Director, Microbiology and Sterility Assurance
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 the Quality Assurance & Quality Control team, the Director, Microbiology and Sterility Assurance is responsible for primarily leading and managing the Microbiology and Sterility Assurance controls and testing for drug/device combination aseptic products. The candidate is responsible for implementing best practices, procedures, systems and processes to develop a strong Microbiology & Sterility Assurance program. Responsibilities include executing the routine day-to-day functions related to all aspects of microbiology and sterility assurance, oversight of microbiology and sterility testing of raw materials, intermediates, drug substance, finished product, process simulation and gamma irradiation of components. The candidate will be the technical lead (SME) for Microbiology and Sterility Assurance related topics during the regulatory audits.
Duties and Responsibilities:
- Provide strategic leadership, manage and support implementation of procedures for drug/device combination aseptic products as it relates to microbiology and sterility assurance controls and testing.
- Develop and maintain a compliant Microbiology and Sterility Assurance Program to comply with internal procedures, US and worldwide regulatory requirements.
- Oversee and manage all aspects of Microbiology and Sterility Assurance activities including management of CTL’s conducting endotoxin, bioburden, and sterility testing.
- Author Microbiology and Sterility Assurance sections of the IND, NDA and MAA.
- Provide hands on and technical support for Environmental Monitoring activities of the facility and processes, including media fills activities.
- Author procedures, technical protocols, reports and quality systems records related to microbiology and sterility assurance.
- Review and approve Specifications, SOPs, Change controls, Deviations, Excursion and OOS reports, CAPA, for microbiology and sterility assurance related activities.
- Lead activities related to qualification/validation and transfer of microbiology and sterility assurance methods.
- Ensure microbial (endotoxin, bioburden) and sterility testing are conducted in compliance with cGMP’s and global regulatory requirements.
- Conduct audit of the CMOs and CTLs performing microbiology and sterility testing for Intarcia products.
- Lead micro and sterility failure investigations and prompt implementation of corrective and preventive actions to prevent reoccurrence.
- Collaborate with Manufacturing, QC functions, external vendors and partners to support corporate objectives and compliance with the submission, quality, regulatory and compliance requirements.
- Prepare the site for inspection and host regulatory inspections (SME for QA) for microbiology and sterility assurance.
- Train, develop talent and provide growth opportunities for employees.
- Manage department functions and responsibilities within the allotted budget and headcount.
- A minimum Bachelor’s degree in microbiology and/or a scientific discipline is required. An advanced degree is preferred.
- Seasoned professional in managing GxP Quality Systems for drug/device combination aseptic products with a thorough knowledge of cGMP regulations (21CFR211, 21CFR820, 21CFR4, EMA), ISO 11135, 11137, 11193 13485, ISO F838, ISO/ASTM 51702 and ICH guidance’s.
- A minimum experience of 15 years in the drug/device pharmaceutical and biopharmaceutical
- A minimum of 10 years in Microbiology Sterility Assurance managing Microbiology Department functions either in small and/or big pharma.
- Ability to work independently on Departmental projects and initiatives with minimum supervision.
- Pro-active and identifying opportunities along with strong problem solving and negotiation skills.
- Ability to work "hands on" in an entrepreneurial, fast paced environment. Leads by example and highly collaborative with the proven ability to work in a cross-functional team.
- Self-starter and team player with strong leadership, administrative, interpersonal, and team-building skills.
- Strong verbal, written communication skills and computer skills are required. Must be goal-oriented, quality-conscientious, and customer-focused.
- Must be able to travel (15 – 25 %).