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Senior Scientist - Downstream Proces Development

  • Job type: Permanent
  • Location: Houston, Texas
  • Salary: Bonus & other benefits
  • Job reference: 324291/001_1559755359
  • Sector: Pharmacology, EPM Scientific
  • Date posted: 05/06/2019

Senior Scientist - Downstream Process Development

A leading international biologics company with a solid history of promoting positive working environments as well as providing opportunities for positive career progression is seeking talented scientists from across the United States to ensure the success of a new, state-of-the-art, cell and gene therapy manufacturing facility. This is an exciting opportunity to join a proven industry leader experiencing exponential growth. This role will lead a group of junior scientists within the downstream process development group.

We are seeking highly motivated senior level process scientists with diverse experience in biological processes. The successful candidate will have 2+ years of biopharmaceutical industry experience developing, optimizing, and characterizing downstream processes. This role will also participate in all facets of downstream process development for a wide array of viral vectors, including adeno-associated virus (AAV).

The major responsibilities are described, but not limited to, as follows:

  • Develop and troubleshoot scalable downstream processes for viral vectors.
  • Support the technical transfer of processes to the manufacturing team.
  • Author technical developments reports and presentations.
  • Lead and participate in client-facing technical discussions relating to ongoing PD and manufacturing efforts.
  • Support internal manufacturing and participate in troubleshooting as an SME.
  • Maintain good documentation with high level of detail, close-out experiments in a timely manner and work with fellow downstream team members to maintain the PD downstream labs in a professional working environment.

Responsibilities

  • 40 % - Independently perform experiments and provide guidance to junior level laboratory staff.
  • 30 % - Design experiments, discuss experimental plan, analyze data and provide a summary and further suggestion.
  • 15 % - Prepare process development reports and tech transfer documents.
  • 15 % - Prepare presentations for either team or client meetings.

Qualifications

  • Strong organizational skills and detailed documentation abilities are required.
  • Perform tasks for multiple projects simultaneously, keep accurate records, follow instructions, and comply with company policies.
  • Excellent writing and verbal communication skills is required.
  • Team work a must.
  • Must be comfortable in a fast-paced, multi-tasking CMO environment.

Requirements

  • Advanced degree in biochemistry, chemistry, chemical engineering, bioengineering, or related area is preferred.
  • Demonstrated downstream process development experience of biological molecules, such as viral vectors, therapeutic recombinant proteins, monoclonal antibodies or vaccines for biopharmaceutical applications is required.
  • Deep knowledge and understanding of downstream process of biologics is required.
  • Hands-on experience of AKTA purification system or equivalent system is required.
  • Hands-on experience with the operation and development of TFF units is required; preferably using the SciLog system.
  • Working knowledge and skills for viral vector or vaccine purification is a plus.
  • Ability to plan, organize, problem solve (troubleshoot), prioritize, work efficiently independently and in a team under tight timelines.

Beneficial Skills and Knowledge

  • Scientific understanding or hands-on experience with analytical assays such as HPLC, spectrophotometry, SDS-PAGE, DLS, IEF and PCR.
  • Experience of process characterization is a plus.
  • Statistical analysis, including DOE.
  • Viral clearance studies.
  • Regulatory submissions (e.g. IND, BLA) CMC sections.
  • External publications and presentations.

This is a full-time, permanent position located in the greater Houston Texas area offering full relocation for the right candidate. Salary is commensurate with experience.

To apply: For a more detailed description, please respond with a detailed resume and preferred method of contact.

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