Director S&T API

AbbVie Inc.; Chicago (IL); Híbrido; USD 180 000 - 260 000; Tempo integral

Resumo da oferta

AbbVie Inc. seeks a Director of Operations Product Development, Science & Technology (PDS&T) to set vision, plan and lead manpower, facilities and budgets to keep projects on track, aligning development with manufacturing and customer requirements.

You will lead a diverse staff, liaise between R&D and contract manufacturers, and drive seamless scale-up from pilot to full-scale manufacturing with a focus on quality and regulatory compliance.

Qualificações

• 10+ years of API development/manufacturing, formulation, analytical chemistry and/or technical services in pharma.
• At least 6+ years of managerial experience in the pharmaceutical industry.
• Strong background in drug development, marketed product support and regulatory/compliance fields.

Responsabilidades

• Manage strategies, assessment, planning, decision-making, and risk management of API and dosage form projects.
• Provide mature, credible CMC leadership at AbbVie.
• Direct a cross-functional staff to meet scientific, regulatory and commercial standards.
• Evaluate new technology and integrate regulatory guidance into strategy.
• Develop cost estimates, business plans, timelines and contingency plans.
• Recruit resources and make go/no-go decisions for projects.
• Interface with R&D and Operations; engage with external manufacturers and customers.

Conhecimentos

CMC leadership

Drug development

Regulatory knowledge

Cross-functional leadership

Formação académica

Master’s Degree or equivalent related experience

PhD or equivalent experience

Descrição da oferta de emprego

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 at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Director, Operations Product Development, Science & Technology (PDS&T)'s primary responsibility is to set vision and strategy, plan, coordinate, direct, coach, develop, hire, communicate and control the use of manpower, facilities, and budgets to keep his/her projects on track within their technical, time and budget objectives. 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 manufacturing.

Responsibilities

• Manage the strategies, assessment, review, planning, decision-making, completion and risk-management of all activities related to existing API and dosage forms improvement, formulation/process development and improvements, analytical support, product and process scale-up, technology transfer from R&D to Operations/TPMs, product validation, post validation monitoring and commercial support. In these responsibilities the director shall manage decisions, people and budgets within agreed objectives.
• Provide mature, credible CMC leadership at AbbVie
• Provide a positive senior leadership model for scientists within Operations PDS&T.
• Maintain and direct a highly diversified cross functional staff of professionals to ensure that all aspects CMC life cycle management are completed on time, within budget and meet highest scientific, regulatory, quality, marketing and commercial standards
• Evaluate and introduce new technology with applications in development and manufacturing while assuring the incorporation of knowledge of current regulations, guidance documents and competitive environment into decisions and strategy
• Provide rapid and accurate evaluation of new business opportunities. Develop and communicate cost estimates, business plans, timelines and contingency plan
• Provide technical leadership for process and regulatory deficiency issues. Provide guidance, create and implement strategic systems to improve PDS&T and Operations support for technical issues
• Identify and recruit resources to accomplish project and departmental objectives within agreed time scope, and operating in an open communication environment while 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. Provide effective technical and business leadership at the R&D/Operations interface.
• The director must be able to develop relationships, interact with and influence the R&D organization and R&D management, as well as operations management. He/she must also be able to interact effectively with external contract manufacturers and customers to secure Abbvie interests. Challenges their staff to explore new technological opportunities and establishes an environment for their staff that promotes open communication, knowledge sharing and problem solving.

Qualifications

• 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 have10+ years of experience in API development / manufacturing, formulation, analytical chemistry and/or technical services roles, including at least 6+ years of managerial experience in the pharmaceutical industry.
• Director, MS&T must have strong background and expertise in drug development, marketed product support, technical issue resolution & related technical, manufacturing, regulatory and compliance fields.

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 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 employer remains in the Company's sole and absolute discretion 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, learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html