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Director of Quality Control

Employer
AltPep Corporation
Location
Seattle, Washington
Start date
Sep 13, 2022

View more

Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioForest
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Job Details



AltPep Corporation is a biomedical start-up located in Seattle, Washington, with a breakthrough approach for diagnosing and treating some of the world’s most intractable conditions:  amyloid diseases.  Our lead programs are focused on Alzheimer’s Disease and Parkinson’s Disease.

We are seeking a highly motivated and experienced Quality Control (QC) Director. This key position will lead the Quality Control function for AltPep’s diagnostics and therapeutic programs, which are currently in early-stage development.

Principal Responsibilities

 

  • Drive strategic decisions, implement processes and manage activities related to QC systems. Build roadmap for the QC function through sound scientific and regulatory knowledge and experience.
  • Work cross-functionally with internal and/or external partners (i.e. CDMOs) to write technical documentation for incoming materials, in-process and finished products, and post-launch monitoring. This includes product specifications, SOPs, test-methods, qualification protocols/reports, and method transfer protocols/reports, as required.
  • Oversee stability studies and shelf-life programs including authoring shelf-life reports.
  • Serve as QC Subject Matter Expert (SME) for analytical methods, sampling, troubleshooting, investigations, deviations, non-conformances, etc.
  • Work with other SMEs (internal and/or external) to review and author application sections of regulatory submissions, and to provide support for information requests, as required.
  • Work with Quality Assurance and Regulatory to establish and sustain an effective and efficient quality management system.

 

Education and Experience

 

  • in chemistry, biochemistry, pharmaceutical sciences, bioengineering, or related discipline
  • At least 5 years QC management experience and 10+ years industry experience in analytical development and/or quality control (CDMO experience preferred).
  • In depth knowledge of therapeutics and/or diagnostics raw material release and stability testing, methods, and quality systems.
  • Strong working knowledge of CLIA, cGMP, GLP, and FDA guidance and regulations related to diagnostics and/or therapeutics.

 

Required Skills and Abilities

  • Ability to work cross-functionally, both internally and externally, to advance company goals and initiatives.
  • Strong technical acumen, including proficiency at determining the root cause of a problem, and working with others to implement solutions.
  • Ability to articulate information in a logical and clear manner to internal and external teams.
  • Strong technical writing skills.
  • Comfortable in a fast-paced small company environment and able to balance workload based upon changing priorities.

Company

AltPep, a startup located in Seattle Washington, is developing early disease-modifying treatments and detection tools for amyloid diseases by targeting one of the earliest molecular triggers – toxic soluble oligomers. These oligomers are associated with many diseases, including neurodegenerative diseases and type 2 diabetes. Decades of scientific research by the Daggett Research Group culminated in the discovery of a novel protein structure, alpha-sheet, the foundation of our innovative approach.

Our lead program aims to identify Alzheimer’s Disease long before symptoms occur and then neutralize the toxic soluble oligomers associated with the disease.

Find Us
Website
Phone
+1 (425) 658-0277
Location
100 NE Northlake Way
STE 300
Seattle
WA
98105
United States
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