04 Nov
|
Guires Solutions
|
Ambattur
04 Nov
Guires Solutions
Ambattur
: Pharmaceutical Formulation Consultant (Tablets & Capsules, NPD)
Engagement type: Consultant, project-based
Work location: Chennai office (on-site)
Domain: Pharmaceutical drug formulation and recent product development (oral solid dosage)
Duration: Project-based, to be defined at onboarding (extendable)
1. Role Summary
We are looking for an experienced Pharmaceutical Formulation Consultant to develop new tablet and capsule products. The consultant will work from our Chennai office for the project duration. The role covers hands-on formulation preparation along with market research that supports product selection and positioning.
2. Eligibility
- Freshers are not eligible to apply.
- Minimum 3+ years of hands-on, practical experience in formulation (lab-level preparation and trials for tablets and/or capsules).
- Candidates with only theoretical or academic exposure, or with experience limited to QC, QA, or regulatory work, will not be considered.
3. Key Responsibilities A. Formulation Development (Tablets & Capsules)
- Design and develop oral solid dosage formulations (immediate-release, and modified or sustained-release where applicable) for new products.
- Conduct pre-formulation studies: API characterisation, solubility, compatibility, and excipient selection.
- Personally prepare lab-scale formulation trials and optimise them using QbD / DoE principles.
- Select the manufacturing process (direct compression, wet or dry granulation, capsule filling) and define critical process parameters.
- Evaluate and troubleshoot trial batches: hardness, friability, disintegration, dissolution, assay, and content uniformity.
- Run stability studies as per ICH guidelines and interpret the results.
- Prepare formulation documents: Master Formula, development reports, and technical data packages.
- Support scale-up and tech transfer to the manufacturing site.
B. Market Research
- Carry out market and competitor analysis for target molecules and dosage forms (market size, demand trends, key players, pricing).
- Identify new product opportunities, including generics, 505(b)(2), nutraceutical-pharma crossover, and niche or unmet-need segments.
- Review the patent landscape, exclusivity status, and reference listed drug (RLD) details.
- Assess the regulatory pathway and market-entry feasibility (India CDSCO and, where relevant, regulated markets).
- Prepare product feasibility reports and a recommended product pipeline with a go / no-go view.
C. Documentation & Reporting
- Maintain accurate lab records and development documentation.
- Share regular progress updates and present findings to management.
- Deliver a final project report with formulation, data, and recommendations.
4. Required Qualifications
- M.Pharm (Pharmaceutics / Industrial Pharmacy) or Ph.D. in Pharmaceutical Sciences. B.Pharm with strong practical experience may be considered.
- 3+ years of practical formulation experience in oral solid dosage forms (tablets and capsules).
- Demonstrated involvement in product development trials, from pre-formulation through optimisation.
5. Required Skills
- Strong working knowledge of excipients, granulation, compression, coating, and capsule-filling technologies.
- Hands-on use of formulation equipment (blenders, granulators, tablet press, capsule filling machine, coating pan).
- Knowledge of ICH, QbD, and cGMP, plus regulatory requirements for product filing.
- Familiarity with analytical methods: dissolution, HPLC, and related quality tests.
- Ability to conduct market research using IQVIA, patent databases, regulatory databases, and similar sources.
- Strong analytical, report-writing, and presentation skills.
- Ability to work independently and deliver to timelines.
6. Preferred
- Experience with modified-release or complex generics.
- Exposure to regulated-market filings (US FDA, EMA, WHO-GMP).
- Prior consulting experience.
7. Deliverables
- Pre-formulation and feasibility reports
- Optimised tablet and capsule formulations with trial batch data
- Stability data summary
- Market research and product opportunity report
- Final technical and project report
8. Terms
- Compensation: Consultant fee (fixed or monthly retainer or Project Based feedback ), to be discussed
- Reporting to: Project Head
- Work mode: On-site at the Chennai office for the project duration
Language:
- Hindi (Preferred)
- English (Preferred)
Work Location: In person
📌 Pharmaceutical Formulation Consultant (Tablets & Capsules, NPD) (Ambattur)
🏢 Guires Solutions
📍 Ambattur