Posted to MedZilla on 8/18/2019

Takeda Pharmaceuticals

US-CA, Manufacturing Lead Operator SR0038705-MZ


This position reports Weekend Swing. This shift schedule is Saturday and Sunday 10:00 AM to 10:00 PM. This shift requires working on all company designated holidays. Due to business need, you may be required to work your designated third day, in addition to the company designated holiday(s).

The Manufacturing Lead Operator is responsible for executing processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. Under the overall direction of the supervisor, this person must aid in establishing daily shift priorities, and then skillfully communicate and delegate tasks in order to safely accomplish those priorities. They are expected to exercise proper judgement with regards to Safety, Quality, and Production decisions. They must be able to apply their subject matter expertise and their understanding of the capabilities and performance of their team members in order to quickly assess critical issues. They must be able to effectively escalate all relevant information and be prepared to recommend appropriate actions. They are expected to be able to communicate all critical information to their respective teams as well as be able to relay the appropriate shift-to-shift updates through all applicable communication tools and at shift handoffs. In addition to being fully accountable in production processes, this person may help problem solve in other functional areas. They are expected to fully participate in both departmental projects and quality working teams. The incumbent shall act as a delegate to the supervisor and may conduct departmental activities in their absence. They fully understand the regulations and may make recommendations according to their interpretations. They have a high level of technical and administrative knowledge to perform complex troubleshooting tasks on manual and automated equipment, and they may assist during the transfer of new processes/methodologies into the manufacturing area. Manufacturing Lead Operators are expected to serve as a mentor and set the example for all team members since their team will interpret that behavior as acceptable. They must display the appropriate conduct, compliance, cleanliness, and culture while promoting Takeda s focus on Patient, Trust, Reputation, and Business.

Essential Duties and Responsibilities

  • Follow all safety rules, SOPs, cGMP, work rules and other company policies and initiatives.
  • Complete relevant paperwork following GDP/GMP guidelines.
  • Perform hands-on execution of manual and automated manufacturing operations. Equipment may include: Centrifuges, Filter Presses, Ultrafiltration,Tangential Flow Filtration and Nanofiltration systems, CIP/COP, Chromatography and material handling devices. Manual activities include weighing and addition of chemicals, paste suspension, equipment cleaning, room cleaning, equipment assembly/disassembly, transfer panel connections, titrations and other activities.
  • Receive and distribute supplies into the production area as necessary.
  • Perform removal of hazardous waste.
  • Troubleshoot process problems and respond to process alarms.
  • Act as the primary manufacturing personnel to resolve and communicate issues related to safety, quality, compliance and process to the supervisor. Main interface with other departments including maintenance, metrology, engineering and validation.
  • Assist supervisor in organizing, scheduling, and directing other team members.
  • May act as a delegate to the supervisor in their absence.
  • Participate in the training and mentoring of team members on the manufacturing floor.
  • Write, revise, and review manufacturing related documents as appropriate.
  • Participate in Safety and Continuous Improvement Teams and may serve in a leadership role.
  • Initiate and/or coordinate other process improvement projects.
  • Drive performance of team members by promoting a positive work environment emphasizing Patient, Trust, Reputation, and Business.


  • Must have demonstrated interpersonal and leadership skills and be able to lead a team effectively.
  • Demonstrated record of exercising proper judgment with regards to Safety, Quality, Compliance, and Production decisions.
  • In-depth process knowledge of related manufacturing techniques and specialties.
  • Advanced automation experience using DeltaV, Electronic Batch Management, PLC, etc.
  • Familiarity with pharmaceutical production equipment including but not limited to centrifuges, filtration systems and CIP/SIP (Clean in Place/Steam in Place).
  • Must have strong communication skills (both verbal and written) and a robust understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.
  • Must be able to read and follow detailed written procedures.
  • Must be able to apply quantitative analysis to analyze process performance.
  • Must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.
  • Knowledge of basic chemical and biological safety procedures.
  • Must have good computer skills including knowledge of Microsoft Office applications. Experience with applications such as LIMS and JD Edwards preferred.

Education and/or experience

Requires high school diploma and a minimum of 6 years related experience, or Bachelor with minimum of 4 years related experience. College degree in Science or Engineering discipline strongly preferred.

Physical Demands

  • Must be able to lift, push, pull and carry up to 50 lbs.
  • Must be able to stand for extended periods of time throughout the duration of an 8 or 12 hour shift.
  • Must be able to climb ladders and stairs while wearing special gowning.
  • May require bending, twisting, reaching, and/or squatting motions to perform certain tasks.
  • In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.

Working Environment

  • Must be able to work in controlled 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 the manufacturing environment.
  • Will work around chemicals such as alcohol, acids, buffers and filter aid that may require respiratory protection. Facial hair must be removed if required to wear respirator.
  • Will work in a cold, wet environment.
  • Must be able to work multiple shifts, including weekends.
  • Must be able to work overtime as required. (only for non-exempt positions)
  • May be required to work in a confined area.
  • Some Clean Room and cool/hot storage conditions.

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.

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Pay Transparency Policy -

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.

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