The purpose of this role is to develop our growing pipeline of oral products. We are looking for an expert in the area of Oral Solid Dosage Forms (small molecules, NCE). As a member of the team, you will play a key role in the development of formulations and processes for oral dosage forms with end-to-end scope, from first-in-human trials to marketing phase.
You will plan, perform and document scientific experiments for formulation- and process development for preparation and timely delivery of drug products including support at GMP manufacturing, primarily in the area of Oral Solid Dosage forms. You will participate in scientific teams and contribute to the overall Technical Research and Development strategies and goals.
For the development of oral solid dosage forms, we are looking for an experienced associate. Your duties will be to develop formulations of capsules, film coated tablets or sachets, to develop manufacturing processes including scale-up. In addition, you will support the process transfer to GMP Pilot Plant and Technical Operations sites, and support the manufacture of clinical supplies under a GMP environment. Your responsibilities will be to plan, perform scientific experiments (or pilot plant processes) for formulation- and process development under minimal guidance from team members, and to contribute to the interpretation and report of results. You have experience in using digital tools, e.g. for reporting of experiments, and are curious to utilize and to further advance data & digital tools.
Your accountabilities will include:
- Plan, coordinate, perform and document scientific experiments in collaboration with functional and project leads
- Develop phase appropriate formulations for oral drug products
- Develop efficient and robust processes for oral drug products
- Provide raw data documentation, evaluation and interpretation of results
- Propose and provide input for the design of next experiments
- Transfer procedures/instructions to GMP production facilities (e.g. Pilot Plant, NTO), including troubleshooting
- Support the manufacture of clinical supplies under a GMP environment
- Contribute to maintenance of infrastructure/equipment.
- Adherence to quality, quantity, and timelines for all assigned tasks.
- Adherence standards, in particular, quality, ethical, health, safety, and environment (HSE), and information security (ISEC) standards.
- Reproducibility of experiments and results.
You have a degree in Pharmaceutical Sciences or a related discipline (e.g. B.Sc. with 2 years industry experience or a College of Applied Science Diploma or equivalent, lab technician with 3 years industry experience and relevant on the job training).
- Experience in manufacturing under GMP is advantageous Experience Ideally a minimum of 3 to 5 successful years of experience in pharmaceutical development of oral solid dosage forms, e.g. in lab, technicum or Pilot Plant setting, with experience in the most common pharmaceutical technologies and unit operations
- Awareness/proven experience for safe handling of chemicals, potentially dangerous materials and equipment.
- Good scientific or technical knowledge in galenic/pharmaceutical technology / formulation- and/or process development at lab, pilot and production.
- Excellent user experience of software and computer tools (e.g. electronic documentation).
- Adequate knowledge in related scientific/technical areas.
- Proficient with laboratory and/or technical tools.
- Excellent Communication skills
- Basic presentation skills and scientific/technical writing skills.
- Excellent organizational skills with respect to planning, tracking, priority setting and adherence to project timelines
For more information, please contact Fandi Hatib on +44 1727 817 600 or email email@example.com
- Agency: Achieva Group Limited
- Reference: FH-34
Website: Achieva Group Limited
- Posted: 6th May 2022
- Expires: 3rd June 2022