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Wave Life Sciences USA

Clinical-stage biotech developing stereopure oligonucleotides

Associate Director - Drug Product Technical Services

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeLexington, MA, USAIn-person

About the Job

Requirements

  • A degree in Pharmaceutical Sciences, Chemistry, or Engineering is preferred, or equivalent work experience.
  • At least 8 years of biopharmaceutical industry experience in an aseptic drug-product good manufacturing practice environment, including process performance qualification campaign experience.
  • Experience authoring drug-product sections of clinical trial application, investigational new drug, new drug application, or biologics license application submissions.
  • Strong scientific authoring experience and communication skills.
  • Practical knowledge of current good manufacturing practice regulations.
  • Proficiency with Microsoft Office Word, Excel, and PowerPoint.
  • Ability to manage time and prioritize tasks independently in a fast-paced environment.
  • Ability to work independently and collaboratively in a team environment.

Responsibilities

  • Plan and execute drug-product formulation development studies to select phase-appropriate drug-product presentations.
  • Initiate and oversee process performance qualification activities at contract manufacturing organizations, ensuring commercial readiness for drug product.
  • Author drug-product sections of regulatory submissions and provide timely responses to questions.
  • Ensure effective and efficient technology transfer and good manufacturing practice manufacturing of oligonucleotides in accordance with strict quality standards at Wave and contract manufacturing organization sites.
  • Serve as the interface between Process Development, Analytical, Quality, Regulatory, and Supply Chain departments.
  • Support continuous improvement initiatives by identifying areas for improvement and communicating strategies.
  • Respond to changing priorities and schedule work to meet current and future needs.
  • Technically review batch records and process instructions internally and at contract manufacturing organizations.
  • Manage contract manufacturing organization relationships to ensure sufficient drug-product supply for Wave assets for clinical and commercial supply.

Desired Qualifications

  • Experience in oligonucleotide manufacturing and managing contract manufacturing organizations.
  • Experience with pre-filled syringes and/or autoinjectors.
  • Experience in drug-product formulation development for liquid and lyophilized presentations, including drug delivery systems and combination products.

About the Company

Wave Life Sciences USA

Clinical-stage biotech developing stereopure oligonucleotides

Wave Life Sciences develops stereopure nucleic acid therapies for genetically defined diseases. Its PRISM platform designs stereopure oligonucleotides that enable RNA interference, antisense silencing, splicing modulation, and RNA editing, including AIMers that recruit ADAR enzymes to edit RNA without changing the DNA. The company funds R&D mainly through partnerships and licensing (notably with GSK) and has programs in conditions like Alpha-1 antitrypsin deficiency, Duchenne muscular dystrophy, Huntington’s disease, and obesity. Its goal is to bring approved RNA medicines to patients by advancing a diversified pipeline and sustaining long-term collaborations that fund development.

Company size
201-500
Company stage
IPO
Headquarters
Cambridge, MA
Founded
2012

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