Associate Director, Process Chemistry (External Manufacturing)

BioSpace; North Chicago (IL); On-site; USD 150,000 - 230,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k)

Long-term incentive programs

Paid time off

Job summary

AbbVie is seeking an Associate Director I, Process Development (External Manufacturing) to lead development and external manufacturing strategies for small molecules, t-LNPs, peptides, and ADC assets. You will partner with CROs/CDMOs to ensure high-quality, cost-effective supply from preclinical through cPOC programs.

The role requires deep CMC planning experience, strong cross-functional leadership, and the ability to navigate a matrix organization while driving supply chain resilience globally.

Qualifications

• PhD in Process Chemistry with 8+ years of pharma/biotech experience or MS with 10+ years, in small molecule process development and cGMP manufacturing.
• Experience managing external partners (CROs/CDMOs) in fast-paced environments with strategic influence.

Responsibilities

• Lead external manufacturing strategies for SM, t-LNPs, peptides and ADC assets across global CRO/CDMOs.
• Own CMC timelines, supply/demand planning, and budget oversight with phase-gate governance.

Skills

Process development

External manufacturing

CRO/CDMO management

Regulatory understanding

Leadership

Program management

Budgeting

Digital transformation

Education

PhD in Process Chemistry

MS in Chemistry

Job description

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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

AbbVie is seeking a highly experienced and strategic Associate Director I, Process Development (External Manufacturing) to join our Synthetic Molecule (SM) CMC organization. In this role, you will lead and support the development and external manufacturing strategy for AbbVies small molecules (SM), t-LNPs, peptides, and ADC clinical assets across a global network of CROs and CDMOs. This role is ideal for a seasoned process chemistry leader who thrives in a fast-paced, matrixed environment and can successfully manage multiple projects simultaneously. You will serve as a trusted scientific and operational partner, influencing cross-functional teams, guiding external partners, and ensuring reliable, high-quality, and cost-effective supply for preclinical through cPOC programs. You will also play a critical role in CMC planning, budget stewardship, phase-gate governance, and supplier relationship management. The successful candidate will bring deep expertise in early- and mid-stage process development, strong technical judgment, and the ability to lead with both scientific credibility and operational discipline. This is a high-visibility role representing AbbVie in strategic partnerships and in-licensing activities, with meaningful impact on development timelines, external manufacturing performance, and overall portfolio success.

Key Responsibilities

• Lead SCPS responsibilities across multiple AbbVie programs and mentor API teams and PPDST members in developing robust external manufacturing strategies for SM, t-LNPs, peptides, and ADC clinical assets.
• Serve as the process chemistry subject matter expert for external CROs/CDMOs and provide technical guidance on process development, scale-up, and lifecycle planning.
• Own CMC timelines, drug substance supply/demand planning, and budgetary oversight, including proactive phase-gate management of external spend and alignment with SM CMC leadership on at-risk spend.
• Develop and maintain cost of goods estimates to support R&D and clinical development decisions.
• Identify, allocate, and communicate critical supply chain issues at the program level, partnering with appropriate subject matter experts to develop and execute mitigation plans.
• Influence cross-functional decisions in a matrix organization, balancing asset team priorities, functional requirements, and business objectives.
• Build, coach, and retain high-performing talent with strong capabilities in outsourcing, external manufacturing, and matrix teamwork.
• Drive cross-functional improvements in workflows, CRO/CDMO management practices, in-licensing readiness, and CMC development execution.
• Partner closely with Purchasing, Finance, Regulatory, and Quality to ensure all CRO/CDMO activities meet AbbVie requirements for quality, finance, ethics, and compliance.
• Support TQA and MSA activities as needed to enable effective external partnerships.
• Strengthen leadership capability across the organization to address complex outsourcing challenges and improve decision-making.
• Drive supplier diversification while actively managing strategic CRO/CDMO relationships.
• Lead due diligence and onboarding CMC activities for in-licensed assets, including gap assessment and DS/DP supply chain mitigation planning.
• Support development and manufacturing activities across global CROs/CDMOs and participate in meetings across multiple international time zones as needed.

Qualifications

• PhD in Process Chemistry with 8+ years of relevant pharmaceutical/biotech industry experience, or MS with 10+ years of relevant experience.
• Extensive experience in small molecule process development, cGMP manufacturing, tech transfer, and lifecycle management.
• Strong understanding of CMC regulatory expectations, quality systems, and process safety.
• Demonstrated success managing multiple projects, priorities, and external partners in a fast-moving environment.
• Excellent program management skills with a strong sense of ownership and accountability.
• Proven ability to influence without authority and collaborate effectively across scientific, operational, and leadership teams.
• Recognized technical expert and strategic thinker with the ability to guide complex external manufacturing decisions.
• Experience with digital transformation, automation, and operational excellence initiatives is highly desirable.
• Willingness and ability to travel domestically and internationally up to 25%.

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof thisposting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission,incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless anduntil paid andmay bemodifiedat the Companys sole and absolute discretion, consistent withapplicable law.

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.

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

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html