Software Development Manager

Title: Software Development Manager

Location: Waltham, MA

Reports to: VP, IT

About AlloVir

AlloVir is a publicly held, high-growth biotechnology company pioneering science in the field of virus-specific T cell (VST) therapies.

We embrace a shared mission to prevent and defeat life-threatening viral disease, champion truth, and challenge the status quo in pursuit of constant improvement.

Our innovative spirit lives beyond the lab, in a world where patients fighting viral infection have access to revolutionary allogeneic cell therapies. A world where everyone has access to a healthy immune system.

Success in this role means partnering across the organization to establish an innovative cell therapy manufacturing supply chain, taking a pro-active approach to identifying and overcoming risks and barriers, and challenging in the pursuit of continuous improvement.

At AlloVir, the expectation is that regardless of title, people are both group leaders and individual contributors. Much like medicine, we believe that this person can both do the work and set the work, working across functions seamlessly, sometimes in the lead position sometimes in support.

The Role:

We are seeking a highly skilled and experienced Software Development Manager to join our dynamic IT team. As the Software Development Manager, you will play a critical role in leading and managing the development of critical applications with the successful and on time delivery of high-quality software solutions that comply with 21 CFR Part 11 regulations. Expertise in software development, integrations, vendor management, contractor management, and regulatory compliance will be essential in order to partner with various internal and external stakeholders to coordinate the development and to deliver innovative software solutions while maintaining regulatory compliance.

Responsibilities:

• Lead and manage an outsourced code development team, which includes external vendors and contractors, providing guidance, mentorship, and performance management to ensure optimal team performance and development.
• Collaborate with internal stakeholders, such as Supply Chain, Quality, and Regulatory Affairs, to define software requirements and ensure alignment with business objectives and regulatory compliance.
• Identify and evaluate external partners for code development based on project requirements, expertise, track record, and compliance with regulatory standards.
• Architect and implement integrations with internal and external systems.
• Manage the entire software development lifecycle for outsourced projects, including requirements gathering, design, development, testing, deployment, and maintenance, ensuring adherence to project timelines and quality standards.
• Partner with Quality to ensure compliance with 21 CFR Part 11 regulations throughout the outsourced software development process, including documentation, electronic signatures, audit trails, and data integrity.
• Establish and enforce software development best practices, coding standards, security, and quality assurance processes for outsourced projects, ensuring the delivery of reliable and compliant software solutions.
• Conduct thorough evaluation and selection of external vendors and contractors, ensuring their capabilities, expertise, and compliance with regulatory requirements.
• Monitor and manage relationships with external partners, including contract negotiation, performance monitoring, and issue resolution, to ensure successful delivery of outsourced software development projects.
• Identify and mitigate risks, issues, and dependencies related to outsourced software development projects, proactively implementing strategies to address challenges and ensure project success.
• Stay updated with the latest advancements in software development methodologies, tools, and regulations, and effectively communicate these changes to the outsourced code development team and internal stakeholders.
• Foster a culture of collaboration, innovation, and excellence within the outsourced code development team, encouraging knowledge sharing and professional growth.

Qualifications:

• Bachelor's or Master's degree in Computer Science, Software Engineering, or a related field.
• Proven experience as a Software Development Manager or similar leadership role, preferably in a biotech, pharmaceutical, or a regulated industry.
• Strong understanding and practical experience with 21 CFR Part 11 and GAMP 5 regulations and their application to software development.
• Experience in managing outsourced software development projects, including vendor selection, contract negotiation, contractor management, and performance management.
• Proficiency in software development methodologies, such as Agile or Scrum, and the ability to tailor them to meet regulatory requirements.
• Solid knowledge of programming languages, frameworks, and technologies commonly used in software development, such as Java, C#, Python, JSON or JavaScript.
• Experience with cloud-based software development and deployment platforms, such as AWS, GCP or Azure.
• Excellent leadership and interpersonal skills, with the ability to effectively communicate and collaborate with technical and non-technical stakeholders at all levels of the organization.
• Strong problem-solving and analytical thinking abilities, with a focus on delivering practical and compliant software solutions.

Why join AlloVir?

AlloVir is the global leader in developing novel cell therapies that restore natural immunity against life-threatening viral diseases for immunocompromised patients.

We have an innovative pipeline of allogeneic, off-the-shelf, T-cell therapies that treat and prevent many devastating and life-threatening viral diseases. Our technology and manufacturing process enables the potential for the treatment and/or prevention of up to six devastating viruses with each single allogeneic cell therapy.

As part of the ElevateBio portfolio of companies, you’ll have access to award-winning facilities with centralized cell and gene therapy manufacturing capabilities that help advance the development of our revolutionary therapies for immunocompromised patients.

Join a team committed to scientific excellence, focused on passionate engagement, and united in purpose to treat and defeat viral diseases.

At AlloVir, we are committed to fostering and expanding diversity in the workplace. We strive to create an environment where everyone feels a sense of belonging and differences are celebrated as strengths. With a company vision of “ImmUnity for all”, we place special emphasis on unity, on equality, and on inclusion for all employees, patients, and partners.

AlloVir is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. AlloVir will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.