Drug Product Shift lead
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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 Role:The Sterile Shift Lead- Drug Product reports to the Sterile Drug Product Operations Manager.
The primary role of the Sterile Shift Lead is daily management of the workload in Drug Product manufacturing, be the primary point of contact for day-to-day activities within Equipment Preparation, Recombination, Filling and Visual Inspection activities within Operations. Come join our team and make a meaningful impact on patients’ lives.
BioMarin has a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy and motivation are key role requirements, as well as excellent organizational skills.
They will work in a leadership role with a team environment that will be committed to continuous improvement, process understanding, personal development, and demonstration of production techniques that will result in agile and compliant manufacture of Drug Product Material.
The main areas of responsibility of this role are as follows:
- Shift Lead will be responsible for managing the workload on the shift and ensuring tasks are completed as per the relevant production schedule to ensure consistent delivery of results and maintenance of plan
- Drive the handover process within manufacturing and attend relevant morning escalation meetings when necessary
- Primary point of contact (POC) on the shift team for all internal and external requests
- First Line troubleshooting for any issues on the floor including equipment, process, automation, sampling, validation, engineering
- Responsible for escalation of potential safety, quality and production related issues.
- Strong understanding of basic cGMP expectations; set a good example and act as a role model in observance of cGMP policies, safety and compliance in the manufacturing group
- Interact with manufacturing, QA and compliance to help champion a compliant work environment
- Contribute to the inspection readiness team and possible requirement to be involved in regulatory inspections
- Participate in electronic batch record review and logbook review and closure
- Collaboration with Bioprocess Specialists and Process Engineers to ensure overall batch execution is successful
- Communication and Collaboration with other manufacturing and cross functional teams
- Develop and maintain internal and external relationships and ensure customer satisfaction through effective communications
- Lead and implement initiatives that add value to Manufacturing and site operational excellence e.g., Standard Work, 5S, RCARs, Area continuous improvement.
- Coach, mentor and train team members on area processes, procedures, use of operational excellence tools, and high-performance team behaviors.
- Effectively and consistently prioritize and delegate daily assignments and projects to technicians and associates. Ensure that all staff understand, properly prioritize, and execute their assignments and adhere to production schedule.
- Supervise, and perform as needed, employee training in Sterile DP Manufacturing Operations. Effectively and consistently prioritize and delegate daily assignments and projects to the technicians and associates.
- Continuing education initiatives highly desirable (e.g., Six Sigma, Lean Manufacturing, industry specific coursework)
- At least 5 years of related experience in a regulated manufacturing environment with excellent knowledge of aseptic controls and practices
- Experience in drug product filling, visual inspection and packaging and labelling beneficial
- Demonstrated ability to partner with other functional groups to achieve business objectives
- Strong knowledge of cGMPs (US & EU), OSHA, ISO, and other regulatory agency standards and requirements applicable to a pharmaceutical production facility.
- Experience of successfully contributing to a startup operation highly desirable
- Strong communication and interpersonal skills – Oral, written and formal presentation skills
- Creative problem-solving skills
- Experience in delivering results as part of a project or in a manufacturing operation
Leadership Behaviors and Personal Competencies:
- Builds partnerships and works collaboratively with others to meet shared objectives.
- Develops and delivers communications which convey a clear understanding of the unique needs of different audiences;
- Skilled influencer; able to distill complex concepts into concise, salient points.
- Holds self and others accountable to meet commitments by following through, acting with a clear sense of ownership, and taking personal responsibility for decisions, actions and failures.
Drives Vision and Purpose
- Paints a compelling picture of the vision and strategy which motivates others to action.
- Credible, trustworthy and empathetic leader; calm under pressure; can do attitude; relates openly and comfortably with diverse groups of people.
Agility and Flexibility
- Handles multiple projects and priorities simultaneously; operates effectively, even when things are not certain or the way forward is unclear.
- Able to work in a variety of roles and settings, with a diverse group of people and/or functions.
- Able to prioritize and focus on the few critical objectives;
- Design simple, flexible organizational structures and systems that can align and adapt with evolving strategy.
High Ethical Standards and Integrity
- Effectively adjusts to new, changing and unpredictable situations; able to learn new things quickly and easily; solicits and responds to feedback and coaching
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.