Job location: Cracow
Ref no.: SEL/081R
The Head of Formulation Development will be primarily responsible for development of formulations for APIs during clinical phases. This position will oversee Drug Product (DP) manufacturing process design and coordination for new therapeutics developed by Selvita R&D department in cooperation with dedicated CROs/CMOs. Successful candidate should be able to design and execute formulation development trials as per Quality by Design (QBD), design stability studies for API and DP and efficiently use collected data from studies to provide optimal formulation composition. Will utilize professional skills to recognize problems related to formulation, DP manufacturing processes, packaging in support of clinical development. Appreciated know-how related to process validation and cleaning validation studies. Knowledge necessary to support analytical and bioanalytical methods development/validation is expected.
Key responsibilities are:
- Design and oversee pre-formulation, formulation development, process development, process optimization, scale-up and clinical manufacturing activities on assigned projects.
- Direct drug substance physicochemical and solid-state property characterization of small molecules including crystallinity assessment, solubility determination, and stability evaluation to aid in selection of candidates and development that will lead to drug products with desirable physicochemical and pharmacokinetic properties.
- Design and direct formulation development screening studies to develop clinical oral and parenteral formulations and processes for drug products.
- Oversee analytical method development and validation as is appropriate for stage of development.
- Lead development of drug substance and drug product specifications, including qualification of impurities.
- Oversee drug substance and drug product testing and stability.
- Define and develop appropriate primary packaging for the finished drug product as needed.
- Manage the non-GMP and GMP manufacture and testing of drug products at contract facilities for preclinical and clinical studies.
- Author CMC regulatory documents including INDs, NDAs, and IMPDs.
- Work with Project Management and Executive Leadership to develop and manage detailed budgets and timelines for multiple programs.
- Build and maintain strong working relationships with CRO/CDMO/CMO partners ensuring that activities are managed collaboratively, efficiently, and effectively. Be on-site, as necessary.
- Maintain high scientific and technical standards for all development activities and documentation in accord with corporate and departmental SOPs.
- Contribute to drug product regulatory strategy development through Project Team participation and contribution to components of regulatory filings.
Your background should include:
- M.S in Pharmaceutical Sciences or related field with at least 10 years of experience in formulation of small molecule NCEs or Ph.D. in Pharmaceutical Sciences or related field with at least 8 years of industrial experience with documented involvement in successful IND/IMPD submissions.
- Knowledge of drug development process, GMP/GLP manufacturing of active pharmaceutical ingredients and drug products and follows procedures effectively.
- Working knowledge of QC/analytical methods, quality assurance, and technology transfer.
- Working knowledge of process development, scale-up, process/equipment validation, and cGMP compliance.
- Working knowledge of solid-state characterization techniques such as XRD, DSC, TGA, laser diffraction, dynamic light scattering, electron microscope, as well as wet chemistry.
- Experience with small molecules & development of solids, semi-solid, oral, and parenteral dosage forms.
- Excellent written and verbal communication skills and ability to collaborate well internally and externally.
As standard You will receive benefit package, which consists of:
- Training program enabling scientific development: Peer to Peer Academy, scientific lectures, participation in conferences.
- Extensive research facilities and modern laboratories.
- Daily cooperation and know-how exchange with an experienced research team.
- Non-wage benefits: private medical care, Multisport card, co-financing for meals, English language courses in the company.
- Possibility to participate in sports activities (football, volleyball) and access to attractive sports infrastructure: gym and sauna in the building.
- Long-term cooperation based on stable employment conditions.
If you are interested please send your CV to email@example.com with subject line Head of Formulation Development SEL/081R.
We kindly ask you to add the following clause to your application: „I hereby express my consent to the processing of my personal data by Selvita S.A. for the purpose of existing recruitment process”.
If you want us to keep the submitted documents also for the purposes of future recruitment processes, we kindly ask you to add the following clause to your application: „I hereby express my consent to the processing of my personal data by Selvita S.A. for the purpose of future recruitment processes for a period of 3 years from the date of submission of this document, in order to analyze them in terms of the recruitment processes carried out in the Selvita Group”.