Director, ADC Process Development

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.

The Operations Science & Technology department supports technical and scientific activities related to the manufacture of pharmaceutical products in AbbVie facilities or in contract facilities. The director establishes goals that are consistent with development, manufacturing and customer requirements, implements plans/policies, assigns duties and responsibilities, and controls subordinates performance to meet division goals and commitments. The director through his/her section managers and direct reporting lines will manage a technically diverse staff of highly specialized scientists and technicians. He/she is a key link between development organizations and operations/third party contract manufacturers and ensures a seamless link between pilot scale and full scale manufacture. The director is accountable for all the activities of the department and provides technical/scientific and business leadership for the department.

Responsibilities:

• Provide mature, credible CMC leadership at AbbVie. Mentor and support development of people managers and future leaders. Coach scientists/engineers within the team to develop cross-functional CMC experience.
• Provide a positive leadership model for scientists within Product Development Science & Technology. Maintain and direct a highly diversified cross functional staff of professionals to ensure that all aspects of CMC development are completed on time and meet highest scientific, regulatory, quality, and commercial standards
• Drive development of platform technologies and innovation to enable operational efficiency and cost of goods reduction.
• Provide rapid and accurate evaluation of new business opportunities
• Develop and communicate cost estimates, business plans, timelines and contingency plans . Distill technical and cross-functional updates (timelines, deliverables, results) to provide concise, effective, and clear updates across programs for leadership.
• Identify and recruit resources to accomplish project and departmental objectives within agreed time scope, and operating in an open communication environment whilst stressing scientific/compliance excellence
• Make go/no-go decisions related to project responsibilities
• Represent AbbVie to regulatory agencies (US/ROW as appropriate) by supplying verbal or written information and/or participation in face-to-face meetings for responsible activities. Operate cross-functionally and maximize relationships with key CMC stakeholders including R&D, manufacturing, regulatory, quality, and analytical development.

• Master’s Degree or equivalent related experience in a related scientific field is required.
• PhD or equivalent experience in a related scientific discipline is highly desired.
• The incumbent would be expected to have 10+ years of experience in pharmaceuticals development / manufacturing, including at least 6+ years of managerial experience in the pharmaceutical industry.
• Strong background and expertise in process development, technical issue resolution & related technical, manufacturing, regulatory and compliance fields.

 

Preferred Qualifications

• PhD in Chemical Engineering, Biochemistry, Chemistry with 10+ years of related experience; Master’s Degree with 14+ years of related experience
• Excellent technical skills and expertise in process development, tech-transfer, continuous process improvement, and new technology implementation.
• Demonstrated record as a successful people manager developing strong cross-functional leaders and effective communicators
• Strong understanding of QbD principles and experience with late-stage process development, process characterization, and control strategy development

 

 

 

 

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 long-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.

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