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Career Openings


Sr. Director, Technical Operations

ID: 1419
Department: Global Operations
Location: Cambridge Headquarters
# of Openings: 1

Description

It’s an exciting time for Ironwood. After two decades of growth and innovation, in 2018 we announced our intent to create two focused, independent companies: Ironwood and “R&D Co.” This new way of doing business will enhance our agility and innovation, and empower our teams to make a bigger impact on our patients and on our industry.

The new Ironwood will focus on accelerating the growth of our marketed product Linzess® (linaclotide) and advancing the development of our innovative pipeline of treatments for GI diseases and abdominal pain. Following completion of the separation, the Sr. Director, Technical Operations position will be part of the new Ironwood. The role will remain as described here.

Functional Area:  Global Operations

 

Position description:

The successful candidate will lead and develop the Technical Operations capability at Ironwood. Working closely with the Pharmaceutical Development, Global Supply Chain and Quality organizations, the role of Technical Operations is to provide technical and operational support for the development of late phase product candidates and existing commercial products.  The leader will oversee an international network of drug substance and drug product CMOs, ensuring continuity of supply, execution of tech transfer and validation activity and continuous improvement of processes.   We welcome candidates interested in joining a highly collaborative team, contributing toward our goal of bringing high quality, innovative medicines to patients which treat unmet medical needs.

 

Responsibilities:

  • Oversee activities for drug substance, drug product, and finished goods for products from approval through process validation
  • Provide technical support for commercial products
  • Provide launch planning support and commercial scale estimates for new products in partnership with Pharmaceutical Development and Commercial stakeholders
  • Technology transfer of new and existing commercial API, drug product, and finished goods manufacturing processes to Ironwood’s contract manufacturing organizations. 
  • Development of validation and product life-cycle strategies and plans for each commercial product & process
  • In partnership with Quality and CMOs, conduct risk assessments on commercial manufacturing processes and develop risk mitigation plans
  • Working with Pharmaceutical Development, directly contribute to and represent Global Operations in areas of process and product development strategy
  • Working with Pharmaceutical Development, Global Quality, Global Supply Chain, and Commercial Operations, directly contribute to product design
  • Participate in vendor/supplier selection business processes and make strategic recommendations on commercial manufacturing sites to include in the global supply chain network
  • Review the CMC sections of new NDAs and author CMC sections of post-approval changes,
  • Assess and communicate the status and scalability of manufacturing processes as appropriate for registration, commercial, validation, etc.
  • Communicate with internal and external project and functional teams, present alternate paths forward, identify and evaluate gaps and provide recommendations, establish new internal and external collaborations to bridge gaps
  • Author, review and/or approve deviation and investigation reports, change controls, and corrective/preventative actions (CAPA) when appropriate
  • Manage internal and external interactions with quality and regulatory organizations to ensure speedy resolution of manufacturing and product related technical issues in facilitating product releases
  • Work closely with Ironwood partners as well as internal departments to ensure effective working relationships
  • Partner with network CMO organizations to manage process lifecycle, develop process improvements and cost efficiencies
  • Responsible for assessing the CMOs and raw material supplier’s performance and capacity to develop supply chain contingency strategies

 

 

Minimum Qualifications:

  • A BS in Engineering, Life Science or related discipline and at least 12 years of pharmaceutical experience
  • Hands on experience with small molecule and synthetic peptide API manufacturing processes, solid oral drug product manufacturing and finished goods packaging
  • Vendor/Supplier management skills and excellent communication and cross-department collaboration skills
  • Direct experience planning and executing process validation activities
  • Excellent data analysis skills and the ability to make recommendations that impact the scientific and business goals of the company
  • Thorough knowledge of INDs, NDAs, etc.  Extensive experience interfacing with regulatory agencies.  Experience authoring and taking a drug candidate through NDA submission to market commercialization
  • Solid understanding of ICH, FDA and USP guidelines is essential, including the ability to apply the guidelines in context of the stage of pharmaceutical development
  • Ability to articulate complex issues and ideas with clarity to enable understanding and direction
  • Strong oral and written communication skills with experience in writing SOPs, technical reports, and related documents, including regulatory filings
  • The ability to work successfully in both a team/matrix environment as well as independently is required
  • Ability to influence cross-functionally to enable improvements and performance throughout Development and Operations
  • The ability to travel to contract labs and manufacturing sites

 

Preferred Qualifications:

  • An MS or PhD in Engineering, Life Sciences or related discipline and at least 15 years of pharmaceutical experience
  • Experience with peptide manufacturing 
  • MBA or relevant financial training and education


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.





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a website to which our privacy policy does not apply. You are solely
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