Vice President, Technical Operations – Achaogen – South San Francisco, CA, USA
Reporting to the Chief Operating Officer, the Vice President of Technical Operations will have overall responsibility for drug manufacturing and for ensuring the continuous clinical and commercial supply of the company’s products, through management of the company’s external supplier and contract manufacturing relationships and leadership of the company’s CMC and supply chain organization.
Lead, develop and communicate CMC’s vision, strategic direction, and resource requirements solutions.
Identify, recruit, develop and retain key talent in the technical operations group. Actively encourage effective leadership, decision-making, collaboration and innovation.
Enable team to effectively achieve the mission and stated objectives of their respective functional areas. Continually provide clarification, guidance, coaching and feedback regarding functional area performance to expectations and requirements.
Implement and direct the Sales and Operations Planning (S&OP) process.
Oversee Forecast planning and inventory management of all drug products in the pipeline. In addition, provide Forecast planning and inventory control of all intermediates and final products.
Identify, evaluate and ensure that outsourced vendors have the required scientific expertise, capabilities, and quality/compliance standards to support API process development and supply and drug product formulation and supply.
Provide expertise and scientific leadership regarding the evaluation and selection of new product technologies and process optimization.
Oversee product purchasing and planning at contract manufacturing and logistic suppliers. Includes establishment and oversight of rolling forecasts for clinical and eventually commercial products, and coordination of clinical packaging, logistics and labeling operations for drug product.
Transition the Supply Chain organization to a fully commercial / compliant level of performance and excellence in inventory flow and product distribution.
Establish key CMC interfaces with Clinical Operations, Quality Assurance, Regulatory Compliance, Sales & Marketing, and FP&A
Develop and manage annual Operating Budgets
Prepare management reports, metrics, presentations, KPI’s sufficient to communicate and measure functional area performance.
Provide expertise and oversight on the development, review, approval, and follow-through of technical sections of regulatory submissions, e.g., IND and NDA, as they relate to packaging, labeling, shipping, and distribution of clinical supplies.
Ensure that all Company manufacturing work is conducted in a manner that is in full compliance with all pertinent regulations.
Represent the Company externally on CMC matters with relevant stakeholders.
Preferred Skills and Experience:
15+ years biotechnology, pharmaceutical and/or chemical supply chain experience required. Familiarity with manufacturing operations and processes for pharmaceutical/biologic products including API (drug substance), drug product and finished goods production.
Outstanding managerial and employee development skills. Strong executive leadership skills, communication and business partnering ability. Proven strategic thinker and experience building effective organizations.
Ability to comprehend high-level business strategy objectives and effectively develop / execute ‘roadmaps’, milestones, detailed implementation plans and KPI’s.
Strategic, in-depth understanding of Chemistry and Manufacturing Controls (CMC), Supply / Production Planning, Materials Management, Warehousing / Storage, Distribution, ERP / Business Systems, and Data Management.
Demonstrated ability to create and manage work plans and timelines. Able to effectively handle multiple tasks and priorities in a fast paced environment.
Strong interpersonal skills and ability to work with others in a positive, collaborative manner. Ability to work well on cross-functional basis internally and with business partners.
Comprehensive understanding and expertise of GMP’s, GDPs and other regulatory requirements sufficient to establish compliant clinical / commercial stage supply chain operations, and contribute towards product development / licensure activities.
Experience with drug substance / drug product shipping validation (cold-chain and ambient), including drug product packaging for domestic and international shipments, materials tracking, and multi-national distribution.
Regulatory agency interaction experience and communication skills with emphasis on NDA / MAA application review / negotiation.
Previous management of contract manufacturing / contract testing organizations and Third Party Logistics (3PL) providers.
Experience in labeling, labeling requirements and packaging for US, EU and ROW markets.
Effective communication (written / oral), presentation and organization skills.
Ability to self-motivate and function independently.
Ability to demonstrate effective leadership in ambiguous and frequently changing situations.
BS / BA in science, business or management.
Graduate degree (MBA) and / or equivalent experience and education in strategic leadership and business preferred.
Strong supervisory / managerial leadership experience of CMC and supply chain professionals, technical contractors and expert consultants.
Preferred Additional Skills:
Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
Current US work authorization required.
Ability to travel domestically and internationally.