Job Description

Company Overview: Baebies (headquarters in Durham NC USA) is a growth-stage medical device company developing innovative products to enable early disease detection and multifunctional diagnostics for syndromic testing for children and adults. Baebies Diagnostics India Pvt Ltd located in Hyderabad, India is a wholly owned subsidiary of Baebies Inc. Baebies India is in its nascent stages of establishment and team development.

Job purpose

As a Research and Development Program Manager for our India site, you will be responsible for leading and managing research and development projects. You will play a critical role in advancing our diagnostic technologies, ensuring they meet regulatory requirements and maintaining our position as an industry leader. This position is based in India and involves working closely with cross-functional teams and international partners.

Duties and responsibilities

\xc2\xb7 Program Leadership: Lead and manage cross-functional R&D teams including product development, feasibility studies, and process improvements.

\xc2\xb7 Project Planning: Develop and execute project plans, timelines, and budgets in accordance with quality and regulatory standards.

\xc2\xb7 Regulatory Compliance: Ensure that all activities adhere to relevant regulatory guidelines and standards, such as ISO and FDA requirements, and actively participate in regulatory submissions. Ensure compliance with all applicable requirements of the company\'s quality management system.

\xc2\xb7 Stakeholder Collaboration: Collaborate with internal and external stakeholders, including regulatory affairs, quality assurance, manufacturing, and external partners, to drive projects forward.

\xc2\xb7 Resource Management: Oversee and optimize resource allocation, including personnel, equipment, and budget, to meet project objectives efficiently.

\xc2\xb7 Risk Management: Identify and proactively manage potential risks, issues, and obstacles to ensure timely project completion and mitigate any negative impacts on project outcomes.

\xc2\xb7 Documentation and Reporting: Maintain thorough documentation of project progress, ensure accurate reporting, and communicate program status and updates to senior management.

\xc2\xb7 Continuous Improvement: Champion a culture of innovation and process improvement, encouraging the development of best practices in IVD research and development.

\xc2\xb7 Team Development: Foster the professional growth and development of team members, providing mentorship, guidance, and coaching.

\xc2\xb7 Lead and develop a high-performing team, fostering a culture of accountability, collaboration, and professional growth.

\xc2\xb7 Leads project meetings. Generates meeting minutes and manages action item lists.

\xc2\xb7 Ensures team\'s adherence to Product Development Process deliverables.

\xc2\xb7 Develops, coordinates and monitors the scheduling of company product programs. Ensures adherence to schedules and develops creative solutions to program problems.

\xc2\xb7 Set clear performance expectations, provide feedback, and support team members in achieving their goals. \xc2\xb7 Identify talent needs, recruit top talent, and provide training and development opportunities.

\xc2\xb7 All other functions and responsibilities that may be assigned by management.

Qualifications

\xc3\x82\xc2\xb7 Bachelor\'s or Master\'s degree in a relevant scientific life sciences field (e.g., Microbiology, Molecular Biology, Biotechnology etc.). An MBA or PMP certification (or equivalent) is a plus.

\xc3\x82\xc2\xb7 A minimum of 5 years of experience in research and development, including a proven track record of managing projects in the IVD or medical device industry.

\xc3\x82\xc2\xb7 Strong knowledge of IVD product development processes, regulatory requirements, and quality standards.

\xc3\x82\xc2\xb7 Excellent project management skills, including the ability to lead cross-functional teams and manage multiple projects simultaneously.

\xc3\x82\xc2\xb7 Exceptional communication and interpersonal skills to collaborate effectively with a diverse team and external partners.

\xc3\x82\xc2\xb7 Strategic thinking and problem-solving abilities.

\xc3\x82\xc2\xb7 Strong leadership and mentoring skills.

\xc3\x82\xc2\xb7 Knowledge of regulatory agencies and guidelines (e.g., FDA, ISO) is highly desirable.

\xc3\x82\xc2\xb7 Familiarity with IVD technologies and diagnostic platforms is a plus.

Working conditions

We will only consider applicants local to Hyderabad. This position collaborates with colleagues at our United States office. Will require the incumbent to work hours on Eastern Standard Time (EST) approximately 2 days per week.

Physical requirements

Laboratory work

Direct reports

Senior Scientist

Scientist

PI21a9be274374-8722-33227258

Baebies Inc.