Less than 1 hour

Supply Chain Senior Specialist

WindMIL Therapeutics
Philadelphia, PA 19104
Supply Chain Senior Specialist


 


 


COMPANY BACKGROUND


At WindMIL, we are harnessing the power of bone marrow derived lymphocytes to develop groundbreaking immunotherapies to treat cancer patients.  We have developed a proprietary process to activate and expand bone marrow derived T cells.  The result of this process is called Marrow Infiltrating Lymphocytes or MILs.  Owing to their derivation from the bone marrow, which is a natural reservoir for memory T cells, MILs have unique properties that make them well suited for autologous cell therapy.  MILs can be used in both non-gene modified and gene modified forms, and therefore form the basis for our broad technology platform.  Our lead program is a Phase 2 study in non-small cell lung cancer, and we have additional MILs programs in solid tumors advancing to the clinic.  MILs can also be used for CAR-T therapy (CAR-MILs) and WindMIL will shortly be advancing CAR-MIL products into the clinic as well.


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OVERVIEW


Based in Philadelphia, PA or Baltimore, MD and reporting to the Senior Director, Manufacturing & MS&T, this position will conduct work of significant scope and technical complexity supporting the supply planning process and the supply and demand dynamics affecting an assigned portfolio of products.  Will have full exposure across clinical space to commercial launch planning activities to support clinical and commercial supply.  He/She will serve on cross-functional teams, working closely with Strategy, Planning & Operations Management, Clinical Operations, Quality Assurance and Regulatory.  This role will most likely be


75% Remote/ 25% Onsite with some travel required.


 


KEY QUALIFICATIONS




  • Proficient in Microsoft (Excel, Word, Outlook)

  • BS with 2 years of relevant or equivalent experience

  • Supply Chain Experience

  • Planning Experience

  • Working knowledge of cGMP/pharmaceutical regulations

  • Understanding of a pharmaceutical quality system specifically related to: CAPA, Deviations, SOPs, Production Batch Records in a GMP environment

  • Understanding of aseptic technique, cell culture and cryopreservation

  • Knowledge of warehousing and logistics operations, planning/ ERP systems, reporting and analytic tools




ESSENTIAL DUTIES AND RESPONSIBILITIES



  • Regularly review Master Production Schedule to ensure Supply Network Planning elements are accurate and relevant

  • Supports weekly meetings amongst internal and external stakeholders

  • Involved with Clinical Operations team to assess lead times and product availability

  • Identifies areas for improvement in existing cross-functional processes, and develop plans to address

  • Provide insight and visibility to capacity across manufacturing, highlighting and addressing supply opportunities and risks

  • Possesses basic industry knowledge, ideally background in the pharmaceutical and biotechnology industry or cell and gene therapy

  • Possesses basic and fundamental engineering and mechanical knowledge

  • Possesses basic and fundamental understanding of technical transfer activities

  • Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and understands why behind the regulations. 

  • Identifies, communicates, addresses and improves simple cGMP compliance and regulatory gaps and issues

  • Follows and executes Standard Operating Procedures (SOPs) and Batch Records (BRs)

  • Partner with Manufacturing and Clinical Operations teams to assess lead times and product availability

  • Maintain inventory at optimum levels via routine review of planning parameters, ensuring appropriate levels of safety stock are set and achieved across the assigned portfolio

  • With support from the Manufacturing team, provide insight and visibility to capacity across manufacturing, highlighting, and addressing supply opportunities and risk

  • Help develop reports, presentations and recommendations to Manufacturing management

  • Serve as supply chain resource/representative for special projects/initiatives

  • Help create, review and update the clinical supply and demand plans

  • Participate in cross-functional project team meetings

  • Monitor inventory levels and take preventative actions to avoid potential issues

  • Help coordinate distribution and logistics with CMOs

  • Support the review and update of SOPs and identify the need for assistance in establishing new supply chain-related departmental procedures

  • Role will most likely 75% Remote/ 25% Onsite; some travel required



 


SUPERVISORY RESPONSIBILITIES



  • No supervisory responsibilities initially; opportunity to grow into supervisory role



 


QUALIFICATIONS



  • A proven self-starter willing to roll up their sleeves and deliver

  • High level of demonstrated accountability

  • Flexibility and adaptability and a can-do attitude

  • BS in life sciences, business or supply chain, or a related discipline.

  • Minimum two (2) years industry supply chain management experience with specific experience in:

    • Cell culture and/or analytical/ bioanalytical/ cell-based assay development in a laboratory or cGMP manufacturing setting with experience



  • Passionate about teamwork and delivering groundbreaking therapies for patients

  • Highly organized with thorough attention to detail ensuring timely follow-through and closure

  • Demonstrated collaborative and influencing skills to work effectively in a cross functional team-based environment

  • Excellent writing and verbal communication skills

  • Proficient with MS Office (Word, Excel, Power/Point)

  • Ability to perform under pressure and effectively handle conflict/resolution situations both internally and externally and work effectively in a team environment



 


 


WindMIL is committed to providing an environment of mutual respect where equal opportunity and diversity are embraced and recognized as crucial to our success. We welcome diverse backgrounds, perspectives, and skills in our workforce and our culture.

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Posted: 2021-05-18 Expires: 2021-06-17

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Supply Chain Senior Specialist

WindMIL Therapeutics
Philadelphia, PA 19104

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