Drug Product Coordinator I

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Job description

Company Description
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 at . on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .

Job Description
Purpose

Responsible for the project management and planning of manufacturing and supply chain activities for products used in phase I-III clinical trials and drug development manufacturing. This is accomplished by interacting with project representatives from multiple cross-functional groups including API development teams, formulation, analytical, QA and other R&D manufacturing sites worldwide.

Responsibilities

• Develop supply chain strategies and operational strategies to assure the pilot plant and project teams meet API and/or drug product delivery requirements. Identify any conflicts and resolve issues that may impact the schedule, including issues related to quality, safety, material or equipment availability. Resolution may require interaction with individuals who are cross-functional, global and/or senior management.
• Responsible for identifying project specific requirements, such as special commodity needs, packaging and lot distribution requirements and assures all factors are ready for manufacturing start.
• Collaborates with the materials manager, program manager and/or team lead to set expectations for procurement needs. Forecasts material needs to assure timely receipt, testing and release, as applicable. Identifies significant changes in forecast volumes or deliveries that may require a change in purchasing strategy or adjustment in manufacturing timelines and drives any gaps to resolution.
• Collaborates with project teams and commercial operations during product tech transfer to establish expectations and set strategies for material transfers and deliveries.
• Responsible for the SAP production planning for his/her assigned projects. This includes BOM maintenance, master recipes and issuing SAP process orders or equivalent to the warehouse for staging and to manufacturing for production. Issues PI sheets to production for use and maintains XSteps for production operations, as applicable. May also include generation and maintenance of material numbers in the DSP system, as applicable.
• Identifies, develops, communicates and tracks project timelines, activities and logistics. Generates metrics for area KPI reviews.
• Utilizes knowledge and experience to identify opportunities for improvement. Leads cross functional initiatives as a subject matter expert.
• Takes a leadership role in the implementation of new systems.
• Provides guidance to junior coordinators when necessary.

Qualifications

• Bachelor's degree required. Science based degree is preferred.
• Minimum experience: 4+ years total experience in the pharmaceutical industry.
• Must have experience in one of the following areas: Drug Development (e.g., process chemistry, formulation), Manufacturing Operations, Supply Chain, or Quality Assurance.
• Proficient in the application of business requirements (e.g., standard operating procedures, quality regulations, customs, foreign trade zone, etc.)
• Must have understanding of importance of compliance in a regulated environment and be capable of applying this knowledge to improve current processes.
• Demonstrates strong competence of plant, manufacturing and development processes, including understanding of equipment trains, processing capabilities and commodity requirements.
• Ability to work collaboratively across departments/functions and interact in a tactful, professional and effective manner.
• Ability to manage and prioritize multiple tasks under tight deadlines and high pressure.
• Strong problem solving and project management skills.
• Strong communication skills (both written and oral).

Key Stakeholders

• Project team members from development, analytical, CMC, and QA
• Coordinators from other operations/sites
• Supply chain and tech transfer teams
• Purchasing

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 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.

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