Bio/Sterile Drug Product Process Expert

Job Title: Bio/Sterile Drug Product Process Expert (12- Month Contract + Benefits) Location: Boston, MA (Hybrid) | Remote Considered About the Opportunity Our client is seeking a Sterile Drug Product Process Expert to provide technical oversight of sterile drug product manufacturing at external Contract Manufacturing Organizations (CMOs). This individual will serve as a subject matter expert supporting commercial sterile products, driving technical investigations, process improvements, regulatory activities, and cross-functional collaboration across Quality, Operations, Supply Chain, and Manufacturing. Primary Responsibilities Day-to-day technical oversight of activities at external CMO partners Provide technical oversight at Drug Product CMOs within the External Manufacturing organization framework Proactively drive technical deviation investigations, change implementations and continuous improvements in alignment with technical team and Virtual Plant Team goals Collaborate efficiently with Quality, Operations, Supply Chain and extended teams Maintain and review Drug Product manufacturing process monitoring for commercial products as part of robust Continuous Process Verification Cross-functional team participation Actively participate in Virtual Plant Team led by Operations Serve as the primary 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 minutes Subject Matter Expertise (SME) Perform process risk assessments to define improvements and mitigate gaps as per Quality and Regulatory requirements and industry best practices Familiarize with and author/review CMC related sections for regulatory filings Other duties as required by management Education and Required Skills Minimum B.S. degree in Pharmaceutical Sciences or Chemical Engineering or related technical field with a 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 submissions In-depth knowledge of sterile drug product formulation concepts/techniques and aseptic fill/finish processes as well as relevant GxPs and multinational regulatory guidelines In-depth knowledge of container closure components as well as single-use components and technologies typically used in aseptic processing Experience 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 simultaneously Strong interpersonal skills and demonstrated accomplishments working in interdisciplinary teams that require collaboration, influencing and negotiation skills, and analytical judgement Working knowledge in microbiology and extractables/leachables techniques and regulations Experience with basic statistical methodologies and software (e.g., Minitab, JMP or equivalent) Experience in collaborating with Contract Development / Manufacturing Organizations and external partners Excellent written and oral communication and presentation skills EOE Statement: Specialist 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, or veteran status. In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change. #J-18808-Ljbffr Real Staffing