AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell & gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant supply, Right, On time. For more information, visit www.agcbio.com.

 

SUMMARY:

The Sr. Director of Process Development (PD) will be responsible for overseeing the development and commercialization of Cell & Gene (CGT) products. The Sr. Director will provide leadership to an organization responsible for developing and providing clients with solutions and support of technology, formulation and process development for CGT products from pre-clinical thru commercial/GMP lifecycle status and scale.  In addition, the Sr. Director of PD will be a member of the site senior Leadership Team, responsible for providing leadership and decision making to the Longmont site.

 

PRINCIPAL RESPONSIBILITIES:

  • Provide leadership and direction to the Process Development organization
  • Serve as an active member of the site Leadership Team responsible for development and setting of site strategy and goals
  • Mentor and develop staff members within the organization
  • Oversee development operations working on projects ranging from early phase to commercial stage CGT products
  • Champion the development and implementation of new technologies, methodologies and systems to drive innovation in CGT development
  • Develop strong relationships with CMC customers; support the creation of strategic plans with clients for the development of biologic drug candidates
  • Work closely with Business Development in support of recruiting new customers and partners
  • Drive development and implementation of new systems to improve project execution and data management
  • Support regulatory filings (INDs, BLAs, MAAs, etc.) and associated product related inspections from regulatory agencies (FDA, EMA, etc.)
  • Provide technical support to the cGMP manufacturing operation
  • Develop and manage department budgets
  • Ensure the department is positioned well for future growth

 

KNOWLEDGE, SKILLS & ABILITIES:

  • Staff Leadership.  Translates mission, vision, values into actionable goals and objectives.  Provides adequate structure, direction and feedback.  Creates environment where staff feel valued, respected and empowered.  Shows appreciation for and rewards individual and group excellence.  Demonstrates high standards of ethics and fairness.  Takes appropriate risks and encourages staff to do the same.  Works through conflict and insures productive resolution.  Maintains confidentiality of private and sensitive information.
  • Job Knowledge and Skills.  Possesses required knowledge and skills to successfully perform job.  Rapidly embraces and applies new ideas and approaches where doing so adds value.
  • Results Orientation.  Knows how to get things done in an effective and efficient manner with available resources.  Plans and prioritizes work, sets and accomplishes goals, and completes quality work on schedule.  Maintains a sense of urgency in accomplishing work.  Strives to improve company and individual performance.
  • Takes personal responsibility, leads by example and conscientious.  Demonstrates initiative and is committed to and enthusiastic about achieving company success.
  • Decision Making.  Makes timely and sound decisions based on a combination of analysis, experience and judgment.  Consults others, as appropriate.  Understands and takes into consideration how decisions impact others.
  • Customer Focus/Team Work.  Develops and maintains adequate customer satisfaction levels with internal and external audiences.  Demonstrates a bias toward service, quality and teamwork.  Builds constructive and effective working relationships.  Is committed to the success of all stakeholders.
  • Communication.  Cultivates a culture of openness and information sharing.  Demonstrates integrity and honesty in all communication.  Is willing to “speak the truth” and advocate positions even when unpopular.  Provides constructive feedback.  Assumes ownership and accountability.

 

 

EDUCATION / EXPERIENCE:

  • BS/BA degree in Science or Engineering with 15+ years industry experience or MS with 13+ years or PhD with 10+ years
  • 8+ years of experience in biopharmaceutical development with a strong background in biologics product development and 5+ years in a leadership role
  • Experience with Viral Vector and/or Cell Therapy process development preferred
  • Experience and understanding of ICH guidelines and GMP requirements for development and manufacturing of biologics
  • Experience supporting regulatory filings (e.g., INDs, BLAs, MAAs, etc) and supporting product-related inspections for US and foreign regulatory agencies
  • Experience developing, implementing and executing strategic plans and objectives for organizations and departments

 

Compensation Range:

$202,100.00 - $242,500.00

 

 

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

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