Careers

Associate Director/Director, Late Stage Process Development and Tech Transfer

Job Purpose

Amunix is seeking an experienced and highly-skilled professional to join our Technical Operations Team as Associate Director or Director of Late Stage Process Development and Tech Transfer. In this position, the selected individual will lead Amunix’s Tech Transfer of processes for E. coli or CHO cell based XTENylated biologic therapeutics. Working closely with Director of BioProcess Development and other members of the TechOps team, the incumbent would participate in the selection of Contract Manufacturing Organizations (CMOs) for Amunix products. The individual would lead the effort to transfer processes used for pre-clinical production at laboratory scale for scale-up and GMP manufacturing of drug substance for clinical trials at selected CMO facilities. She/he will work closely with BioProcess Development, Quality, Clinical and Regulatory teams to optimize suitable processes for late stage development and manufacturing efforts internally and at CMOs including detailed process evaluation and validation leading up to registration of our drug candidates. This position will require excellent technical, analytical, and problem-solving skills, leadership skills and ability to work in a multi-functional, fast-paced environment.

Essential Functions

  • Develop robust processes suitable for process transfer, large scale manufacturing and eventual commercialization 
  • Participate in selection of suitable CMOs for manufacturing of Amunix’s drug candidates for GMP and commercial manufacturing
  • Lead and conduct process optimization, process characterization, technology transfer, process scale-up for clinical production and eventual full-scale commercial production
  • Define strategy and plans for processes leading to high quality drug substance with targeted Critical Quality Attributes
  • Prepare technical reports and CMC sections for regulatory filings
  • Introduce new or modified technologies into the process to improve quality, yield and ease of operations in manufacturing
  • Define suitable in-process controls, critical process parameters and acceptable operating ranges for process steps for process characterization studies
  • Design and lead process validation activities for late stage products for registration
  • Train and develop staff to become proficient in late stage process development, process characterization and tech transfer

Qualifications

  • PhD in life sciences, chemical engineering, biochemical engineering or related relevant field
  • Minimum of eight (8) years of experience in biopharmaceutical industry exercising scientific and operational expertise in development and transfer of late stage processes to commercial plants
  • Demonstrated technical proficiency in biologic drug substance processes with expertise in downstream purification operations, such as centrifugation, filtration, UF/DF, chromatography and formulation
  • Excellent problem solving and analytical skills
  • Excellent project management and time management skills
  • Ability to manage multiple projects and competing deadlines
  • Excellent written and verbal communication and computer skills
  • Understanding of cGMPs, ICH Q10 guidelines, QbD principals, and DOE
  • Ability and willingness to work in the laboratory and perform hands-on training
  • Ability to function independently, exercise good judgement and provide thoughtful leadership
  • Ability to work in a fast-paced, high-growth, and team-based environment
  • Ability to detect problems, identify solutions, then act to resolve them in a timely manner
  • Experience in processing labile or metastable molecules is favored

About Amunix

Amunix is leveraging our expertise in precision protein engineering to enable the promise of T cell engagers in solid tumors. Our goal is to save cancer patients’ lives through the development and commercialization of breakthrough therapies that harness the immune system. We have invented XTEN, a validated therapeutic half-life extension technology. Our current focus is Pro-XTEN, a next-generation protease activated pro-drug platform, which enables selective activation of potent cancer therapies in the tumor microenvironment. This overcomes a common challenge facing potent immune system activators: on-target, off-tumor toxicity. Amunix’s two lead programs employ the Pro-XTEN technology to enhance the safety profile of T cell engagers. XPATs (XTENylated Protease-Activated T Cell Engagers) have the potential to make off-the-shelf therapies redirecting T cells to solid tumors a reality.

Amunix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Amunix complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training.

HOW TO APPLY

To apply, please submit your cover letter and resume to hr@amunix.com