Project Manager, CMC External Manufacturing

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

As a Project Manager in Supply Chain and Program Strategy Group (SCPS), you will manage multiple projects, contributes to project and budget prioritization, drive external outsourcing strategy and provide oversight for research, process development, analytical, manufacturing activities at CROs/ CDMOs to support AbbVie’s early t-LNPs, SM, Peptides, and ADC clinical assets. They will align and excite internal stakeholders to develop a phase appropriate supply chain to manufacture RSMs, Intermediates, APIs and DPs. They will collaborate across multiple disciplines and will have strong ability to influence in matrix organization and senior leaders. They will represent AbbVie on high profile partnerships and in-licensing of externally developed assets. They will either lead or support SM CMC strategic initiatives. Manufacturing, Quality, People Management, CMC clinical development experience and knowledge are highly desired.

Responsibilities:

• Perform SCPS responsibilities on multiple AbbVie projects and as a part of SM CMC team develop and implement the internal and external manufacturing strategy from GLP tox through IND and cPoC towards tech transfer to commercial sites for t-LNPs, SM, Peptides and ADCs
• Manage direct reports and support direct material purchase API PP including custom materials, raw materials, solvents and commodities. Develop supply chain and operational strategies to assure the pilot plant and project teams meet API and/or drug product delivery requirements. 
• Manage project-specific sourcing challenges for API PP, such as special commodity needs or DEA-regulated materials.
• Lead and support SM CMC strategic initiatives, partnerships and collaborations with other pharma/biotech companies in forums like DCAT and CPHI.
• Manage and support development and manufacturing activities at CROs/CDMOs and available to participate in call across multiple international time zones.
• Develop supply chain network for new modalities, such as targeted LNPs.
• Engage on various aspects of the program to identify issues and work with appropriate SMEs for mitigation. Share ownership of CMC timelines, DS/ DP supply/demand, proactively gating and aligning at-risk spending. Develop Cost of Goods estimates for R&D projects
• Work closely with AbbVie’s purchasing, fiancé, regulatory and quality organizations to ensure that all the third-party activities are performed in compliance with AbbVie’s internal requirements for quality, finance, ethics and regulatory . Facilitate TQA and MSA activities as appropriate.
• Ownership of key deliverables and SM CMC external budget. Establish monthly LBE (latest best estimate) and 2-year look ahead for external budgets to support project activities
• Reviews contracts with external partners and consultants. Develops a budget in collaboration with PPDST, obtains resources from functional areas and stays within the approved funding. Accountable for the success and overall CMC quality of a given project.
• Ensures timely execution of project plan to deliver high quality with respect to science, technology, compliance and cost effectiveness at external vendors

• Experience obtained through a combination of appropriate education in chemical engineering and BS 5+ years of relevant pharma/biotech industry experience
• Experience working in CMC development for clinical stage candidates and with external CROs/CDMOs
• Experience working in large scale production facility and pilot plant.
• Strong technical knowledge of CMC development and cGMP manufacturing
• Working knowledge of CMC regulatory is desired
• Experience managing budgets, revenue recognition, invoices, and contract in close partnership with purchasing and finance
• Small molecule, t-LNPs and ADC experience
• Exceptional program management skills and act as owner, ability to collaborate and influence effectively cross functionally
• Strategic thinker, ability to support multiple projects, and keep pace with fast moving organization
• Ability and willingness to domestic and international travel up to 25%

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. ​

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AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

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