Director, Business OperationsLocation Novato, California Apply
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 Director of Business Operations (CMO) is a member of the Contract Manufacturing Leadership team with accountability for strategic planning, continuous improvement, risk assessment / mitigation, portfolio management and training. The Director of Business Operations is also a member of the Global Continuous Improvement Council and a key contributor to BioMarin Operational Excellence culture, a key aspect of which is developing the problem- solving skills of the Contract Manufacturing Organization.
The Director of Business Operations supports Drug Substance, Drug Product, Label-Packaging, Device Development, and Packaging Engineering globally for clinical and commercial, Biologic, Small Molecule, Oligonucleotide and Gene Therapy products by establishing and facilitating an annual strategic planning and budgeting process, prioritizing key performance and capability gaps for remediation, managing a portfolio of process improvement projects, leading key initiatives and owning the management systems used to develop the organizational capability of the Contract Manufacturing Organization.
The Director of Business Operations is accountable for closely collaborating with Contract Manufacturing partners, the Production Management Teams at each site, Global and CMO quality, Quality Control, Supply Chain, MSAT, Process Engineering and Science, Product Development, Finance, Information Management, CMC Teams and TOPs Leadership to deliver on TOPs strategic and annual objectives. Facilitation of Contract Manufacturing governance, leadership meetings, weekly/monthly operations reviews and the effective interface with Global Manufacturing Network operations reviews to ensure timely and effective execution of actions designed to secure delivery of quality product to patients and attainment of key objectives is also a core accountability of the role.
Key interfaces include:
- Business Operations Directors in the two internal plants, and in Quality;
- Strategic contract manufacturing partners;
- BioMarin legal;
- Global Quality Systems, Supplier Quality and Compliance;
- Global Quality Business Operations;
- Business Technology Management;
- Global Continuous Improvement/ Continuous Improvement Council;
- Sharing Operational Excellence best practices in the OE community;
- Product development (CMC) product teams to ensure that the materials, capacity and staff needed to deliver the pipeline in accordance with defined milestones are provided when required;
This crucial role is a member of the BioMarin Continuous Improvement community and participates in network initiatives and efforts, including improving governance, and collaborating with Clinical Operations operational excellence professionals.
- Governance / Operations Reviews: Design, deploy and facilitate leadership meetings – including semi-annual strategy sessions that incorporate key partners.
- Work with finance to understand financial performance improvement opportunities across the contract manufacturing organization. Use these insights to prioritize improvement efforts and dollarize trade-offs / build credible business cases/use cases for systemic improvements.
- Build and improve interfaces with strategic contract manufacturing partners – performance/business reviews and improvement projects.
- Root Cause Analysis: Serve as a resident expert in problem-solving techniques and help facilitate root cause analyses as well as Before-Action Reviews (BARs) and After-Action Reviews (AARs) as required.
- Mentor internal Green Belt candidates in the Contract Manufacturing Organization as applicable
- Create and maintain a diverse and inclusive workplace that is safe and healthful for all employees. Build focus and engagement by fostering opportunities for ownership, impact and continual professional development.
The work product from the Director of Business Operations (CMO) will directly support product revenue and other programs executed in the network, will be a major driver for Manufacturing expenses, and will highly impact operational and transportation costs of external operations.
The Director of Business Operations is a senior leader, member of the Global Continuous Improvement Community and Contract Manufacturing Leadership Teams.
- Bachelors in Business, Operations Management, or Industrial Engineering required
- Six Sigma Black Belt, Lean Sensei, APICS certification and/or supply chain education preferred
- Other continuing education initiatives or relevant industry or information management (Oracle) certifications
- Minimum 10-15 years of operational excellence, aseptic processing, small molecule synthesis, gene therapy, supply chain, finance, portfolio management or other relevant experience.
- At least 10 years GMP/GCP compliant Biopharma operations experience required
- Experience with kaizen / work out events, various process mapping tools, human error prevention / human factors engineering, combination product rule compliance, knowledge management / design history file, ERP (Oracle) systems, and new product launches desirable.
- Demonstrated ability to partner with other functional groups to achieve business objectives required
- Mandatory: Experience successfully leading transformational change, change agent and sponsor training skills
- Superior communication skills – Oral, written and formal presentation skills with diverse audiences including senior management, middle management and line staff
- Creative problem- solving skills
- Comfortable and effective working indirectly through others
WORK ENVIRONMENT / PHYSICAL DEMANDS
The work environment characteristics described here are representative of those an employee will likely encounter 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.
Standard office desk equipment
Manufacturing, Contract Manufacturing Operations (CMO), Regulatory, Quality, Demand Planning, Clinical Supply Chain, Finance, Compliance, Commercial Operations, TOPS Program Management Group
CAREER DEVELOPMENTRefer to Responsibilities section; Consistent track record of exceeding objectives and leading continuous improvement within area of influence.