Formulation Specialists For Ophthalmic team
- Orbicular
- 6 - 11 years
- Hyderabad
- 2 months ago
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Job Description
Dear Candidate,
We are looking for formulation scientists for our Ophthalmic 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.
Position: Assistant Manager
Department: Ophthalmic team - Formulation Development
Required Exp : 6-12years
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: ki****k@or******r.co.in / pr*******p@or******r.co.in
Ph.No 9000251***
Regards
Team HR.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Research & DevelopmentRole Category: Research & Development - OtherRole: Research & Development - OtherEmployement Type: Full timeContact Details:
Company: OrbicularLocation(s): Hyderabad
Keyskills: Ophthalmic Scale Up NASAL scaleup batches regulatory Suspension Formulation Development Research And Development Emulsion MDI Formulation Research Development Exhibit Batches sterile Injectables Technology Transfer DPI
Orbicular
We are Orbicular, a dynamic fully diversified speciality pharmaceutical company setting standards of excellence in product development. As a speciality company we deliver quality pharmaceutical solutions by resolving technological complexity, create expedited regulatory filing strategies, provide s...
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