15 days old

Manufacturing Supervisor Purification

Baxalta U.S., Inc.
Los Angeles, CA 90012
  • Job Code
    R0033396

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Job Description

This position reports to Swing (2) shift. This shift schedule isMonday-Friday from2:00 PM to 10:00 PM. This shift requires working on all company designated holidays.Due to business need, on select occasion employees may be required to work overtime and/or support operations on an alternate shift.

Summary:

The Building 8 Purification Supervisor is responsible for supervising daily activities in Building 8, which may include small, mid or large scale manufacturing, to ensure manufacturing goals and project deadlines are met by the commitment date while maintaining compliance with the current good manufacturing practices (cGMPs), environmental health and safety (EHS) guidelines, and any other applicable regulations.

The supervisor is expected to drive results to support plant strategic imperatives, enforce company rules and regulations and promote Takeda Values within his/her shift. The supervisor is expected to coach/mentor employees to drive performance and is expected to set the example for all other employees of Takeda. The supervisor must have the ability to manage multiple priorities in a manufacturing plant setting and prioritize responsibilities of self and direct reports appropriately. The supervisor must have organizational and administrative skills and be able to prepare and present technical reports and trends.

The supervisor must promote plant culture including Safety Culture, Quality Culture and Guiding Principles, including decision making based on Patient, Trust, Reputation and Business.

Essential Duties and Responsibilities:

  • Supervise the daily manufacturing operations in B8 Manufacturing maintain (audit, refine, improve) equipment and processes within this area

  • Interface and Navigate through the DeltaV, Programmable Logic Controller (PLC), and Electronic Batch Management (EBM) systems to effectively respond to process events, changes, and tasks

  • Respond to alarms properly and accurately escalate the issue to supervision/management, and the appropriate support groups when necessary

  • Coordinate manufacturing process-related issues with Quality Operations prior to intervening in the system

  • Train and supervise across all purification product lines within multiple manufacturing suites

  • Provide a positive and equitable working environment emphasizing the Takeda Leadership Behaviors

  • Support and Emphasize the Safety and Quality commitments of the department make decisions concerning these commitments within the area

  • Ability to utilize resources and raw materials in the most efficient and productive manner possible

  • Identify/prioritize/provide resources in an area to assist management to meet the annual operational plan and budgetary commitments

  • Facilitate and verify appropriate training for employees in the area (including but not limited to cGMP, job skills, and safety)

  • Ensure compliance with all cGMP rules, good document practices (GDP), product specifications, standard operating procedures (SOP), and FDA requirements as required.

  • Commit to employee feedback and developmental process support Talent Management goals, conduct recognition and disciplinary action for employees, facilitate employee representation throughout the organization

  • Submit and/or maintain and distribute reports related to attendance, labor, efficiency, safety, scrap, and others as needed

  • Provide leadership to assess and provide guidance and risk assessments regarding requirements for the design of the manufacturing and pilot plant facilities

  • Create and Update Manufacturing SOPs and batch records

  • May supervise more than one group

Qualifications:

  • Experience in pharmaceutical/industrial manufacturing, plasma fractionation, protein purification, and clean room experience a plus

  • Experience with Tech Transfer activities

  • Experience implementing Lean Manufacturing concepts

  • Knowledge of Batch Processing and/or Campaign Manufacturing

  • Experience with scheduling of Process Operations

  • Successful track record of managing wide-ranging activities within the business unit

  • Demonstrates strong leadership skills

  • Extensive cross-functional team experience, including technical and non-technical work

  • Ability to correct GDP type errors in the electronic systems (DeltaV, EBM, PLC, etc.)

  • Ability to trend data in DeltaV and EBM systems for investigations and/or process deviations

  • Proficient in DeltaV and EBM to a level that aligns with the area of responsibility and standard operating procedure (SOP) guidance

  • Ability to organize and present technical and project management overviews without assistance

  • Demonstrated interpersonal and leadership skills with the ability to interface well with other departments and lead effectively and efficiently in a team environment

  • Interact with all levels of personnel to analyze and solve problems related to manufacturing, quality, documentation, and personnel issues.)

  • Ability to manage multiple priorities in a manufacturing plant setting

  • Ability to understand cGMPs/cGDP and other regulatory guidelines applicable to the medical/pharmaceutical industry

  • Strong assessment and troubleshooting skills

  • Good computer skills

  • Ability to respond to detailed inquiries, and present information to groups and senior management

Education and/or experience:

  • Requires High School diploma or GED with 5+ years of related experience OR BS degree in a science, engineering, or other related technical disciplines with a minimum of 2+ years related experience. Some leadership experience preferred

Physical Demands:

  • Must be able to lift, push, pull and carry up to 50 lbs

  • 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 work environment

  • Will work in a cold, wet environment with climbing to access platforms and/or equipment

  • Will be working in a loud area that requires hearing protection and other protective equipment to be worn

  • Will work around chemicals such as alcohol, acids, buffers, and celite that may require respiratory protection

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

  • May be required to work in a confined area

  • Inside working conditions

  • Some Clean Room and cool/hot storage conditions

  • 0-5% travel

This job posting excludes CO applicants.

Locations

USA - CA - Los Angeles

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2021-03-26 Expires: 2021-04-24
Sponsored by:
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Sponsored by:
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Manufacturing Supervisor Purification

Baxalta U.S., Inc.
Los Angeles, CA 90012

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