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Executive Director, Commercial Manufacturing & Technical Operations

Executive Director, Commercial Manufacturing & Technical Operations

The Executive Director, Commercial Manufacturing & Technical Operations will own and develop the Commercial Technical Operations capability at RedHill. Working closely with Supply Chain and Quality, this role is to provide technical and operational support for the commercialization of late phase product candidates and existing commercial products. The leader will oversee an international network of drug substance, drug product CMOs and CPOs ensuring continuity of supply, execution of tech transfer and validation activity and continuous improvement of processes.   

Other roles will include cross-functional team leadership and/or membership, authoring technical reports and supporting CMC aspects of regulatory dossiers. The role will involve significant cross functional collaboration with other functions including Regulatory, external manufacturing and Quality, working towards existing and new product introduction and ensuring all processes are understood, robust, efficient and in control. 

This position is in our Raleigh, NC office.

Minimum Qualifications:

A BS in Engineering, Chemistry or related discipline and at least 15+ years of pharmaceutical experience directly supporting and/or managing manufacturing or technical operations.Travel expectations of up to 25%, including some international travel. 

Principal Responsibilities:

Oversee activities for drug substance, drug product, and finished goods for commercial 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 Commercial stakeholders.

Technology transfer of new and existing commercial drug product, and finished goods manufacturing processes to RedHill’s contract manufacturing organizations.

Monitors and identifies key process and business performance indicators for each of the sites and implement improvements as appropriate.

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 project-based CMC teams, directly contribute to and represent Operations in areas of process and product development strategy.

Working with Quality, 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 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 RedHill 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.

 

If you are interested in applying for an Open Position, please follow the directions below: 

  1. Submit your resume to redhillemployment@redhillus.com

  2. In the subject line put the full job title of the position you are applying for (including city), your name and the date of your submission. Note that we will only consider applicants that specify the Open Position that they are applying for.

  3. Cover letters are optional.


We offer a Comprehensive Benefits package that includes:

  • Medical, Dental, and Vision Coverage
  • Domestic Partner Coverage
  • Life Insurance
  • Short-Term and Long-Term Disability
  • Flexible Spending Accounts (Healthcare and Dependent Care)
  • Employee Assistance Plan
  • 401(k)

Job Applicants should be aware of job offer scams that are committed though the use of the internet and social media platforms. All legitimate correspondence from a RedHill Biopharma employee will come from a “@redhillus.com” or “@redhillbio.com” email address.