Job Details

Position Summary

Responsible for development, production, and supply chain management of components purchased by or produced by/for Amprion to support manufacture of proprietary in vitro diagnostic tests. Optimizes manufacturing processes to produce critical protein components and oversees manufacture of critical protein components in accordance with ISO 13485 and other applicable regulations. Ensures appropriate quantity and quality of components required to perform testing of validated tests in the Amprion Clinical Laboratory. Assists with development/procurement of components to develop IVD kits.

Job Responsibilities

• Apply engineering and scientific principles to develop, optimize, scale-up, and manufacture recombinant protein components.
• Oversee and manage production and control of recombinant proteins used as components for IVDs.
• Oversee planning, procurement, storage, control and distribution of materials required for in-house production of components, purchase of components for performance of IVD tests, and sale of manufactured components.
• Evaluate suppliers based on quality and reliability of products.
• Respond to queries from customers purchasing manufactured components.
• Mange vendor relationships and negotiate supply agreements.
• Assess supply needs and coordinate delivery schedules.
• Manage orders and coordinate shipping schedules.
• Assist with the development of IVD kits and specimen shipping kits.
• Design and perform bench scale experiments such as fermentation media optimization, optimization of elution profiles, tangential flow filtration, and autoclave sterilization cycle validation.
• Develop and recommend new processes and technologies to achieve cost effectiveness and improved product quality. Proactively identify production and supply issues and suggest solutions.
• Consistently demonstrates production and supply chain leadership in the organization.

Supplementary Responsibilities

• Collaborate with Operations, R&D, Marketing, Finance, Quality, and other teams, as needed, for achievement of project objectives. May manage external collaborators.
• Effectively communicate ideas, project goals, needs and results across departments.
• Interact with management on advanced technical matters.
• Author and review quality documents including process verification, component specification, facility and equipment management, etc.

Education and Experience

• BS with 5 years' experience, MS with 2 years' experience, or PhD with 1 year experience in protein production and supply chain management in a biotech setting with a degree in chemical/biochemical engineering, biochemistry, or related scientific discipline.

Knowledge, Skills and Abilities

• Proficient in programming, operating, and troubleshooting E. coli fermentation and AKTA chromatography systems. (5-20L scale)
• Proficient in designing and conducting fermentation and purification development and optimization studies.
• Understands fermentation and purification process design limits for implementation in an ISO 13485 manufacturing environment.
• Initiates, designs, and executes experiments independently. Capable of independent data interpretation. May apply advanced modeling or statistical analysis tools where appropriate.
• Highly skilled communicator of ideas, project goals, and results.
• Capable of working effectively in teams.
• Knowledge of ISO 13485, cGMP, CAP/CLIA and familiarity with manufacturing and materials management support.

Compensation

• Base Salary: $95,000 – $135,000 annually, depending on experience
• Competitive health and welfare benefits
• Private company stock options

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Management and Manufacturing

Industries

• Biotechnology