The Karyopharm Workplace
Karyopharm Therapeutics, Inc. (the "Company") is an equal opportunity employer. All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law. Consistent with its obligations under applicable law, the Company will make reasonable accommodations for qualified individuals with disabilities. If you require an accommodation in the application process, please contact a member of the Company’s Human Resources department.
Position: Director, Commercial Supply Chain
Karyopharm Therapeutics is a clinical-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.
The Director, Commercial Supply Chain is a new position established in preparation for Karyopharm’s upcoming NDA filing and commercial product launch strategy for Selinexor. The person in this role will be responsible for coordinating all activities and relationships required to assure the timely and compliant delivery of commercial Selinexor for USA and Ex-US market distribution and external Contract Manufacturing Organizations (CMO’s), Contract Packaging Operations (CPO’s) and Contract Testing Labs (CTL’s). The role will interact extensively with Quality, Regulatory, Pharmaceutical Sciences, Product Strategy, Marketing, and program management functions.
Establish and lead the Commercial Supply Chain operation at Karyopharm including but not limited to the following responsibilities:
- Build and lead the commercial supply chain group responsible for the timely manufacture, packaging, and distribution of all commercial finished goods in compliance with cGMP, cGDP, and the best practices of the pharmaceutical industry.
- Work collaboratively with Karyopharm Business Development (BD), Pharmaceutical Sciences (PS), and Regulatory Assurance (RA) groups to efficiently & effectively transfer validated supply chain manufacturing to the Commercial Supply Chain group prior to commercial launch of Karyopharm products.
- Work collaboratively with Karyopharm BD and Sales & Marketing (Sales) groups to determine market supply forecasts/needs and develop and establish distribution routes.
- Responsible for selecting and validating commercial supply under cGDP using CPO, CTL, and third party logistics (3PL) as applicable for the commercial launch of Karyopharm products.
- Coordinate all manufacturing, packaging, and testing activities with Karyopharm CMOs, CPOs, and CTLs to assure timely and compliant supply of all required commercial product to Karyopharm 3PL’s or to other designated sites as required.
- Negotiate/re-negotiate commercial supply agreements with Karyopharm 3rd party suppliers to support the ongoing commercial manufacture and transportation of Karyopharm products.
- Coordinate Karyopharm Active Pharmaceutical Ingredients (API), Raw Materials (RM) and Packaging Component suppliers to assure timely and compliant supply of all required materials needed for commercial finished product manufacture.
- Responsible for preparing and adhering to annual budgets and forecasts for the commercial supply group.
- Collaborate as needed with Karyopharm Quality Unit to assure all commercial product complies with all filed specifications, quality standards and Current Good Manufacturing Practices (cGMP’s) and to address any product deviations, failures, complaints, investigations, etc.
- Responsible for coordinating all transportation, FDA/Competent Authority clearance, customs clearance, QP release etc. activities necessary for all API’s, RM’s, bulk products and finished products.
- Responsible for documenting and communicating detailed commercial supply chain metrics on supply and performance to Karyopharm operating departments/groups and external vendors.
- Continuously work to improve and streamline Karyopharm commercial product supply chain using risk based approaches.
- Four-year degree in life sciences/engineering/pharmaceutical sciences required, with an advanced degree or MBA preferred.
- Minimum of 15 years of experience in the pharmaceutical industry, with a minimum of 10 years of progressive experience in commercial supply chain management and manufacturing experience.
- Proven & successful commercial supply chain management record within the pharmaceutical industry including drug product launch experience. Solid oral dosage experience is preferred.
- Overall pharmaceutical industry knowledge, including appropriate industry contacts, intimate knowledge of the US and EU drug commercial supply chain and distribution processes, working knowledge of the US and EU drug approval, regulatory and manufacturing processes and cGMP compliance regulations.
- Strong business knowledge of biotech/pharma manufacturing operations, product and process development, finance, and supply chain operations.
- Ability to plan and facilitate effective, efficient meetings; excellent interpersonal, oral, and written skills.
- Demonstrated working experience and respect for cGMP-regulated environments, including knowledge of relevant US/EU regulatory and quality requirements, standards, practices, and statutes for commercial drug product.
- Strong interpersonal skills to develop effective working relationships with internal stakeholders, CROs/CMOs, and cross-functional, cross-cultural project teams.
- Proven ability to develop and manage business relationships.
- Ability to travel domestically and internationally, (25-40%)
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