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 Facilities, Maintenance and Engineering Team, the Manufacturing Engineer is responsible for providing engineering support for cGMP manufacturing operation related to either Spray Drying, Mixing or Filling/Finishing. The role is the technical expert within commercial manufacturing and will work closely with other technical functions in product development & process development. This role is operational, supporting production to ensure on time supply of the quality product needed by our patients. The Manufacturing Engineer will also ensure technical processes are maintained to be compliant with latest regulations. The Engineer will raise our overall performance through technical improvements, ensuring our validation status is always maintained.
Duties and Responsibilities:
- Acts as technical expert to train and coach process technicians
- Writes and reviews technical documentation (batch records, SOPs,)
- Assesses any technical changes brought to the change control committee
- Supports and Drives technical investigations
- Ensures any new process is properly transferred and validated from development to commercial manufacturing
- May perform hands-on activities in operations, ranging from setting equipment, inspection of parts and support to maintenance.
- Ensures successful manufacturing production runs by assessing risk, establishing preventative measures, investigating and troubleshooting equipment issues
- A Bachelor's degree in Engineering, Chemistry, Biology or equivalent
- 5 to 8 years of pharmaceutical manufacturing experience in a technical function
- Fluency with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
- Experience managing in a commercial pharmaceutical production environment
- Spray Drying or aseptic processing with isolators experience is a plus
- Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is required; process validation experience is a plus
- Demonstrated knowledge of pharmaceutical manufacturing of sterile products, aseptic processing, medical device manufacturing, and process development
- Demonstrated ability to think critically and analytically; demonstrated troubleshooting and problem solving skills
- Good interpersonal, follow up, and excellent verbal and written communication skills
- Ability to function efficiently and independently in a fast-paced, changing environment
- Strong team player aligned with Intarcia Corporate Values