Website:
olivepharmascience.com
Job details:
Olive PharmaScience Ltd. is the space where R&D brilliance, sustainable industrial scale, and an uncompromising obsession with quality converge. We engineer value for our global stakeholders through scientific rigor and operational agility.
We believe the best ideas come from people who feel genuinely invested in what they are building. We are looking for visionary scientists who can transform complex formulation concepts into commercial success. We have openings for experienced FRD professionals as given below:
Designation : Asst. Manager / Manager / Senior Manager (Position and responsibilities will scale based on experience ranging from 8 to 15+ years. Salary and designation will not be constraints for the right candidate).
Extensive exposure to and expertise in either Softgel gelatin capsules or Gummy is mandatory
Major Responsibilities:
1. Strategic Leadership
- Define and implement the R&D strategy for softgel/gummy product development aligned with organizational goals.
- Lead formulation development projects from concept to commercialization.
- Establish departmental objectives, budgets, and resource planning.
- Drive innovation in drug delivery technologies and softgel/gummy platform development.
- Support business development in evaluating new product opportunities and customer requirements.
2. Formulation Development
- Provide scientific leadership for development of solution, suspension, lipid-based, SEDDS/SMEDDS, and complex softgel formulations (OTC & Nutraceuticals for gummy professionals)
- Oversee pre-formulation studies, excipient selection, compatibility studies, and optimization activities.
- Review and approve formulation strategies, experimental designs, and development reports.
- Guide development of bioavailability enhancement and differentiated products.
- Lead product lifecycle management and reformulation activities when required.
3. Technology Transfer and Commercialization
- Lead scale-up and technology transfer activities from lab scale to commercial manufacturing.
- Approve manufacturing processes, batch records, master formulas, and control strategies.
- Ensure smooth transfer of products to manufacturing sites and contract manufacturing organizations (CMOs).
- Support process validation, cleaning validation, and commercial launch activities.
- Monitor performance of commercial products and initiate improvements where needed.
4. Production Troubleshooting and Manufacturing Support
Act as the primary technical expert for troubleshooting manufacturing issues including but not limited to:
- Leakage and seam integrity failures.
- Sticking and tackiness.
- Air entrapment and bubble formation.
- Shell brittleness and cracking.
- Capsule deformation and flattening.
- Shell migration and fill-shell interaction issues.
- Capsule size and weight variation.
- Gummy shape integrity.
- Consistency and texture of the gummy
Fill Formulation Issues
- API precipitation and crystal growth.
- Suspension settling and non-uniformity.
- Viscosity variation.
- Fill oxidation and degradation.
- Incompatibility between fill and shell components.
- Stability failures during commercial production.
Gelatin and Shell Issues
- Bloom strength variation.
- Gel mass viscosity fluctuations.
- Shell discoloration.
- Moisture imbalance.
- Cross-linking problems.
- Drying defects.
Process Improvement
- Identify root causes using scientific and risk-based approaches.
- Recommend corrective and preventive actions (CAPA).
- Optimize process parameters to improve yield, quality, and productivity.
- Reduce manufacturing downtime and rejection rates.
5. Cross-Functional Departmental Guidance
Production Department
- Provide technical guidance for manufacturing operations.
- Support implementation of process improvements.
- Train operators and supervisors on critical process controls.
- Ensure robust batch execution and yield improvement.
Quality Assurance (QA)
- Review deviations, change controls, CAPAs, and investigation reports.
- Support regulatory inspections and customer audits.
- Ensure compliance with cGMP and data integrity requirements.
Quality Control (QC)
- Guide investigations related to OOS, OOT, and laboratory deviations.
- Support analytical method troubleshooting.
- Review stability trends and analytical data.
Regulatory Affairs
- Provide technical support for dossier preparation.
- Review development reports and regulatory submissions.
- Respond to regulatory deficiencies and product-related queries.
Engineering and Maintenance
- Guide equipment qualification and process optimization.
- Support procurement and commissioning of new softgel/gummy equipment.
- Recommend engineering solutions for recurring manufacturing issues.
Supply Chain and Procurement
- Qualify alternative suppliers and excipients.
- Resolve raw material quality-related issues.
- Ensure uninterrupted material availability.
Marketing and Business Development
- Evaluate feasibility of new product opportunities.
- Support customer presentations and technical discussions.
- Provide scientific input for product differentiation strategies.
6. Regulatory Compliance and Quality Systems
- Ensure compliance with USFDA, MHRA, EU GMP, WHO, PIC/S, and ICH guidelines.
- Lead preparation for regulatory inspections and customer audits.
- Review development documentation and validation protocols.
- Ensure implementation of QbD, risk assessment, and continuous improvement initiatives.
7. Team Leadership and People Development
- Lead and mentor formulation scientists, group leaders, and managers.
- Build a high-performance R&D team.
- Conduct technical training and competency development programs.
- Establish succession planning and talent development initiatives.
- Foster a culture of innovation and scientific excellence.
8. Continuous Improvement and Innovation
- Implement lean and productivity improvement initiatives.
- Identify opportunities for process automation and digitalization.
- Evaluate emerging softgel/gummy technologies and new excipients.
- Drive patent evaluation and innovation projects.
- Benchmark industry best practices and implement improvements.
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