Lyophilization Development Specialist
Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA. The company is dedicated to serving highly innovative companies in the biopharmaceutical and molecular diagnostics industries. Argonaut is a full service, cost-effective partner, providing complete solutions in the areas of formulation, filling and final kitting of reagents and consumables. In July of 2018, Argonaut acquired LyoGen, a leader in dose specific lyophilization capabilities for the diagnostics markets. Argonaut provides the quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence.
Argonaut is seeking a motivated chemist or biochemist with strong RT and DNA amplification process optimization skills for the role of Lyophilization Development Specialist. Lyophilization is one of the hottest technologies in life sciences and molecular diagnostics, thanks to the growing demand for point-of-care devices, cost reduction, and ambient storage. Argonaut is fortunate to have one of the world’s leading lyophilization experts leading our team and working with clients worldwide to develop and produce lyophilized plates, cartridges, vials, and our proprietary LyoDose™ beads. This is an incredible career development opportunity for the right person to learn from a world leader in modern lyophilization techniques and solutions. Take advantage of this rare opening to develop these valuable skills.
Position and Scope
Reporting to the Chief Technology Officer the incumbent in this role will be accountable for developing and supporting all activities associated with the research and development of lyophilized products.
- Communicate the benefits of lyophilization to new and existing clients
- Based on client requirements, develop and communicate a strategy for the successful lyophilization of the client’s reagent utilizing such tools as the Argonaut feasibility program to the client. This will include the development of a proposal in conjunction with the business development team
- Optimize lyophilized products for use in DNA amplification assays such as PCR, LAMP, qPCR, etc. by selecting reagents such as excipients, buffers, etc. and validating reagent selection by running DNA amplification experiments
- Develop and optimize in-situ lyophilization conditions as required
- Actively promote Argonaut lyophilization capabilities at conferences, trade shows and on social media
- Play a supportive role in optimizing a client’s final package including cartridges, etc.
- Actively promote Argonaut’s capabilities, not only in lyophilization, but formulation, production, assembly, and kitting
- Develop processes that are well-documented, robust, and can be easily transferred to production
- Work actively with manufacturing to solve challenges in the production environment related to specification discrepancies, material dispositions and process changes
- Work actively with Client Services to provide fee-for-service process development services to clients wants to more effectively scale their manufacturing processes
- Provide ongoing technical training to clients and staff related to products, industry trends, new technologies, etc.
- Be available 24/7 for attending to processes and equipment
- Meet regularly with new and existing clients to support their needs
- Formulae robust client reagent/Argonaut proprietary excipient systems
- Develop robust bead formation protocols (using manual methods) that can readily be transferred to automated processes
- Develop lyophilization cycles that are robust, well documented and easily scaled-up
- Actively plan all development packaging activities with operation personnel
- Strive to develop products and processes that meet or exceed our quality system requirements
Position Requirements and Experience
- Advanced degree in a relevant field (Biology, Computational Biology, Biochemistry, or Bioengineering) or a bachelor’s degree with at least 5 years of relevant work experience in a similar industry
- Demonstrated technical/subject matter experience in molecular biology and immunochemistry
- Experience with lyophilization is desired but not required
- Experience in reagent formulation, DNA amplification, and material inspection methods
- Excellent laboratory skills and the ability to set-up and run reverse transcription and DNA amplification experiments. This will include the ability to optimize DNA amplification reactions through experimental design and execution
- Ability to multi-task, handle multiple projects at one time and the ability to change priorities based on business needs and competitive intelligence
- Excellent written and verbal communication skills
- Effective interpersonal, team and relationship management skills
- Experience building compliance and standardization of processes (building a scalable organization)
- Exceptional analytical and problem-solving skills
Argonaut Manufacturing Services, Inc. is proud to be an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. Argonaut complies with all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.
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