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.
The Front Line Leader (Swing/Graveyard), will be responsible for managing specific unit operations activities related to production of the ITCA 650 at the Hayward site. These responsibilities include building and leading a team of technicians to aseptically produce the product in the Hayward facility; ensuring performance and documentation of all work in manufacturing in accordance with cGMPs; providing leadership and guidance to the production technicians’ to ensure activities are executed in compliance with our procedures; performing simple to moderately complex tasks required for pharmaceutical manufacturing and development activities as needed; and interacting with and providing support for engineering personnel including assembling, operating and troubleshooting equipment. The Front Line Leader is responsible for driving all equipment and facilities issues to a resolution.
This role may also lead key initiatives that are critical to the continuous improvement of our compliance, quality, and robustness of our manufacturing capability. This role will have direct people management responsibilities.
- Responsible for directing and coordinating one or more of the following areas; cleaning, formulation preparation, spray-drying, aseptic filling and assembly, component assembly, injection molding, and component washing and sterilization.
- Establishes and administers operational procedures for one or more of the following areas; formulation preparation, spray-drying, aseptic filling and assembly, component assembly, injection molding, and component washing and sterilization.
- Lead and direct activities and technicians in carrying out manufacturing activities.
- Develops department employees through orientation, training, establishment of objectives, communication of rules and policies, while building employee morale and motivation.
- Periodically perform safety inspections or observations. Ensure that a safe work environment is maintained at all times.
- Ensures adequate resources are available to manufacture product (equipment, supplies, and labor) in a safe, quality and a compliant manner.
- Ensure manufacturing area and staff are cGMP inspection-ready at all times.
- Advises department management on matters relating to daily operations and makes recommendations for improvements when feasible and takes the lead in addressing them as needed.
- Leads cross-functional team to manage and coordinate activities and performance of assigned staff to ensure the achievement of department objectives and performance goals.
- Ensures proper maintenance of production equipment and GMP facilities to deliver on production targets.
- Takes necessary action to eliminate delays ensuring adherence to production and shipping schedules.
- Provides reports concerning scheduling, production goals, equipment and maintenance problems and other studies or reports as requested.
- Works in a team environment with other department management to coordinate a production schedule to achieve required deadlines, objectives and budgets.
- Maintains compliance with company policies, cGMP’s, safety standards, and good housekeeping practices.
- Conducts continuous review and follow-up on projects to ensure completion of assigned work.
- Bachelors degree required: Engineering, Chemistry, or Biology Degree preferred.
- Minimum five (5) years supervisory experience, in the pharmaceutical or medical device industry. Knowledge of sterilization and aseptic processes preferred.
- Ability to lead cross-functional teams to manage the day-to-day business and deliver continuous improvement initiatives.
- Proven communication and employee relations skills necessary.
- Excellent computer skills; Word, Excel, PowerPoint, and Database programs
- Proven leadership skills in managing matrix teams, influencing outcomes and key project decisions, and strategic problem-solving ability.
- Proven ability to communicate clearly and present key information objectively and collaborate effectively with management.
- Results oriented and possess the ability to work independently, as well as within a team environment and maintain positive, productive relationships with others
- Strong troubleshooting and technical skills
- Must be able to work day or swing or night shift
- Willing to work overtime or different shift schedules
- Able to sit or stand for two to three hours at a time
- Must be able to lift up to 50 lbs and push/pull up to 70lbs
- Must be able to speak and write in English
- Must have good verbal communication skills and be able to read and follow detailed written instructions and document activities in writing.