Senior Analytical Expert - Barcelona, España - Galderma

Galderma

Empresa verificada

Barcelona, España

hace 1 semana

Publicado por:

Isabel García

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Descripción

With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration.

Above all, they must be passionate about doing something meaningful for consumers, patients and the healthcare professionals we serve every day.

We aim to empower each employee and to promote their personal growth all the while ensuring business needs are met now and into the future.

Across our company, we embrace diversity and respect the dignity, privacy and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world.

With us, you have the ultimate opportunity to gain new and challenging work experiences and create unparalleled, direct impact.

Job Description:

Senior Analytical Expert contributes to design and oversee Small Molecule (Oral and Topical) drug substance and drug product control strategy in accordance with the global CMC strategy, any applicable regulatory requirements and/or local rules and industrial requirements, to fulfill patients, health care professionals and payers' needs.

Job responsibilities:

Design and to contribute to specific analytical development plans for Drug Substance and Drug Product in cooperation with external partners and internal experts, in line with business priorities, following a Quality by Design framework (ICH Q8, ICH Q11, ICHQ12)
Contribute to/or support the conception, design, and interpretation of scientific and technical data to support project decision making
As a core team member on multiple concurrent project developments, prepare and present data to internal project team meetings and recommend sound scientific/technical and business decisions based on data analysis and experience
Solve complex problems (e.g. deviations, OOS) through collaborations with others, taking a new perspective on existing solutions
Identify, technically qualify and recommend external partners (e.g. CDMO, CRO) and contribute strategic partnerships (e.g. academia) through relationships based on collaboration and trust
Act as key contributor to create and enhance collaborative and trusting relationships with external partners
Ensure close liaison with Operations to prepare, execute and support technical transfer to the late stage of development
Act as key contributor to create and enhance collaborative and trusting relationships with external partners
Contribute to set a risk management table, update it as necessary and escalade in a timely manner any critical risk
Contribute to define and execute mitigation and contingency plan
Plan efficiently activities and ensure strict monitoring of milestones and budgets
Issue monthly reporting of the activities
Act as a voice and ambassador of its department at various governance bodies / meetings
Author, review and/or approve key documents such as: method development reports, validation protocols/reports, comparability protocols and reports, justification of specifications, stability protocols/reports, shelf life and storage conditions statement and relevant sections of regulatory filings (DMF, IND, IMPD, BLA, etc.)
Author standard operating procedures and working instructions required by the activities
Ensure close oversight of GMP activities that are conducted externally to ensure an appropriate level of quality requirements at each stage of development
Ensure that external partners operate in compliance with Safety, Health and Environment according to Galderma's policies
Actively contribute to the preparation of audits and inspections, internally or at the external partner's site
Scout and benchmark cuttingedge and specific technologies in the field of small and large molecules and ensure knowledge acquisition
Monitor, assess and proactively contribute to implement regional regulatory requirements and guidelines that impact analytical sciences in close cooperation with CMC Expert and other functions
Maintain current awareness of GMP and other regulations, guidance documents, advisory committees, industry standards, scientific literature and trends that are applicable to current and future operations and products
Communicate summary findings within the Team and to other staff, as appropriate, and provide key strategic analytical development inputs to projects and crossfunctional teams
Identify and attend congresses, conferences and training courses to ensure continuous expertise growth and visibility of Galderma
Publish/present in journals/conferences