Contract Development & Manufacturing Manager

PE Global; South Dublin; Hybrid; EUR 90,000 - 120,000; Part time

Job summary

PE Global is recruiting a Contract Development & Manufacturing Manager for a biopharmaceutical client in Dublin. This 12-month contract role is hybrid, with on-site presence required two days per month.

You will lead external testing activities, manage supplier relationships and drive optimization across drug product and substance testing. The position requires a Master’s or Bachelor’s degree in engineering or sciences with relevant experience and a strong background in analytical method

Qualifications

• Master's degree in engineering or sciences with 2+ years of scientific experience OR Bachelor's degree with 3+ years of scientific experience.
• Experience in external contract testing laboratories and CROs considered a plus.
• Knowledge of cGMP, quality systems, regulatory expectations and import/export policies.

Responsibilities

• Laboratory supplier relationship management, including metrics reporting and performance monitoring.
• Project management of cross-disciplinary external projects across Drug Product, Drug Substance and Attribute Sciences.
• Ensure quality, cost and delivery targets for external CTL/CRO activities; lead issue resolution and escalation as needed.
• Capture and communicate analytical escalations accurately and timely.
• Identify opportunities to optimize timelines, budgets and technical execution across projects.
• Ensure designated programs meet compliance, speed, quality and cost targets; collaborate with cross-functional teams.
• Travel domestically and internationally as needed.

Skills

Contract management

Biopharma

Analytical development

cGMP

Vendor management

Project management

Education

Master's degree in engineering or sciences

Bachelor's degree in engineering or sciences

Job description

PE Global is recruiting for a Contract Development & Manufacturing Manager for our biopharmaceutical client in Dublin. This is an initial 12-month contract, hybrid role.

Hybrid = Onsite 2-days per month.

Overview

Seeking an external contract worker to join the External Process Development Organization initially for a 12 month period . The Contract Testing Laboratory (CTL) CW will work with CRO's/CTLs's to deliver on pipeline molecules. The CTL team will develop the external sourcing strategy for commercial and development portfolio for external contract testing laboratory. The CTL team is part of the External Supply organization is accountable for the execution of testing activities associated with the laboratory within scope.

Position Responsibilities

• Laboratory Supplier relationship management, including development and reporting of metrics and monitoring performance to continuously improve efficiency and effectiveness of suppliers. Building and maintaining strong partnerships with all external laboratory functions to increase overall effectiveness and success of programs. Ability to operate in highly matrixed teams.
• Project management of a portfolio of cross-disciplinary external projects traversing the areas of Drug Product, Drug Substance, and Attribute Sciences. Primary focus will be to manage delivery of analytical work packages (method qualification, method transfer, release testing, stability testing, characterization sample management ) with external contract laboratories
• Actively participate in cross-functional teams with clear accountability for performance and ensure the quality, cost, and delivery of products from Contract Testing Laboratory sites are consistently met, as well as lead issue resolution, problem solving and serve as an escalation agent.
• Responsible to ensure analytical escalations are captured and communicated accurately and timely
• Identification of project optimization opportunities (timeline, budget, technical execution), prioritization of a rolling portfolio of projects
• Ensure that designated lead programs meet compliance, speed, quality, and cost targets through strong scientific and technical understanding of the programs and drug product development.
• Identification of project optimization opportunities (timeline, budget, technical execution), prioritization of a rolling portfolio of projects
• Supplier evaluation and selection
• This position will require occasional domestic and international travel

Education

• Master's Degree & 2 years of Scientific experience

OR

• Bachelor's Degree & 3 years of Scientific experience

Core Competencies

• Advanced degree in engineering or the sciences.
• Experience in large molecule analytical development including method development, method qualifications/transfers/validations, release, stability and characterization testing.
• Self-starter with a high-level of comfort with ambiguity and complexity and the ability to multi-task while consistently delivering quality results
• Experience interfacing with domestic and international CTL /CRO organizations
• Strong understanding of cGMP, Regulatory/CMC, legal, Quality requirements and import/export policies
• Demonstrated understanding of drug development and commercialization for synthetic and/or biologic therapeutics
• Experience as team member/leader of cross-functional and matrixed teams including effective writing, presentation, organizational and interpersonal skills to address a broad scope of audiences
• Proven business acumen, high level strategic thinking, and strong analytical skills with the ability to structure, pragmatically scope, and solve complex problems
• Demonstrated quantitative skills including experience in business process development, continuous improvement, operational excellence and performance management

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***