Vice President, CMC (Chemistry, Manufacturing, Controls)

Summary & Scope of Position:

Lead drug product development and manufacturing for INTERCEPT Class III single-use medical devices. Ensure design, development, manufacturing, and release of new products which meet requirements for regulatory approval. Provide ongoing technical support for commercial products. Interact extensively with Cerus project teams and contract manufacturers globally.

Primary Responsibilities:

• Lead the CMC function responsible for Cerus medical devices (drug - device -biologics combination products), including new products and product life-cycle management projects and activities.
• Build relationships with existing external consultants and contract manufacturers. Lead negotiations and qualifications of new suppliers.
• Regular interactions with peers in Project Management, Product Management, Development, Regulatory, Quality, and Operations. Work with project managers to identify issues/risks and ensure appropriate actions are taken to accomplish specific goals, milestones, and budget(s).
• Participate in the authoring and review of regulatory submissions as required.
• Assume overall responsibility and accountability for performance against department, project and corporate objectives. Motivate employees to fulfill their commitments.
• Responsible for establishing and adhering to budgets and reporting requirements for Cerus projects and external contracts.
• Responsible for building infrastructure required to support a growing commercial organization with a portfolio of commercial and pipeline portfolio products. Manage and participate in human resources, and other organizational development and infrastructure activities.
• Ensure quality system compliance as it relates to areas of responsibility. Examples include design control/change control, design transfer to manufacturing, ISO/EP/USP standards, cGMP, and other relevant requirements.
• Participate in annual planning, budgeting and forecasting for CMC activities and resourcing.
• Manage daily activities of the CMC team ensuring that recruitment of key talent, training, employee development and performance requirements are met.
• Perform other related duties as required

• Requires U.S. and International travel (up to 25%).

Qualifications/Requirements:

• B.S. degree (Master's or Ph.D. preferred) in chemistry or chemical engineering with a minimum of 15 years related experience.
• A minimum of 10 years of people management experience.
• Experience with medical device and drug development process; GLP and GMP; FDA, European, ISO, and ICH requirements; and regulatory submissions.
• Demonstrated experience in developing and sustaining successful working relationships with contract manufacturers, contract laboratories, and partner organizations.
• Flexible; ability to adapt to changing priorities.
• Demonstrated ability to provide vision and accomplish goals while managing the scope, time and resource needs of multiple projects and programs.
• Strong leadership, interpersonal, and influencing skills in cross-functional team environment.

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 California hybrid position is $300,000-$352,000 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.