Head of Formulation and Process Development

Head of Formulation and Process Development

Head of Formulation and Process Development (oral/topic)

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their team in Switzerland, Vaud Canton. Due to this growth my client is looking for a Head of Formulation and Process Development to lead activities of oral and topic products.

RESPONSABILITIES :

1-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

       Contributes for the conception, design, and interpretation of scientific and technical data to support projects decision making 

       Collaborates with others to solve complex problems, taking a new perspective on existing solutions

       Identify, technically qualify and recommend external partner (e.g. CDMO, Academia) and set strategic partnership (e.g. raw material suppliers, packaging suppliers)

       Provides 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

       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

 

2-Regulatory Submissions, Documentations 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 that external partners operate in compliance with Safety, Health and Environment policy

       Contributes to the preparation of audits and inspections

 

3-Knowledge Management :

 

       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

       Provides 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

 

QUALIFICATION :

 

       PhD in Chemistry, Pharmaceutical Sciences, Pharmacist, MS in Chemical Engineering or closely related to the field with at least 10+ years of relevant experience in pharmaceutical industry

       Strong exprience with oral and topical developments, freeze-dried and sterile processes

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

       Strong experience with developing formulation strategy and manufacturing process engineering

       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)

axmanag info@axepta.com