, and break down of simple/routine equipment.


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


• Identify processing gaps and assist with implementation of new technologies.


• Perform minor to moderation troubleshooting


• Draft simple to moderate DCRs and complete minor NCR investigations.

Qualifications

• Results oriented, self-motivated, and able to work independently


• Able to work effectively and efficiently in a team environment.


• Able to provide feedback for operations & elevate concerns as needed


• Demonstrate initiative, proactiveness and effective communication


• Actively seeks opportunities for personal growth and development and monitors progress toward achieving development goals.


• Proactively assists others in accomplishing work


• Listens carefully and is receptive to feedback from others.


• Basic knowledge of CGMP and SOPs preferred

Education and/or experience

• High school diploma or equivalent required; Bachelor’s degree preferred

• 0-2 years of related work experience

Physical Demands

• 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.


• Will not be required to operate foot controls or repetitive foot movement.


• 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.

Cell Culture/Purification

• 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 in Bulk and between 1-2 hours in Suite A.


• 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 in Bulk and over 75lbs in the Suite A area; 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 in Bulk and up to 14 times in Suite A.


• 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 in Bulk; between 1-2 hours in Suite A.

Formulation/Filling

• May be required to walk, stand or bend at the neck/waist for over 4 hours

• May be required to squat between 1-2 hours


• May be required to reach above/below the shoulder between 3-4 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 50lbs; Lifts per shift are up to 100 times.


• May be required to carry up to 50lbs; Carry distance of up to 6 feet; Carries per shift are up to 100 times.


• May require simple grasping & pushing/pulling with hands/arms between 3-4 hours; power grasping for over 4 hours; fine manipulation between 1-2 hours.


• May be required to work with biohazards such as: bloodborne pathogens, seage or medical waste.


• Will require entering a 2-8 degree Celsius & -60 degree Celsius freezer to store and retrieve materials and various chemicals in support of mfg such as IPA, 500ppm sodium hypochlorite.

Working Environment

• Must be able to work in controlled or clean room environments requiring special gowning.


• Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments.


• May be required to manage hazardous wastes 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 and have exposure to hot, cold, wet environment/conditions


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


• May be required to work in confined areas; may be required to work around moving equipment and machinery


• May be required to drive to travel to other facilities, training sites, and off-site meetings.


• Will not be required to walk on uneven ground.


• May require office work activities between 1-2 hours.


• This position requires overtime, weekend and holiday work. 


• May be required to work or be assigned to a different shift as needed.

WHAT TAKEDA CAN OFFER YOU:

• 401(k) with company match and Annual Retirement Contribution Plan


• Tuition reimbursement Company match of charitable contributions


• 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

Empowering Our People to Shine

Discover more at takedajobs.com

This job posting excludes CO applicants.

Locations

USA - CA - Thousand Oaks - Rancho Conejo

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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