Associate Director, Drug Substance Tech Transfer - United States
Position can be located in Smithfield, RI or New Haven, CT
The position will oversee technical transfer for new or existing drug substance manufacturing processes to internal or external manufacturing companies. This position is responsible for providing strong project management, technical and process validation leadership for all aspects of technology transfer to drug substance manufacturing activities at internal or external facilities worldwide. Responsibilities also include providing support for regulatory submissions related to clinical and commercial products. This Associate Director is expected to make efficient and effective use of available resources, have a well-managed staff, and be effective collaborator with vendor and supporting departments.
- Effectively manage 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, CMO Management and Supply Chain teams to ensure efficient tech transfer of Alexion's commercial drug substance manufacturing activities.
- Provide project management, technical and process validation leadership and direction for technology transfer teams
- Manage external collaborations, ensuring close partnership through scientific and strategic understanding, and attention to Alexion’s priorities to maximize integration and synergy with CMOs
- Support development, maintenance and continuous improvement of process validation program for all drug substance manufacturing processes.
- Ensures open communication and effective collaboration of all involved functions and external parties
- Proactively manages risk and drives project related decision to ensure teams are successful in achieving their goals and team milestones
- Sets high standards for team to meet or exceed compliance requirements
- Identify and implement improved business processes and systems targeted at ‘right first time’, improving resource utilization efficiency and speed to commercialize products
- Review IND, BLA and other technical documents for regulatory agency submissions
- Recruit, retain and develop first class scientific staff to support technical transfer activities. Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
- Global role requiring management of local and remote staff and international travel (~30%)
- 10-12 years of tech transfer experience in biopharmaceutical organization with expertise in multiple process areas. Requires project management experience of tech transfers
- Requires strong understanding of technology transfer, process fit analysis, scale-up/down, and process validation
- Ability to organize and lead staff responsible for project management, process transfer and process validation
- Ability to organize and lead cross functional team responsible for commercial tech transfer of drug substance
- Extensive experience in managing contract manufacturing companies
- Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product drug manufacturing operations are cGMP compliant
- Ability to present and defend technology transfer process and validation aspects of manufacturing operations during regulatory agency inspections
- Ability to see beyond own function to understand business issues and implement best practices and proven track record in leading teams with cross-functional scope
- Ability to drive for results independently and adapt to rapidly changing priorities
- 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
- Drive towards timely decision making and escalate issues appropriately
- Bachelor Degree (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) field with 12 years of tech transfer experience or advanced degree (MS, PhD) with 8 to 10 years of tech transfer experience.
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