Program Manager, Life Sciences - Durham, United States - Baebies
Description
Job Description
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 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
Program Leadership: Lead and manage cross-functional R&D teams including product development, feasibility studies, and process improvements.
Project Planning: Develop and execute project plans, timelines, and budgets in accordance with quality and regulatory standards.
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.
Stakeholder Collaboration: Collaborate with internal and external stakeholders, including regulatory affairs, quality assurance, manufacturing, and external partners, to drive projects forward.
Resource Management: Oversee and optimize resource allocation, including personnel, equipment, and budget, to meet project objectives efficiently.
Risk Management: Identify and proactively manage potential risks, issues, and obstacles to ensure timely project completion and mitigate any negative impacts on project outcomes.
Documentation and Reporting: Maintain thorough documentation of project progress, ensure accurate reporting, and communicate program status and updates to senior management.
Continuous Improvement: Champion a culture of innovation and process improvement, encouraging the development of best practices in IVD research and development.
Team Development: Foster the professional growth and development of team members, providing mentorship, guidance, and coaching.
Lead and develop a high-performing team, fostering a culture of accountability, collaboration, and professional growth.
Leads project meetings. Generates meeting minutes and manages action item lists.
Ensures team's adherence to Product Development Process deliverables.
Develops, coordinates and monitors the scheduling of company product programs. Ensures adherence to schedules and develops creative solutions to program problems.
Set clear performance expectations, provide feedback, and support team members in achieving their goals. Identify talent needs, recruit top talent, and provide training and development opportunities.
All other functions and responsibilities that may be assigned by management.
Requirements:
Qualifications
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.
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.
Strong knowledge of IVD product development processes, regulatory requirements, and quality standards.
Excellent project management skills, including the ability to lead cross-functional teams and manage multiple projects simultaneously.
Exceptional communication and interpersonal skills to collaborate effectively with a diverse team and external partners.
Strategic thinking and problem-solving abilities.
Strong leadership and mentoring skills.
Knowledge of regulatory agencies and guidelines (e.g., FDA, ISO) is highly desirable.
Familiarity with IVD technologies and diagnostic platforms is a plus.
Working conditions
We will only consider applicants local to Hyderabad. Thisposition 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
PId654aaf