- Manages the relationships and activities with all CMOs
- Help to create a world where no cancer patient ever runs out of options
About Our Client
Our client is a publicly-traded biopharmaceutical company focused on developing medicines to improve survival and quality of life of cancer patients. Their portfolio consists of small molecule kinase inhibitors that inhibit critical signaling pathways, which promote cancer cell survival and tumor growth. They believe that empowering employees is what makes them truly care about the important work they do.
- Develop and oversee plans for commercial RSM, drug substance, drug product, and packaging that results in meeting commercial requirements for assets
- Responsible for supplying drug product for all company sponsored clinical trials as well as all Investigator Sponsored Trials (IST's)
- Establish and implement inventory policy and materials risk mitigation strategies
- Develops and executes Supplier Governance Model at all CMO's to ensure appropriate controls and oversights are in place.
- Responsible for managing Oracle ERP system database and compliance.
- Works closely with CMC function to resolve any technical issues that arise at any CMO.
- Partner with Quality assurance to ensure CMO's are in compliance with all cGMP guidelines and SOP requirements.
- Support the financial planning processes (e.g., forecasting, strategic planning) by analyzing raw material and external supply partner requirements (e.g., Drug substance, drug product and packaging demand) on an annual basis and create material budget forecasts for strategic planning.
- Responsible for working with outside packaging graphic design companies to assure all approved artwork is up to date and secured and that any changes that occur are approved by regulatory.
- Overall responsibility for compliance with DSCSA regulations and management of company's third party serialization partner.
- Responsible for managing the relationship with company 3PL.
- Responsible for global logistics function for movement of all materials.
- Authors and/or reviews pertinent CMC sections for pre and post approval regulatory submissions. (IND, IMPD, NDA, MAA)
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
- BA/BS in Supply Chain/Operations or life sciences/health-related field.
- Minimum of 12 years' experience in supply chain planning within the Pharmaceutical or related industry.
- Expertise in use of MS Excel, as well as demonstrated proficiencies in MS Project, Oracle ERP systems, and Visio.
- Understanding of supply chain management and associated resources/tools, for both oral solid product and sterile vials with knowledge of contract manufacturing operations.
- Must have the technical project management & external relationships experience necessary to lead the teams in a strategic and tactical manner
- Adept and diplomatic in interacting with senior management both within the organization and with external organizations, consultants, and vendors.
- Strong negotiation skills and demonstrated ability to work well under pressure and within tight time constraints.
- Demonstrated written and oral communication skills and ability to work / lead in a cross functional team environment
- Able to prioritize multiple tasks from multiple parties and work in a fast-paced environment with tight deadlines.
- Ability to forecast and allocate resources to meet objectives.
- Ability to travel up to 25% domestic and international travel along with the wiliness to attend various meetings at CMO sites
What's on Offer
- Extermetly competitive compensation and equity package
- Excellent benefits package
- Novel drug portfolio with strong pipeline
- Great company culture
- Contribute to development of cutting edge treatments for cancer