drjobs Associate Scientist, AAV Production and Bioanalysis

Associate Scientist, AAV Production and Bioanalysis

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Job Location drjobs

Boston - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Manifold Bio is a dynamic biotech company building a pipeline of targeted biologics using a novel in vivo-centric discovery approach. Our drug discovery engine is differentiated by massively parallel screening in vivo from the beginning of our discovery process. This unique platform is powered by a proprietary protein barcoding technology that allows multiplexed protein quantitation at unprecedented scale and sensitivity. We combine this and other high-throughput protein engineering approaches with computational design to create antibody-like drugs and other biologics. Our world-class team of protein engineers biologists and computational scientists are working together to aim the platform at therapeutic opportunities where precise targeting is the key to overcoming clinical challenges.

Position

We are seeking an exceptional Associate Scientist with hands-on expertise in adeno-associated virus (AAV) vector production purification and analytical characterization to join our this role you will contribute end-to-end to the generation of high-quality well-characterized AAV lots that enable both rodent and non-human-primate (NHP) in vivo studies. You will scale transient-transfection optimize downstream purification processes (affinity chromatography ion-exchange tangential-flow filtration) and perform or coordinate key release assays (qPCR/ddPCR ELISA HPLC CGE capsid ratio endotoxin sterility). You will work closely with molecular biology protein engineering in vivo pharmacology and external CDMO partners to ensure timely delivery of qualified vector lots.

Responsibilities

  • Produce purify and qualify AAV vector lots from DNA to study-ready material.
  • Maintain and troubleshoot cell-culture systems and bioreactors.
  • Develop and execute QC assays; analyze and report data.
  • Drive process-optimization experiments to improve yield and quality.
  • Draft and maintain SOPs batch records and other quality documents.
  • Provide regular updates to team members.

Requirements

Education & Experience

  • B.S. or M.S. in Biochemistry Molecular Biology Chemical Engineering Virology or a related field with 25 years of relevant industry experience; experience in regulated GLP/GMP environments preferred.

Wet-Lab Expertise

  • Hands-on experience producing AAV in HEK293 (triple transfection) and/or baculovirus-Sf9 systems from 1 L to 550 L scale.
  • Proficiency with downstream purification techniques including affinity and ion-exchange chromatography and density gradient based purification methods and tangential-flow filtration.
  • Familiarity with closed-system or single-use bioreactors and process automation is a plus.

Analytical Expertise

  • Experience with viral-genome titer assays (qPCR ddPCR) and capsid quantification (ELISA A260/280).
  • Working knowledge of purity and impurity assays such as SEC-HPLC/UHPLC Capillary Gel Electrophoresis (CGE) LC-MS SDS-PAGE and host-cell protein/DNA ELISAs.
  • Ability to troubleshoot analytical methods and interpret data to drive process decisions.

Core Competencies

  • Meticulous attention to detail and commitment to high laboratory standards including electronic lab-notebook documentation.
  • Excellent organizational and communication skills with the ability to manage multiple projects in a fast-paced environment.
  • Collaborative mindset and a passion for integrating experimental and computational approaches to solve complex problems.

Preferred Qualifications

  • Prior experience leading or supporting 1 10 vg-scale AAV campaigns for NHP studies.
  • Familiarity with design-of-experiments (DoE) process characterization and technology transfer to CDMOs.
  • Exposure to GMP quality systems including drafting SOPs batch records and deviation investigations.
  • Experience with other viral vectors (e.g. lentivirus adenovirus) or lipid-nanoparticle formulation.

We value different experiences and ways of thinking and believe the most talented teams are built by bringing together people of diverse cultures genders and backgrounds.


Required Experience:

IC

Employment Type

Full Time

Company Industry

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