Analytical Sciences Manager Apply Now

Job Family

Regulatory

City

La Tour-de-Peilz

Region

Vaud

Country

Switzerland

Contract Type

 

Posting Start Date

19-Dec-2020

Company Overview

Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetics solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com     

Job Description

We are currently looking for the Analytical Sciences Manager to join our growing global Product Development team. The position is based in Entre-deux-Villes, Switzerland.

Analytical Sciences Manager

Mission of the role:

Lead, 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.

Lead, design and oversee scientific studies in support of technical programs as they progress from early development into confirmatory development, technology transfer up to registration and to support, as needed, manufacturing processes at the commercial site (e.g. troubleshooting, maintenance).

Major activities include outsourcing of key activities such as product characterization, method development/optimization/validation/transfer, setting scientifically justifiable comparability strategies, specification and analytical control strategies, designing stability programs and ensuring packaging safety (i.e,. leachable and extractable).

Job Responsibilities

(1)- Operations:

• Design and lead 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)


• Responsible for the conception, design, and interpretation of scientific and technical data to support project decision making


• Design stability programs for Drug Substance and Drug Product in close cooperation with internal subject matter experts and external partners


• Apply statistical analysis for interpretation of analytical and stability data, set the shelf life and storage conditions of drug substances and drug products


• 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 set up strategic partnerships (e.g. academia) through relationships based on collaboration and trust


• Ensure close liaison with Operations to prepare, execute and support technical transfer to the late stage of development 

(2)- Regulatory Submissions, Documentation and Compliance:

• 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

(4)- Knowledge Management:

• Scout and benchmark cutting-edge 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 Pharmaceutical Development 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 this within the Team and to other staff, as appropriate, and provide key strategic analytical development inputs to projects and cross-functional teams


• Identify and attend congresses, conferences and training courses to ensure continuous expertise growth and visibility of Galderma

(5)- Management:

• Ensure management of the Team in line with Galderma’s strategy and policy


• Set annual objectives and ensure mid-Year and end-Year appraisals


• Define and implement training and development plans

(6)- Other activities:

• Contribute to the innovation and continuous improvement process by proposing solutions in line with the strategy of the R&D


• Contribute to Department budget preparation and ensure continuous monitoring


• Contribute to due diligence, scientific assessment of external opportunities and divesting projects


• Support strategy for patent submission and/or defense in close cooperation with the Industrial Property Team and Head of Functions

 

Minimum Requirements

• PhD/MSc in Chemistry, Analytical Chemistry, Biotechnology, Pharmaceutical Sciences or closely related to the field and at least 10+ years of relevant experience


• Established track record of success with systemic and topical drug development


• Experience of working with external partners (e.g. CDMO, CRO, Academic)


• Sound technical qualifications and deep knowledge in developing and validating analytical methods, including comparability studies and various analytical instrumentation (e.g. LC, GC, LC-MS, NMR, FTIR, DSC)


• Solid understanding of performance, characterization, technology transfer and troubleshooting when it comes to drug substances and drug products (Systemic and Topical small molecules)


• Sound technical knowledge of analytical sciences related to solid state characterisation (e.g microscopy (SEM, TEM, SEM-EDX, ATR-FTIR), spectroscopy (FTIR, Raman, confocal RAMAN, UV-vis), laser scattering and solid-state characterization techniques (XRPD, DSC, TGA, ITC), powder rheology, surface area determination by BET, particle size and particle shape and morphology techniques)


• Excellent understanding of cGMP, Pharmacopeia, ICH guidance and applicable guidelines


• Experience in authoring analytical-related CMC sections of IND/IMPD and NDA/CTD/BLA regulatory submissions


• Practical experience in implementing the principles of Quality by Design


• Knowledgeable in statistical analysis


• Excellent communication, negotiation and external follow-up


• Excellent verbal and written communication skills (English) and the ability to work in a team environment with cross-functional international interactions

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