Allergan
Director, CMC Product Development (all genders) (full-time, permanent)
Allergan, New York, New York, us, 10261
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
www.abbvie.com . Follow @abbvie on
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Overview Advance your career as
Director, CMC Product Development (all genders) , where you’ll oversee the CMC aspects of drug and combination product development across programs, align strategy with clinical and regulatory goals, and lead a global, cross-functional team. Collaborate with key partners, communicate critical updates to senior management, and drive robust CMC plans in support of global filings and approvals. Ideal candidates bring deep CMC drug development and team leadership experience, strategic vision, and a strong record in supporting clinical and regulatory milestones.
Join us to shape the future of global drug development.
Responsibilities
Serves as spokesperson for CMC on the Asset Development Team, promoting effective information flow and collaboration across all line functions
Ensures excellence in science, technology, and deliverables while maintaining compliance with global regulatory and quality standards, including active participation in meetings with authorities and pre-approval inspections
Critically evaluates and integrates drug substance, product, and device inputs into CMC strategies aligned with business and compliance objectives
Utilizes a matrix management approach to oversee a limited project portfolio, negotiating resources and fostering efficiency in timelines, budgets, and team development
Leads contract reviews with third-party partners, manage project budgets with ADT collaboration, and ensure successful CMC execution and quality deliverables within approved funding
Guides CMC development teams by organizing meetings, setting agendas, highlighting achievements and risks, and conducting reviews to efficiently meet phase transition criteria
Advances corporate and divisional initiatives, encourage creative and scientific thinking, and champion quality and resource management.
Develops, updates, and implements CMC product development plans while ensuring regulatory, health, safety, and environmental compliance, and support high-quality global filings, approvals, and product launches
Qualifications
Bachelor’s Degree with at least 20 years of CMC experience, a Master’s Degree with at least 18 years of relevant CMC experience, or a PhD with at least 12 years of relevant CMC experience
Strong educational foundation, with significant experience across CMC functions
Excellent scientific writing and verbal communication skills
Expertise includes regulatory requirements and familiarity with relevant research instrumentation and techniques
Solid knowledge of pharmaceutical sciences and the drug development process
Interdisciplinary CMC experience and depth of expertise
Negotiation, influencing, and leadership abilities are well developed
Creative and entrepreneurial thinking to guide smart business decisions
Fostering a high level of team morale within the CMC group
Additional Information
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
This job is eligible to participate in our long-term incentive programs
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 employee remains in the Company's sole andabsolutes discretion unless and until paid andmay be modified at the Company’s 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, visit
https://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
#J-18808-Ljbffr
www.abbvie.com . Follow @abbvie on
X , Facebook , Instagram , YouTube , LinkedIn
and
Tik Tok .
Overview Advance your career as
Director, CMC Product Development (all genders) , where you’ll oversee the CMC aspects of drug and combination product development across programs, align strategy with clinical and regulatory goals, and lead a global, cross-functional team. Collaborate with key partners, communicate critical updates to senior management, and drive robust CMC plans in support of global filings and approvals. Ideal candidates bring deep CMC drug development and team leadership experience, strategic vision, and a strong record in supporting clinical and regulatory milestones.
Join us to shape the future of global drug development.
Responsibilities
Serves as spokesperson for CMC on the Asset Development Team, promoting effective information flow and collaboration across all line functions
Ensures excellence in science, technology, and deliverables while maintaining compliance with global regulatory and quality standards, including active participation in meetings with authorities and pre-approval inspections
Critically evaluates and integrates drug substance, product, and device inputs into CMC strategies aligned with business and compliance objectives
Utilizes a matrix management approach to oversee a limited project portfolio, negotiating resources and fostering efficiency in timelines, budgets, and team development
Leads contract reviews with third-party partners, manage project budgets with ADT collaboration, and ensure successful CMC execution and quality deliverables within approved funding
Guides CMC development teams by organizing meetings, setting agendas, highlighting achievements and risks, and conducting reviews to efficiently meet phase transition criteria
Advances corporate and divisional initiatives, encourage creative and scientific thinking, and champion quality and resource management.
Develops, updates, and implements CMC product development plans while ensuring regulatory, health, safety, and environmental compliance, and support high-quality global filings, approvals, and product launches
Qualifications
Bachelor’s Degree with at least 20 years of CMC experience, a Master’s Degree with at least 18 years of relevant CMC experience, or a PhD with at least 12 years of relevant CMC experience
Strong educational foundation, with significant experience across CMC functions
Excellent scientific writing and verbal communication skills
Expertise includes regulatory requirements and familiarity with relevant research instrumentation and techniques
Solid knowledge of pharmaceutical sciences and the drug development process
Interdisciplinary CMC experience and depth of expertise
Negotiation, influencing, and leadership abilities are well developed
Creative and entrepreneurial thinking to guide smart business decisions
Fostering a high level of team morale within the CMC group
Additional Information
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
This job is eligible to participate in our long-term incentive programs
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 employee remains in the Company's sole andabsolutes discretion unless and until paid andmay be modified at the Company’s 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, visit
https://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
#J-18808-Ljbffr