Head of Process Development, Drug Product Services

Head of Process Development, Drug Product Services

Lonza

Basel, Switzerland

We have a new position currently as Head of Process Development responsible to build, establish and lead process development services for biologics, small molecule and peptide parenteral products. Become part of this exciting opportunity by applying for the position of Head of process Development.

Responsibilities

  • Lead process characterization, process validation and commercialization strategy for parenteral dosage forms (liquid, lyophilisate), especially for late-stage and commercialization, but possibly also post-launch and for early stage projects, as required;
  • Ensure compliance to GMP regulations and Health authority expectations;
  • Build and define strategy & knowledge management in area of responsibility, in close alignment with current best practices;
  • Contribute to Drug Product transfer and comparability strategy and ensure smooth transfers to Drug Product manufacturing;
  • Contribute to defining Drug Product development strategies and target product profile of customer programs in pre-evaluation, evaluation or execution stage;
  • Lead and manage a group of scientists, technicians and/or engineers and related project leads and customer execution;
  • Contributes directly to business priorities and planning, adapts and executes business strategy to achieve organisational objectives;
  • Ensure documentation of work (e.g. development reports, support for preparation of regulatory documents);
  • Ensure effective use of resources (time, personnel, equipment, material, rooms), maintenance of equipment, order and safety and health protection and following lab and safety instructions and guidance;
  • Enable innovation and technical strategy projects, generate IP and contribute to scientific publications and conference talks, and evaluate and implement of new methods and technologies, as required;
  • Collaborate across LPB with product analytical development and QC, formulation development, bioprocessing, drug substance analytics and manufacturing functions at various sites globally, and with commercial development, proposals and sales.

Experience Required

  • Ph.D. in pharmaceutical sciences, chemistry, food chemistry, biochemistry, or related fields;
  • Experience: 10-15 years industry experience in drug product process development of biologics as well as lyophilisation, aseptic product manufacture or protein drug products incl process validation, transfer, registrations (IND/IMPD) and BLAs/MAAs, with sufficient experience in the major and relevant markets (EU, US, JP, Emerging Markets including China, Brazil);
  • Excellent communication in English;
  • Computer software: PPT, MS Office in general, SAP;
  • Ability to identify creative commercial, workable solutions;
  • Proven persuasive communication skills in a highly scientific and technical environment (written and verbal). Diplomacy, negotiation skills;
  • Independent work skills. Self-motivation with strong organization;
  • Excellent organizational and planning abilities. Ability to manage multiple priorities in a fast paced, pressured environment;
  • Experience in working with a diverse team;
  • Customer facing experience;
  • Excellent leadership and management skills/experience;
  • Strong team player;
  • Self driven, innovative and entrepreneurial spirit;
  • Is a systemic thinker focused on the big pictures;
  • Can manage complexibility in a range of situations;
  • High external visibility in Biotech Drug Product area.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

© EuroJobsites 2019

EuroJobsites is a UK 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

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2019

EuroJobsites is a UK 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

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies