Location: San Diego, CA

Key responsibilities

• Leading efforts in planning supply chain activities, liaison with CMO\'s, and working closely with internal manufacturing, quality, clinical materials management and project teams to ensure products are available as scheduled.
• Advise management of any issues which may impact project/production timelines.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Communicates critical path items and priorities to Mfg./QC/QA and provides information that allows for resource planning.
• Manages contract manufacturing and packaging, schedules as well as project management support as needed.
• Collaborates with internal cross-functional teams and CMOs to ensure that manufacturing plans are executed as intended.
• Ensures on-time and predictable delivery of products and projects at CMOs. Manages the operational activities (schedule, timelines) of the CMOs, ensuring cost, quality, metrics, delivery and program objectives are met.
• Manages operational risk at the CMOs. Assist the Manufacturing and Quality Team in scheduling and managing the day-to-day manufacturing activities of contract manufacturing site(s).
• Work with Quality Assurance to ensure the manufacturing of products adheres to the implemented quality systems, cGMPs and process specifications at the Contract Service Provider(s).
• Assist the Manufacturing and Technical Services with the transfer of new products/line extensions from the development stage to commercialization.
• Assembling project plans and team assignments, directing and monitoring work efforts on a daily basis, identifying resource needs, and escalating functional, quality, timeline issues appropriately.
• Utilize project management processes and methodologies to ensure projects are delivered on time, within budget, adhere to high quality standards and meet customer expectations.
• Coordinate communication with all areas of the enterprise that impact scope, budget, risk and resources of the work effort being managed.

Requirements:

• BS degree in Engineering, Science or related field with a minimum of 6 years biotechnology/pharmaceutical manufacturing experience.
• Demonstrated ability to work with Contract Service Providers and accomplish company objectives through tactful encouragement and motivation.
• Direct and proven CMO and Manufacturing Operations experience, including tech transfer, validation and commercial scale production.
• Demonstrated success in project planning, resource management, and collaboration with Development, Quality and Manufacturing.
• Strong analytical and creative problem-solving skills.
• Extensive knowledge and expertise in the use of project management methodologies and tools, resource management practices and change management techniques.
• Strong knowledge and demonstrated practice of ICH/cGxP Guidelines. Experience preparing business processes.
• Previous experience in API or Drug Product Research, Development, Analytical/QC, Manufacturing or Supply Chain Management.
• Experience managing CMO relationships including contract reviews. Ability to thrive in a small group setting with limited administrative support, developing and maintaining collaborative internal and external relationship.
• Good organizational, communication and presentation skills, effective project and time management skills with the ability to work under pressure.
• Motivated, self-directed, able to work autonomously and have a proven ability to work in a team environment.
• Proficient in Microsoft Project, Microsoft Outlook, Word & Excel. Must be highly organized and possess excellent attention to detail, strong oral, written, and interpersonal communication skills.
• The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.