Formulation Specialists For Ophthalmic/NASAL team Orbicular Pharmaceutical Technologies

7.0 - 12.0 years

5 - 15 Lacs

hyderabad

Work from Office

Dear Candidate, We are looking for formulation scientists for our Ophthalmic and Nasal teams in Formulations, focusing on the formulation development of sterile ophthalmic dosage forms solutions, suspensions, and emulsions. This role involves complete ownership of formulation and process development with a strong emphasis on regulatory compliance and timely execution. Position1: Assistant Manager Department: Ophthalmic team - Formulation Development Required Exp : 8-12years Position2: Research Associate/Sr.Research Associate Department: Nasal team - Formulation Development Required Exp: 4-8years(Candidates from injectables background can also apply.) Role & Responsibilities: Formulation & Process Development Independently develop formulations for ophthalmic, injectables and nasal sprays Design and interpret DoE studies for optimization and robustness Technology & Excipient Evaluation Select excipients, containers/closures, and delivery systems (BFS, vials, spray pumps) Conduct risk assessments for compatibility, leachables, and functionality QbD & Risk Mitigation Define QTPP, CQA, and CPPs Apply DoE-based approaches for robust formulation and process design Scale-up & Technology Transfer Design scalable processes and identify critical material and process attributes Support scale-up, exhibit, and validation batches (in-house/CMO) Regulatory Documentation Prepare 3.2.P.2 / 3.2.P.3 sections, development reports, and risk assessments Address regulatory queries and support ANDA / 505(b)(2) filings DeviceDrug Integration Oversee device evaluations (spray pattern, plume, PSD, E&L) Ensure alignment between formulation and device requirements Cross-functional Collaboration Work closely with ARD, QA, RA, SCM, device, and manufacturing teams Coordinate packaging/device-related studies and tech transfer activities Project & Team Management Lead development of complex sterile products Mentor junior team members and ensure GLP/documentation compliance Drive timelines in alignment with CMC and regulatory milestones Required Skills and Qualifications: M.Pharm (Pharmaceutics) Strong understanding of formulation science, aseptic processing, and regulatory pathways (USFDA and other markets) Hands-on experience with E&L studies, ICH Q3D, and risk-based development Proven problem-solving skills and scale-up troubleshooting Experience with CMO/CRO coordination and technology transfer Benefits: 5day week, Canteen/Bus facility, Mediclaim, accidental benefits..etc. Suitable and Interested candidates can share their profiles along with basic details curr.org., total exp, Curr.Location, CTC,Expected CTC, Notice period..etc Mail ID: kiran.k@orbicular.co.in / pranathi.p@orbicular.co.in Ph.No 9000251866 Regards Team HR.

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