Manufacturing

Head of Supply Chain Direct Hire MA

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Job ID: 16439 Direct Hire

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Our client is a mid-sized, public, therapeutics company in Cambridge and they are growing!  They are seeking an experienced Supply Chain Leader to join the CMC leadership team and head up all commercial and clinical supply chain activities for the company.  Reporting to the SVP, this is a urgent and critical hire as the company prepares for commercialization of their 2nd product!  

The main function of this role is to ensure the uninterrupted supply of clinical and commercial products within the product forecast and budget.

Responsibilities include but are not limited to;
•  Oversee purchasing, planning, warehousing and control of materials from the receipt of forecasting replenishment needs to the delivery of the finished product into finished goods inventory and delivery of products.  
•  Work closely with Clinical Operations to maintain adequate supply of clinical trial material including fulfillment of all supply milestones across development programs. Activities include demand forecasting, trial monitoring, resupply planning, label design, packaging, and IRT set-up and distribution. 
•  Oversee domestic and international shipments to ensure smooth transit through the logistical path.
•  Oversee the periodic supply planning and scheduling process, as well as inventory tracking, reporting, auditing. 
•  Lead, coach and mentor direct reports to ensure alignment with their role and responsibilities.   

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS degree or higher and 10+ years of pharmaceutical industry experience, ideally with small-molecule therapeutics.  MBA or graduate degrees related to supply chain welcome.  Certifications such as CPM, CPIM, CSCP, and CPP are a plus.

Must have experience with commercial supply chain networks and systems to be considered.  Experience with clinical supply chain (in addition to commercial experience) highly preferred.  Also must have working knowledge of MRP systems and global pharmaceutical regulatory requirements (e.g. cGMP, GDP, and GCP).    

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

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

Sr. Manager, CMC Project Management Contract MA

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Job ID: 16433 Contract

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FTE available in 2020

Our Cambridge, MA genome editing client uses CRISPR/Cas9 technologies to develop medicines for people with serious, genetically-defined diseases.  The Manufacturing team is looking to hire this contract role to contribute to the clinical translation of CRISPR technology by supporting the development and operationalization of their clinical protocols.

Responsibilities:

- Collaborate with the CMC Program Leads to develop and execute project plans.

- Manage team communications including meeting agendas, decision logs, task lists, risk analyses, and mitigation strategies.

- Effectively manage timelines to execute on project objectives. 

- Exhibit analytical problem solving to maintain and revise project plans with escalation of unforeseen changes in resource demand, risks, gaps and challenges to the CMC Lead.

- Create and maintain integrated portfolio resources and budgets across CMC sub- functions for assigned projects.

- Facilitate short and long term planning activities of CMC/Technical Operation functions.

- Adhere to GxP requirements in performing duties within established SOPs.

Requirements:

- Bachelor’s degree in life sciences or relevant field.

- PMP certification and/or advanced degree is highly desirable.

- 5+ years of relevant biotech experience with 3+ years of Project Management experience.

- Experience in analytical development, process development and/or manufacturing of biologics/cell & gene therapy

- Clear verbal and written communication skills.

- Ability to work independently and collaborate cross-functionally within a team.

Formal descriptions can be supplied for interested candidates.

Must be authorized to work in the U.S. indefinitely to be considered.

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

Manager, CMO Manufacturing Direct Hire MA

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Job ID: 16314 Direct Hire MA

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Are you experienced in the manufacture of a cell-based product?  Have you had responsibility for the business relationship management of contract manufacturing organizations or external vendors?  If so, this may be your next career move!  

Our client is one of the top cell & gene therapy companies in the Cambridge/Boston area. This role is with a mid-size company and they have a culture that can't be beat.  Don't miss your chance to make a significant impact for patients afflicted with rare diseases and cancer. 

The main function of this role is to support process and technology transfer and GMP manufacturing operations for gene therapy and manufacturing processes. 

Responsibilities include but are not limited to;
• Provide management oversight for technical support of GMP manufacturing runs for ongoing clinical studies
• Work closely with QA and CMOs as applicable for successful resolution of deviations, CAPAs, Change Controls, etc.
• Identify risks and drive continuous improvement in the manufacturing process and disposition
• Manage timelines and deliverables for technology transfer to CMOs including raw material and equipment procurement
• Conduct on-site or off-site training of CMO personnel
• Author, review, and approve CMC documentation for regulatory filings 

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS degree or higher and 5 - 10+ years of cGMP manufacturing of Phase I/II  cellular and gene therapies and previous management experience.  Preference given to those with tech transfer and CMO management experience and/or prior cGMP cell or gene therapy manufacturing experience for clinical-stage products.  

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 very limited assistance.  

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