Lupagen is in the process of transforming how we treat patients with serious diseases in a safer, more efficacious manner by enabling gene modification of peripheral blood mononuclear cells at the bedside. The company is based in Dallas, TX and has global footprint of employees, consultants, contract manufacturing and collaborators. Now is the time to get in on the ground floor of a fast-growing company that is looking to transform gene therapy. Consider joining our team and unlocking your potential. We seek the fiercely independent free thinkers.
Lupagen is seeking a fiercely independent resourceful self-starter with a “can-do” attitude comfortable with innovation, uncertainty, and flexibility with broad responsibilities. The motivated individual will support next-generation gene therapy programs in the field of Cancer Immunotherapy and will be responsible for overseeing and managing product development for Lupagen’s cell & gene therapy delivery device at our new facility in Dallas, TX. The candidate must be self-driven, resourceful, and able to work independently. The position will require domestic travel to our development partner(s) and customer sites.
As a leader in a small company, this role will have accountability for our device development program. Qualified candidates will have experience in the areas of program planning, execution, and operations in the development of investigational medical devices from prototypes to pre-production products. Demonstrated ability to lead development programs to delivering on: budget, timeline, design specification, and quality metric commitments is required.
This role is responsible for overseeing product development and managing key relationships with external development partners. The Program Lead is the primary interface between Lupagen, and the contract engineering firms, partners and selected end users and field development engineer(s). This role provides oversight and ensures the contract engineering firm is accountable for meeting all project requirements including design requirements, timing, and quality. The role requires strong technical device background and a good knowledge of principles and practices of related specialties.
This position will require protocol development and troubleshooting instrumentation in a laboratory environment and will include handling of cells and blood components.
Dallas / Fort Worth metro; Travel 25-50%
Role and Responsibility
- Work closely with business and R&D (therapeutics, biology, formulations) teams to integrate new product development requirements into device designs
- Interface and manage Field Development Engineers to gather data, feedback from key customers to integrate into design development plans
- Utilize their background and experience to provide product-specific technical support to the field-based team.
- Maintain in-depth knowledge on product design and operations
- Generate technical protocols and SOPs for customers leveraging key experts and contractors
- Troubleshoot procedures/writing detailed reports explaining the cause of any unexpected system behavior. The position will also use their extensive knowledge of current system limitations to suggest enhancements for future product development projects.
- Understands and ensures alignment to Lupagen policies, FDA and other regulatory requirements
- Ownership of master design plan.
- Ownership of detailed: program, resource, and budget planning for all development programs (hardware, software, and integrated systems)
- Help identify and recruit internal and external engineering resources.
- Source, implement, and utilize program management tools.
- Responsible for meeting development program: milestones, budgets, and timelines.
- Act as a liaison between the contractors and development partners
- Provides oversight for all aspects of the relationship between Lupagen and its contract engineering partners
- Review designs from outside design partners and suggest improvements where required.
- Proactively highlights and communicates risks to Lupagen leadership and contracting firms to avoid serious delays and considerable expenditure of time and resources
- Advises, guides and directs contract partners as required on design requirements, risk analysis and regulatory compliance.
- Interacts and consistently communicates with key stakeholders within software, engineering, regulatory and quality functions to ensure alignment to project goals within and across functions
- Provide feedback on the selection of outside design partners for individual projects.
- Execution control for programs outsourced to contractors, consultants, and suppliers.
- Execution control and reporting for all engineering programs.
- May be required to adjust drawings and other Engineering documentation to be compliant with internal standards and design history files from partners.
- May work with manufacturing partners & vendors and other functional groups on manufacturing and regulatory compliance issues
- Will work cross functionally with associates in other business areas such as procurement and legal to define contract requirements for outside design partners.
- Assess the effectiveness individual Engineers at outside design partners as it relates to their ability to perform on a given project.
Education & Experience
- B.S or M.S. degree in Engineering (Biomedical, Biochemical, Mechanical, Systems, or similar) with over 3-4 years of related experience
- Has a minimum of 2-4 years of experience managing the relationship between a device manufacturing organization and a contractor engineering organization or working with a contract engineering firm.
- Working knowledge of all aspects of device manufacturing and contract engineering process from contract through product delivery
- Success in leading medical device product development teams.
- Track record of delivering on commitments, timelines, budgets and quality metrics.
- Experience in managing engineering programs with multiple sub-systems.
- High bandwidth, strong leadership with ability to scale to manage operations.
- Demonstrated technical leadership, including creative problem solving.
- Ability to provide technical and operational leadership at various organizational levels.
- Experience in blood collection, transfusion, apheresis/plasmapheresis related devices preferred
Knowledge, Skills, Abilities
- Requires demonstrated skills in technical innovation, technical leadership, mechanical and or chemical engineering, fluids engineering, and cellular biology
- Strong interactive skills in general communication, cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team member, team behavior, and support for subordinates, junior engineers, technicians, and management
- Strong technical problem-solving skills
- Mechanical and electronic ability aptitude to assist with equipment troubleshooting
- Understanding of and adherence to GMP practices and FDA regulations
- Knowledge and ability to implement FDA or regulatory requirements as necessary
- Demonstrated ability to communicate effectively both verbally and in writing
- Knowledge and use of relevant PC software applications and skills to use them effectively
- Entrepreneurial spirit: Ability to work in low-structure, tight-resource environment of early stage, high-growth company.
- Experience with full lifecycle program management (program planning, implementation, execution control, and pre-production readiness).
- Desire to travel overnight, at least twice a month for meetings with key engineering partners and customers.
- Work with a sense of urgency: Leads and motivates the team to deliver on development milestone commitments.
- Process oriented with strong operating mechanisms.
- Ability to create and deliver executive materials for decision making.
- Demonstrates clear and thoughtful communication.
- Demonstrates risk retirement analysis and implementation.
LUPAGEN seeks to globally commercialize technologies that will transform point-of-care disease detection and diagnosis, and the monitoring of therapies. With our employees, LUPAGEN focuses on attracting, developing and retaining the best talent. We seek people with a positive “can-do” attitude and we foster a collaborative and mutually supportive environment.
LUPAGEN is not for everyone…hard work, exciting challenges, limited resources, highly collaborative, fast-paced, and a path toward making a significant impact in the medical device and cell and gene therapy field!
LUPAGEN offers a competitive pay and benefits package with short and long-term incentives for individual, team, and company success. We offer benefits associated with company growth.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, protected veteran status, or disability status. LUPAGEN is a drug-free workplace.
Please forward your CV if interested via email to: firstname.lastname@example.org
Note to Recruiting Agencies: All resumes submitted by search firms or recruitment professionals to Lupagen, Inc. in any form without a current signed search agreement will be deemed the sole property of Lupagen; no fee will be paid in event that a candidate is hired.