Director, Technical Operations
Company: AbbVie, Inc.
Posted on: February 23, 2021
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
- 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
- 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/
- 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
- 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
- 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
- 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
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
- Understanding of problem-solving methods, with the ability to
influence selection and implementation of viable options for
- Ability to perform risk analysis and assess data to help drive
required technical service needs, compliance, and process
- 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
- 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)
Job Level Code
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
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