Associate Director, Formulation & Process Development
You will bring scientific and technical knowledge to the organization related to the development of formulations and processes for sterile dosage forms, especially for biologics.
The position will encompass all technical operations activities for example, establishment and implementation of new formulations, site transfer activities, upscale, validation for existing and new products to be in-licensed into the Horizon Pharma product portfolio.
This is a virtual role where interaction with CMOs and CROs is a critical aspect of the job function as well as the internal cross-functional cooperation with R&D and other TechOps functions such as Quality, Manufacturing, and Supply Chain Management. Additional responsibilities include authoring and reviewing development plans, technical protocols and reports and authoring of specific sections of the CMC portion of regulatory dossiers.
- Manage scientific, strategic, planning and execution aspects of formulation and process development for Horizon´s early and late stage development project portfolio and Life Cycle Management (LCM) activities.
- Designs and executes phase-appropriate activities for early development compounds and lifecycle management initiatives and document these in development plans, study protocols and study reports.
- Develops scalable sterile formulations and manufacturing processes to meet Target Product Profiles (TPP) and LCM requirements.
- Responsible for a seamless transfer of the established formulations and processes to the clinical and then later to the commercial manufacturing scale.
- Develops matching placebo formulations for clinical trials.
- Provide engineering and technical support for development, technology transfer and commercial production of Drug Product and collaborates with Analytical Development, Clinical Trial Supplies, Manufacturing Operations, Project Management, and Supply Chain Management.
- Preparation of documentation to support key development and regulatory milestones such as preparation of BLA, MAA, PAI, CBE and PAS submissions and fulfilment of post marketing commitments.
- Maintains currency with applicable global regulations and industry standards dealing with the development of sterile dosage forms and combination products.
- Leads and/or participates in various cross-functional teams or committees with regards to formulation and process development.
- Develops/supports intellectual property; evaluate external IP.
- International travel of up to about 1-2 weeks at a time will periodically be required.
Qualifications and Skills Required:
- Extensive experience in formulation and process development of sterile dosage forms (for example, liquids and freeze-dried products, prefilled syringes, auto injectors).
- Demonstrated expertise in excipient screening using DoE approaches.
- You will ideally have an analytical background with method development expertise, thus understanding the structural and functional attributes of proteins in order to assess the stability of the developed formulations, for example HPLC-SEC, RP-HPLC, MFI, CIEX, CIEF.
- Demonstrated experience in developing freeze-drying cycles for therapeutic proteins.
- Hold a deep understanding of fill/finish processes that includes critical and key process parameters as well as an understanding of equipment attributes.
- Demonstrated expertise in scale-up of processes for sterile dosage forms and managing technology transfer into the manufacturing environment.
- Experience performing media fill qualifications and process validations.
- Knowledge of process characterization activities and Quality by Design (QbD) principles.
- Experience in working with alternate device delivery options and combination products, proficient in combination products guidelines and requirements.
- Knowledge of primary packaging materials for sterile dosage forms as well as assemblies for prefilled syringes.
- Have a familiarity with quality systems and both FDA and EU regulations as they relate to process / product development and manufacture of biologics.
- Prepared technical reports for formulation and process development activities, publications and oral presentations.
- Have contributed to the preparation of CMC regulatory documents.
- Demonstrated track record of delivering timely and consistent results and familiarity with project management skills for technical programmes.
- Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals.
- Bachelor’s degree in engineering or an applied science is required. An advanced degree is advantageous.
- 10+ years of relevant pharmaceutical development and manufacturing experience in Biologics.