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.
As a key member of our Manufacturing Operations team, the Continuous Improvement Manager, Manufacturing is responsible for providing Quality System and Continuous Improvement support for the manufacturing team via ownership and resolution of deviations, CAPA’s, change controls, and Continuous Improvement initiatives in support of the company’s aseptic and non-aseptic manufacturing processes.
Duties and Responsibilities:
- Identify opportunities for improvement and lead/support Kaizen initiatives to streamline processes
- Identify and resolve manufacturing issues in response to non-conformance and other Quality data metrics.
- Initiate and resolve deviations and CAPA’s. Own or assist with internal investigations and ensure timely completion.
- Revise/edit existing documents as required in accordance with GMP regulations and guidelines.
- Working with QA and Production Engineering, verify/validate critical processes.
- Perform root cause analysis for investigations, perform risk assessments and identify the appropriate corrective and preventative actions.
- Perform data trending, analysis and maintain balanced scorecard.
- Bachelor’s degree in a scientific discipline.
- Knowledge of biopharma manufacturing processes, experience with aseptic operations, Fill/Finish or Spray Dry manufacturing highly desirable.
- Knowledge of cGMPs required.
- Project managementexperience and managing multiple activities required.
- Technical writing experiencerequired.
- At least 5 years of experience in Biopharma or Medical Device commercial manufacturing.
- Quality system experience highly desirable.
- Experience with microbiology and environmental monitoring a plus.
- Demonstrated ability to perform GMP operations including following detailed SOP’s, maintaining training and good documentation practices.
- Strong organizational skills and ability to manage multiple tasks/priorities at a time.
- Excellent written and verbal communication skills required.
- Demonstrated ability to work as both a team player and independently.
- Possess excellent problem solving and analytical skills
- Proficient in MS Office (Word, Excel/Access/Visio/PowerPoint)
- Able to work with minimal supervision, with a track record of leading projects to completion.
- Physical Requirements: Able to wear personal protective equipment, able to gown and gain entry to controlled manufacturing areas, able to stand for prolonged periods of time in