Downstream Process/Analytical Scientist

VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industries.

We are looking for a Downstream Process/Analytical Scientist to lead a process transfer team in the planning, execution and implementation of downstream (preferred) and/or upstream processes as well as analytical assays.

Responsibilities:

• Lead a process transfer TEAM in the planning, execution and implementation of downstream (preferred) and/or upstream processes which include but are not limited to:

1. UF/DF clarification/concentration (TFF/Dead-End UF)
2. Ion Exchange Chromatography, IEX (QSFF, SP-Sepharose, )
3. Mixed-mode/multi-modal chromatography (Hydroxyapatite)
4. Affinity Chromatography (Protein G)
5. Hydrophobic Interaction, HIC Chromatography (Phenyl Sepharose)
6. Size Exclusion Chromatography, SEC (Superdex 200)
7. Cell Culture Roller Bottle/Spinner Cell Expansion and Analysis

• Lead a process transfer TEAM in the planning, execution and implementation of analytical assays which include but are not limited to:

Protein/Bio-Assays

1. ELISA (Activity, Host Cell Protein)
2. UV Spectrophotometry (Protein Concentration)
3. SDS-PAGE

LC Assays

1. Size Exclusion Analysis
2. Glycan Analysis/Sialic Acid Content
3. High Performance Anion Exchange Analysis

Cell Culture Analytics

1. Automated Cell Counting (LUNA Cell Counter)
2. Metabolite Analysis (BioProfile FLEX Instrument)
3. Cellular Morphology and Viability (Inverted Microscope)

• Lead, execute and support the lab work where needed which includes but is not limited to: Buffer preparation/Material preparation, Instrument programming and preparation, Run execution, Sample collection, Data recording/reporting

Desired Skills and Experience:

• Bachelors Degree in a related field.
• Prior experience in pharmaceutical industry
• Must have experience and a firm and thorough understanding of the theories and principles of each SOW technique listed.
• Must have experience with downstream (preferred) and/or upstream process/analytical transfers which include design, drafting, and execution of qualification protocols and test plan.
• Have a good understanding of cGMP/GDP guidelines and Data Integrity
• Good verbal, written, and interpersonal communication skills.
• Must have the ability to proficiently analyze, summarize as well as properly report and present run data (Official reports, presentations, etc.)
• Must work very well in a TEAM environment as well as working independently.
• Have experience with and understanding of the following instruments and software: AKTA Avant and Pilot with Unicorn Software, TFF lab-scale systems, Agilent 1290 LC system with Chemstation Software, Dionex HPAE-FLD ICS System with Chromeleon Software, SpectraMax Plate Reader with SoftMax PRO Software, SoloVPE with Cary 60 Spectrophotometer with SecureVPE Software.
• Have experience with the following General Lab Equipment: pH meter, Conductivity meter, Balances, Pipets.
• Have experience with the following Cell Culture Instruments: Inverted Microscope, LUNA Cell Counter, BioProfile Flex

VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries. VTI offers professional development, training, competitive compensation, excellent benefits, 401K plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.

As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees as well as competitive hourly pay for our contractors. www.validation.org

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