Formulation Specialists For Ophthalmic/NASAL team

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:

Required Exp :

Position2:

Department:

Required Exp: 4-8years(Candidates from injectables background can also apply.)

Role & Responsibilities:

Formulation & Process Development

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.