Senior Program Manager Jobs

Job Title: Project Manager

Job Statement: The Hands-On Project Manager will lead the fast-paced development and commercialization

of in vitro diagnostic products in a startup environment, with experience taking products

through advanced development to commercial launch. The role requires strong project

management skills, regulatory knowledge, the ability to wear multiple hats, and work

collaboratively across multiple functions.

Location: Santa Barbara, CA (Hybrid/On-site or Remote for the right candidate)

About Us

Aptitude Medical Systems is a startup deep-tech healthcare company. Our mission is democratizing diagnostics by empowering individuals to access their health and diagnostic information anytime, anywhere. Aptitude created a simple, accurate, and easy-to-use diagnostic platform that fits in the palm of the hand and allows anyone to run a complex lab-quality PCR test in their own hands in minutes. Aptitude’s lead product, Metrix™ COVID-19 Test, is the first FDA-authorized molecular diagnostic test to work with saliva or swab samples for at-home and over-the-counter use without physician supervision, and we have a product pipeline that includes tests for a wide range of health and wellness conditions. Imagine being able to consult your doctor, run the diagnostic tests you need, and get a prescription without having to leave your home. That's the future we're building. Come join us!

About The Role

The Hands-On Project Manager will be responsible for leading the fast-paced development and commercialization of our first in class and best in class IVD products from advanced development to launch. This includes managing the product development process, ensuring compliance with regulatory requirements, integration with manufacture, and coordinating cross-functional teams to ensure successful commercialization. This person must be highly resourceful and a team-oriented relentless problem-solver that is comfortable being strategic as well as operational, and willing to roll up their sleeves and take on tasks themselves as needed if there are gaps on the team, or there is a time crunch.

The work location for this position is Santa Barbara, California – an idyllic location offering immense natural beauty, outdoor adventure, big city amenities in a mid-sized town, and easy access to California’s metropolitan centers. This position can be remote or hybrid for the right candidate.

Job Summary:

Responsibilities

• Develop and manage aggressive project plans, timelines, budgets, and resource allocation
• Ensure compliance with regulatory requirements, including FDA, ISO, and other relevant standards
• Work closely with R&D, clinical, regulatory, and commercial teams to ensure alignment and successful product development
• Ensure that all product development and commercialization activities are performed in accordance with company policies and procedures
• Lead the fast-paced development and commercialization of IVD products, from conception to launch
• Manage relationships with external partners, including CROs, CMOs, and regulatory consultants, with a focus on speed and efficiency
• Collaborate with commercial teams to develop and execute rapid product launch plans, including marketing and sales strategies
• Communicate project updates and progress to senior management and stakeholders, with a focus on speed and transparency
• Participate in the continuous improvement of product development and commercialization processes, tools, and systems, with a focus on speed and efficiency

Qualifications

• Strong attention to detail and quality orientation, with a focus on speed and efficiency
• Excellent project management skills, including experience developing and managing aggressive project plans, timelines, budgets, and resource allocation
• Ability to manage multiple projects and priorities simultaneously in a fast-paced environment
• Strong communication and interpersonal skills, with the ability to work collaboratively across multiple functions and levels of the organization
• 5+ years of experience managing projects in the IVD industry, including experience taking a product through development to commercial launch in a fast-paced startup environment
• Demonstrated problem-solving and decision-making skills, with a focus on speed and efficiency
• Bachelor's or Master's degree in a scientific or technical field
• Knowledge of regulatory requirements for IVD products, including FDA, ISO, and other relevant standards

Benefits

• Flexible paid time off.
• Medical insurance, including medical, dental, and vision coverage.
• Competitive compensation, including equity.
• 401K Plan with company matching.
• Immigration support.
• Growth opportunities inherent to a fast-growing startup.

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