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Director of QC & Analytical Development, Dublin



Dublin, Ireland 

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€0.00 - €0.00

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Job Description:

I am currently recruiting for a Director of Analytical Development and Quality Control with a global bio-pharmaceutical company based in Dublin. This position is a direct result of the company’s expansion into Europe, by setting up their office in Dublin.

You will be responsible for the oversight and direction of analytical methods development and quality control (QC) activities related to the company’s new product development programs.

Duties and Responsibilities:

You will provide strong technical leadership in proactively managing the day-to-day activities at selected external third party testing laboratories to ensure that analytical development and quality control activities are conducted in an efficient and timely manner, while maintaining compliance with all relevant regulatory requirements.

* Balance batch delivery requirements with contract lab QC testing plans.
* Provide direction for Materials Management issues (Logistics, Timing, etc).
* Ensure stability testing activities are carried out in a timely and efficient manner, consistent with the approved stability protocols.
* Provide direction for Materials Management issues (Logistics, Timing, etc).
* Provide oversight of contract lab activities (determining when a functional rep should be deployed to the contract lab’s facility).
* Identify/select new contract labs and negotiation of contract terms, as required.
* Responsible for implementation of contract term logistics, including purchase orders, forecasts, and invoice payments and that these are consistent with the contracts and Quality Agreements.
* Dispute resolution (w/ appropriate escalation).
* Participate (by providing relevant technical/CMC expertise in the area of analytical development and quality control) in the company’s due diligence and life cycle management activities. Partner with Business Development function and external experts/consultants to critically evaluate and select in-licensing and partnering opportunities as related to potential new programs.
* Design and manage analytical development activities and quality control strategies. Partner with Project Management, Preclinical, Clinical, Quality Assurance, and Regulatory functions (typically as part of cross-functional project teams) to ensure that appropriate timelines are in place and aligned with the company’s overall objectives and timelines.
* Create and manage expertise-specifc CMC sections of the company’s global regulatory submission documents (INDs, IMPDs, NDAs, BLAs, MAAs, Meeting Requests, Briefing Documents, Responses to Health Authority questions, etc). Partner with Project Management and Regulatory functions to ensure CMC submission timelines are established and maintained. Identify and collaborate with external experts/consultants to ensure submission content is aligned with current Health Authority requirements/ expectations.
* Proactively collaborate with other TechOps functional areas regarding relevant cross-functional activities such as: evaluation, selection, and management of contract service providers (CMOs and CLOs); transfer of analytical methods; design of method validation strategies. Provide technical expertise with regards to routine and nonroutine cGMP activities (eg, deviations/investigations, process improvements, change controls, shelf-life extensions, CAPAs, etc).
* Manage and track departmental budgets for global analytical development and quality control activities, including the preparation of cost estimates for new projects. Track invoice approvals and proactively verify versus work performed. Partner with Finance function to periodically review and report on the status of departmental spend versus the approved budget. Recommend appropriate budgetary adjustments in conjunction with changing project scope and timelines.
* Develop and/or provide critical review of development and quality control documents (batch records, experimental data, protocols, reports, analytical methods, SOPs, etc). Support the creation, maintenance, improvement, and routine use of Quality Systems. Participate as required in internal audits and health authority inspections.
* Proactively support the generation and protection of the company’s intellectual property. Maintain awareness of current industry trends and practices. Review/author technical papers for publication in industry journals and/or present at outside conferences.

Education and experience required:

* Requires Ph.D. (or equivalent) in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
* 15+ years’ experience in the pharmaceutical or biotech industry with 10+ years’ demonstrated leadership in the area of analytical development and quality control.
* Experience with global pharmaceutical or biotech development and quality control testing operations for development-stage pharmaceutical and biological products.
* Demonstrated strong working knowledge of supply chain management at both the development stage for clinical supplies as well as at the commercial stage is considered essential for the position.
* Must have broad base of experience with a wide range of product types (eg, small molecules, synthetic peptides, oligonucleotides, proteins, etc) and wide range of dosage forms (eg, oral, parenteral, immediate release, modified release, etc.).
* Knowledge of cGMP regulations for analytical methods validation and specifications setting required.
* Very strong technical knowledge of analytical methods development, characterization testing, and quality control strategies associated with both small molecules and biologics; understanding of drug substance development, preformulation and formulation development, analytical development, manufacturing process development (including lyophilization operations), and clinical supplies management; experience with scale-up and technology transfer, cGMPs, ICH guidelines; as well as CMC content of global regulatory submissions.
* Office environment with both domestic and international travel (up to 25%) required

Morgan McKinley is acting as an Employment Agency in relation to this vacancy.

Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.
Company Info
Morgan McKinley

Phone: +353 (0)21 2300300
Web Site: http://www.morganmckinley.ie
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