Associate Director, Global Biologic Drug Product CMOLocation Cork, Ireland Apply
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
The AD Global Biologic Drug Product CMO (Contract Manufacturing) is a newly created position in BioMarin which will have Global responsibility for management and oversight of contract manufacturers responsible for the manufacture of BioMarin’s clinical & commercial biologic drug product portfolio.
This role will be responsible for leading cross functional teams who will manage day to day operations at 4-5 global CMOs. S/he will also be expected to directly lead a team of dedicated CMO managers and associates and work cross functionally with other key functions such as Quality and Supply Chain to ensure delivery of Quality product on time from our Sterile Drug Product Contract Manufacturers.
A high level of initiative, energy, and motivation are key role requirements, as well as excellent leadership and organizational skills and effective collaboration with internal and external stakeholders.
- Establish standardized global operating model to leverage cross functional operations teams to deliver quality sterile filled drug product on time for patient supply
- Ownership of the business relationship with CMOs ensuring relevant metrics and management systems are in place
- Resolve schedule conflicts with CMOs to ensure BioMarin products are prioritized according to plan
- Lead negotiations of new contracts or contract updates with CMOs
- Leadership of the team by providing clear structure and organization of work as well as development opportunities for team members
- Demonstrate personal leadership while managing talent selection, talent development, training, succession planning and performance management
- Develop and deliver strategies that will transform this area of the business and ensure readiness to meet rapid growth
- Set objectives for the team and ensure measurement system is in place to track performance vs plans
- Further develop the team culture focusing on inclusivity and cross functional leadership of the business
- Work closely with Sterile Technical services group to ensure project delivery on time (eg. Technical transfers)
- Ensure smooth handover of new products from technical transfer into routine operations
- Ensure routine meaningful and clear metrics and reporting are in place for Sterile Contract Manufacturing
- Leverage business process improvement resources to deliver streamlined business processes within Sterile Contract Manufacturing
- Partner with Sterile Technical Services group to deliver process improvements which will enhance product quality, efficiency and process capability
- Ensure up to date and accurate SOPs and work procedures are in place
- Co-host business review meetings quarterly with cross functional business partners (Technical services, Supply Chain, Quality)
- With the Corporate Compliance and Quality departments, ensure that the CMO is compliant with cGMPs
ScopeS/he will assist in the establishment of the budget to accomplish project requirements. This includes component materials, testing, consultants, and all other expenses required to meet drug product manufacturing needs. S/he will assist in determination of capital investment requirements for Short- and Long-Range Planning
EducationA relevant third level qualification in Science, Engineering, Business administration or related discipline is preferred.
- Minimum of 8 years working in a GMP Manufacturing Management role preferably in the Contract Manufacturing area
- Sterile Drug Product manufacturing experience would be beneficial
- Demonstrated development, leadership and implementation of process change programs
- Demonstrated ability to organize, structure and lead a global team (approx. 5 people)
- Proficiency with Trackwise and with Oracle or other materials management systems is desired. Excellent MS Office, MS Project, and Visio skills.
- Experience with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment preferred.
- Working knowledge of EU and FDA Sterile regulatory GMPs
- Must have excellent interpersonal, written, verbal, and presentation skills
- Demonstrated project management skills
- Collaboration/Influence Management, Decision Making, Results Orientation
- Ability to work effectively with cross-functional and multi-location teams.
- Successful track record in execution of deliverables. Changes in plans and updates are proactively communicated to management and teams.
- Strong quality orientation with attention to detail
- Excellent organizational, interpersonal communication, and problem-solving skills
- Ability to find, communicate, and implement ways to continuously improve processes
- Strong organizational and leadership skills.
- Excellent written, verbal, and presentation communication skills.
Work Environment / Physical Demands
Travel: 20% - 40%
This would arise from time spent primarily at European & US CMO sites, other travel would include the BioMarin facilities in Marin County, US and Shanbally, Co. Cork.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.