Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. Our passion and pursuit of potentially life-changing treatments for patients are deeply rooted in over 230 years of distinguished history in Japan.
“Every vial has a name” is a core value at our Thousand Oaks CA campus, a multiproduct facility with over 20 years of operational expertise.  We have an excellent opportunity for a high performing Manufacturing Associate I.  The schedule is 1st shift, Wednesday through Saturday from 6am to 4:30 pm.

The Manufacturing Associate I is responsible for executing all manufacturing department processes while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations that could apply.  The Manufacturing Associate I is expected to fully participate in both departmental projects and any quality working teams that may be applicable. This position shall be responsible for the hands on execution of activities as they relate to the manufacturing of products.  All of the specific requirements presented in this job description are applicable to the functional area in which it resides.

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 operationsExecutes processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could applyClean, 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.Basic QualificationsTechnical Skills – Comfortable with set-up and operations, daily maintenance, and break down of simple/routine equipment. Qualified to perform CIP, SIP autoclave, small parts preparation.  Able to identify processing gaps and assist with implementation of new technologies. Has access to JDE and understand how to create facility Work OrdersTroubleshooting – Proficient at troubleshooting minor to moderate problems.  Understands when and to whom to elevate.Theoretical Knowledge - Understands the scientific and technical background associated with areas they are performing.Written Communication - Able to draft simple to moderate DCRs and complete minor NCR investigations.Interpersonal Communication - Communicates professionally within and outside of the department.Presentation Skills – Able to present clear-cut concepts to local group.Sphere of Influence – Able to influence within the operational group.Leadership – Able to lead group through a major process step.Logistics - Understands systems for purchasing routine items.  Able to procure items and supplies.Planning – Consistently understands and provides feedback for operations occurring within the current work week.Processing Capabilities - Takes the lead during processing steps.  Prepares the shift for upcoming processes.Project Performance - Able to lead a department team or moderate project with oversight.  Consistently works as a project team member on Kiazen and other improvement initiatives.Training - Can successfully train newer team members on routine processes.Continuous Improvement - Actively performs as equipment and room owner.  Applies 5S and TPM as required to improve area.

All Positions:

The position requires shift, weekend, and holiday work.  Overtime may be required at timesEmployee maybe 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. Demonstrated understanding and compliance in Standard Operating Systems, Current Good Manufacturing Processes (cGMP) & Good Documentation (GDP).Ensure safety, security, and the environment in all aspect of the daily activities and any potential safety hazardous are addressed and corrected immediately.Understand ergonomic relationship between people, equipment and working environment. Must be able to navigate, conduct searches, and fill on line forms on Personal Computer for the purposes of training, performance management, and self service applications.Must have the ability to navigate electronic mail systems and intranet for communication purposes.Employee 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.

Education and/or experience

Bachelor’s degree preferred or AA degree with 2 years of related work experience or a high school diploma with a minimum of 4 years of related work experience.   Scientific degree preferred.

Internal Candidates: The aforementioned requirements are preferred for internal candidates. They must demonstrate the proficiencies/qualifications in order to qualify for the position.

Physical Demands

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

May be required to sit between 1-2 hours in all Manufacturing areas.May be required to walk between 3-4 hours in Bulk and over 4 hours in the F/F  and Suite A areas.May be required to stand for 3-4 hours in Bulk and Suite A and over 4 hours in F/F.May be required to bend at the neck/waist for up to 1 hour in Bulk, between 1-2 hours in Suite A and over 4 hours in the F/F areas.May be required to squat up to 1 hour in Bulk, and between 1-2 hours in Suite A and F/F.May be required to climb (use step stools and ladders) up to 1 hour in all Manufacturing areas.May be required to reach above/below the shoulder between 1-2 hours in Bulk and Suite A and between 3-4 hours in the F/F areas.May be required to kneel  up to 1 hour in all Manufacturing areas.May be required to twist at the neck up to 1 hour in Bulk and Suite A and between 3-4 hours in the F/F area.May be required to twist at the waist up to 1 hour in Bulk and between 3-4 hours in the F/F and Suite A areas.May be required to lift up to 50lbs in the F/F area, up to 75lbs in Bulk and over 75lbs in the Suite A area. Lifts per shift are up to 14 times in Bulk and Suite A and up to 100 times in the F/F area.May be required to carry up to 25lbs  in Bulk and Suite A and up to 50lbs in the F/F areas.  Carry distance of up to 30ft in Bulk and Suite A and up to 6 feet in the F/F areas.   Carries per shift are up to 6 times in Bulk, up to 14 times in Suite A and up to 100 times in the F/F areas.Requires repetitive use of both right and left hands and arms up to 3-4 hours in all Manufacturing areas.May require simple grasping up to 1 hour in Bulk and Suite A and between 3-4 hours in the F/F areas.May require power grasping up to 1 hour in Bulk and Suite A and over 4 hours in the F/F areas.May require fine manipulation up to 1 hour Bulk and Suite A and between 1-2 hours in the F/F areas.May require pushing/pulling with hands/arms between 1-2 hours in Bulk and Suite A and between 3-4 hours in the F/F areas.May require office work activities with hands/arms up to 1 hour in Bulk and between 1-2 hours in Suite A and the F/F areas.May be required to gown frequently and balance when gowning into clean areas.Will not be required to drive cars, trucks, forklifts or other equipment.May be required to work around moving equipment and machinery.Will not be required to walk on uneven ground.May be exposed to noise above 85 dBA in Bulk and Suite A.  This may require hearing protection and other protective equipment to be worn.May work and have exposure to hot, cold, wet environment/conditions in all Manufacturing areas. May be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes.  May require respiratory protection.May be required to work at heights above floor level.Will not be required to operate foot controls or repetitive foot movement.May require the use of special visual or auditory protective equipment in Bulk and F/F areas.May be required to work with biohazards such as: bloodborne pathogens, seage or medical waste in the F/F areas.May be required to drive to travel to other facilities, training  sites, and off site meetings.May be required to work in confined areas.

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 in the F/F area.

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.Will have interaction with other people.Pace may be fast and job completion demands may be high.This position requires shift, weekend and holiday work. Overtime may be required at times.

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