Director, CMC Product Development

Found in: Resume Library US A2 - 2 weeks ago

North Chicago Illinois, United States AbbVie Full time
Job Description

Leads global Product Presentation and Device Strategy Teams (PPDST) and Chemistry, Manufacturing and Controls (CMC) teams of functional representatives from various departments and divisions. Accountable for creating a CMC development plan in collaboration with line functions and the Asset Strategy Team (AST). Serves as the spokesperson for all CMC functions and ensures information flow among AST and various line functions and stakeholders. Partners with Clinical, Regulatory, Operations, Quality, Preclinical Safety, and Commercial organizations. Apprises CMC and Stakeholder Management of strategies, plans and risks through regular communications and periodic reviews throughout development and in support of global filings and approvals

 

 

Represents all CMC areas on the AST serving as spokesperson for the CMC project team and ensures information flow among the AST and all line functions. Ensures high quality science, technology, deliverables, and collaborates to ensure compliance with global regulatory and quality requirements. Participates in meetings with Regulatory Authorities, responds urgently to regulatory queries, and participates in Pre-Approval Inspections.

Leads the Product Presentation and Device Strategy Team (PPDST), a key deliverable team of the AST. Develops an integrated CMC strategy considering value drivers incl. patient convenience

Critically evaluates and integrates drug substance, drug product, and device inputs to CMC team strategies and plans that align with corporate business objectives. Decision-making will often require assessment and integration of physical chemical properties, formulation science, engineering, analytical, and device technical information in conjunction with the project strategy, with full consideration of current regulatory and compliance requirements.

Leads several early stage projects and one or more late stage projects in one modality area (NBE, NCE, gene/cell therapy) using matrix management approach. Mentors junior colleagues or Peers. May have direct reports.

Negotiates for additional resources when required, influences project timelines to ensure proper completion of required activities. Implements creative approaches to conserve resources, and achieves efficiency with respect to time, and budget.  Serves as a mentor for functional representatives, provides feedback and input to their functional managers and identify growth needs for team members.

Reviews contracts with Third Party Manufacturers and consultants. Develops a budget in collaboration with AST, 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.

Leads CMC development teams for assigned projects: schedules meetings, develops agendas, issues highlights, apprise risks and plans with CMC Management, conduct periodic reviews, to ensure that phase transition criteria are met in the most efficient and resource sparing manner.

Supports and implements corporate and divisional initiatives and strategies. Promotes scientific and entrepreneurial thinking, encourage creativity and manage quality and results with respect to science, time, budget and resources.

Develops and implements a CMC product development plan and updates as necessary in collaboration with the ADT and respective line functions.

Ensures compliance with regulatory, health, safety and environmental requirements. Is always informed of developments in the global technical, regulatory and compliance arena and industry practices.

Apprises CMC Management of plans and risks through regular communications and periodic reviews throughout development and in support of global filings, approvals and launches.

Responsible for the Quality / Module 3 content of global filings of high quality CMC dossiers, approvals and commercialization of products. 

  

 

 

 

  • Director of Regulatory Affairs, CMC

    5 days ago

    Chicago, United States Meitheal Pharmaceuticals Inc Full time

    All Jobs > Director of Regulatory Affairs, CMC & Regulatory Sciences Director of Regulatory Affairs, CMC & Regulatory Sciences WFH Flexible • Chicago • Operations Job Type Full-time Description SUMMARY Associate Director/Director of Regulatory Affairs, CMC & Regulatory Sciences will be responsible for providing regulatory guidance to (Bio)Pharma product...

  • Director, Product Design and Development

    Found in: Resume Library US A2 - 7 days ago

    Chicago, Illinois, United States Adtalem Global Education Full time

    Job Description Opportunity at a Glance The Director of Product Design and Development uses his/her extensive experience in higher education, understanding of pedagogical concepts, and knowledge of regulatory requirements to provide day-to-day strategic leadership and execution of all product design and development activities for designated...

  • Director, Combination Product Development

    Found in: Resume Library US A2 - 1 week ago

    North Chicago, Illinois, United States AbbVie Full time

    Job Description We are looking for an experienced technical leader to join our Device Engineering management team and contribute to the development and launch of exciting new drug / device combination products. Within Combination Product Development, the Device Engineering team is responsible for developing products informed by user needs and product...

  • Principal Research Scientist I/II

    Found in: Resume Library US A2 - 1 week ago

    North Chicago, Illinois, United States AbbVie Full time

    Job Description We are looking for a highly motivated person who can drive the development of antibody-drug conjugate drug substances, from FIH programs to late-stage development. The candidate will lead a group of scientists in the development of conjugation chemistry as well as downstream unit operations culminating in drug substance and may have...

  • Scientist I, Analytical Research

    Found in: Resume Library US A2 - 7 days ago

    North Chicago, Illinois, United States AbbVie Full time

    Job Description AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. AbbVie combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader to develop and market advanced therapies that address some of the world's...

  • Finance Manager

    Found in: Resume Library US A2 - 1 week ago

    North Chicago, Illinois, United States AbbVie Full time

    Job Description This position oversees the financial planning and analysis processes and requirements for the Externals expense for the Chemical, Control, and Manufacturing (CMC) within Development Sciences across Small Molecule and Biologics.  Provides financial guidance in compliance with financial policies, prepares management analysis of actual vs....

  • Director, Manufacturing and MSAT

    5 days ago

    Chicago, United States Page Mechanical Group Inc Full time

    Position OverviewThe Director, Manufacturing and MSAT will work in a dynamic, small team supporting external manufacturing of Medexus Products. The Director, Manufacturing and MSAT is responsible for day-to-day management of direct reports and contract manufacturing organizations for Medexus products. As a company liaison to CMOs, the Director ensures...

  • Principal Research Scientist II, Biologics ARD

    Found in: Resume Library US A2 - 1 week ago

    North Chicago, Illinois, United States AbbVie Full time

    Job Description AbbVie Biologics Analytical Research & Development (Biologics ARD) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's therapeutic biologic products.  Our scope includes AbbVie's diverse pipeline of innovative therapeutic biologics medicines, including monoclonal...

  • Senior Associate Director, Analytical Development

    1 week ago

    North Brunswick, United States Boehringer Ingelheim Pharmaceuticals Full time

    Description Are you looking for an opportunity to grow your leadership and analytical chemistry experience to further support the lives of animals? Are you looking to coach a team of scientists to develop further innovation in animal health? Are you passionate about building a team structure and foundation to meet present and future needs? If these questions...

  • Associate Director, IT Clinical Development Operations

    Found in: Resume Library US A2 - 1 week ago

    North Chicago, Illinois, United States AbbVie Full time

    Job Description Take the next step in your career with an organization that strategically invests in the long-term health of the company, its technology, and its people. The AbbVie Business Technology Solutions (BTS) team shapes the digital transformation necessary for our treatments to positively impact patients’ lives. In the role of Associate Director,...

  • Remote Manufacturing Planning Director

    Found in: Jooble US O C2 - 2 weeks ago

    Chicago, IL, United States Page Mechanical Group, Inc. Full time

    The Director, Manufacturing and MSAT will work in a dynamic, small team supporting external manufacturing of Medexus’ Products. The Director, Manufacturing and MSAT is responsible for day-to-day management of direct reports and contract manufacturing organizations for Medexus products. The Director will provide technical and scientific subject matter...

  • Senior Scientist II, Molecular Profiling and Drug Delivery

    Found in: Resume Library US A2 - 1 week ago

    North Chicago, Illinois, United States AbbVie Full time

    Job Description The Molecular Profiling and Drug Delivery (MPDD) function within the Small Molecule CMC organization is accountable for a broad range of deliverables across various stages of drug discovery and development. During lead optimization and through candidate selection, MPDD scientists utilize state of the art automation and computational tools...

  • Director, Manufacturing and MSAT

    1 week ago

    Chicago, United States Page Mechanical Group Inc Full time

    Position Overview The Director, Manufacturing and MSAT will work in a dynamic, small team supporting external manufacturing of Medexus’ Products. The Director, Manufacturing and MSAT is responsible for day-to-day management of direct reports and contract manufacturing organizations for Medexus products. As a company liaison to CMOs, the Director ensures...

  • Scientific Director, Oncology Clinical Development

    Found in: Resume Library US A2 - 1 week ago

    North Chicago, Illinois, United States AbbVie Full time

    Job Description Oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy.  Core Job...

  • Director of Partnership Development

    Found in: Resume Library US A2 - 2 weeks ago

    Chicago, Illinois, United States CADDi Full time

    At CADDi, we're revitalizing American manufacturing by unlocking the potential of historical drawings and supply chain data. Our product, CADDi Drawer, empowers customers to break the cycle of reinventing the wheel, transforming individual tribal knowledge into valuable company assets. Equipping our clients with Drawer, we're paving the way for a more...

  • Scientific Director, Toxicology Development Biological Sciences

    Found in: Resume Library US A2 - 1 week ago

    North Chicago, Illinois, United States AbbVie Full time

    Job Description AbbVie’s Development Biological Sciences department is seeking a Scientific Director for its Portfolio Leadership Group. The primary function of this role will be to serve as a nonclinical safety representative for assigned molecules across AbbVie’s diverse portfolio. As a safety representative, the Scientific Director will be...

  • Medical Director/Sr. Medical Director Oncology Clinical Development

    Found in: Resume Library US A2 - 1 week ago

    North Chicago, Illinois, United States AbbVie Full time

    Job Description Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business...

  • Director of Product Management

    Found in: Resume Library US A2 - 2 weeks ago

    Chicago, Illinois, United States McDonald's Corporation Full time

    Job Description About Us: At McDonald's we are pioneering the future of digital customer interactions through conversational commerce. Our innovative approach aspires to go beyond traditional voice ordering to offer seamless, interactive ordering experiences across a variety of platforms and devices. By replicating the familiar interaction models of...

  • Senior Manager/Associate Director, Regulatory Affairs, Strategic Global Labeling

    Found in: Resume Library US A2 - 6 days ago

    North Chicago, Illinois, United States AbbVie Full time

    Job Description The Associate Director, Regulatory Affairs, Strategic Global Labeling – Combination Products and Devices, combines the knowledge of scientific, regulatory, and business issues to support labeling for products that are developed, manufactured or distributed to meet required legislation. This individual has influence within the department...

  • Group Medical Director, Product Safety Teams

    15 hours ago

    North Chicago, United States AbbVie Full time

    **Company Description** **Job Description** Purpose**: Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors. Leading Product Safety Teams (PST) and support one or more products as the PST Lead and ensuring safety of one or more products through the product lifecycle (e.g. surveillance, signal detection, validation and...