You are now leaving ironwoodpharma.com. This link will take you to
a website to which our privacy policy does not apply. You are solely
responsible for your interactions with that website.
Ironwood selected as one of Boston Globe's Top Places to Work.
Ironwood named honoree in the Museum of Science's "Invented Here" awards.

Career Openings


Manager, Commercial Manufacturing

ID: 1414
Department: Supply Chain
Location: Cambridge Headquarters
# of Openings: 1

Description

Functional Area:  Global Supply Chain

 

Position Description:

We are seeking an experienced, talented, motivated, and goal-oriented individual to serve as Manager of Commercial Manufacturing.  This individual will be responsible for the day-to-day management of the drug substance (API), drug product (DP), and finished goods (FG) operations manufactured at contract manufacturing organizations (CMOs).  The successful candidate will work in a highly cross functional environment and closely with several departments including: Quality, Regulatory Affairs, Supply Chain, and Commercial Operations.  This position reports to the Associate Director of Commercial Manufacturing. The ideal candidate will have a scientific background and experience working with external suppliers.  This role is external-facing, involves direct interaction with external suppliers and partners, and also requires travel as needed.

 

Responsibilities:

  • Oversee and manage external relationship, and day-to-day operations supporting the supply of Ironwood’s products. 
  • Serve as Ironwood’s primary point of contact and representative to the external supplier
  • Ensure adherence to the terms and deliverables of the CMO contracts and other joint policies and procedures
  • Work with Supply Chain group to manage production and delivery to plan. 
  • Serve as an important communication conduit within Global Operations and with suppliers.
  • Review CMO-executed batch records and external investigations. 
  • Work with CMOs and Ironwood Quality to initiate and resolve change controls, CAPAs, deviations, and investigations within Ironwood’s electronic Quality Management Systems.  This will involve obtaining, discussing and ensuring closure of external partner and CMO documentation. 
  • Work with Pharmaceutical Development to initiate and complete technology transfers and process validation activities, as required for drug substance, drug product, and finished goods transitions into commercial manufacturing
  • Troubleshoot technical issues and improve product quality by providing technical guidance to CMOs
  • Track and monitor critical process parameters, in-process controls, and release data to ensure process is under control and remains within a validated state. 
  • Develop metrics and KPI reports to measure performance against plan or expected results; improve team, supplier and company performance; and support periodic CMO business meetings
  • Support regulatory filings through review and authorship of relevant manufacturing modules

 

Minimum qualifications:

  • Bachelor’s Degree in a science discipline such as biochemistry or engineering
  • Minimum of 5-8 years of relevant work experience in commercial manufacturing managing external suppliers
  • Fully experienced with cGMPs and all applicable regulations and guidance
  • Sound technical knowledge (process and equipment) in the area of small molecule, peptide, tablet and capsule manufacturing, as well as in labeling and packaging.
  • Proven track record of managing CMOs, improving their performance, and building and leading strong teams.
  • Able to express ideas and present information clearly, concisely, and effectively within teams, functions, and with external partners.
  • Self-directed, highly organized, and personable individual capable of seeing tasks through and having influence on external partners
  • Demonstrate active listening and constructive feedback within team, ability to facilitate problem solving, decision making, and issue resolution.
  • Travel requirements will vary, but approximately 20% on average (domestic and international)

 

Preferred qualifications:

  • Demonstrated analysis and technology skills, including proficiency in electronic systems (ERP, QMS), Microsoft Office, and/or project management software
  • Project Management:  Able to define scope, budget, plan, and lead projects and cross-functional project teams with excellence
  • Process-oriented thinker who is well organized and a collaborative team member.
  • Professional certifications in Lean Sigma, Project Management, Supply Chain, or related areas
  • Financial – Active setting, monitoring and delivery of cost improvement and containment targets to support business growth. 
  • Possess a mindset of continuous improvement toward cost and risk reduction within the process, operations, and across the supply chain.
  • Business Continuity Planning – Experience creating, maintaining and implementing effective business continuity plans to ensure patient supply of product.
  • Strong facilitation and management skills: 
    • Communicating cross functionally to align on shared goals and responsibilities;
    • Working with teams to clarify actions and desired outcomes;
    • Developing work plans to meet goals;
    • Managing external vendors to meet goals and deliverables, tracking progress toward plan;
    • Highlighting areas of risk and tracking mitigation plans;
    • Identifying options and facilitating decisions to enable projects to move forward;
    • Ability to plan and facilitate effective, efficient meetings.


Ironwood is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.





Are you a returning applicant?

Previous Applicants:

If you do not remember your password click here.

Back to Search Results

New Search


Powered By Taleo


You are now leaving ironwoodpharma.com. This link will take you to
a website to which our privacy policy does not apply. You are solely
responsible for your interactions with that website.