Summary We are seeking a CDMO Technical Transfer Lead who will be responsible for process transfer activities at C(D)MO level (inbound, outbound and within), including any development and scale-up or other process adaptations, who collaborates with the technical transfer project teams at C(D)MO sites, and who liaises efficiently with involved ARTBIO internal and C(D)MO functions (e.g. Technical Development, Supply Chain, Production Unit, Quality Control, HSE, other sites.).
\n ResponsibilitiesLead the tech transfer process between ARTBIO and CDMOs, and from CDMO to other CDMOs ensuring the ARTBIO and relevant regulatory requirements are met.Provide scientific and technical leadership and/or supporting transfer of isotope (with use of generator AlphaDirect™) and Drug product manufacturingProvide technical leadership and oversight for change control as required during technology transfer & process validationPartner with internal and external stakeholders, communicate, escalate and resolve technical transfer project issuesWork cross-functionally with ARTBIO teams (e.g. CMC, QA, QC) and the functions relevant at giving and receiving C(D)MOPartner with External manufacturing and engineering teams to provide process inputs for process fit assessments and to define process requirements for new C(D)MO manufacturing facilities. Qualifications & EducationMinimum of 3-5 years of experience in technology transfer and cGMP for personalized therapies drug substance and drug product manufacturing processes. Demonstrated track record of leading cross-functional teams and managing complex projects.B.S or M.S in relevant scientific/technical disciplines; advanced degree (e.g. PhD) or technological certificates preferred but not required.Experience with aseptic manufacturing; preferred scientific and technical knowledge of radiopharmaceutical processes from isotope use to drug product manufacturing. Previous experience with C(D)MO management strongly preferred.Team player, able to work in autonomy with an appreciation of detail while being cognizant of the "big picture". Someone who can balance the needs of an entrepreneurial environment with the requirements of structured product developmentProven ability to efficiently work with and/or lead cross-functional teams with CDMOs and business functions in a matrix environment. Ability to work within and lead different technical teams (internally and externally). Proactive mindset with strong leadership, facilitation, teamwork and influence management/negotiation skillsTravel may be required and is dictated by product needs and project deliverables, including overnight travel and stay.
\nAbout Us ARTBIO is a clinical-stage radiopharmaceutical company redefining cancer care by creating a new class of alpha radioligand therapies (ARTs). The unique ARTBIO approach selects the optimal alpha-precursor isotope (212Pb) and tumor-specific targets to create therapeutics with the potential for highest efficacy and safety. The company's AlphaDirect™ technology, a first-of-its-kind 212Pb isolation method, enables a distributed manufacturing approach for the reliable production and delivery of ARTs. ARTBIO is advancing multiple pipeline programs with lead program AB001 currently in first in human trials. ARTBIO is shaped by a long-standing scientific legacy with nearly a century of pioneering work in radiation therapy conducted at the University of Oslo and Norway's Radium Hospital. For more information, visit www.artbio.com, and follow us on LinkedIn and Twitter. As an emerging, global biotech with locations in Boston, Massachusetts, Basel, Switzerland, London, England and Oslo, Norway, we take advantage of diverse scientific depth and insights which makes ARTBIO a unique place to work. We are driven by a desire to do better for cancer patients, lowering the burden of toleration and safety while at the same time raising the bar on clinical efficacy and duration. EEO Statement ARTBIO is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know. Questions and Application Process If interested, please apply and send your CV to ******** ; All inquiries are treated confidentially.