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Clinical Manufacturing Lead I/II

Learn more about AbbVie
AbbVie

AbbVie

Clinical Manufacturing Lead I/II

North Chicago, IL
Full Time
Paid
  • Responsibilities

    Company Description

    AbbVie North Chicago API Pilot Plant (APIPP) is an integral part of Small Molecule CMC Development function under Research and Development. APIPP supports the manufacturing of small molecule and antibody drug conjugate drug substances for clinical and development use.

    AbbVie is seeking a highly motivated individual with a proven track record of accomplishment to join the API Pilot Plant. This position will own and manage the manufacturing systems used in API Pilot Plant to ensure smooth and sustained plant operations

    Job Description

    • System owner for essential production systems like SAP, factory flow, and shift connect for API Pilot Plant.
    • Lead the implementation and customization of those essential production systems in API Pilot Plant.
    • Manage/develop/update SOP’s, training CBT’s/materials, and provide hands-on training for pilot plant staff.
    • Provides meaningful assistance with troubleshooting and identifies solutions to issues that arise during manufacturing.
    • Interface between API pilot plant and BTS functions to improve existing manufacturing systems and develop new applications. Clearly communicate pilot plant needs and timeline with BTS functions.
    • Partner with Operations, Tech Ops, Plant Engineering teams to evaluate and implement new manufacturing systems and/or automation solutions, e.g. scale-SAP integration, electronic batch records, etc. Identify opportunities to modify or leverage existing assets to enhance operational efficiency.
    • Advise pilot plant leadership on the strength and weakness of existing systems and the next generation technology for investment.
    • Support the implementation, customization, training, and troubleshooting of the other documentation archiving systems used in API pilot plant, e.g. One Vault, Valgene, Share Point, etc.
    • Collaborate with trainers on procedure updates and staff training as needed.
    • Follows cGMP requirements, established policies, procedures, and practices; Follows established safety requirements.

    Qualifications

    • Bachelor in STEM fields with 5+ years of industry related experience.
    • Understanding of cGMP and pharmaceutical manufacturing requirements.
    • Experience with working in an API Plant environment. Familiarity with API manufacturing systems, e.g. SAP, Distributed Control Systems, electronic logbooks, and batch records.
    • Experience with training.
      • Creating aids, CBT’s, and procedures

    Key Leadership Competencies:

    • Builds strong relationships with peers and cross functionally with partners to enable higher performance.
    • Learns fast, grasps the "essence" and can change course quickly where indicated.
    • Raises the bar and is never satisfied with the status quo.
    • Creates a learning environment, open to suggestions and experimentation for improvement.
    • Embraces the ideas of others, nurtures innovation and manages innovation to reality.
    • Strong interpersonal and communication skills with demonstrated ability to work within a team environment.

    Can hire at either level depending on experience.

    Additional Information

    Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

    • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​
    • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
    • This job is eligible to participate in our short-term incentive programs. ​

    Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

    AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

  • Industry
    Pharmaceuticals
  • About Us

    AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.