Director, Technical Operations

Company: AbbVie, Inc.
Location: Waco
Posted on: February 23, 2021

Job Description:

Job Description About AbbVie
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. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

The Operations Science & Technology department supports technical and scientific activities related to the manufacture of pharmaceutical products in AbbVie facilities or in contract facilities. The director establishes goals that are consistent with development, manufacturing and customer requirements, implements plans/policies, assigns duties and responsibilities, and leads subordinate--performance to meet division goals and commitments. The director ,through his/her section managers and direct reporting lines, will manage a technically diverse staff of highly specialized scientists and technicians. He/she is a key link between development organizations and operations/third party contract manufacturers and ensures a seamless link between pilot scale and full scale manufacture. The director is accountable for all the activities of the department and provides technical/scientific and business leadership for the department. Manages the Technical Operations, validation, compliance, and process improvement initiatives and ensures associated activities are performed in compliance with regulatory guidelines.This senior leadership role is also responsible for the following:

• Provide mature, credible Chemistry, Manufacturing and Control (CMC) leadership at AbbVie.
• Provide a positive leadership model for scientists within Operations Science & Technology.
• Maintain and direct a highly diversified cross functional staff of professionals to ensure that all aspects of CMC life cycle management are completed on time, within budget, and meet--highest scientific, regulatory, quality, marketing and commercial standards.
• Evaluate and introduce new technology with applications in development and manufacturing while assuring the incorporation of knowledge of current regulations, guidance documents and competitive environment into decisions and strategy.
• Provide rapid and accurate evaluations of new business opportunities.
• Develop and communicate cost estimates, business plans, timelines and contingency plans.
• Identify and recruit resources to accomplish project and departmental objectives within agreed time scope, and operating in an open communication environment whilst stressing scientific/ compliance excellence.
• Planning, maintaining and managing a departmental salary budget, an operating budget and project budgets.
• Participate in capital planning and capital projects execution to advance the department.
• Make go/no-go decisions related to project responsibilities.
• Represent AbbVie to regulatory agencies (US/ROW as appropriate) by supplying verbal or written information and/or participation in face-to-face meetings for responsible activities establish, maintain and foster good working relationships with Technical Operations customers: Operations and other functional areas.
• Provide effective technical and business leadership at the R&D/Operations interface.Provides technical expertise to Operations in order to establish or enhance current work processes.
• Establish robust work practices and procedures to meet or exceed regulatory expectations.
• Improve current work processes and practices for Operations Departments: Compounding, Filling and Packaging.
• Develop training to ensure concepts are well understood and technical performance for the site is enhanced.
• New products, new processes, plant validation/re-validation activities, new equipment/systems and Investigation Team.
• Create and maintains the site validation Master Plan.
• Generates, on a timely basis and according to project needs, Validation Protocols, reports, project Gantt charts, etc.
• Provides support for critical projects, marketing (justification for packaging changes), and Science and Technology.
• Develops and administrate the department's budget, sets up department goals, interprets administrative policies for employees including but not limited to hiring, terminations, promotions, work performance reviews, safety, etc.
• Supports supplier audits/appraisals and internal and external audits.
  Qualifications
  Knowledge, Skills and Abilities:
  • Quality System knowledge (FDA/cGMP, ISO 13485/13488).
  • Ability to affect change without having direct responsibility for the levels of the organization being impacted.
  • Ability to thrive in a team-oriented environment, as well as the ability to develop and maintain a team environment within the functional area.
  • Understanding of problem-solving methods, with the ability to influence selection and implementation of viable options for resolving issues.
  • Ability to perform risk analysis and assess data to help drive required technical service needs, compliance, and process improvement initiatives.
  • Ten (10) years of experience in manufacturing, formulation, analytical chemistry and /or technical services roles, pharmaceuticals and/or validations of sterile pharmaceutical drugs, ophthalmic or sterile injectable solutions, suspensions, ointments, gels, and unit dose products.
  • Audit experience with MOH.
  • Proficient in Microsoft Office. Advanced SAP user experience preferred. Knowledge of LIMS and Trackwise preferred.
  • Working knowledge of current pharmaceutical production technologies, quality control procedures, and regulatory requirements.Education
    • Master's Degree or equivalent related experience in a related scientific field. PhD or equivalent experience in related scientific discipline is highly desired
      Significant Work Activities
      Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
      Travel
      No
      Job Type
      Experienced
      Schedule
      Full-time
      Job Level Code
      IC
      Equal Employment Opportunity
      At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.
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Keywords: AbbVie, Inc., Waco , Director, Technical Operations, Executive , Waco, Texas