Clinical Manufacturing Lead I/II

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.

Lead production teams to produce high quality solid dosage form clinical supplies utilizing state-of-the-art technologies. This requires interaction with formulation colleagues to develop reliable and efficient manufacturing processes. These processes are then translated into executable manufacturing instructions when followed appropriately result in the efficient production of GMP compliant clinical supplies.

Responsibilities:

• Operations: Leads manufacturing activities, including the preparation and close out of batch records; Ensures the batch record documentation is executed with minimal errors; Starts and completes manufacturing activities on time, according to the established schedule. Manages X-step content to ensure PI sheets are accurate.
• Formulation Development: Provide meaningful collaboration on formulation development and research activities occurring in the pilot plant.
• Technical Support: Provides leadership with trouble-shooting and identifies solutions to issues that arise during manufacturing; Provides strategic product development and technology improvement activities; actively participates in functional area improvement initiatives.
• Compliance: Follows cGMP requirements and established policies, writes and follows procedures and practices; Conducts business activities needing minimal deviations or exceptions; Follows established safety requirements, reports incidents/near misses and recommends improvements.
• Project Coordination: Works with the CMC team and other supporting areas to assure project commitments are met, for example, providing draft batch records for review, assuring material availability, preparing cleaning documentation and completing inventory transactions.
• Communication: Records, tabulates and reports results within the group or team using the necessary tools (Reports, memos, presentations, spreadsheets, notebooks, etc.); Reports significant issues to management with appropriate sense of urgency; Attends group and project meetings, being prepared to communicates concerns and participate in discussions.
• Leadership: Direct activities of manufacturing technicians in a matrix environment.

Clinical Manufacturing I:

• B.S. in Chemistry, Biology, Supply Management or related scientific/operations area or equivalent and relative work experience.
• 7+ years experience in operations, R&D and/or related area
• Experience in a cGMP environment is highly desired

Clinical Manufacturing Lead II:

• BS with 5-8 years of experience preferred. OR
• MS with 3-6 years of experience preferred. OR
• PhD/ PhramD with 1-2 years of experience
• Strong technical background in pharmaceutical dosage forms. Developed problem solving abilities.
• Scientific report writing skills. Knowledge and experience in working in a cGMP environment. Knowledge
• of regulatory issues involved with CMC. Good organizational skills. Excellent communication (oral and
• written) and interpersonal skills.
• Functions as a team player. Has knowledge of related areas of development to incorporate into local
• problem solving. Must be able to work with commercial operations to determine prioritization of projects
• and meet tight timelines. Use good judgment to make sound decisions. Needs to be adaptable and maintain
• the ability to give clear directions flexible in an ever changing and challenging environment.

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 ingood faith it will pay for this role at the time of this posting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay 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/visioninsurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs.

Note: No amount of payis considered to bewages 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 benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies 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.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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https://www.abbvie.com/join-us/reasonable-accommodations.html