Manufacturing

Sr. Director/Director, Manufacturing & Tech Transfer Direct Hire MA

Apply with LinkedIn
Get hired faster
Apply

Job ID: 14870 Direct Hire MA

< Previous Job Back to List Next Job >

Our client is one of the top gene therapy companies in the Cambridge/Boston area and they are seeking a Sr. Director/Director to lead a team focused on Clinical Manufacturing and Tech Transfer activities.  VP level candidates may also be considered.  

The main function of this role is to lead and develop the clinical manufacturing management team and support tech transfer of GMP Manufacturing processes to CMO partners as the company prepares for commercialization. 

Responsibilities include but are not limited to;
•  Drive the strategy for early and late-stage clinical development programs and lead and evolve this function to support a broad portfolio.
•  Develop and mentor a high-performing clinical manufacturing group in a virtual manufacturing environment
•  Manage the interface between other CMC, Quality, Regulatory, Clinical, and Program Management functions 
•  Facilitate/lead tech transfers for early and late stage clinical programs to/from CMOs
•  Identify risks and drive continuous improvement
•  Author, review, and approve CMC documentation for regulatory filings.
•  Participate in meetings with regulatory bodies and respond to observations or questions concerning late stage development or clinical manufacturing processes.  

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a degree in life sciences or engineering (advanced degrees welcome), with 15+ years of relevant industry experience and a track record of successfully managing biologics programs through late-stage clinical development.  Preference for those with experience in autologous cell and/or gene therapy.  Technology transfer and extensive CMO relationship management experience is required.  

Must be authorized to work in the US indefinitely to be considered.  This position will be based in the Boston/Cambridge area.  Relocation assistance available for qualified candidates.    

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Clinical Manufacturing/Tech Transfer Project Manager Direct Hire MA

Apply with LinkedIn
Get hired faster
Apply

Job ID: 14750 Direct Hire MA

< Previous Job Back to List Next Job >

Our client is one of the top gene therapy companies in the Cambridge/Boston area and they are seeking an Associate Manager/Manager with background in preclinical biologics and/or cell therapy manufacturing.  This will mainly support tech transfer of GMP Manufacturing processes to CMO partners the company works with currently.  

Responsibilities include but are not limited to;
•  Serve as point of contact with contract manufacturing organizations (CMOs) and manage day-to-day operations for development programs.  This includes conducting internal technology transfer meetings, managing timelines and deliverables for technology transfer, and raw material and equipment procurement
•  Provide technical support of GMP manufacturing runs for clinical material
•  Serve as person in plant for process engineering or training runs and conduct onsite or offsite training of personnel

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS or MS in a life sciences discipline and 5-10+ years of industry experience in a GMP, cell culture and/or cell-therapy manufacturing environment.  Preference given to those with Project Management and/or CMO relationship management experience.  The Hiring Manager is open to candidates coming from early or late stage clinical development settings.    

Must be authorized to work in the US indefinitely to be considered and must be commutable to the Cambridge area or able to relocate with limited assistance.  

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Director/Associate Director, Clinical Manufacturing and Tech Transfer Direct Hire MA

Apply with LinkedIn
Get hired faster
Apply

Job ID: 14748 Direct Hire MA

< Previous Job Back to List Next Job >

Our client is one of the top gene therapy companies in the Cambridge/Boston area and they are seeking a Director/Associate Director to lead a team focused on Clinical Manufacturing and Tech Transfer activities.  The main function of this role is to lead and develop the clinical manufacturing team and support tech transfer of GMP Manufacturing processes to CMO partners. 

Responsibilities include but are not limited to;
•  Drive the strategy for early and late-stage clinical development programs and lead and evolve this function to support a broad portfolio.
•  Develop and mentor a high-performing clinical manufacturing group
•  Manage the interface between other CMC, Quality, Regulatory, Clinical, and Program Management functions 
•  Facilitate/lead tech transfers for early and late stage clinical programs to/from CMOs
•  Identify risks and drive continuous improvement
•  Author, review, and approve CMC documentation for regulatory filings.
•  Participate in meetings with regulatory bodies and respond to observations or questions concerning late stage development or clinical manufacturing processes.  

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a degree in life sciences or engineering (advanced degrees welcome), with 10-15+ years of relevant industry experience and a track record of successfully managing biologics programs through late-stage clinical development.  Preference for those with experience in autologous cell and/or gene therapy.  Technology transfer and extensive CMO relationship management experience is required.  

Must be authorized to work in the US indefinitely to be considered.  This position will be based in the Boston/Cambridge area.  Relocation assistance available for qualified candidates.    

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Global Sales & Operations Planning Manager Direct Hire MA

Apply with LinkedIn
Get hired faster
Apply

Job ID: 14739 Direct Hire MA

< Previous Job Back to List Next Job >

Global Pharmaceutical Company here in MA looking to add to their Supply Chain Team!  They are seeking a Global Sales & Operations Planning Manager to lead global S&OP processes for a portfolio of products from late stage product development to end of product lifecycle to meet patient demand, achieve business revenue and profit goals, while optimizing cost.  Other responsibilities include but not limited to:

  • Manage key product portfolio within the monthly S&OP cycle.
  • Lead regular market demand and supply reviews with business and finance stakeholders.
  • Ensure the resolution of demand and supply imbalances to ensure achievement of the financial plan and other KPIs .
  • Lead and execute improvements across demand / supply planning and S&OP processes to improve business value chain; strategic planning of inventory, capacity utilization, and drive integrated executive alignment to improve customer service level, market share, working capital, cost competitiveness, and profitability.
  • Partner with Supply Chain Planning and Regional Supply Chain to refine the demand forecast and supply plan to understand and reflect updated assumptive drivers and to drive scenario planning.
  • Lead and participate on cross functional teams in support of strategic initiatives within technical operations and across the business.
  • Identify and implement continuous improvement initiatives that optimize inventory turns, service levels and maximize profitability.
  • Develop thorough understanding of customer and market dynamics, trends, competition, pricing, as well as marketing strategies and tactics designed to achieve business objectives.
  • Develop thorough understanding of all aspects of supply chain strategies including total delivered cost, profitability, inventory turns and service levels.
  • S&OP representative on product launch teams.
  • Responsible for specific S&OP area (process, metric, etc.) Develop, implement, maintain, and improve the S&OP playbook, learning and development program, and operating standards.
  • Drive S&OP process standardization throughout the regions and functions.

Requirements:

  • Bachelor’s Degree with a minimum 7 years of experience in life sciences (pharmaceutical, biologics, medical devices) supply chain/ operations / manufacturing / product management
  • Strong familiarity with a broad variety of supply chain concepts, with specific expertise in global Biopharmaceutical supply chain management preferred

Preferred:

  • MBA / Masters or higher degree
  • APICS, CSCMP, or other Supply Chain certification
  • Experience implementing and leading Sales & Operations Planning processes
  • Experience with ERP (SAP, JDE/Oracle) / Advanced Planning Systems (Kinaxis) initiatives