Posted to MedZilla on 8/20/2019


Takeda Pharmaceuticals

US-CA, Supervisor, Manufacturing SR0038907-MZ


 
 

Summary

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 Supervisor, Manufacturing. The selected candidate is responsible for supervising day shift manufacturing operations (M-F, 6:00am 2:30pm) to ensure manufacturing goals and project deadlines are met while maintaining compliance with environmental health and safety (EHS) guidelines, current good manufacturing practices (cGMPs), and any other regulations that could apply. Focus is on optimization for the use of raw materials, equipment and personnel in producing safe and quality products. May monitor and control labor and capital expenditures. May assist in developing budgets. Recommends manufacturing policies, procedures and programs.

Essential Duties & Responsibilities

  • Supervise the day to day production, scheduling, staffing, material management, compliance, training, and auditing activities for area of responsibility.
  • Develop and manage performance of direct reports.
  • Maintain operational expenses within budget.
  • Supervisor on the floor 75% of the time
  • Support and ensure the execution of all manufacturing processes with strict compliance to EHS & cGMPs regulations.
  • Lead technical reviews, investigation and process improvement projects.
  • Provide input into integration and validation of new equipment and process.
  • Resolve technical, material, and cGMP issues.
  • Review, approve, and manage documentation for batch and system records for production.
  • Interface with other departments to help resolve issues related to equipment, process and compliance including facility support departments and external vendors.
  • Lead in technical reviews, investigation and process improvement projects to meet objectives
  • Participate in change control and exception management processes
  • Commit to employee feedback and developmental processes
  • Assess impact of new regulatory guidelines on current practice, initiate document change proposals, prepare/review protocols to justify process changes, assist with training and auditing as appropriate.
  • Owner for implementation of new equipment, system and/or procedures.
  • Participate in Internal or external audits as SME for department.
  • May perform other duties as assigned.

Qualifications

  • Demonstrated supervisory and leadership skills.
  • Able to manage multiple priorities in manufacturing plant setting.
  • Employee 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 manufacturing operations expertise.
  • Knowledge of utility systems and how they impact the Manufacturing Departments.
  • Understands the flow and design/interdependency of manufacturing support departments.
  • Knowledge of manufacturing equipment operation, including set up and changeover, as well as commissioning, validation, and troubleshooting.
  • Basic scientific understanding of biology (cell culture, microbiology) and chemistry/ biochemistry as it applies to the manufacturing process.
  • May have more specific skill sets in areas depending on need/opportunity: Inspection of lyophilized products, assembly of medical device/combination units, VHP sanitization, labeling, bulk packaging, final packaging, e.t.c.
  • Working knowledge in a clean room environment (ISO 8/9) using aseptic technique.
  • Strong professional writing skills and ability to prepare and write technical reports.
  • Strong verbal and written communication skills across multiple functional areas.
  • Computer skills, including PowerPoint, Word, Excel, Access.
  • Knowledge of basic chemical and biological safety procedures.
  • Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.
  • Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
  • Must be able to read, write, and converse in English.
  • 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.
  • Must have advanced word processing, spreadsheet, and typing skills.
  • Good interpersonal skills and be able to work effectively and efficiently in a team environment.
  • May support cross functional teams
  • Conduct documentation review, as needed
  • Communicate to management any concerns and feedback related to floor issues
  • Participate in Tier boards and Gemba walks
  • Passion for Improving Lives: Must be able to put our patients at the center of everything we do.
  • Quest for Innovation: Must be able to operate with agility and a learning mindset so that we can accelerate breakthrough innovations.
  • Inspired Teams environment: Must be able to thrive in diverse high performing teams.
  • Engaged with the World Around Us: Must be able to embrace change and seek diverse perspectives and partnerships to benefit patients and make a positive impact on the world.
  • Role model for self and the organization in the areas of being positive, accountable, results driven, and excellent manager of self and others.

Education and/or Experience

Bachelor s Degree preferably in Science, Engineering or Business plus 3-6 years of manufacturing experience, or AA Degree in in Science, Engineering or Business with 5-7 years of manufacturing experience, or HS Diploma with 7-10 years of manufacturing experience. This role requires at least 2-4 years of leadership experience.

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 work in a cold, wet environment.
  • May be exposed to dust, gases, and fumes.
  • May be around and operating moving equipment and machinery.
  • May climb up and into large processing tanks for cleaning or inspection.
  • May be working in a loud area that requires hearing protection and other protective equipment to be worn.
  • May work around chemicals such as alcohol, acids, and buffers that may require respiratory protection.
  • May be required to work in a confined area as defined by the Environmental, Health, & Safety office.
  • Possible exposure to cool/hot storage conditions.
  • Will have interaction with other people.
  • Pace may be fast and job completion demands may be high.
  • May be required to travel for business reasons, e.g. training and meetings .
  • May be required to work or be assigned to a different shift as needed.
  • Must be able to work more than 8 hours a day or 40 hours a workweek as required.
  • This position requires shift, and may require weekend and holiday work as required.
  • Maybe required to work 4 days a week 10 hour days.

Physical Demand

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

  • May be required to sit between 1-2 hours in the Manufacturing areas.
  • May be required to walk between 1-2 hours in in the Manufacturing areas.
  • May be required to stand between 1-2 hours in in the Manufacturing areas.
  • May be required to bend at the neck for up to 1 hour in the Manufacturing areas.
  • May be required to bend at the waist for up to 1 hour in in the Manufacturing areas.
  • May be required to squat up to 1 hour in the Manufacturing areas.
  • 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) up to 1 hour in all Manufacturing areas.
  • May be required to kneel up to 1 hour in all Manufacturing areas.
  • May be required to twist at the neck/waist up to 1 hour) in all Manufacturing areas.
  • May be required to lift up to 10lbs in all Manufacturing areas. Lifts per shift up to 2 times in all Manufacturing areas.
  • May be required to carry up to 10lbs in in all Manufacturing areas. Carry distance of up to 20ft in all Manufacturing areas. Carries per shift up to 2 times in all Manufacturing areas.
  • Requires repetitive use of both right and left hands and arms for over 4 hours in all Manufacturing areas.
  • May require simple grasping between 3-4 hours in in all Manufacturing areas.
  • Does not require power grasping.
  • Does not require fine manipulation.
  • May require pushing/pulling with hands/arms of up to 1 hour in all Manufacturing areas.
  • May require office work activities with hands/arms over 4 hours in all Manufacturing areas..
  • May be required to gown frequently and balance when gowning into clean areas.
  • Not required to drive a car, truck, forklift and other equipment.
  • May be required to work around moving equipment and machinery in all Manufacturing areas. Machinery includes bioreactors and associated pumps and controllers.
  • May require walking on uneven ground.
  • Does not require exposure to noise above 85 dBA.
  • Does not require exposure to hot, cold, wet environment/conditions.
  • May be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes in all Manufacturing areas. May require respiratory protection. May be exposed to IPA, bleach and cleaning chemicals.
  • Does not require work at heights above floor level.
  • Does not require operation of foot controls or repetitive foot movement.
  • Does not require the use of special visual or auditory protective equipment.
  • Does not require working with biohazards such as: bloodborne pathogens, sewage or medical waste.
  • May be required to drive to travel to other facilities, training sites, and off-site meetings.
  • May be required to work in confined areas.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.


Please visit our website at takedajobs.com

 
 


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