Sr. Manager, Logistics Engineering
BioSpace, Inc. - norwood, MA
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Job Details The Role In this role, the Sr. Manager, Logistics Engineering will ensure development, deployment, monitoring, governance and continual improvement of cold chain, supply chain visibility and secondary distribution requirements across the Moderna organization. He/She will ensure that Moderna pre-clinical, clinical, and commercial products complies with relevant cold chain and GDP best practices, guidance, and regulations. He/She will Assist in the deployment of end-to-end cold chain and distribution procedures and guidelines that will ensure compliance and meet business needs. He/She will act as the key SME for supply chain visibility projects and enhancements that lead to a world class customer experience for internal and external stakeholders. Heres What Youll Do Deploy, enhance, maintain, and oversee implementation of Modernas Logistics Engineering program, strategy, requirements, and milestones. Act as a core member for Modernas Cold Chain cross functional team. Act as an owner for Logistics Engineering / Supply Chain visibility projects (i.e. real time and temperature tracking, digital twins and IoT analytics) Provide expert advice to Modernas various business units and staff on the handling, storage, and visibility of cold chain products according to current best practices, guidelines, and regulations. Liaise with internal and external stakeholders such as Manufacturing, Distribution/Logistics, and Quality to support new shipping system implementation activities at internal and external sites. Support technical transfer Distribution and Cold Chain operations at CMO and 3PL sites including the handling, storage, and visibility of cold chain products. Provide training on cold chain and supply chain visibility best practices, guidelines, and regulations across departments. Provide subject matter expert support during Good Manufacturing Practices/Good Distribution Practices audits, regulatory agency inspections. Develop cold chain monitoring and controls to assess the application of measures to meet compliance requirements and mitigate risks. Interact and liaise with External Quality for the qualification of vendors and service providers such as Freight Forwarders, Carriers, etc. including developing of Standard Operational Procedures (SOP), Quality Agreements and SOWs. Maintain current knowledge of relevant cold chain requirements and monitor emerging industry trends to determine potential impacts on Moderna to ensure that our practices, guideline, and procedures remain compliant and up to date. Support Modernas mission and core values. Additional duties as may be assigned from time to time Heres What Youll Need (Minimum Qualifications) Education: University degree in technology, engineering, or related field. Experience: 8-10 years (BA/BS) or 5-7 years (MS) in various Cold Chain, Supply Chain, Manufacturing & Science, and Logistics functions (strong preference towards Pharmaceutical and Biotech experience. Experience working in a cGMP environment). Heres What Youll Bring to the Table (Preferred Qualifications) Experience and proficient knowledge of supply chain visibility platforms, IoT devices, AI, Machine Learning Experience with managing Quality System events (Change Controls, CAPAs, Deviations, etc) Experience with creating GMP Documentation (SOPs, Work Instructions, Policies, etc) Experience and knowledge of cold chain technology, tools, and shipping qualification. Other government agency regulatory experience relating to biotech manufacturing. Outstanding communication skills (verbal and written) to collaborate with senior CMC Management in a dynamic, cross-functional matrix environment you are outgoing, communicative, and seek to build relationships on a daily basis. Well organized a natural ability to be organized in how you think, communicate, and conduct your work. You drive for results you set a high bar for yourself and others. You love what you do, and it shows. Ability to manage projects in a fast-paced environment. A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative. Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including: Highly competitive and inclusive medical, dental and vision coverage options Flexible Spending Accounts for medical expenses and dependent care expenses Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities Family care benefits, including subsidized back-up care options and on-demand tutoring Free premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipment Adoption and family-planning benefits Dedicated care coordination support for our LGBTQ+ community Generous paid time off, including: Vacation, sick time and holidays Volunteer time to participate within your community Discretionary year-end shutdown Paid sabbatical after 5 years; every 3 years thereafter Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning tools Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options Complimentary concierge service including home services research, travel booking, and entertainment requests Free parking or subsidized commuter passes Location-specific perks and extras! About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit /careers to learn more about our current opportunities. Moderna is a smoke-free, alcohol-free and drug-free work environment. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is proud to be an equal opportunity workplace and is an affirmative action employer. Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at . (EEO/AAP Employer) -
Created: 2024-10-19