Pre-Clinical Manufacturing Associate - Downstream

Location
Philadelphia, Pennsylvania
Salary
Salary not provided
Posted
November 24 2021
Ref
812338100
Organization Type
Biotech
This position is a key participant in the day-to-day operation and planning of rAAV vector purification related work, with primary responsibility to execute established protocols of manufacturing research and pre-clinical (GLP) grade rAAV vectors. The individual in the role will participate in, but not be limited to, purification of rAAV vectors including vector package cell lysis using chemicals or microfluidization, cell lysis treatment by enzyme, clarification, tangential flow filtration (TFF), vector purification by ion exchange chromatography, size-exclusion chromatography, gradient centrifugation, affinity chromatography, vector formulation, filtration and vial filing. Additionally, the individual will contribute to the implementation of documentation, production scale up in order to support research and GLP rAAV vector manufacturing.

This position requires good knowledge and experience with AKTA Pilot, AKTA AVANT, Axichrom columns, ultracentrifugation, microfluidization, and good knowledge and skills related to purification of biopharmaceutical products. Good written and verbal communication skills and ability to work effectively in a team environment are required.

Responsibilities

  • Hands-on purification of AAV vectors including vector package cell lysis using chemicals or microfluidization, cell lysis treatment by enzyme, clarification, TFF
  • AAV vector column purification, ultracentrifuge gradient purification
  • Production purification scale up
  • Final vector formulation
  • Execute lab operations and document on GLP batch records according to standard operating procedures and GDP
  • Plan and prepare purification buffers for diafiltration, enzyme digestion, clarification, column purification, gradient ultracentrifuge purification and final formulation.
  • Participate in investigations
  • Review and revise SOPs and GLP batch records for virus purification
  • Perform routine calculations and maintain appropriate records
  • Maintain manufacturing equipment and records
  • Maintain laboratory safety procedures and compliance records
  • Participate in other projects upon request
Education and Experience Requirements

  • BA/BS in biological sciences, engineering, biochemistry, or related discipline preferred
  • Generally, has more than 4 years of relevant working experience in the life sciences industry or has more than two-year experience with MS degree in life sciences.
  • Experience in industry laboratory using GLP or GMP
  • Experience with large scale vector or protein purification
  • High degree of flexibility of skills and hours
  • Thorough knowledge of Microsoft Office suite
Key Skills, Abilities, and Competencies

  • Delivering routine assignments with general instructions; Delivering new assignments with detailed instruction.
  • Moderate understanding/awareness of cGLP regulations
  • Value research integrity and collaborative research
  • Strong interpersonal, communication, analytical, and critical thinking skills, including being able to adapt to work areas requiring various intellectual and professional approaches
  • Excellent organizational and time management skills
Complexity and Problem Solving

  • Able to make decisions whether results obtained through the manufacturing process comply
with written procedures

  • Verify process variations with more senior personnel
  • Able to learn new techniques and work under supervision on multiple tasks
  • Discuss process variations and/or out of range results with supervisor and refer to
policies/practices for guidance

  • Exercise judgment within defined procedures and practices to determine appropriate action
  • Consults with higher level personnel on unexpected or out of range results
  • Work under supervision
Internal and External Contacts

  • Contacts are primarily interactions with members of his/her team
  • In addition, minimal interaction with cross functional team members such as:
  • Translational Research
  • Process & Technology Development
  • Quality Control & Analytical Sciences
  • Quality Assurance
  • Manufacturing Sciences & Technology
  • Facilities
  • Materials Management
  • Service Personnel
  • Vendors
  • Other Job Requirements

    • Must be able to lift 25 pounds
    • Must be flexible with work schedule
    • Must be available to work extended shift hours as determined by management
    • Must be able to wear all appropriate Personal Protective Equipment
    • Must be able to stand for long periods

    Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.


    Nearest Major Market: Philadelphia



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