Associate Director / Director, CMC Procurement
Location: South San Francisco, California, United States
Summary: This position will oversee all process development and manufacturing efforts critical to advancing clinical drug candidates for our hepatitis B programs. He/she will be a member of the CMC Manufacturing and Process Development leadership team working in close collaboration with Legal, Business Development and Finance and will be responsible for procurement to support all HBV manufacturing ranging from pre-clinical, Phase I, Phase II/Phase III through commercial launch.
Key Responsibilities include:
- Provide strategic oversight and leadership of all CMC procurement activities with external partners and providers of materials and services.
- Work closely with technical lead to identify, select, and manage third party CMOs for DS/DP development & manufacture, analytical, packaging/labeling and distribution activities. Responsible for proposal writing, contract negotiation, campaign scheduling budget planning/tracking and invoice processing.
- Develop and manage external relationships with partners and suppliers which benefit Assembly Bio, the partners, and patients
- Identify high risk suppliers and sole-sourced materials and develop risk mitigation strategies
- Work with cross-functional program teams to support budget development and project management required to achieve development and commercialization timelines, managing spend to deliver optimal value across cost, performance, quality and risk.
- Lead and standardize the CMO/contractor selection process, analyzing operations and technical capabilities that affect prices, ensuring lowest cost consistent with quality, reliability, and ability to meet required schedules
- Ensure that outsourced manufacturing organizations operate within the appropriate regulations of GMP, ICH, ISO, or environmental control
- Negotiate manufacturing schedules and prices, track a variety of outsourced manufacturing projects in the production of API, intermediates, drug product and packaged supplies in coordination with contract manufacturers, and ensure availability per established schedules
- Establish strong and effective communication/collaboration with internal and external development partners for small molecule products/intermediates
- Maintain documentation to reflect the effectiveness and efficiency of procurement activities
- Bachelor’s degree in a technical discipline; Master’s degree (MBA, MS) is preferred and a Professional Procurement Certification (CPSM, MCIPS, Etc.) a plus.
- Significant years of experience in a procurement function with the majority of that experience within a biopharmaceutical company. Candidate's at the Director level should have 15+ years; an advanced degree will be considered in lieu of actual years of experience
- Advanced-level skills in the following key competencies/skills: communications, project management, relationship management, influencing, negotiation, financial acumen, analytical, presentation, aptitude for technology, results-focus, professionalism, and success in a matrixed environment.
- 5+ years of category management experience in biopharmaceutical manufacturing categories including direct materials, contract manufacturing, capital services and equipment, manufacturing and facilities support services, and quality services.
- Current knowledge of FDA, NMPA, EU, MHRA, Canadian, ICH, and other international GxP regulatory requirements.
- A proven track record of increasing value/savings delivery to world-class levels in multiple environments.
- Ability to work in a global, fast paced and increasingly metric-driven environment and delivering against challenging performance targets.
- Ability to influence senior leadership and cross functional stakeholders and deliver world-class results in a collaborative manner without direct authority.
- Experience in working, negotiating with and managing CDMO partners
- Computer Skills: Facility with and passion for working with systems and data and a demonstrated advanced proficiency with MS Excel and PowerPoint applications
About Assembly Bio
Assembly Biosciences (NASDAQ: ASMB) is a clinical stage biopharmaceutical company with cutting-edge therapeutics potentially capable of improving millions of lives around the world. We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add great people to our dynamic team who are driven to transform the lives of patients. We are currently focused on the development of two intelligently designed, scientifically novel clinical platforms:
An HBV program intent on creating a new class of oral therapeutics to finally cure hepatitis B. Our program is built on ingenuity, vision and experience and has the potential to improve cure rates for individuals with chronic hepatitis B (HBV) in our lifetime. Our strong scientific expertise in discovering small molecules targeting the HBV core protein has made us a leader in the field.
A Microbiome program of potentially life-changing oral live biotherapeutics to transform the treatment of an entire range of diseases linked to the microbiome. We believe our Microbiome platform represents a best in class approach, translating naturally evolved, bacteria-host pharmacological interactions into rationally selected, live oral biotherapeutics.
Assembly Bio has a strong balance sheet and is well-positioned to advance our innovative research and potential medicines in HBV-cure and the Microbiome. Headquartered in South San Francisco, CA, Assembly Bio also operates a microbiome manufacturing facility in Groton, CT, and has offices in China.
Assembly Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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