Head of Formulation and Process Development

Head of Formulation and Process Development

Galderma

Vevey, Switzerland

Job purpose

Lead, design and oversee formulation and process development projects in accordance with the SIG Rx strategy, any applicable regulatory requirements and/or local rules and industrial requirements, to fulfill patients, health care professionals and payers’ needs.

Responsibilities

The Head of Formulation and Process Development is expected to lead, design and oversee scientific studies in support of technical programs as they progress from early development into confirmatory development, technology transfer up to the registration and to support as needed manufacturing process at the commercial site.

Operations:

  • Design and lead specific formulation and manufacturing process development plan in cooperation external partner, in line with business priorities, following a Quality by Design framework
  • Responsible for the conception, design, and interpretation of scientific and technical data to support projects decision making
  • Collaborate with scientific staff to design, implement, and interpret the data from pharmaceutical development projects
  • Solve complex problems through collaborations with others, taking a new perspective on existing solutions
  • Generate strong relationships in the area with preferred partners beneficial to the organization, both internally and externally, to deliver innovative products, pre-clinical and clinical materials
  • dentify, technically qualify and recommend external partner (e.g. CDMO, Academia) and set strategic partnership (e.g. raw material suppliers, packaging suppliers)
  • Prepare and present data to internal project team meetings
  • Function effectively as a core team member on multiple concurrent project developments
  • Ensure close liaison with Operations to prepare, execute and support technical transfer to the late stage of development
  • Communicate effectively within CMC Development Department, SIG Rx and beyond and with external partners (e.g. Suppliers, Vendors) and is able to defend scientific and technical decisions at the appropriate governance body / meeting
  • 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 budget
  • Act as a voice and ambassador of its department at various governance bodies / meetings

Regulatory Submissions, Documentation and Compliance:

  • Author, review and/or approve key documents such as: formulation development reports, manufacturing process development report, technology transfer document, justification of in process controls, and relevant sections of regulatory filings (IND, IMPD, CTD)
  • Author standard operating procedures and working instructions required by the activities
  • Ensure close oversight of GMP activities that are conducted externally to ensure at each stage of development an appropriate level of quality requirements
  • Ensure that external partners operate in compliance with Safety, Health and Environment policy
  • Actively contribute to the preparation of audits and inspections, internally or at external partner’ site

Knowledge Management:

  • Scoot and benchmark specific technologies in the field of formulation and process development and ensure knowledge acquisition
  • Monitor, assess and proactively contribute to implement regional regulatory requirements and guidelines that impact formulation and process development activities in close cooperation with CMC Development Expert
  • Ensure communication and training within the Organization
  • Identify and attend congresses and forum to ensure continuous expertise growth and visibility of Galderma
  • Publish/present in high quality journals/conferences

Other activities:

  • Contribute to the innovation and continuous improvement process by proposing solutions in line with the strategy of the SIG Rx
  • Contribute on purpose to due diligence, scientific assessment of external opportunities and divesting projects
  • Define and execute strategy for patent submission and/or defense in close cooperation with Industrial Property Team
  • Proactively support biologic downstream process development
  • Contribute to Department budget preparation and ensure continuous monitoring

Education and Experience requirements

  • PhD in Chemistry, Pharmaceutical Sciences, Pharmacist, MS in Chemical Engineering or closely related to the field
  • At least 10+ years of relevant experience in pharmaceutical industry
  • Established track record of success with oral and topical developments, freeze-dried and sterile processes
  • Experience working with external partners (e.g. CDMO, Academic)
  • Sound technical qualifications and deep knowledge in developing formulation strategy and manufacturing process engineering including primary packaging
  • Demonstrated laboratory experience in the field and in developing innovative solutions
  • Solid understanding of characterization and performance of product, notably when screening formulations
  • Excellent understanding of cGMP, ICH guidance and applicable guidelines
  • In-depth knowledge how to implement a Quality by Design approach including design of experiment and statistical analysis
  • Experience in authoring pharmaceutical development related CMC sections of IND/IMPD and NDA/CTD/BLA regulatory submissions
  • 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 interactions

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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