Director, Manufacturing

职位描述

The Director of Manufacturing is an exciting key role at the Oceanside CA site which is responsible for leading and developing a biologics team to successfully establish a high functioning and robust clinical and commercial operations producing viral vectors in a complex single use technology environment. This role will instill a culture that achieves competitive commercial and clinical operational excellence with continuous improvement, operational efficiency, quality, and safety as its foundation.

This is a “hands-on” leadership role. The leader will be able to continue the build of three biologics operational units for upstream, downstream and fill finish/packaging. The leader will collaborate with cross-functional teams of Facilities & Engineering, Supply Chain, MSAT (Manufacture Science & Technology), and Business Operations. The Director of Manufacturing will be knowledgeable and have had demonstrated experience to ensure compliance with Biological Single Use Technologies, Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), product licenses, Pivotal Clinical and Commercial Manufacturing, corporate policies and safety practices.

Responsibilities (include but are not limited to):

• Leads manufacturing team with a focus on consistent and reliable biologics operations with high success rates per batches and no to low deviations per batches
• Works hands-on to supervise and monitor performance of manufacturing manager and supervisor and the development of overall skills and expertise of the manufacturing team
• Assures successful transfer of new biologic technologies/platforms and processes
• Continuous improvements in all operation processes including safety
• Investigates and resolve problems, identifying root causes, and proposes process improvements through clear communication utilizing expertise coupled with OE tools
• Ensure operational readiness of team to perform and utilize single use technologies for upstream, downstream and fill finish platforms via training and preparation deliverables
• Ensures manufacturing areas, team, and equipment meet all cGMP and regulatory specifications
• Manages manufacturing of products which closely impact budget line of the department
• Coordinates with Supply Chain on the creation and revision of production schedule based on Capacity Review Management and Operations Council Process.
• Ensures cGMP training and readiness of Manufacturing Team for compliance audits and day to day compliance
• Creates operational efficiencies related to materials, labor and overhead
• Resolves organizational targets and interprets company policies for the department
• Create an environment where productivity and efficiency are achieved and recognized
• Establish operational plans, goals and assignments
• Anticipate, prepare organization, and address inspection issues that impact plant operations.
• Maintain a high level of compliance through effective monitoring and reporting of operational, key quality and safety metrics while incorporating in 6S systems
• Ensure timely execution of deviations, CAPA’s, change control support and continuous improvement initiatives
• Manufacturing leader prepare team members for inspection activities, observation commitments, submission and agency requests for products for assigned manufacturing plant
• Develop team’s technical capabilities for single use technologies, upstream and downstream manufacturing and fill/finish manufacturable activities for both pivotal clinical and commercial manufacturing
• Provide necessary training and ongoing coaching, discipline and recognition of direct staff, including performing annual performance reviews
• Collaborate with cross functional leaders to implement strategy and shared goals
• Communicate, collaborate and interact with Manufacturing Leadership Team and functional department heads
• Develop, administer, and execute to budgets, schedules, and goals
• Independently determine approach and requirements to managing teams and executing operations with meaningful collaborations with peer leaders
• Other duties as assigned

Basic Qualifications:

• Doctorate and 8+ years of experience managing a cell culture and/or purification manufacturing team in the biotechnology or biologics industry OR
• Master’s and 10+ years of experience managing a cell culture and/or purification manufacturing team in the biotechnology or biologics industry OR
• Bachelor’s and 12+ years of experience managing a cell culture manufacturing and/or purification team in the biotechnology or biologics industry

Preferred Qualifications:

• Demonstrated ability to work side by side on the biologic floor or operations environment to develop a team
• Deep understanding of the business, science, engineering, and technology of biotechnology, processes, equipment and facilities
• Very knowledgeable of the current regulations, Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP's)
• Clinical (Pivotal-Phase II/III) and commercial cell culture and/or purification manufacturing experience highly preferred
• In depth knowledge of process operations related to upstream and downstream equipment and ability to troubleshoot with facilities and the team
• Expertise or knowledge
• in how Upstream bioreactors and Downstream TFDF/UFDF, Chromatography and Fill/Finish/Packaging Equipment operates.
• Expert knowledge of electronic quality systems
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
• Willingness to think outside of the box and adapt best practices to our small, but growing environment
• Ability to adapt in a constantly evolving environment
• Always leading with safety area ownership utilizing 6 S and Gemba walks to establish a world class safety culture
• Self-motivated with a thorough sense of ownership in areas of responsibility

Does this sound like you? If so, apply today!