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Insmed Inc. Associate Director, Scientific Operational Excellence Lead, Translational Bioanalytical Sciences (TBAS) in Bridgewater, New Jersey
Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Consistently Ranked Science 's Top Employer Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science 's Top Employers survey for four years in a row.A Certified Great Place to Work® We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists. Overview This translational sciences role within the Clinical Development organization works closely with colleagues in other functional areas including multiple Research groups. The role will provide operational and scientific guidance to global project teams and provide direction to internal and CRO resources to ensure appropriate progress and alignment with Translational Bioanalytical Sciences (TBAS) goals and strategies. Responsibilities The Scientific Operational Excellence Lead reporting to the head of the TBAS group will: * Cultivate collaboration and accountability through relationships with our external CROs and internal stakeholders, maintaining alignment with our organizational goals and standards of excellence. * Foster and build on our culture of continuous improvement, evaluating current processes with a focus on reimagining the most optimal framework for our operational network. * Proactively lead and manage TBAS vendor partnerships to drive scientific and operational excellence. * Facilitate discussions with TBAS staff and vendors and communicate expectations and timelines to ensure delivery of high-quality deliverables. * Establish and manage governance procedures for all TBAS external vendors performing regulated work. * Participate in scientific discussions for planning of experimental designs at external vendors. * Drive discussions and activities related to building our internal processes through SOPs, business practices, and working instructions. Qualifications: * PhD or MS or BS in Biology, Chemistry, Biochemistry, or another relevant field. * +Minimum of 4 years of scientific experience working in regulated or scientific environment. Large molecule or biological experience is preferred. * +Minimum of 6 years or more of project management, vendor management, or similar business experience. * Demonstrated situational leadership and creative problem solving. * Demonstrated expertise in best practices recommended by FDA, EMA, CLSI to conduct development, qualification and validation of assays (e.g. M10 Bioanalytical Method Validation). * Strong understanding and experience with current GxP and/or CAP/CLIA/ISO standards * Well-developed and effective team facilitation skills, able to establish cooperative team environments. * Strong project management skills. * Excellent communication skills (verbal and written) and presentation skills are required. * Ability to manage confidential information and understand the relevance and sensitivity. * Excellent interpersonal skills and the ability to function in a matrixed team environment. Salary Range $147,000 - $206,333 a year Compensation & Benefits At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location: * Flexible approach to how we work * Health benefits and time-off To view the full job description, click hereApply here: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjIxNjExLjEwNDEyQGluc21lZGNvbXAuYXBsaXRyYWsuY29t