Associate Director, Drug Product Tech Transfer - United States
Position can be located in Smithfield, RI or New Haven, CT
The position will oversee technical transfer of clinical drug product manufacturing processes to external manufacturing companies. This position is responsible for providing strong scientific leadership and subject matter expertize for all aspects of sterile clinical drug product including: technology transfer, process fit analysis, sterile filtration, container closure integrity, primary and packaging evaluation. Other areas of responsibility include technical support for ongoing clincal drug product manufacturing, process troubleshooting to aseptic drug product manufacturing activities such as discrepancy resolution and process monitoring external facilities worldwide. Review of technical documents and support for regulatory submissions are some of the other responsibilities.
- Manage clinical technical transfer process and ensure alignment with CMC schedule to meet with corporate goals and metrics, as required. This includes continuous communication with Quality Assurance, Quality Control, Process Development and Analytical Sciences and Supply Chain teams to ensure efficient tech transfer of Alexion's commercial and clinical drug product manufacturing activities
- Provide technical leadership and direction for drug product technology transfer teams
- Takes a lead role in selection of external manufacturing facilities for drug product
- Provide technical input to Process Development for defining the process control strategy for new processes
- Review IND, BLA and other technical documents for regulatory agency submissions
- Provide technical oversight and direction cllincal CMOs and internal manufacturing sites as needed. Provide technical depth and lead deviation investigations. Provide support to process monitoring and communicate operation status to management. Lead process optimization initiatives and address opportunities for efficiency and capacity improvements.
- Ensures effective collaboration of all involved functions and external parties
- Global role requiring management of local and remote staff and international travel (~20%)
- 8-12 years of tech transfer experience in biopharmaceutical organization with expertise in commercial drug product manufacture including compounding, filtration, drug product aseptic fill, lyophilization is a must. Visual inspections, sterile drug product investigation expertise preferred.
- Requires strong understanding of technology transfer, process fit analysis and clinical phase appropriate process oversight and control
- Extensive experience in managing contract manufacturing companies
- Comprehensive understanding of global cGMP requirements for clinical and commercial biopharmaceutical and NCE drug product manufacturing
- Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections
- Ability to influence others without direct authority and communicate with all levels of the organization
- Strong project leadership and resource management skills along with good verbal and communication skills
- Experience with drug product manufacturing process validation.
- Advanced degree (MS, PhD) in related Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) field
Smithfield, RI, United States
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Alexion is an Equal Opportunity /Affirmative action employer