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Stability Analyst, Commercial QC Operations at Intarcia Therapeutics, Inc. in Hayward, CA

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Description

Intarcia Therapeutics, Inc., is a rapidly emerging biopharmaceutical company committed to developing innovative therapies that merge medicine with technology.

At Intarcia, we seek to transform the standard of care and improve patient outcomes in major therapeutic categories for serious chronic diseases, such as diabetes. We successfully completed our Phase 3 clinical trial program for our lead product, ITCA 650, and submitted our New Drug Application filing in the U.S. in 2016.

Additionally, we are developing a pipeline of products for our proprietary Medici Drug Delivery System, comprised of three unique technologies: 1) A stabilization technology that allows for proteins, peptides, antibody fragments, and other highly potent small molecules to be stabilized at or above human body temperatures for up to three years or more; 2) A matchstick-sized osmotic mini-pump that is placed just under the dermal layer of skin to deliver a continuous and consistent flow of medication; and 3) A placement technology including proprietary tools designed to provide an optimal user experience.

We Are Growing

Since our 2012 round of financing, much progress has taken place at Intarcia, including significant enhancements to our world-class manufacturing facility, the opening of our new headquarters in Boston's Innovation Center, and the diversification of expertise on our Board of Directors and Leadership Team through new senior leaders who contribute vital new capabilities and experiences.

A key element of pride during our progress has been our ability to remain fully independent throughout our rounds of financing so that we continue to have full strategic and executional control over all aspects of our rapidly evolving business. While we are always accountable to our stakeholders, we are - and intend to remain - the driving vision and force behind our progress and our ultimate success.

Your Opportunity

As a key member of the Commercial Quality Control team, the Stability Analyst, Commercial QC Operations will be responsible in assisting with the set-up and execution of Intarcia's combination device-drug product (DP) commercial stability studies and daily operations in stability. This role maintains stability studies, assists with set-up of studies, delivers stability samples for analytical testing, coordinates test results, monitors chamber activities, writes and reviews stability documents, performs trend and statistical analysis of data and coordinates PM/calibration/mapping activities of the chambers.

Duties and responsibilities:

Maintains stability programs, assists in the execution and set-up of stability studies and executes statistical analysis and data trending. Writes interim and final stability data reports. Clearly presents results of work, interprets data using standard statistical software and draws conclusions.

* Coordinates stability studies per protocol.
* Handles and monitors the stability chambers and reviews daily temperature and RH monitoring such as BAS and chart recorder outputs.
* Writes and reviews stability study protocols and summary reports as requested.
* Performs and reviews statistical analysis and data trending.
* Ensures all work is carried out following GMP and required regulatory standards.
* Conforms to company policies and standard operating procedures (SOPs).
* Presents data clearly and concisely to management.
* Identifies and implements process improvements and lean activities with the stability programs.
* Prioritizes and manages multiple projects consisting of varying degrees of complexity in-order to maintain efficient workflow and meet timelines.
* Ensures stability information and documentation are properly archived, tracked, trended and analyzed as needed.

Qualifications:

* A minimum of a Bachelor's Degree in a health sciences-related field is required.
* A minimum of 6 years working in a pharmaceutical analytical GMP regulated environment with cGMPs as they apply to laboratory practices, compliance, safety practices and stability experience is required.

Skills:

* Ability to effectively communicate (orally and via written communication).
* Excellent organizational skills, good time management, attention to detail, ability to work well under pressure and time constraints while maintaining a high level of work quality.
* Experience with set-up and execution of stability programs.
* Experience with electronic systems such as, LIMS, eDOC, statistical analysis e.g. JMP.
* Strong collaboration, team work skills and team player aligned with Intarcia's Corporate Values and ability to work individually.
* Result and performance driven while maintaining the highest standard of ethical behavior.
* This individual must have sound judgment, be self-motivated, and possess the social skills necessary to work well with colleagues.
* Strong proficiency in the use of excel, word, power point, etc.

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