Repligen is seeking a highly motivated and experienced applications specialist for the Analytics market, primarily to support Repligen’s customers during implementation of SoloVPE systems in their laboratories to ensure rapid adoption of the technology. This includes to support SoloVPE qualification and validation for GMP use according to regulatory standards and the customer’s requirements, document support and computer systems validations, method development and validation, as well as troubleshootings with the goal to drive expansion of the business into new groups, customer sites, and support adoption of new applications. The systems are sold primarily into the pharmaceutical and biotech industry and are commonly used for quantifying concentrations of analytes (proteins, antibodies, nucleotides etc) in drug discovery and development, manufacturing and quality assurance. Furthermore, this role will include close interaction with the sales team to provide pre-sales technical support to build new business and achieve expansion in existing accounts across North America. The Bioanalytics Applications Specialist shall also be a strong internal voice of the customer to provide feedback on existing and new applications and NPIs to product management and the business.

The ideal candidate will demonstrate a high level of motivation to succeed, highly developed technical expertise and territory management skill sets in the Life Sciences and bioprocessing industry sector and is now looking for the next challenge at a rapidly evolving and innovative bioprocessing-focused life sciences company. The role is part of the Analytics Customer Success Group, reporting directly to the Director of Bioanalytics Applications.

• Work with new and existing VPT customers on developing and improving Slope Spectroscopy methods.
• Work in coordination with the Customer Success Group (CSG) to provide pre and post-sales support to customers for the for all analytics product lines. This will include responding to customer requests for technical support, giving technical seminars, performing product demonstrations, providing on-site/in-lab support, troubleshooting, and assisting with the execution of development and validation
• Develop and proactively execute project plans to meet customer needs using all VPT Technology and Slope Spectroscopy methods.
• SOP Development/Review, Software Validation, and Method Development/Validation. Knowledge of 21 CFR Part 11, Annex 11, and ICH Q2 (R1)
• Establish and maintain Strategic Key Account relationships by supporting the sales team with account planning and bridging customer functional
• Provide accurate and timely activity reporting, management of customer projects, and support forecasting reports using CRM, com

Skills:

• Excellent analytical, presentation, and communication skills
• Technical understanding of biomanufacturing processes and relevant analytical technologies, in particular UV-Vis spectroscopy
• Lab experience in bioanalytical method development and troubleshooting is preferred
• Work experience in a GMP-regulated environment or with GMP customers, especially with regards to formal instrument qualification and analytical method validation is an asset
• Proven ability to build mutually beneficial, personable, trusting relationships with customers, suppliers and partners
• Outstanding interpersonal skills: ability to build strong relationships with cross-functional team members and lead through influence

Qualifications:

• A minimum of a BSc degree in a scientific discipline (biology, biochemistry, or related field)
• A minimum of 3+ years of experience in the biopharmaceutical or life science
• Willing to travel extensively throughout the territory
• Experience in using MS Office
• Professional attitude, appearance, and overall work

Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated base salary range for this role, based in the United States of America is $75,000-99,000. Compensation decisions are dependent on several factors including, but not limited to an individual's qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.