JOB POSTING

Director / Senior Director, Biologics Drug Substance Process Development

ALX Oncology (ALX) is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway. Our lead candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents.

ALX is seeking a highly motivated and talented individual to lead and manage drug substance (DS) process development, process improvements, and process validation. This impactful position will report to the Vice President of Chemistry, Manufacturing, and Controls and will be the primary point of contact for process development activities with leadership partners in Manufacturing and Quality. This position will be responsible for DS process development deliverables including: DS process development and process characterization;; process control strategy for Process Performance Qualification (PPQ); preparation and response to regulatory inquiries and submissions. ALX is advancing recombinant compounds, targeted for intravenous delivery, from preclinical development to late-stage clinical trials and commercialization.

Responsibilities

These may include but are not limited to:

  • Lead biologics DS technical, development and validation activities.  Manage collaboration with contract service providers on DS technical activities.
  • Oversee and manage DS process characterization and process validation studies, as well as technology transfer for all phases of development and products.
  • Serve as a subject matter expert (SME) in DS process development, scale-up, process transfer, process characterization, process validation, and GMP manufacturing.
  • Provide technical recommendations for assay development, validation, evaluating process data, trouble-shooting and root cause analysis as well as providing strategic recommendations leading to improved: yields, cost of goods, and process robustness.
  • Support DS manufacturing and quality in problem solving production issues and deviation investigations.  Provide technical oversight on manufacturing batch record review.
  • Identify drug substance critical quality attributes impacting safety, efficacy, and manufacturing robustness. Establish phase appropriate regulatory specifications.
  • Participate in preparation, review and approval of CMC sections of regulatory submissions.  Respond to questions from regulatory authorities.
  • Oversee and author the preparation of DS technical reports, data summaries and CMC related documents required for various regulatory submissions.
  • Develop resourcing strategies, allocate budget for department to meet company objectives and efficient operations.
  • Collaborate with project teams to meet project objectives, budget, and timelines.
  • Travel as required to CMO and key service provider sites to represent ALX for DS technical feasibility assessments, oversight and partnership development purposes.
  • Partner with key ALX Oncology functions including Quality, Project Management, Clinical Operations, Finance and Regulatory.

Requirements

  • Technical expertise in development, validation, and full-scale manufacture of recombinant mammalian biologic therapeutic products.  
  • Detailed understanding of all stages of late stage process development for biologics: commercial process development, process characterization, process design, Design of Experiments (DoE), Process Performance Qualification (PPQ), control strategies.
  • Proficient in Quality and Regulatory requirements of biologics products.  Working knowledge of US and EU cGMP and ICH guidance and relevant standards and quality system requirements regulations and guidelines for biologics drug substance manufacturing.  In-depth knowledge of worldwide regulatory requirements for DS CMC sections of INDs and BLAs.
  • Experience in authoring IND/BLA submission documents and relevant technical documents.
  • A thorough understanding of protein structure, chemistry and stability attributes to process development.
  • Demonstrated ability in providing scientific and engineering expertise to multi-functional teams in Process Development, Manufacturing, Quality and Supply Chain to advance complex projects to completion and to interface on technical problem resolution.
  • Ability to navigate and be successful in a fast-paced, highly matrixed work environment.
  • Strong technical communication skills, both written and verbal, to interact effectively with all stakeholders.
  • Ability to lead and challenge multifunctional teams, facilitate decision-making, work effectively in cross-cultural environments.
  • Proficiency in common computer programs (e.g., Word, Excel, PowerPoint, Outlook, Project).

Education & Experience

  • Ph.D. in Biochemistry, Molecular Biology, Pharmaceutics, Pharmaceutical Chemistry, Bioengineering or a related discipline with 10 years of industry experience or a Master’s degree with a minimum of 12 years of relevant industry experience or a Bachelor’s degree with a minimum of 14 years of relevant industry experience .
  • 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.
  • Prior experience with DS process characterization, process performance qualification and commercial manufacturing for therapeutic proteins products.
  • Significant experience working in an outsourcing environment.
  • Experienced in both early stage development and late stage/commercial development with strong record of successful Regulatory approvals.  Prior experience with regulatory submission and interactions with regulatory agencies.

ALX Oncology is an equal opportunity employer. All applicants should be legally entitled to work for any employer in the US. Title and salary are commensurate with experience. Our compensation program includes competitive salary, equity participation and attractive bonus incentives.

To apply for this position, please send your cover letter and resume to hr@alxoncology.com