Director of Biologics Manufacturing

JOINN Biologics - San Pablo, CA (30+ days ago)


JOB DESCRIPTION:
The position of Director of Manufacturing is accountable for biologics manufacturing activities at assigned Contract Manufacturing Organizations (CMOs). The primary focus of the position will be to support the establish cGMP upstream and downstream process of monoclonal antibody and protein therapeutic durgs, evaluating new manufacturing opportunities both internally and externally, and building future manufacturing expertise and infrastructure to support our monoclonal antibody and protein therapeutic drug programs.

This position leads a team of manufacturing technical experts who are directly responsible for all manufacturing activities. Team responsibilities including driving all project management initiatives at the supplier site including technical transfers, new product introductions, compliance initiatives and continuous improvement projects. The candidate will routinely manage and contribute to projects requiring close collaboration with Technical Development, Regulatory, Legal, Quality, Logistics, Planning and Program Management.

We are looking for a demonstrated leader with the breadth of professional experience and expert knowledge of biological therapeutics manufacturing to define and implement our vision for this business-critical function. The right candidate will be strategic and understand the challenges and impact of managing a highly complex global manufacturing network.

RESPONSIBILITIES:

  • Build and leading a high performing team by hiring and coaching experts and innovators with skill sets in biopharmaceutical manufacturing, operational excellence, and project management.
  • Partner with internal stakeholders to develop and deliver a strategic Tech Ops manufacturing framework including risk analysis, internal vs external manufacturing evaluations and product quality outcomes.
  • Development and leadership of vendor management program including setting the strategic agenda, orchestrating interactions, overseeing manufacturing execution and performance, resolving issues that may occur and conducting regular monitoring and KPI tracking.

Triage in depth and complex process investigations, as appropriate.

  • Partner with Quality leaders.
  • Proactively identify and drive continuous improvement opportunities and effectively lead timely resolution of manufacturing issues.
  • Partner with key stakeholders to draft, manage, and deliver on annual manufacturing goals, objectives, and operating budget.
  • Point of reference regarding pharmaceutical technology and GMP compliance.

QUALIFICATIONS:

  • 10+ years of experience working in biopharmaceutical manufacturing\
  • Expert performance management coaching and people development experience.
  • Extensive knowledge of cGMPs and ISO regulations.
  • Demonstrated knowledge of procurement principles and best practices
  • Strong quantitative and qualitative analytical abilities
  • Ability to influence senior management both internally and externally
  • Experience negotiating commercial terms, contracts, and service agreements
  • Excellent interpersonal, communication, and presentation skills
  • Strong leadership and an innate ability to collaborate and build relationships is critical
  • Thorough understanding of best in class tools and processes to build scalable systems
  • Ability to think strategically yet execute tactically when necessary
  • A mentor and leader who excels at staff engagement and development

EDUCATION REQUIREMENTS:

  • Bachelor’s degree in Engineering or Science
  • Advanced technical degree in Engineering or Science strongly preferred

ABOUT JOINN Biologics:
JOINN Biologics, is a biopharmaceutical manufacturing contract service company dedicated to biologics therapeutic drugs manufacturing services for global pharmaceutical and biotech clients. JOINN Biologics is an independent company from JOINN group, we build upon a strong heritage of scientific innovation and highest standard of quality and customer services. The near term goal of the company is to recommission the cGMP facility in JOINN Innovation Park and provide contracted manufacturing services in the near future.

We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic.

Job Type: Full-time

Experience:

  • Biopharmaceutical Manufacturing: 10 years

Education:

  • Bachelor's

Language:

  • English

Required work authorization:

  • United States