Senior Manager, Contract Manufacturing

About the Company
Our purpose at Talis Biomedical is to advance health equity and outcomes by delivering accurate infectious disease testing in the moment of need, at the point of care.
While timely diagnosis of infectious diseases is critically important to enable effective treatment, testing is primarily performed in centralized laboratories, which require samples to be shipped for processing, delaying the return of results by days. Point-of-care testing solves this problem by delivering the timely information necessary for clinical care.
To deliver our purpose we focus on three things:

• Putting customers and patients first
• Making Talis a great place to work
• Living our values to Dream Big, Share Our Screens, Serve Others, Bring Our "A" Game, and Build Trust

Job Summary:
The Senior Manager of Contract Manufacturing will be responsible for overseeing the relationship with Contract Manufacturing organizations (CMOs) to ensure the timely and cost-effective delivery of high-quality products. This position will be responsible for organizing internal resources to transfer products into manufacturing at CMOs, oversee production, and ensure compliance with regulatory requirements.
Key Responsibilities:

• Manage the relationship with CMOs to ensure the timely and cost-effective delivery of high-quality products.
• Oversee transfer of new products to production at CMOs, including managing timelines, budgets, and quality.
• Ensure compliance with regulatory requirements, including FDA, EMA, and other relevant agencies.
• Develop and maintain relationships with key stakeholders across the organization, including R&D, manufacturing, quality, and commercial teams.
• Collaborate with internal teams to ensure that CMO production meets customer needs and company goals.
• Potential for growing a team responsible for managing CMO relationships and overseeing production.
• Use data to drive improvement and provide insights and recommendations to support decision-making.

Requirements:

• Bachelor's or Master's degree in a scientific or technical field.
• At least 10 years of experience in the pharmaceutical or biotech industry, with a focus on Contract Manufacturing.
• Strong technical background in manufacturing, with a deep understanding of current Good Manufacturing Practices (cGMP) and other relevant regulatory requirements.
• Proven track record of successfully managing CMO relationships and overseeing production.
• Experience working with multiple CMOs and managing timelines, budgets, and quality.
• Excellent communication skills, with the ability to present complex technical information in a clear and concise manner.
• Strong leadership skills, with the ability to inspire and motivate a team.
• Innovative and forward-thinking, with a focus on developing new solutions to improve Contract Manufacturing relationships.
• This job description is not intended to be all-inclusive. The Senior Manager, Contract Manufacturing may perform other related duties as required to meet the ongoing needs of the organization.

10-20% traveling
Talis Biomedical offers a comprehensive health and well-being benefits programs, long-term equity incentives, time-off policies, a 401(k) retirement savings plan with an immediate Company match, Education Assistance Program, a rotating suite of snacks, Happy Hours, office perks, and other fun company events! Best of all, join us by working at a growing company like Talis with dedicated and collaborative employees committed to making a difference in Health Care.
Talis Biomedical is proud to be an equal opportunity workplace. All aspects of employment decisions will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of any status protected under federal, state, or local law. We celebrate diversity and are committed to creating an inclusive environment for our colleagues. Talis Biomedical is an E-Verify Participation company.
More About Talis Biomedical:
Built on a foundation of world-class science and engineering, we are developing the Talis One platform, a sample-to-answer, cloud-enabled molecular diagnostic platform that could be rapidly deployed to distributed diagnostic settings in the United States and around the world to diagnose infectious disease at the point-of-care. The Talis One platform comprises a compact instrument, single-use test cartridge, and innovative software including a central cloud database. This system is designed to provide central laboratory levels of accuracy and be operated by an untrained user.
Talis has raised more than $500 million to date and went public in February 2021.