Downstream Process Development Associate - Discovery Solutions

Location: Gaithersburg, MD
Categories: Biotherapeutic
Website: http://www.discoverysolutions.net

Position Description

Our company, located in Gaithersburg, MD, is a biotechnology company developing innovative therapeutics to treat cancer, heart disease and ophthalmic disorders. Each of our gene-based product candidates uses a common patent-protected technology platform to deliver genes that produce medically beneficial proteins directly at the site of disease. We have three product development programs in various stages of clinical testing. We also are using proprietary adenovector technology to develop vaccines for infectious diseases.

Currently seeking a DOWNSTREAM PROCESS DEVELOPMENT ASSOCIATE

GENERAL JOB DESCRIPTION
The Process Development Associate will perform recovery and purification process development including: ultra-filtration and diafiltration, column chromatography including ion exchange, size exclusion, and hydrophobic interaction. Additional responsibilities include:
Participating in experimental design and process characterization, equipment cleaning and specification, process scale-up, writing technical reports and SOPs, and technology transfer from
-The Process Development Laboratory to manufacturing sites.

GENERAL JOB RESPONSIBILITIES
The responsibilities of the Process Development Associate include but are not limited to:
Recovery and column chromatography process development:
-Process operation at the 20L scale
-Process discovery
-Process parameter mapping
-Process characterization and experiment design
-Process scale-up to 400L
Maintaining accurate laboratory notebooks
- Data summary and writing technical reports
Serving as a member of the team responsible for technology transfer of processes to
manufacturing sites. This includes writing and/or reviewing SOPs and batch records, and
training of contract manufacturing staff.
-Assistance in troubleshooting of manufacturing processes
-Cleaning and Maintenance of process development equipment

MINIMUM QUALIFICATIONS
-It is required that the incumbent has a B.S. or M.S. degree in Biochemical Engineering, Chemical Engineering or Life Sciences
and a minimum of 5 years (w/ B.S.) or 2 years (w/ M.S.) industrial experience in recovery and purification processes for viruses, proteins, or plasmids.
Candidates are expected to have skills in recovery and purification unit operations: filtration, ultra filtration
and diafiltration (TFF), and column chromatography (e.g. affinity, ion exchange or size
exclusion).
-The candidate should have experience in Unicorn programming and operation of AKTA
and chromatography skids.
The candidate also should have experience in process characterization and
design of experiments.
-In addition, applicant must have the ability to work both independently and
within multi-functional teams, must have good communication skills (oral and written), and should demonstrate a strong commitment to quality work with attention to detail. Experience in cGMP is preferred. Experience in large-scale production and process control is a plus.


We are an equal opportunity employer that values diversity at all levels. All individuals, regardless
of personal characteristics, are encouraged to apply.

How to Apply

Please send a copy of your resume to diane.ranney@discoverysolutionsllc.com for consideration.

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