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Senior Scientist, Analytical Development and Quality Control

Employer
ALX Oncology
Location
South San Francisco , CA
Start date
Aug 28, 2024
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ALX Oncology Inc. (ALX) is a clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway. Our lead candidate, evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. For more information about us, please visit www.alxoncology.com.  

 

ALX is looking for a full time Sr. Scientist to join our Quality Control team to develop analytical methods and perform/manage structural characterization activities for new biological molecules to support IND and BLA filling.  The position will report to the head of CMC QA/QC.

 

The successful candidate will be required to reside within a commutable distance of our Palo Alto facility and will be required to work in the laboratory as needed, with options for some work from home arrangements.

 

 

Responsibilities:

 

  • Conduct hands-on analytical method development, evaluation, and/or optimization for lot release, stability testing, and/or characterization of biological molecules, such as fusion proteins and antibody-drug conjugate (ADC).
  • Participate and/or lead analytical method transfer/qualification/validation to Contract Testing Laboratories (CTL) and Contract Manufacturing Organizations (CMO). 
  • Characterize impurities and degradation products as well as other physical and chemical properties.
  • Manage and/or support CTL/CMO analytical activities. Review executed QC test results and reports for product in-process, release and stability testing, including investigation and resolution of non-conformance events.
  • Review technical documents including but not limited to standard operating procedures, analytical study data summaries and reports, analytical method development reports, method qualification/validation protocols and reports, process characterization/validation data summaries and reports.
  • Collaborate with cross-functional teams (CMC teams, QA, Regulatory, and CMOs/CTLs) to meet project timelines.
  • Assist in the preparation of CMC dossiers and data packages for regulatory submissions.

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    Qualifications:

     

  • PhD in chemistry, biochemistry, or related field with analytical development experience in the biopharmaceutical industry.
  • PhD with 5+ years related industry experience.
  • Experienced in characterization of proteins and protein conjugates using applicable techniques.
  • Hands-on experiences with HPLC/UPLC methods.
  • Knowledgeable of mass spectrometry data analysis.
  • Extensive knowledge and understanding of current guidelines and related industry practices for drug product characterization
  • Strong problem-solving skills with sound technically driven decision-making ability
  • Effective written and verbal communication skills
  • Self-motivated and detail-oriented
  • Ability to work independently, multitask and meet deadlines in a fast-paced environment.

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    Salary: $145,000-$175,000

     

     

    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.

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