Formulation Engineer
Apply NowCompany: Accelerate
Location: Tucson, AZ 85705
Description:
Accelerate Diagnostics is looking for a candidate that will be an integral part of a small, focused inter-disciplinary team working at high pace and will be
required to work in a self-directed fashion. Effective interaction with and coordination of members of AXDX development and manufacturing teams will be required. The candidate will be responsible for the rapid development of formulation methods that support high volume, low cost production of critical platform
components in a timely manner.
Critical Skills and Experience:
Extensive knowledge of excipient use with microbial growth medias and antibiotics to enhance or tailor: wettability of glass and plastic surfaces, kinetic solubility, solution rheology (flowability, viscosity, lubricity), and optimization of coatings and films for desired characteristics.
Experience with analytical method experience to characterize the impact of dehydration processes on chemical activity and potency of antimicrobials, growth media, and buffers (or equivalent).
Thorough knowledge of reagent dry down processes including lyophilization, dry down under inert atmosphere conditions with or without vacuum assistance, and formulated tapes.
Experience designing formulations to scale up robust and consistent production across consumables, lots of consumables, and
reagent/formulation batches while maximize product shelf life and product stability.
Excellent understanding of regulated environment such as IVD or PMA and GDP/GMP and design transfer processes.
Other Desirable Skills and Experience:
Clean/sterile packaging processes using heat sealing, silicone adhesives, films, and tapes, automated reel to reel material handling, pick and place automation and conveyance, and packaging design for consumable reagent storage stability.
The role will span both R&D and manufacturing and will assist medical consumable design. Candidate will be responsible for optimization of formulations
as well as provide key input on manufacturing process decisions, creation of specifications for quality control, selecting and directing third parties
involved in reagent and consumable manufacturing. The ideal candidate will be self-motivated, curious, and enjoy independent work in a dynamic, high-pressure
environment.
Minimum Qualifications:
required to work in a self-directed fashion. Effective interaction with and coordination of members of AXDX development and manufacturing teams will be required. The candidate will be responsible for the rapid development of formulation methods that support high volume, low cost production of critical platform
components in a timely manner.
Critical Skills and Experience:
Extensive knowledge of excipient use with microbial growth medias and antibiotics to enhance or tailor: wettability of glass and plastic surfaces, kinetic solubility, solution rheology (flowability, viscosity, lubricity), and optimization of coatings and films for desired characteristics.
Experience with analytical method experience to characterize the impact of dehydration processes on chemical activity and potency of antimicrobials, growth media, and buffers (or equivalent).
Thorough knowledge of reagent dry down processes including lyophilization, dry down under inert atmosphere conditions with or without vacuum assistance, and formulated tapes.
Experience designing formulations to scale up robust and consistent production across consumables, lots of consumables, and
reagent/formulation batches while maximize product shelf life and product stability.
Excellent understanding of regulated environment such as IVD or PMA and GDP/GMP and design transfer processes.
Other Desirable Skills and Experience:
Clean/sterile packaging processes using heat sealing, silicone adhesives, films, and tapes, automated reel to reel material handling, pick and place automation and conveyance, and packaging design for consumable reagent storage stability.
The role will span both R&D and manufacturing and will assist medical consumable design. Candidate will be responsible for optimization of formulations
as well as provide key input on manufacturing process decisions, creation of specifications for quality control, selecting and directing third parties
involved in reagent and consumable manufacturing. The ideal candidate will be self-motivated, curious, and enjoy independent work in a dynamic, high-pressure
environment.
Minimum Qualifications:
- Minimum of 5 years related experience as a Chemical Engineer in medical consumable manufacturing experience.
- B.S. Degree in related field with equivalent industrial experience.
- Direct experience or knowledge of vendors/consultants to provide reagent chemistry expertise including excipient formulation and timed release in
dried, lyophilized, or thin films desired. - Ability to work in a fast pace, cross functional team environment.
- Willingness to roll up sleeves to get work done.
- Ability to take initiative and proactive planning.