Summary & Scope of Position:

Provide oversight to full Commercial team production and operations. Responsible for: startup, ongoing relationship management and maintenance, contract life cycle, supply chain auditing, production and fulfillment oversight and quality/ regulatory compliance with all production partners, blood centers, and other commercial customers

Primary Responsibilities:

• Oversee Blood Center Services and Production Staff including daily activities, deliverables, employee development, training and performance management.
• Partner with manager on annual planning, budgeting, resourcing and forecasting.
• Manage relationships with critical vendors, including order management system, final product specific suppliers, and logistics providers.
• Successful initiation and maintenance of business and quality contracts/agreements. Emphasis on controlling price while ensuring quality.
• On time and on budget build out, validation, startup and licensure of blood center / GMP manufacturing facilities.
• Sourcing of plasma and other materials required for production of certain products.
• Matrix and interface with: company and business unit leadership, sales, clinical, research, development, technical, quality, supply chain, product management and others, as required, to build appropriate operational infrastructure to develop, manufacture and deliver finished biological goods.
• Lead development and cross functional efforts resulting in Cerus, production partner, and blood center operational buildout and on time readiness.
• Ensure compliance with applicable international, federal, state and local regulations for product manufacture and distribution of biologics and blood components.
• Proactively develop methods and monitor trends to minimize production and shipping loss.
• Implement and maintain best business and operational practices, identifying areas to improve efficiency and reduce costs
• Facilitate problem-solving, contingency planning, and decision-making.
• Partner with Human Resources on employment related activities (staffing, performance management, employee development, etc.)

Qualifications/Requirements/Skills:

• Bachelor's degree with 10 years of experience within a blood component manufacturing facility OR related industry experience.
• People management experience with demonstrated organizational and leadership skills.
• Strong interpersonal, communication, and negotiation skills
• Ongoing evidence of possessing the qualities of a strong individual contributor, manager and team-player.
• Experience with design, commissioning and operation of facilities for the commercial manufacture of blood and/or biologicals.
• Proven technical expertise of the development, manufacture and delivery of blood components or biologicals. Preferably with specific technical expertise in pathogen reduction, cryoprecipitate and/or lyophilization production.
• Understanding of biological product development from pre-clinical to commercial use
• Proven track record of matrix management for complex programs
• Analytical and creative problem solver with ability to execute change in various CMOs with differing structures.
• Strong background and interest in project management and lean processes.
• Ability to project a professional image and interact with a diverse customer population.
• Strong time management and work load prioritization abilities
• Ability to effectively communicate with diverse audiences of varied levels of education.
  • Strong verbal and written communication skills
  • Strong technical writing skills
  • Excellent presentation skills
  • English language skills required
• Proficiency with Microsoft Office.
  • Excellent Excel skills
• Willingness to travel up to 50%.

We understand that our people are essential to our success. This philosophy is revealed in our competitive benefits package, designed to improve employees' lives both on and off the job.

Benefits plans: medical, dental, vision, domestic partner benefits, paid maternity and paternity leaves, healthcare and dependent care flexible spending, life and accidental death insurance, long-term and short-term disability insurance, matching 401(k), ESPP, RSUs

Work and family: EAP, legal and financial services, health club membership discounts, tuition reimbursement

Compensation: The base salary range for this position if candidate is based in the SF bay area: $190,000-$220,000 annually.Compensation may vary outside of this range depending on various factors, including a candidate's qualifications, skills, competencies, experience, and location. Base pay is one part of the total package to compensate and recognize employees for their work.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.