Role & responsibilities

We are looking for highly motivated and experienced Scientists to join our Pharmaceutical R&D; team in Chennai. The ideal candidates should have hands-on experience in the development of dermatological (topical and semi-solid) formulations for regulated markets such as the US, Europe, Canada, Australia, and other ICH regions.

1: Scientist Formulation & Development (F&D;)

Key Responsibilities

- Develop and optimize topical dosage forms including creams, ointments, gels, lotions, foams, shampoos, and solutions.
- Conduct pre-formulation and formulation development studies.
- Apply Quality by Design (QbD) principles and Design of Experiments (DoE) during product development.
- Execute technology transfer to manufacturing sites.
- Prepare development reports, protocols, and regulatory documentation.
- Support ANDA/505(b)(2)/generic product development for regulated markets.
- Troubleshoot formulation and process-related issues.

Preferred candidate profile

- M. Pharm / M.S. (Pharm) / Ph.D. in Pharmaceutics or equivalent.
- 2-10 years of experience in pharmaceutical formulation development.
- Proven experience in dermatology products for regulated markets.
- Strong knowledge of QbD, DoE, ICH guidelines, and cGMP.
- Experience in scale-up, exhibit batch manufacturing, and technology transfer.

2: Scientist Analytical Development (AD)

Key Responsibilities

- Develop and validate analytical methods for topical pharmaceutical products.
- Perform method development using HPLC, UPLC, GC, UV-Vis, FTIR, Dissolution, Particle Size Analysis, Rheology,



and other analytical techniques.
- Conduct method validation, verification, and transfer in accordance with ICH guidelines.
- Support stability studies, impurity profiling, and product characterization.
- Prepare analytical protocols, reports, specifications, and regulatory documentation.
- Investigate OOS/OOT results and laboratory deviations related to R&D; activities.

Required Qualifications

- M.Sc. / M. Pharm (Pharmaceutical Analysis/Quality Assurance/Analytical Chemistry) or equivalent.
- 2-10 years of experience in Analytical Development within pharmaceutical R&D.;
- Experience with dermatological dosage forms for regulated markets.
- Solid knowledge of ICH Q2(R2), USP, EP, and FDA analytical expectations.
- Hands-on experience with HPLC, UPLC, GC, Dissolution, and analytical troubleshooting.

Essential Skills

- Experience in pharmaceutical R&D; for regulated markets (USFDA, EMA, MHRA, TGA, Health Canada).
- Strong understanding of ICH guidelines, cGMP, and Data Integrity requirements.
- Excellent scientific documentation and technical writing skills.
- Strong analytical, problem-solving, and troubleshooting abilities.
- Effective communication and collaboration in cross-functional teams.

Preferred Experience

- Experience with ANDA submissions and regulatory responses.
- Knowledge of IVRT/IVPT, extractables & leachables, and dermatology-specific regulatory expectations.
- Exposure to QbD, DoE, risk assessment, and lifecycle management.
- Experience in technology transfer and commercial product support.

📌 Formulation & Development (F&D) / Analytical Development (AD)
🏢 Caplin Point
📍 Tamil Nadu