Current jobs related to Clinical Supply Operations Manager - Cambridge - Biogen

  • Clinical Supply Operations Manager

    1 month ago

    Cambridge, Massachusetts, United States Biogen Full time

    About This RoleThe Global Clinical Supply Chain (GCSC) at Biogen is seeking a Clinical Supply Operations Manager to ensure high levels of compliance and effectiveness in its operations. This role will be responsible for managing Clinical drug supply in a GMP environment with a complex set of internal and external stakeholders.This person will build positive...

  • Director, Clinical Supply Chain

    2 weeks ago

    Cambridge, United States Lean Six Search | Supply Chain Recruitment Full time

    Job Title: Director, Clinical Supply ChainLocation: Cambridge, MAPosition Overview: The Director of Clinical Supply Chain will oversee and optimize the end-to-end supply chain processes related to clinical trials and research initiatives. This role is critical in ensuring that clinical programs are adequately supported with timely and efficient supply...

  • Director, Clinical Supply Chain

    2 weeks ago

    cambridge, United States Lean Six Search | Supply Chain Recruitment Full time

    Job Title: Director, Clinical Supply ChainLocation: Cambridge, MAPosition Overview: The Director of Clinical Supply Chain will oversee and optimize the end-to-end supply chain processes related to clinical trials and research initiatives. This role is critical in ensuring that clinical programs are adequately supported with timely and efficient supply...

  • Clinical Supply Chain Manager

    5 days ago

    Cambridge, Massachusetts, United States Alnylam Full time

    Clinical Supply Chain Managers at Alnylam Pharmaceuticals play a crucial role in the management and oversight of end-to-end clinical supply chain activities for assigned clinical protocols.This position works closely with key stakeholders, including Clinical Operations, Global Planning, Quality Assurance, Regulatory Affairs, Contract Manufacturing Operations...

  • Clinical Supply Chain, Supply Planner

    2 weeks ago

    Cambridge, United States Beacon Hill Full time

    Job Overview:Clinical Supply Chain Planner supports programs and protocols, in tandem with program leads; packaging, labeling, shipment and drug return logistical activities by interacting with internal and external customers and suppliers in order to accomplish project objectives. He/She will help drive these objectives through system related activities...

  • Clinical Supply Chain, Supply Planner

    2 weeks ago

    Cambridge, United States Beacon Hill Full time

    Job Overview:Clinical Supply Chain Planner supports programs and protocols, in tandem with program leads; packaging, labeling, shipment and drug return logistical activities by interacting with internal and external customers and suppliers in order to accomplish project objectives. He/She will help drive these objectives through system related activities...

  • Clinical Supply Chain, Supply Planner I

    2 weeks ago

    cambridge, United States Proclinical Staffing Full time

    Clinical Supply Chain, Supply Planner I - Contract - Cambridge, MAProclinical is seeking a Clinical Supply Chain Planner to support programs and protocols, focusing on packaging, labeling, shipment, and drug return logistics. Primary Responsibilities:The successful candidate will interact with internal and external customers and suppliers to achieve project...

  • Clinical Supply Chain, Supply Planner I

    1 week ago

    Cambridge, United States Proclinical Staffing Full time

    Clinical Supply Chain, Supply Planner I - Contract - Cambridge, MAProclinical is seeking a Clinical Supply Chain Planner to support programs and protocols, focusing on packaging, labeling, shipment, and drug return logistics. Primary Responsibilities:The successful candidate will interact with internal and external customers and suppliers to achieve project...

  • Clinical Supply Chain, Supply Planner I

    1 week ago

    Cambridge, United States Proclinical Staffing Full time

    Clinical Supply Chain, Supply Planner I - Contract - Cambridge, MAProclinical is seeking a Clinical Supply Chain Planner to support programs and protocols, focusing on packaging, labeling, shipment, and drug return logistics. Primary Responsibilities:The successful candidate will interact with internal and external customers and suppliers to achieve project...

  • Senior Clinical Supply Chain Planner

    5 days ago

    Cambridge, Massachusetts, United States Alnylam Full time

    Job DescriptionThis role is considered Hybrid. OverviewThe Sr. Clinical Supply Chain Planner is responsible for the management and oversight of end-to-end clinical supply chain activity for assigned clinical protocols. This position works closely with key stakeholders, including Clinical Operations, Global Planning, Quality Assurance, Regulatory Affairs,...

  • Clinical Supply Chain Planner

    1 week ago

    Cambridge, Massachusetts, United States Beacon Hill Full time

    Job Overview:A Clinical Supply Chain Planner at Beacon Hill supports programs and protocols by interacting with internal and external customers and suppliers to accomplish project objectives. The planner will drive these objectives through system-related activities such as Interactive Response Technology (IRT) and forecasting. Additionally, the planner will...

  • Sr. Product Manager, Clinical Supply Forecast and Logistics

    1 month ago

    Cambridge, United States Moderna, Inc. Full time

    The Role:As a Senior Product Manager, you will be responsible for driving the product strategy, development, and execution of clinical supply forecasting and logistics applications. This role requires experience in Interactive Response Technology (IRT) and strong product management skills, including proficiency with Jira. You will play a critical role in...

  • Clinical Operations Manager

    2 months ago

    Cambridge, Massachusetts, United States Bristol Myers Squibb Full time

    Job SummaryBristol Myers Squibb is seeking a highly skilled Clinical Scientist to join our team. As a Clinical Scientist, you will be responsible for designing and executing clinical trial activities, working closely with clinical team members to execute activities associated with the conduct of clinical trials.Key ResponsibilitiesDesign and execute clinical...

  • Director, Commercial Supply Chain Operations

    1 month ago

    Cambridge, Massachusetts, United States Akebia Therapeutics Full time

    Job SummaryAkebia Therapeutics is seeking a highly experienced and skilled Director, Commercial Supply Chain to oversee and manage all aspects of our commercial supply chain operations. This role is crucial in ensuring the efficient and effective delivery of our products to market, maintaining high standards of quality and compliance, and driving continuous...

  • Director of Supply Chain Planning and External Operations

    2 weeks ago

    Cambridge, Massachusetts, United States Vericel Corporation Full time

    Job SummaryVericel Corporation, a leading developer of advanced therapies for sports medicine and severe burn care, seeks a seasoned supply chain professional to lead the design, implementation, and oversight of end-to-end supply chain planning and external supply chain capabilities. Reporting to the VP, Supply Chain, this role requires a strategic thinker...

  • Postdoctoral Researcher, Supply Chain Management

    2 weeks ago

    Cambridge, Massachusetts, United States Massachusetts Institute of Technology Full time

    Job OpportunityWe are seeking a highly motivated and experienced Postdoctoral Associate to join our team at the Massachusetts Institute of Technology (MIT) Center for Transportation and Logistics (CTL). The successful candidate will assist with research projects, conduct independent research, and perform other duties as part of the MIT Low Income Firms...

  • Clinical Systems QA Specialist

    2 weeks ago

    Cambridge, Massachusetts, United States Poxy Clinical, LLC Full time

    About the RoleWe are seeking a highly skilled Clinical Systems QA Analyst to join our team at Poxy Clinical, LLC. As a key member of our clinical trials team, you will be responsible for ensuring the quality and integrity of our clinical systems and processes.Key ResponsibilitiesPerform quality reviews of User Requirements Specifications and Study Protocols...

  • Vice President Clinical Operations

    2 months ago

    cambridge, United States QurAlis Full time

    ABOUT THE COMPANY  At QurAlis, we are neuro pioneers on a quest to cure. We work with a relentless pursuit of knowledge, a precise attention to craft, and an optimistic mindset to discover and develop effective precision medicines that will alter the trajectory of amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), and other...

  • Vice President Clinical Operations

    2 months ago

    Cambridge, United States QurAlis Full time

    ABOUT THE COMPANY  At QurAlis, we are neuro pioneers on a quest to cure. We work with a relentless pursuit of knowledge, a precise attention to craft, and an optimistic mindset to discover and develop effective precision medicines that will alter the trajectory of amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), and other...

  • Vice President Clinical Operations

    4 weeks ago

    Cambridge, United States QurAlis Full time

    ABOUT THE COMPANY  At QurAlis, we are neuro pioneers on a quest to cure. We work with a relentless pursuit of knowledge, a precise attention to craft, and an optimistic mindset to discover and develop effective precision medicines that will alter the trajectory of amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), and other...

Clinical Supply Operations Manager

2 months ago

Cambridge, United States Biogen Full time
Job DescriptionJob DescriptionJob Description

About This Role

The Global Clinical Supply Chain (GCSC) is looking to hire a Clinical Supply Operations Manager to assure a high level of compliance and effectiveness for GCSCs operations. GCSC’s goal is to deliver medicines across the world to all patients enrolled in Biogen’s Clinical Studies. The function’s responsibilities include the production planning and distribution execution for all of Biogen’s Clinical Trial materials. This is where this role comes in – the team needs expertise and leadership to manage Clinical drug supply in a GMP environment with a complex set of internal and external stakeholders.

This person will build positive connectivity with the corporate Quality teams and programs and assure effective use of Biogen’s change management system PLM. This role will lead corporate initiatives on behalf of GCSC, such as Business Continuity planning and Business Impact Assessments. Finally, the role will be responsible for knowledge and training management in GCSC.

This is a hybrid role that can be based either at our office in RTP, NC or Cambridge, MA.

What You’ll Do:

Quality Management:

  • Act as GCSCs project lead for any quality-related project or initiative.
  • Facilitate all audits and inspections that include GCSC, originating from both PO&T (Tech Ops) and Clinical Operations (R&D)
  • Become the fully trained go-to expert in GCSC for quality systems and understand the organizations, drivers and goals behind these systems.
  • Closely collaborate with the Clinical Operations Quality team to build clear R&Rs and facilitate seamless quality management between the functions.
  • Owns and executes complex, multi-program or orphaned CAPAs and PEs within R&D and PO&T systems and drives them to conclusion.

PLM Leadership:

  • Super user of the PLM system which is used for change control management, item creation, BOM creation and other product lifecycle management activities.
  • Provide leadership across GCSC to drive PLM system usage excellence via training, support and if needed escalation with other functions.
  • Manage quality metrics for GCSC including change control metrics collection and distribution. This also includes gaining command of quality metrics used in the broader organization, assess them for impact and relevancy to GCSC and apply them as appropriate.
  • Become an active member of the PLM user community and act as voice of GCSC. In this context, collect and organize into themes the challenges and opportunities that the GCSC organization sees, and advocate for them.

Knowledge and training management:

  • Coordinate and deliver Quality and system training to GCSC and stakeholders.
  • Manage training curricula in alignment with job descriptions.
  • Own departmental SharePoint site BRAIN and improve accessibility of information and insights.
  • Maintain a catalog of procedures owned or used by GCSC to streamline onboarding, operations and audit readiness

Corporate connectivity management:

  • Stay connected to Regulatory Intelligence insights and triage them for GCSC.
  • Manage-in corporate requirements such as Business Continuity Plans and Business Impact Assessments.
  • Manage-in security alerts for GCSC and direct supply-relevant alerts to relevant groups.

Who You Are

Without direct people management, you should be able to effortlessly influence while working collaboratively in a matrixed organization. You should be able to draw from past experiences to develop solutions to complex problems that require a degree on ingenuity, creativity and innovativeness. Performance will directly reflect into functional efficiency and may impact compliance and audit findings, as well as business continuity.

Qualifications

Required Skills

  • Bachelor’s degree in related field with a minimum of 5-7 years in a CMP/GCP environment, including managing GMP/GCP activities in enterprise systems.
  • Experience in pharmaceutical supply chain environments.
  • Experience with Quality Management Systems such as Oracle PLM, or similar system.
  • Broad knowledge of quality operations, from theory to practice and from End-to-End process view to tactical system activities in PLM.
  • Excellent written and verbal communication skills in the English language, project management skills as well as stakeholder management skills.

Preferred Skills

  • Clinical Supply Chain experience
  • Familiar with continuous improvement and Lean Six Sigma/ DMAIC
  • Experience with ERPs such as Oracle EBS or similar system.


Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.