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 2nd shift, Sunday through Wednesday from 4pm to 2am.

Primary Role

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 Functions

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.

Education & Experience Requirements

Requires Bachelor’s degree 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.

Key Skills and Competencies

Technical Skills – Developing.Troubleshooting – Developing.Theoretical Knowledge - Basic knowledge of chemicals and laboratory equipment.Written Communication - Able to document process and successfully uses GDP.Interpersonal Communication - Demonstrates appropriate communication within the department and to supervisor.Presentation Skills – Developing.Sphere of Influence – Developing.Leadership – Developing.Planning – Developing.Processing Capabilities - Able to perform operations with oversight.Project Performance - Able to constructively participate in projects affecting the local department.Training - Proactively seeks opportunities to learn new skills.Continuous Improvement - Participates in continuous improvement initiatives.

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.Living our leadership behaviors is a basic expectation for all Takeda employees. Takeda expects all employees to embody the following:
 Leadership BehaviorsBe PositiveBe AccountableBe Results OrientedBe An Excellent Manager of Self and OthersOther Job Components

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.

Physical Demand

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 Suite A areas.May be required to stand for 3-4 hours in Bulk and Suite A.May be required to bend at the neck/waist for up to 1 hour in Bulk, between 1-2 hours in Suite A.May be required to squat up to 1 hour in Bulk, and between 1-2 hours in Suite A.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.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.May be required to twist at the waist up to 1 hour in Bulk and between 3-4 hours in the Suite A areas.May be required to lift 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.May be required to carry up to 25lbs  in Bulk and Suite A.  Carry distance of up to 30ft in Bulk and Suite A.   Carries per shift are up to 6 times in Bulk and up to 14 times in Suite A.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.May require power grasping up to 1 hour in Bulk and Suite A.May require fine manipulation up to 1 hour Bulk and Suite A.May require pushing/pulling with hands/arms between 1-2 hours in Bulk and Suite A.May require office work activities with hands/arms up to 1 hour in Bulk and between 1-2 hours in Suite A.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.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.