Job Description Summary

Leading multi-functional New Product Development Core Team and Project Team(s) within a matrix and ISO compliant organization, the Program Manager is responsible for managing, timely launch and successful commercialization of multiple New Antibody Product development projects. The Program Manager will manage a high volume program using a structured Phase Gate product development process and ensures timely completion of Phases 1 through 4 from idea through launch.

The Program Manager is accountable for leveraging new and diverse approaches resulting in optimized solutions by leading the team through technical, quality, regulatory, manufacturing, and commercial problem solving and decision making, ensuring that the functional experts are held accountable. He or she will drive for continuous improvement and agility in the New Product Development process ensuring that project timelines are consistently met.

Job Description

Job Responsibilities:

• Demonstrates project and program management best practices and contributes to improving our product development process.
• Able to generate novel ideas for defining, implementing technologies and bringing new products to market. Ensures that customer perspectives are appropriately incorporated into every aspect of product development.
• Leads cross-functional core team to successfully deliver on a high volume product portfolio.  Defines the roles, responsibilities, goals and deliverables for core and extended team members.
• Communicates program risks to functional management and the Leadership Team.  Leads the Core Team to conduct thorough assessments of anticipated technical and program risks, to mitigate risks, and to appropriately plan response to program risks.
• Works with functional leadership and/or the Leadership Team for program resourcing, scheduling, risk assessment, design and technical reviews, completion of deliverables and resolution of problems. 
• Conducts program update presentations to the Leadership Team and represents the program and the program team to the rest of the organization.
• Ensures effectiveness and rigor of technical and design reviews.
• Ensures compliance with the company's Global Product Development System and Design Control requirements.
• Is responsible for the coordination and filing of all essential program documentation and business systems requirements.
• Keeps stakeholders informed on the status of work completion relative to scheduled deadlines.
• Participates as required in training on quality assurance and regulatory issues affecting own area of work. Brings quality assurance and regulatory compliance questions/issues to the attention of management.
• Performs other related duties and assignments as required.

• Minimum Qualifications:

  Post graduate degree (Masters or PhD) in biological sciences is a must

• Previous hands on laboratory work experience is required

• Experience in life sciences, biotechnology medical device or diagnostic industries

• Minimum of 5 years of experience in a project or program management role

• Track record of success in leading and managing New Product Development teams

• Track record of success in launching programs and bringing products to commercialization

• Experience working in Design Control, Change Management and ISO environment

• Experience managing external suppliers, vendors, licensors and contractors

• Experience working with Business Development function

• Demonstrate analytical, decision making, problem solving skills.

• Demonstrate results and solutions-orientation with business acumen.

• Strong influencing and interpersonal skills.

• Effective verbal, written and presentation skills required

• Ability to travel up to 10%

Primary Work Location

USA CA - San Diego (BDB)

Additional Locations

Work Shift