CMC Program Scheduler
CMC Program Scheduler
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.
This position will be responsible for of Chemistry, Manufacturing, and Control (CMC) programs controls functions for up to four Technical Operations CMC programs either at the clinical or commercial stage. This role is cross functional, collaborative, and dynamic requiring an understanding of major elements of CMC.
Duties & Responsibilities:
- Builds, maintains, and continuously improves the detailed CMC schedules for up to four programs. Focused on delivering products on-time by identifying constraints and proposing scheduling modifications to relieve constraints. Coordinates personnel and resource requirements with the CMC Program Manager to ensure proposed schedules can be met. The role will ensure alignment with all Technical Operations (TOPs) stakeholders’ requirements, readiness, timeline and commitments, to ensure schedule adherence and maximize efficiency.
- Maintain communication with CMC program manager to ensure schedule alignment with CMC goals and overall program strategy. Ensures the Program Manager is informed on a regular basis of potential changes to the schedule and/or resource planning which may shift critical milestones and/or add scope.
- This role will facilitate scheduling meetings with Sub Team leads and SME’s across TOPS to update schedules, incorporate new activities and maintain resources demand
- Formalizes all key inputs, requirements and parameters into a short-term detailed CMC Program schedule, as well as a high-level long range plan.
- Generate performance reports and customized status reports, identifying and reconciling discrepancies with the CMC program schedule/plan.
- Develop, monitor and update integrated CMC program plans and schedules so that CMC programs can be executed in the most efficient manner possible.
- Assess impacts to the critical path and near-critical activities and report to the project team.
- Maintain record of scope changes, trends and variances that potentially affect schedule performance.
- Create schedule fragments for change or what-if scenarios.
- Apply risk adjustment scheduling techniques (e.g. PERT master) to supports scenario analysis at the CMC program or CMC portfolio level
- Works with the PMO and CMC portfolio groups to implement best practices for scheduling and resources loading
- Ensure administrative activities of program gates are completed and the required program information is collected and distributed accordingly. This includes any required Final Reports, lessons learned, etc.
- Bachelor’s degree from an accredited institution preferably in a science or engineering related field plus 8-10 years experience in a cGMP pharmaceutical environment with positions of progressive responsibility.
- Awareness and understanding of CMC and ability to learn key technical details required to schedule operations.
- Experience with all aspects of Planning and Scheduling including, but not limited to, critical path method analysis, resource planning, milestone tracking, and updating logic driven schedules in Primavera P6 or Microsoft Project.
- Scheduling experience and/ or basic Project Management skills.
- Strong ability to communicate.
- Strong ability to influence in a cross functional environment and collaborate with peers and management.
- Requires intermediate understanding of biopharmaceutical manufacturing and business systems, process flows, controls, and timelines.
- Requires strong organizational skills and advanced interpersonal skills
- Demonstrates working knowledge of GMP, FDA and European regulations. PMP Cert is desirable
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.