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Senior Manager, Technical Operations

Job Title: Senior Manager, Technical Operations
Contract Type: Permanent
Location: Unknown
Industry:
REF: 123664
Contact Name: Director of The RFT Group
Contact Email: gerry@rftgroup.ie
Job Published: 9 months ago

Job Description

Senior Manager, Technical Operations Dublin based, working with German cmo


This is an exciting opportunity for a bright and highly credible, operations manager, possessing strong influencing skills, with a record of success in managing relationships with external contract manufacturers.

Our client is a young, fast-growing Dublin based pharma company. With a management team who possesses a long history of outstanding business success, this highly entrepreneurial organisation is experiencing rapid growth and expansion across its global markets.

Reporting to the V.P. of Technical Operations, the position will work within the Technical Operations team, under minimal supervision from the Dublin office. The role represents our client whilst leading multiple Technical Services initiatives in the oversight and monitoring of product at their CMO(s). facility in Germany, to ensure GMP, regulatory requirements and product specifications are being met.

The role involves the compilation of timelines, management of project budgets, completion of reports, help with regulatory filings and statistical analysis of data related to product quality, efficacy, safety in the support of product/process improvements and investigations etc.

The position will require technical leadership, organization and management of delivery teams and subcontractors. Will build and maintain effective and collaborative relationships with working teams within CMO’s, executive management, and external customers.

Job Spec
  • Manage assigned projects and schedules at the CMO(s) in coordination with the VP of Tech. Ops.
  • Initiate and build productive and collaborative relationships across Device Business Unit & supplier functions.
  • Lead a series of Technical Services improvement projects which may include Regulatory, CMC-Drug and CMC-Device activities. Support the drafting of regulatory CMC documentation such as pharmaceutical development reports.
  • Manage projects involving change management practices, scale up and testing of pharmaceutical dosage forms at third party manufacturers.
  • Lead technical projects and provide the direction and technical leadership and management of all aspects of the teams and projects including subcontractor management.
  • Manage assigned projects and schedules at the CMO(s) in coordination with the VP of Tech. Ops.
  • Initiate and build productive and collaborative relationships across Device Business Unit & supplier functions.
  • Lead a series of Technical Services improvement projects which may include Regulatory, CMC-Drug and CMC-Device activities. Support the drafting of regulatory CMC documentation such as pharmaceutical development reports.
  • Manage projects involving change management practices, scale up and testing of pharmaceutical dosage forms at third party manufacturers.
  • Lead technical projects and provide the direction and technical leadership and management of all aspects of the teams and projects including subcontractor management.
  • Works in partnership with in-house and CMO teams for the delivery of projects and on-going management of same.
  • Lead product/process investigations at CMO’s to ensure that issues (quality, manufacturing, design, regulatory) are thoroughly investigated, documented and closed with the appropriate corrective actions as the voice of the Device Business Unit.
  • Develop and track goals, project plans, timelines and budgets.
  • Track and monitor key performance indicators at CMO’s.
  • Execute spot audits at CMO’s for adherence to GMP, SOP’s and Regulations
  • Establish and lead project core and sub-teams; facilitate discussions, team member conflicts and provide guidance/ direction on key technical project issues.
  • Facilitate issue resolution in a timely manner. Encourage, inspire, and influence others, while creating a positive impact on teams.
  • Build effective and collaborative relationships with peers and executive management, as well as manage and communicate project progress, changes, issues and risks.
  • Act as the project Technical Lead with customer, subcontractor counterparts and key internal stakeholders.
  • Recognize and resolve fundamental and unanticipated technical issues. Where problems arise, can exercise judgment to identify an appropriate course of action for obtaining results. Erroneous decisions may result in critical delay(s) to schedules and/or may jeopardize specific business activities.
  • Support Process Development, process characterization and capturing process knowledge to facilitate subsequent process validation and monitoring activities
  • Ensure all appropriate documentation is in place at CMO’s to support GMP, contractual agreements and compliance requirements in preparation for potential audits or inspections
  • Ability to change the thinking of or gain acceptance of others in sensitive situations.
  • Set project strategy, priorities and milestones and lead project team with this vision.
  • Establish and maintain project timelines and Integrated Financial Plans.
  • Develop, defend and manage project budgets coupled with an ability to manage and evolve as project needs change.
  • Initiate and implement requirements for supplier controls and supplier process validation requirements at existing CMO’s
  • Regularly present to senior management and other key stakeholders in the form of project progress or update Presentations.
  • Complete company and customer reporting requirements through dashboards and other updating tools.
  • Develop and maintain project SharePoint site content.

Person Spec
  • The role requires a strong relevant academic profile along with several years proven track record in the delivery of Technical Services projects within the device industry and/or an engineering background. Additional experience in delivering Technical Services projects in the pharmaceutical / device space is important
  • BS in science, engineering or similar discipline with an advanced degree in science and/or business an advantage.
  • Strong written and oral communication skills.
  • Fluency in written and oral German an important advantage.
  • Able and willing to work in Germany for extended periods at a time.
  • Ability to exercise initiative and creativity in resolving project delivery related issues
  • Experience managing project/program budgets
  • Ability to manage project work plans, documentation and action item follow-up
  • Ability to perform in a fast-paced, fast growing environment with competing priorities under tight deadlines.
  • Be proficient in risk management practices and tools, having high expertise in process risk
  • Have a high proficiency in statistical methods and application. Apply appropriate statistical techniques to ensure the development of robust, predictive quality systems at CMO’s
  • Strong general understanding of pharmaceutical/ biotechnology industry.
  • Experience with medical devices, combination products, regulatory, quality and manufacturing.
  • Experience managing and leading combination product or drug product teams.
  • Excellent leadership, interpersonal and communication skills.
  • Effective critical thinking and problem-solving skills.
  • Strong skills with Microsoft Office software including Visio, Word, Excel and Power Point are required.
  • May be a substantial travel element to the role (estimated between 20% and 50%)

NOTE:

This is a permanent role based in Dublin. Applicants must have a depth of experience in tech ops in the pharmaceutical / device sector, must have fluency in written and oral German and be able and willing to work in Germany for extended periods of time

Cv to gerry@rftgroup.ie