Intarcia Therapeutics, Inc., is a rapidly emerging biopharmaceutical company committed to developing innovative therapies that merge medicine with technology, and have the potential to transform therapeutic categories.
We focus our efforts on serious diseases that are prevalent and poorly controlled. Our most advanced investigational product is ITCA 650 in type 2 diabetes (T2D). Currently in phase 3 development, this matchstick-sized titanium mini-pump is placed under the skin where it delivers exenatide continuously and consistently over 12 months. As such, this product fundamentally changes how therapy gets delivered by the healthcare system to patients, as well as how it is distributed and reimbursed. Our disruptive new approach holds significant promise as a 'game-changing' treatment in this increasingly common and important disease, and will require a new level of thinking and acting.
We Are Growing
Since the 2012 round of financing, much forward progress has taken place at Intarcia, including significant enhancements to our world-class manufacturing facilities, the opening of our new headquarters in Boston’s Innovation Center, and the diversification of expertise both on our Board of Directors as well as on our Leadership Team through newly acquired members who bring vital new capabilities with them.
A key element of pride during our progress has been our ability to remain fully independent through our rounds of financing so that we continue to have full strategic and executional control over our large global phase 3 clinical trial program, and all aspects of our rapidly evolving business plan. While we are obviously accountable to our stakeholders for progress, we are – and intend to remain – the driving vision and force behind our progress and our ultimate success.
As a key member of our diverse manufacturing team, the Manufacturing Supervisor - Swing Shift is responsible for performing and documenting all work in a pharmaceutical manufacturing environment in accordance with cGMPs. He/she will provide leadership and guidance to the production technicians’ crew to ensure activities are executed in compliance with our procedures. Performs simple to moderately complex tasks required for pharmaceutical manufacturing and development activities. Interacting with and providing support for engineering personnel including assembling, operating and troubleshooting equipment. The Manufacturing Supervisor is responsible overseeing all equipment and facilities issues for resolution.
Duties and Responsibilities:
Lead and direct activities and technicians in carrying out manufacturing activities.
Develops technicians to improve on individual and overall manufacturing and development activities
Facilitates in-house training for process technicians on existing process equipment and manufacturing operations.
Makes recommendations to revise/enhance training curriculum.
Develops training materials and communicates observations during training sessions.
Resolve minor manufacturing issues and bring to the attention of engineering and QA staff as appropriate.
Work with project team to schedule activities and technicians for manufacturing operations.
Issue production forms and request batch records required for unit operations.
Perform daily review of production documentation for accuracy and completeness.
Process equipment cleaning, set-up, and operation, as well as component assembly and aseptic operations.
Follow written procedures, document all work in writing, and maintain safe work environment.
Periodically perform safety inspections or observations. Ensure that a safe work environment is maintained at all times.
Perform additional activities to support cleanroom operations, such as stocking supplies, water sampling, and environmental monitoring. Work requires high level of interaction with team members, including technicians, supervisors, engineers, and QA personnel.
Bachelor’s degree in life sciences, biotech, pharmaceutical preferred
Must be able to work evening or night shifts
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
Basic computer skills a minimum; knowledge of MS Word, Excel, Outlook preferred
Must be able to speak and write in English
At least 6 years supervisory experience is required. GMP experience in pharmaceutical manufacturing or related industry is preferred; aseptic manufacturing a plus
Knowledge of cGMPs
Experience in training manufacturing technicians, coaching, and providing feedback
Attention to detail, keen observational skills and good listening skills are necessary
Must be self-motivated, resourceful, flexible, and responsible with follow-through and conflict-resolution skills
Results oriented and possess the ability to work independently, as well as within a team environment and maintain positive, productive relationships with others
Must have good verbal communication skills and be able to read and follow detailed written instructions and document activities in writing