Bio/Sterile Drug Product Process Expert - Hybrid (Boston, MA) preferred or Remote EST

Orbis Clinical is seeking a Bio/Sterile Drug Product Process Expert located in Boston, MA (Hybrid preferred or Remote EST) for 12 months with possible extension but not guaranteed.Job Title: Bio/Sterile Drug Product Process ExpertLocation: Hybrid (Boston, MA) preferred or Remote EST near surrounding statesContract: 12 months with possible extension but not guaranteedRole SummaryThis position is a contract worker (CW) role in which the CW is a subject matter expert (SME) responsible for technical oversight of several sterile drug products at external manufacturing sites related to drug product manufacturing. This CW will work with other SMEs knowledgeable with the CMO and the sterile products.Primary ResponsibilitiesDay-to-day technical oversight of activities at external CMO partnersProvide technical oversight at Drug Product CMOs within Servier External Manufacturing organization frameworkProactively drive technical deviation investigations, change implementations and continuous improvements in alignment with technical team and Virtual Plant Team goalsCollaborate efficiently with Quality, Operations, Supply Chain and extended teamsMaintain and review Drug Product manufacturing process monitoring for commercial products as part of robust Continuous Process VerificationCross-functional team participationActively participate in Virtual Plant Team led by OperationsBe the Servier point of contact (with SME oversight) for Joint Technical Team responsible for coordinating with CMO point of contact to drive agenda, moderate meetings and review minutesSubject Matter Expertise (SME)Perform process risk assessments to define improvements and mitigate gaps as per Quality and Regulatory requirements and industry best practicesFamiliarize with and author/review CMC related sections for regulatory filingsOther duties as required by managementEducation and Required SkillsMinimum B.S. degree in Pharmaceutical Sciences or Chemical Engineering or related technical field with minimum of 6 years relevant experience or a M.S. degree in Pharmaceutical Sciences or Chemical Engineering with a minimum of 5 years of relevant experience in sterile drug product formulation and process development and manufacturing including experience with regulatory submissionsIn-depth knowledge of sterile drug product formulation concepts/techniques and aseptic fill/finish processes as well as relevant GxPs and multinational regulatory guidelinesIn-depth knowledge of container closure components as well as single-use components and technologies typically used in aseptic processingExperience in a variety of problem-solving tools (e.g. Ishikawa, Kepner-Tregoe (KT), five-whys, etc.)Strong analytical skills, attention to detail, and ability to plan, organize, and manage multiple projects simultaneouslyStrong interpersonal skills and demonstrated accomplishments working in interdisciplinary teams that require collaboration, influencing and negotiation skills, and analytical judgementWorking knowledge in microbiology and extractables/leachables techniques and regulationsExperience with basic statistical methodologies and software (e.g., Minitab, JMP or equivalent)Experience in collaborating with Contract Development / Manufacturing Organizations and external partnersExcellent written and oral communication and presentation skillsTravel and LocationDomestic travel up to 20%Preferred location is in Boston, USA, but position is amenable to remote workCompensation Details:Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.The Pay Range for this position is $78.00 - $87.75 per hour, can vary depending on employment status.Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k).  EEO and Reasonable Accommodation Statement:Stone Harbor Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us. By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.