Senior Process 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.
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 lyophilization of client 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.
- Actively promote Argonaut lyophilization capabilities at conferences, trade shows and on social media.
- Play an active role, not only in the lyophilization program, but offer assistance 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.
- Coordinate packaging activities for all lyophilization development programs and support the operations team in all production lyophilization and packaging.
- Develop automation, when required, in all aspects of lyophilization including cartridge assembly and packaging.
- 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.
- Formulate 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.
- Schedule all lyophilization activities and promote so as to achieve a minimum of 80% utilization of all process equipment.
- 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 & Experience
- Advanced degree in a relevant field (Biology, Computational Biology, Biochemistry, or Engineering) with at least 5 years of relevant work experience in a similar industry.
- Demonstrated technical/subject matter experience in molecular biology and immunochemistry.
- Experience in reagent formulation, PCR, and material inspection methods.
- Experience building compliance and standardization of processes (building a scalable organization).
- 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.
- Exceptional analytical and problem-solving skills.
- Must be accountable, proactive, be able to speak up, provide feedback, challenge assumptions and communicate openly and honestly.
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 will 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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