A couple more recent position announcements: (click on position title to read more info)
Requisition Number 18-0074Post Date 10/25/2018
Title Associate Director, Device Design
City Danbury
State CT
Description
MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit
www.mannkindcorp.com.
Position Summary:
MannKind Corporation is currently seeking an Associate Director, Device Design in the Danbury CT facility. As a core management member of the Pharmaceutical Technology Development organization, the Director of Device Design will lead device design, development, transfer and technical support efforts for new and existing products by managing the organization and projects. Create vision and strategy for development of medical devices.
Principal Responsibilities:
As a key member of the Device Technology Development organization, manages timelines and resources to achieve manufacturing cost/capacity targets for new medical products
Works to conceptualize new product concepts and leads prototyping efforts
Works to grow a product portfolio by bridging prototype, pilot, and commercial phase development efforts
Directs group to conduct bridging studies to verify capability and functionality of scale up processes.
Directs qualification and validation activities for component and assembly processing
Establishes developmental and commercial test methodologies for evaluation and release of components/devices Leads investigations to troubleshoot manufacturing, process, and/or quality related deviations.
Develops product specifications for transfer manufacturing systems
Participates in design review activities in support of new device development projects by providing objective and knowledge base critical review
Creates, reviews, and delivers necessary technical writing/reports for devices to support regulatory submissions (CE mark, NDA, IND, 510(K), etc)
Supports device development efforts including procurement of commercial scale-up processes
Directs efforts associated with contract manufacturing during scale up activities
Responsible for observing all Company, Health, Safety and Environmental guidelines
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary
Requirements
BS/BA Degree with 10+ or MS/MBA Degree with 5+ years of experience
5+ years R&D experience with dry powder drug delivery
5 years R&D management or leadership experience within the medical device industry with demonstrated ability to analyze and interpret complex problems, data gathered from a variety of sources and, through effective decision making and planning, to deliver superior business solutions
3-4 years’ experience in successful global development of new process technologies and device product manufacturing operations, with requisite of global regulatory requirements and quality systems
Experience in plastics injection molding, metal stamping, and component assembly technologies
Experience interacting with Third Party Vendors, Contract Manufacturers, External Process Development Companies External Equipment Design and Build Vendors
Experience with digital medical products
Strong scientific and engineering skills in a technical area applicable to medical device development
Knowledge of medical device design and associated regulatory requirement including extensive knowledge of the ISO13485, MDD, CE and FDA requirements alongside knowledge of required standards, e.g., ISO14971, EN60601
Strong meeting facilitation, decision making, and presentation skills
Requisition Number 18-0075Post Date 10/23/2018
Title Associate Director - Program & Alliance Management
City Westlake Village
State CA
Description
MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit
www.mannkindcorp.com.
Position Summary:
We are currently seeking an individual to lead our newly created Program & Alliance Management Office. Our primary product is Afrezza and our primary market is the United States. Therefore, MannKind has focused resources deployed to the commercialization of Afrezza in the US. This person will play a critical role as we explore products/potential products outside of Afrezza, or outside of the United States, ensuring we have the capability to drive projects forward with speed, quality and a sense of urgency, and that items are not falling into the “white space” between functions of our company.
These needs will in part be filled by building a portfolio management capability within MannKind, led by this Associate Director of Program & Alliance Management. This newly created position will report to the CEO and, effectively, the Executive Leadership Team (ELT) of the company, and will help the team to deliver on commitments and aggressive timelines outside of our commercialization of Afrezza in the US.
Roles and Responsibilities:
Primary responsibility will be project managing the recently announced collaboration with United Therapeutics (UT)
Manages ongoing UT Alliance as the business representative for MannKind to extract the most value from the relationship
Serve as the lead MannKind project manager supporting the MannKind-UT Steering Committee, including managing agendas and minutes
Keeps the CEO and ELT updated on progress of current or impending roadblocks, ensures ELT is aware of needed decisions or resources to keep projects moving forward at desired pace
Closely monitors activities across all functions involved in the program to ensure achievement of key decision points and milestones according to time, cost, and quality parameters of the endorsed plan
Create and own the “MannKind-UT Dashboard” and present the dashboard and project update to the ELT on a regular basis
Leads the team in the preparation, implementation, maintenance, communication, and management of integrated risk management plans, including risk assessment and risk mitigation strategies
Drives creation/maintenance of project plans, recognizing and driving delivery of key interdependencies across functional lines
Leads development of the program critical path, decision criteria, and milestones/stage gates. Ensures all lines understand the strategy, key milestones and interdependencies
Responsible for the development and management of the communication plan for the program, including stakeholder management plan
Ensures effective, accurate, and timely communication of program information to meet the needs of the asset team and stakeholders
Conducts lessons learned and after action reviews
Proactively identify improvements to project/portfolio management systems and reporting mechanisms
Partner with CEO and other members of ELT to prepare for business development meetings/conferences
Lead ad-hoc projects, as assigned
Ensure compliance with policies, standards, local laws and regulations
Requirements
B.S./M.S. Degree or higher, preferably in Life Sciences.
The candidate must have 8 or more years of experience in the bio pharma industry.
5 or more years of experience in a portfolio management role, with demonstrated ability to work with product teams to generate portfolio level reports and analysis, as well as provide business management support for executive governance bodies
Demonstrated ability to work successfully in a nimble fast paced matrixed environment
Advanced knowledge and skill with MS Project, MS Excel and other reporting and tracking tools
Demonstrated experience developing and accessing product life-cycle strategies, as well as generating insightful portfolio reports and analyze enabling informed decision making
Demonstrated ability to manage and influence up and across an organization with regards to product strategy, and portfolio trade-off decisions.
Personal Qualifications:
Excellent communication and presentation skills
Self-organized, self-directed, highly motivated with strong critical thinking and analytical skills
Strong intellectual curiosity and rigor, and well-developed program and project management execution skills
Highly collaborative team player capable of collaborating with individuals at all levels (individual contributors to executives), across the business
A confident and strategic individual who is able to think out loud and “brainstorm” in a collegial manner
An innovative, data-driven and effective person with a “can do” attitude
A person who operates effectively in a small company and manage across multiple time zones within a matrixed organization
A goal-oriented person who both plans for the long-term and executes for the short term
Strong track record of performance on cross-functional teams and results through effective implementation of project management methodology, tools, and techniques
Extensive knowledge and experience in drug development, medical, and/or commercial disciplines with proven performance in business performance and project delivery
Strong leadership, negotiation, interpersonal, communication, and meeting facilitation skills
Experience with stakeholder management, governance management, and communicating key messages to senior-level stakeholders
Demonstrated ability to utilize project management tools and techniques (such as developing integrated project plans, critical path management, project change control, project risk management, and decision analysis)
Familiarity with clinical trial execution, working with contract research organizations, budget management, and related areas highly desirable
Track record for delivery against challenging personal and team goals
Proven ability to succeed in a fast-paced, challenging and complex matrix team environment
