Program Manager, Product Launch & Packaging Component ImplementationLocation 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.
The Product Launch and Packaging Component Implementation Program Manager is full-time member of the Supply Planning team with accountability to manage the lifecycle of finished goods packaging component implementations across all Commercial products to ensure product manufactured and delivered to our customers is regulatory compliant. This role is also responsible to define and manage new commercial product launch plans for the products we are introducing in new international markets.
Launch Program Management
This role is responsible for collaborating with the regulatory, commercial, supply chain, logistics, quality, and artworks functions to define and manage the commercial launch implementation plans for international markets. These plans include all the necessary launch activities and dates including, but not limited to, regulatory submissions and approvals, artworks creation, packaging component printing, finished goods manufacturing, quality release, and distribution to the market. This role will be responsible to create finalize launch plans with target dates and work with the respective functions to manage the launch activities, report launch status, and launch products in markets on time.
Packaging Component Implementation Management
As a key contributing leader representing Supply Chain, the Product Launch and Packaging Component Implementation Program Manager will manage the planning and implementation of all regulatory impacting packaging component label changes across all Commercial Products. This role will be responsible to lead cross functional teams including team members from Artworks, Global Regulatory Labeling, Quality Assurance, Product Launch Management, Packaging Engineering, and Supply Chain. Specifically, these teams will plan and manage all activities necessary to prepare and implement packaging component label changes. This role will be responsible for managing all team meetings and to hold accountable the team members to ensure successful planning and implementation of all label changes according to defined Label Implementation Procedure SOPs and respective business processes.
Key interfaces include:
- Supply planning;
- Demand planning;
- Production scheduling in internal plants and for contract manufacturing;
- Commercial operations;
- Procurement and category management teams;
- Enterprise Master Data Management;
- Product Costing and Finance;
- Global Regulatory Labeling
- Quality Assurance
- Launch Management
- Accountable to define commercial launch plans and manage launch activities across several products in international markets
- Accountable to manage packaging component implementation teams for all Commercial products and to successfully track and manage cross functional product label implementation teams
- Responsible to foster a continuous improvement mindset to improve the Packaging Component Implementation process capabilities and lead-times
- Adept at fostering a culture of cross-functional collaboration, objective self-analysis and transparent collective ownership of outcomes. Develops team members, cultivates our leadership bench and provides mentoring to junior staff. Provides real time, constructive feedback to the direct managers of team members.
- Seeking opportunities to improve how we utilize our manufacturing assets to optimize the balance between capacity, cost and service
The work product from the Supply Chain Planning Manager will directly support programs executed in the network, will be a major driver for ensuring regulatory compliance, improving manufacturing expenses, and will highly impact operational costs of external operations.
- Bachelors in Business, Operations Management, or Industrial Engineering required
- APICS certification and/or supply chain education preferred
- Other continuing education initiatives highly desirable (e.g. Six Sigma, Lean Manufacturing, industry specific coursework)
- Minimum 7-10 years of supply chain (required) and regulatory (preferred) experience
- Experienced leader with managing direct reports a plus
- Project Management Certifications a plus with solid organizational discipline
- Experience managing programs, developing and maintaining project plans, issue tracking and risk management required
- Highly skilled with leading cross functional teams, providing direction, and coaching and mentoring team members
- Experience with regulatory impacting label implementations preferred, but not required
- At least 5 years GMP/GCP compliant Biopharma operations experience preferred
- Demonstrated ability to partner with other functional groups to achieve business objectives required
- Experience successfully leading transformational change
- Superior communication skills – Oral, written and formal presentation skills with senior management, middle management and line staff
- Creative problem solving skills
- Comfortable and effective working indirectly through others
WORK ENVIRONMENT / PHYSICAL DEMANDS
This is a global role, and requires travel as appropriate to secure required outcomes in alignment with TOPs and Product strategies.
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.
Manufacturing, Contract Manufacturing Operations (CMO), Regulatory, Quality, Demand Planning, Clinical Supply Chain, Finance, Regulatory Compliance, Quality Control and Assurance, Commercial Operations, TOPS Program Management Group
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.