Specialist, Clinical Packaging OperationsLocation Novato, California 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.
State the overall function or purpose of the job.
The Packaging Operations Specialist is responsible for supporting clinical packaging manufacturing operations inside and outside the Novato facility. S/he will help coordinate clinical material needs between contract manufacturers and the internal project teams to ensure that all clinical product needs are defined and met.
The Packaging Operations Specialist will evaluate upcoming packaging requirements, provide a single point of contact for Contract Manufacturing sites, communicate project details and ensure that all key milestones are met. S/he is the SME for all things involving Production-related activities for selected clinical products.
This role partners with other BioMarin supply chain members to ensure packaged material is available for clinical distribution. The Packaging Operations Specialist will participate in improvement efforts and is an integral member of the product launch team.
The Packaging Operations Specialist is a cross-functional role which S/he will work closely with Clinical Operations, Development Sciences, Regulatory and external vendors to ensure all clinical labeling/packaging operations are met or exceed timelines. The individual will often work under very tight timelines.
List the major responsibilities of the job.
• Initiate and manage label clinical label text following country regulatory guidance.
• Manage packaging and label changes in existing clinical products within study timelines.
• Communicate forecast, detail and communicate routine work items, coordinate internal resources to accomplish project goals.
• Monitor production efforts at contract manufacturers.
• Lead weekly meetings with CMOs and capture discussions in minutes
• Communicate with members of the manufacturing group and other departments to optimize the production schedule. Promptly elevate issues to upper management that compromise on-time drug availability
• Complete tasks within the Oracle ERP system as related to production.
• Initiate Change Control, Deviations, and CAPAs through the Trackwise system.
• Communicate in online meetings with Europe and Asia, which requires availability outside of standard working hours.
• Support Manager to develop budget.
• Proactively identify risks. Create strategies to avoid or minimize their impact. Manage the execution of risk mitigation plans.
• Provide back-up support for other Operations Specialists, Coordinator(s) and/or Manager(s)
• Other duties as assigned
Quantify the scope or impact of the job in terms of revenue, expenses, capital investment, headcount, etc.
He/she will coordinate all clinical labeling/packaging material needs between the various manufacturing groups and the project teams to ensure that all clinical product requirements are defined and met.
State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc.
• Bachelors in Life Sciences, Business, or Engineering with 2-6 years experience in the pharmaceutical field and/or clinical packaging/labeling
• Packaging and project management experience is desired
State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job.
• Demonstrated project management skills related to all aspects of clinical packaging/labeling activities
• Proven track record to successful meet on-time delivery of clinical packaging/labeling projects
• 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
• Working knowledge of current GMP/GCP regulations desired.
• Working knowledge of manufacturing processes
• Proficient in MS Office, MS Project, and Visio
• Excellent organizational, interpersonal communication, and problem-solving skills
• Ability to find, communicate, and implement ways to continuously improve processes
• Proficiency with Oracle or other materials management systems knowledge desired
• Strong organizational and leadership skills.
• Process development or technology transfer experience preferred.
• Excellent written, verbal, and presentation communication skills.
• Negotiation skills
• Networking skills
WORK ENVIRONMENT / PHYSICAL DEMANDS
Describe the work environment characteristics that an employee encounters while performing the essential functions of the job.
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.
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
Describe any equipment required to perform the job.
Standard desk equipment including a computer and requisite software.
List the key positions, internal and external, with which the job incumbent must interact.
Internally this person will interact with Clinical Operations, Developmental Sciences, Supply Chain Planning, Supply Chain Logistics, Purchasing, Quality Assurance, Quality Control, Validation, Process Development, Manufacturing, Finance, Compliance, Legal, and Regulatory.
He/she will also be one of the secondary contacts for all CMO (Contract Manufacturing Organizations) work and contracts. He/she will be responsible for optimizing the inclusion and contributions from the Contract Manufacturing Staff, Process Development, Quality and Contractor staffs.
List the number of personnel directly supervised by this job reporting to this position, and their job titles. List the number of personnel more senior job titles that are functionally reporting to this position supervised (i.e., supervised on a “dotted-line” basis) by this job, and their job titles. State Specify the total number of job incumbents that this job supervises personnel supervised by this position, both directly and through others.
List the key accomplishments and skills that must be achieved to be eligible for promotion to the next position, if any, on the career ladder.
Refer to Responsibilities section; Consistent track record of exceeding objectives and leading continuous improvement within area of influence.
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.