The Senior Formulation Scientist is responsible for the development of the final formulation on a project; actively participates in all the phases of the development including the pre-formulation, process development, scale-up and support for the transfer to the Validation group.
- Designs formulations and conducts formulation trials by using different pharmaceutical techniques.
- Develops manufacturing processes and makes prototype batches, phase I, II, and III clinical trial materials.
- Leads production of engineering, registration, and scale up of batches.
- Supports technical transfer and validation activities.
- Effectively communicate with senior management, internal and external stakeholders, and CMO point of contacts to ensure the successful transfer of optimized final formulations, execute robust technology transfers for key design processes as well as teamwork, creativity, and energy in order to promote positive and collaborative relationships between stakeholders.
- Required to work closely with other functional areas such as Analytical Development, Project Management, Quality, and Commercial Manufacturing, as well as with clients to meet the timelines.
- Participates in research and development activities, and is accountable for preparation of all technical documents and cGMP documentation for supporting our client’s submissions for IND, NDA, and ANDA submissions.
- Review of SOPs, cGMP Documentation (i.e. protocols, reports, etc.) for internal and supporting departments.
- Initiate and prepare investigations in Trackwise and work together with area supervisors and managers and QA to complete the investigations on time.
- Lead and drive assigned projects and coordinate all required activities like documents, materials, and change parts.
- Initiate PRs, equipment parts ordering, etc. as per project requirements.
- Writes formulation trial protocols, manufacturing batch records, packaging batch records, and pharmaceutical development reports, etc.
- Experience on Design of Experiment (DOE) and Quality by Design (QBD) is preferred.
- Other duties as assigned.
- Experience in the pharmaceutical industry, Research and Development, or academics experience in similar area. Knowledge of cGMP.
- Good knowledge of English, oral and written.
- May handle hazardous waste.
- Must be able to move about the laboratory and the facility.
- Must be able to remain sedentary for periods of time.
- Must be able to remain in an upright position for periods of time.
- Required to wear personal protective equipment.
- Minimum of a Bachelor’s degree in pharmaceuticals or a related field. Graduate studies are highly recommended.
- 7 years of experience in pharmaceutical development; broad knowledge on tablets, capsules, semi-solid, and liquid dosage forms.
- Hands on experience with blending, compression, wet granulation, coating, encapsulation, and sustained release formulations, etc.