Executive Director, Biologics Drug Substance Commercialization (BDSC)

Job Description

Are you ready to take a leading role in shaping the future of biologics? Join our company, a pioneer in research-intensive biopharmaceuticals, and be at the forefront of delivering innovative health solutions that transform the prevention and treatment of diseases. As the Executive Director of Biologics Drug Substance Commercialization, you will be crucial in driving the success of our biologic assets within the pipeline. Collaborate directly with our research and development division and manufacturing teams to enhance strategies across cost, quality, and speed dimensions, achieving world-class results.

Your Core Responsibilities:

• Lead the development of integrated control strategies and process design elements, including process characterization and second-generation process development for drug substance processes across diverse expression systems.

• Facilitate technology transfer and PPQ elements for drug substance processes in collaboration with internal and external manufacturing sites.

• Author and review key elements of global regulatory submissions.

• Recruit and nurture a world-class workforce, providing opportunities for growth and development.

• Ensure compliance with our company's Operating Procedures and phase-appropriate GMP standards in core operations and laboratories.

• Maintain a safe and supportive workplace for staff across multiple laboratory settings.

• Provide visionary leadership within and across our company's technical functions.

• Develop and advance innovative technologies and business practices.

• Co-chair the Development Council, enabling strategic and technical guidance to advance our pipeline assets.

• Cultivate strategic partnerships with external technical collaborators.

Education Minimum Requirements:

• B.S. in relevant Engineering or Science fields.

Who You Are:

You are ready if you have the following requirements:

• At least 15 years of experience in biopharmaceutical manufacturing and/or development, emphasizing science and technical roles.

• Expertise and understanding in the commercialization of large molecule drug substance processes.

• Proven experience in managing large, multi-disciplinary scientific organizations.

• Excellent written and verbal communication skills with the ability to effectively communicate and influence at all levels of the organization.

Preferred Experience and Skills:

• Demonstrated success in commercializing multiple large molecule programs across various platforms.

• Expert knowledge in global regulatory requirements for large molecule commercialization and BLA assembly.

• Proficiency in QbD principles.

• Strong organizational skills with the ability to manage multiple projects simultaneously.

• Excellent interpersonal skills and ability to work collaboratively.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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