Manufacturing Lead Operator
Company: Takeda Pharmaceutical Company Ltd
Location: Los Angeles
Posted on: June 12, 2021
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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
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
- Perform removal of hazardous waste.
- Troubleshoot process problems and respond to process
- 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
- Participate in Safety and Continuous Improvement Teams and may
serve in a leadership role.
- Initiate and/or coordinate other process improvement
- Drive performance of team members by promoting a positive work
environment emphasizing Patient, Trust, Reputation, and
- 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
- 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
- Must be able to apply quantitative analysis to analyze process
- Must be proficient in a variety of mathematical disciplines and
be able to work with both the metric and USA standards of
- Knowledge of basic chemical and biological safety
- 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
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
- 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.
- 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
- 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
- May be required to work in a confined area.
- Some Clean Room and cool/hot storage conditions.
Location and Salary Information: This job posting excludes CO
USA - CA - Los Angeles
Keywords: Takeda Pharmaceutical Company Ltd, Los Angeles , Manufacturing Lead Operator, Other , Los Angeles, California
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