• Director, Contract Manufacturing

    Job Locations US-IL-LAKE FOREST
    ID
    2019-1031
    Category
    Other
    Type
    Regular Full-Time
  • Overview

    Responsible for developing and implementing long term Contract Manufacturing strategies and networks that address the needs of Assertio’s clinical and commercial products. Ultimately responsible for the supply of clinical and commercial products from Assertio’s Contract Service Providers (CSP’s) and oversees a team of engineers/scientists that perform related CMC development & manufacturing activities. Works cross functionally across the organization with Quality, Regulatory, Clinical, Sales and Marketing to coordinate the planning and execution of new programs, new products or changes to existing products.

    Responsibilities

    Essential Job Functions

     

    • Develop vision and strategies for Contract Manufacturing group to ensure continuity of high-quality supplies to meet sales/marketing demands as well as internal objectives for the Assertio product portfolio.
    • Establish goals for and manage Contract Manufacturing personnel. Provide direct reports with direction and objectives, training, coaching, and mentoring for effective performance.
    • Lead strategic planning efforts for Contract Manufacturing sourcing.
    • Develop strong/proactive processes related to Contract Manufacturing (CMO, CDMO) selection, qualification, management, and monitoring.
    • Clinical Manufacturing – Manage all aspects of GMP manufacturing processes to produce clinical supplies to support clinical studies, including schedules and budgets. Ensure that processes comply with requirements of regulatory agencies.
    • Commercial Manufacturing – Manage and oversight of CMOs in executing tech transfers, engineering & validation activities, and commercial GMP product manufacturing. Proactively provide engineering/technical insight in to all process design and equipment applications to ensure success.
    • Provide technical expertise in process troubleshooting and investigations to bring them to timely resolution and to eliminate recurrence.
    • Support lifecycle initiatives through process optimizations and reformulations as identified.
    • Work with colleagues in the strategic planning and execution of the corporate goals for the Department (QC, QA, and Manufacturing) including the resources and timelines for carrying out those objectives.
    • Formulate, monitor, and control departmental budgets.
    • Ensure regulatory compliance of manufacturing operations and that related policies/procedures are in place and maintained current; Support & provide subject matter expertise for audits/inspections. Ensure individual and group training compliance is maintained.

     

    Additional Responsibilities/Duties

    • Strong influence management skills including comfort operating in a highly matrix-based environment.

    Qualifications

    Education and Experience

    • BA/BS degree or equivalent experience in related field required. Advanced degree preferred.
    • A minimum of 10 years of pharmaceutical or biotech industry experience, including clinical development, process validation, and commercial pharmaceutical cGMP manufacturing environments.
    • Prior experience related to managing external CMOs is required.
    • Prior experience in working at a commercial manufacturing site is required.

     

    Skills and Abilities

    • Ability to articulate and communicate vision and strategic direction and to lead teams in this capacity.
    • Collaborative – is successful in delivering through influence.
    • Excellent interpersonal, negotiation, and organizational skills.
    • Ability to travel up to 30%.

     

    Assertio Competencies Include

    • Integrity
    • Decisions & Judgment
    • Ownership & Initiative
    • Adaptability & Change Readiness
    • Teamwork & Collaboration

     

    Physical/Mental Requirements

    • Sitting 80%; walking / standing 20%
    • Able to see and read PC screens; detect color coding, read fine print, and/or normal type size print
    • Ability to understand opposing points of view on highly complex issues and to negotiate and integrate different viewpoints
    • Ability to organize and prioritize work on long-term basis
    • Ability to make decisions which have significant impact on the department’s credibility, operations, and services
    • Ability to compose materials such as detailed reports, work-related manuals, publications of limited scope or impact, etc., and/or to make presentations outside the immediate work area
    • Ability to compute, analyze, and interpret numerical data for reporting purposes

     

    Accommodations for Applicants with Disabilities

    Assertio is proud to create a culture of inclusion and diversity and be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

     

    We provide reasonable accommodations to qualified applicants with disabilities and to disabled veterans in accordance with the ADA. If you require a reasonable accommodation for any part of the application process due to a medical condition or disability, please email hr@assertiotx.com or call 224-441-6867 for assistance.

     

    For more information about your EEO rights as an applicant under the law, please click here.

     

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