Senior Director, Biologics CMC Program Leader

Celgene Corporation - Summit, NJ (30+ days ago)4.0


Other Locations:US- NJ- Summit West

Description
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Senior Director, Biologics CMC Program Leader
Summit, NJ
SUPERVISOR

Executive Director, Biologics CMC Program Leadership

DEPARTMENT

Biologics Development and Manufacturing

PREREQUISITES

Minimum of 15-20 years of industrial experience in Biologics Development.

Ph.D. in relevant science or engineering field

Summary

The Senior Director is accountable for leading the CMC development activities for late-stage and post-approval biologics projects. This is a matrix leadership role that collaborates across multiple functions to develop CMC project strategies to support the global product development plans, and coordinates functional activities to deliver on the CMC plans. This is a highly visible and influential role in the organization that will interact extensively with business partners and senior leadership across Celgene and external collaborators. To deliver this accountability, the Senior Director must have depth and breadth of technical understanding, extensive biologics development expertise, regulatory and compliance awareness, strong business acumen and excellent leadership skills.

Responsibilities include, but are not limited to:
Lead a BioCMC matrix team using risk-based and QbD approaches to develop and deliver late-stage and post-approval CMC development strategies for biologics products within Celgene’s portfolio.
Define CMC goals, milestones and timelines for the team, coordinate and monitor progress, and manage team activities to ensure successful implementation of the endorsed development strategy.
Work with line functions to ensure that operational plans and appropriate resources are in place to support the development program plans.
Manage and influence stakeholders at all levels to ensure delivery of the product, process and documentation within established timelines and budget.
Represent the BioCMC team in CMC technical and program reviews with governance boards and senior management.
Serve as the primary liaison with the Global Project Team and Technical Commercialization Team.
Provide regular communications to the team, sub-teams, functional lines, stakeholders, and management. Escalate issues and risks according to governance procedures.
Contribute to the development and implementation of the BioCMC stage gates, milestones, and processes for biologics product development. Establish systems and tools to be used by all BioCMC teams across the development lifecycle.
Provide guidance on best practices and direction to BioCMC teams to support harmonization, efficiency, and continuous improvement.
Support implementation of logistical and technical innovation to improve product development processes.
Maintain currency with applicable global regulations and industry standards for development and registration of biological products.
Create a high functioning team, holding team members accountable for performance, and mentoring/coaching as needed. Provide input into the performance reviews of team member.
Participate in regulatory strategy development, regulatory filings, and meetings with regulatory agencies.

Skills/Knowledge Required:
Ph.D. in relevant scientific or engineering discipline.
15-20 years of experience in biotech/pharmaceutical industry with exposure to all stages of biologics development.
Proven record of successful technical leadership of CMC development teams.
Demonstrated matrix management skills and clear ability to influence and effectively align, motivate and empower the team to progress project goals in a cross functional team environment.
Proven ability to work effectively with cross-functional stakeholders in a complex/changing global environment.
Clear understanding of the process and functional interdependencies required to deliver a biological product to the clinic and to the market.
Subject matter expertise in one or more functional areas (cell culture, purification, drug product, analytical).
Demonstrated experience in preparing and executing complex strategic plans and balancing competing priorities.
Strong problem solving and risk based decision making skills and a strong ability to influence or manage without direct authority.
Highly developed interpersonal, communication and negotiation skills.
Demonstrated ability for critical thinking and innovation.
Potential to take on increasing responsibilities as the Biologics portfolio and organization expands.
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Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.