Director, External Manufacturing

About Allogene Therapeutics, Inc:

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn. 

Allogene’s Supply Chain organization is building a world class team that is focused on delivering potentially lifesaving therapies to patients. We are seeking a highly motivated individual to join us as Associate Director, External Manufacturing. This role will be a hands-on role reporting to our Director, Supply Chain. The primary responsibility will involve providing technical manufacturing support to a CMO for viral vector manufacturing. This person will play a key role in product lifecycle management, including development, characterization, commercialization, and evolution of cell therapy products. This person will collaborate across all CMC functional areas to ensure project advancement, rapid and best in class execution, and communication of challenges/opportunities. 

Responsibilities include, but are not limited to:

• Act as the Person-in-Plant (PIP) at Allogene’s CDMO facilities and provide operational oversight of CMOs to ensure all deliverables meet or exceed Allogene requirements 

• Maintain on-site presence at the CMO facility for extended periods (including some off-hours days to resolve urgent issues), leading up to and during batch manufacturing Collaborate with cross-functional teams, including the CMO joint process team, Process Development, Manufacturing, Quality Assurance and External Manufacturing 

• Provide operational oversight of CMOs to ensure all deliverables meet or exceed Allogene requirements (including but not limited to shipments, quality and compliance) 

• Perform detailed review of draft and completed batch records, including process monitoring (manufacturing data analysis, summary, and presentation) 

• Resolve manufacturing issues along with daily review of manufacturing investigations, change controls, complaints, and CAPAs 

• Collaborate with site personnel to provide real time guidance and determine resolution for manufacturing issues 

• Leverage technical, quality, and regulatory SMEs to provide guidance to CMOs and ensure cross-functional alignment on priorities and deliverables 

• Work closely with CMO and internal Quality, Supply Planning and Technical teams to prioritize and track efficient documentation (including but not limited to change controls, investigations, and deviations) to meet Allogene requirements 

• Identify and escalate business-critical issues effecting Compliance, Operations and Management 

• Manage and track CMO performance prior to (preparation), during (direct oversight) and after (summaries/reports/releases) manufacturing 

• Facilitate collation of data to track CMO performance and compliance on metrics/KPIs including but not limited to contractual agreements, spend/budget, product quality and supply integrity 

• Liaison with internal and CMO stakeholders on business operations including but not limited to contract negotiations, forecast communication, issuance of POs and reconciliation/validation of invoices 

• Support regulatory inspections and audits by ensuring inspection readiness within facility 

• Management of data generated at the CMO 

• Lead continuous improvement initiatives to affect timely resolution of supply issues 

• Build and maintain strategic relationships within the CMO organization as well as key internal stakeholders 

• Act as a resource for CMO stakeholders on their requests to Allogene stakeholders 

• Collaborate with CMO and internal stakeholders to understand planned change and manage the E-2-E implementation process including but not limited to change controls and impact assessments 

• Represent Allogene as a leader when issues arise 

• Adhere with cGMP requirements along with general safety policies 

Position Requirements & Experience:

• Bachelor’s degree required in Life Sciences, engineering, or other related discipline with 8 plus years of experience working in bio-pharmaceutical manufacturing, quality, and/or bio-pharmaceutical development (an equivalent combination of education and experience may be considered) 

• Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects 

• Experience in development and/or characterization of biologics and/or cell therapy manufacturing processes 

• Experience with cGMP, ICH guidelines, PPQ (process validation), and working within a Quality organization 

• Experience working in a self-driven, performance/results oriented, fast paced matrix environment 

• Strong quality and compliance background in a commercial GMP operational environment; sound working knowledge of health authority regulations 

• Excellent problem-solving skills 

• Working knowledge of statistical software 

• Able to creatively manage time and elevate relevant issues to project lead and line management 

• Strong scientific and technical writing 

• Detail oriented with excellent verbal and written communication skills are essential in this collaborative work environment 

• Solid project management skills and experience managing complex projects 

• Strong leadership and an innate ability to collaborate and build relationships is critical 

• Ability to work calmly and make sound decisions in an environment of uncertainty and change 

• PhD candidates with appropriate backgrounds will also be considered 

• Candidates must be authorized to work in the U.S.
  
  

As an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.  

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