Senior Director, Contract Manufacturing Organization (CMO) Management

  • South San Francisco, CA, USA
  • Employees can work remotely
  • Full-time

Company Description

Five Prime is a clinical stage biotechnology company relentlessly focused on rewriting the narrative for people with cancer. By tackling the tough scientific questions and untapped pathways, we aim to offer new hope by developing novel, breakthrough therapies that have potential to alter the course of disease in cancers with few treatment options. This vision is what defines us, and guides our research, clinical development and partnerships. To build a better tomorrow for people with cancer, we are teaming up with patients, physicians, scientists, and industry partners to make a meaningful difference in patients’ lives. Five Prime collaborates with leading global pharmaceutical companies and has therapies in pre-clinical and clinical development.  For more information, please visit www.fiveprime.com.

At Five Prime, we are relentlessly focused on rewriting the narrative for people with cancer.  We tackle the tough scientific challenges with optimism and courage.  Rather than pursue the well-trodden path, we explore untapped pathways that have potential to deliver truly novel, breakthrough treatments for cancers with few options.

Together with patients, physicians, scientists, and industry partners we start each day looking for ways to advance science and use our expertise to develop cancer treatments that provide a fresh start and renewed hope for people facing the challenges of cancer.

We do things in a way that truly matters for patients. We embrace this spirit with pride; with action over words. We bring boldness, passion and commitment to each decision in the fight against cancer, however big or small. We are committed to transforming a cancer diagnosis from a foregone conclusion to a more hopeful future. Let’s rewrite the cancer story. Together.

Job Description

Summary

Reporting to the Vice President of Manufacturing Sciences, this position will be responsible for managing Drug Substances and Drug Products Contract Manufacturing Organizations (CMO’s) for FivePrime’s therapeutic protein pipeline. Working with the Manufacturing Sciences team, the Sr. Director will be the key interface for all aspects of clinical manufacturing including CMO relationship management, planning, technical support and production oversight.  This position requires broad knowledge on protein production technologies including cell culture, purification, and aseptic filling processes. This position requires experience with managing late-stage activities with the CMO such as process characterization, process validation, and BLA preparation.  This role also requires administrative experiences including contract review, budget planning, invoice approvals and managing project-related timeline

Essential Duties/Responsibilities

  • Manage relationship with Drug Substances and Drug Products Contract Manufacturing Organizations (CMO), including coordination, communication, and technical oversight, to ensure timely delivery of quality GMP products to support clinical trials.
  • Manage late-stage activities at CMO including process characterization, process validation, BLA preparation and commercial launch activities.
  • Collaborate with Business Development, Legal, and Procurement to review and negotiate contract terms and execution of agreements.
  • Partner with internal technical teams to coordinate technology transfer, risk assessment, and readiness activities for GMP production at CMO’s.
  • Partner with Process Development and Quality team to review and approve MBRs.
  • Serve as primary point of contact to the CMOs to support batch manufacture, deviation investigation, release, and logistics.
  • Supports Person-In-Plant (PIP) and provides on-site oversight at CMO's during critical activities.
  • Collaborate with CMO project manager in development project plans and schedules and ensure the tasks are executed accordingly to the agreement, cGMP requirements and regulatory commitments.
  • Keep up with the latest regulatory and cGMP guidance.
  • Maintain awareness of state-of-the-art manufacturing practices and monitor status of CMO capacity and provide update to the leadership team.

 

Qualifications

Qualifications

  • Education and/or Job Experience combination to be successful in the role.
  • B.S. or B.A. in biochemistry, chemical/biochemical engineering or related discipline required.  Advanced degree preferred.
  • Minimum 12 years' experience within biopharmaceutical CMC development, such as process development, cGMP production and regulatory.
  • Direct experience in tech transfer to CMO and oversight of GMP production is required.
  • Direct experience with managing process characterization, process validation activities and successful BLA submission is required.

Additional Information

California Consumer Privacy Act

At FivePrime, we believe a diverse workforce drives our success as a company. We are always working to create an environment where different backgrounds and viewpoints are valued and celebrated.

FivePrime is an equal opportunity employer. FivePrime makes employment decisions, including in recruitment and selection, without consideration of race, color, national origin, religion, sex, gender, gender identity or expression, sexual orientation, age, veteran status or disability.

Five Prime acknowledges that providers may be a valuable resource for identifying and recruiting candidates for employment.  However, we require that all recruiters engage directly with Five Prime’s Talent Acquisition Team and comply with Five Prime’s requirements prior to transmitting any resumes/CVs or introducing any candidates to Five Prime.  Five Prime’s Talent Acquisition Team is the only function within the Company that can enter into contractual relationships with external recruiters and recruiting agencies.   As such, all unsolicited resumes, CVs, anonymous profiles, or candidate information you may submit to employees of Five Prime will become property of Five Prime and Five Prime will have no obligation to pay you or anyone else for the use of such information, including any finder’s, placement, introduction or placement fee.

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