07 Nov
|
Guires Solutions Private
|
India
07 Nov
Guires Solutions Private
India
Department: Research & Development (R&D;) / Formulation Development
Role: Pharmaceutical Consultant – New Product Development (NPD)
Engagement Type: Consultant / Project-Based
Work Location: Client's Pharmaceutical Formulation Laboratory (On-Site Visits Required)
Location : Chennai
Experience: Minimum 2+ Years of Relevant Hands-on Industry Experience
Qualification: (Pharmaceutics / Pharmaceutical Technology / Industrial Pharmacy)
1. Job Summary
We are seeking an experienced and technically competent Pharmaceutical Consultant – Recent Product Development (NPD) & Formulation Development with strong practical expertise in pharmaceutical formulation development, laboratory setup, and end-to-end product development.
The consultant will be responsible for providing technical expertise and, most importantly, personally executing hands-on formulation development activities by visiting the client's laboratory/R&D; facility.
The assignment involves supporting the complete pharmaceutical product development lifecycle, starting from initial concept assessment and preformulation studies through formulation design, laboratory trials, prototype development, optimization, stability studies, scale-up, and technology transfer.
The ideal candidate should have practical industry experience in developing pharmaceutical dosage forms, particularly tablets, capsules, powders, liquids, and semisolid formulations, along with the ability to establish and operationalize formulation development laboratories.
This is strictly a hands-on, laboratory-based consulting assignment. Candidates must be willing to physically visit the designated laboratory and actively participate in formulation development and experimental activities. Remote-only consultants or professionals providing only theoretical guidance will not be suitable for this role.
2. Key ResponsibilitiesA. End-to-End New Product Development (NPD)
- Lead and support end-to-end pharmaceutical NPD activities based on specific business and project requirements.
- Assess product concepts, development feasibility, and technical requirements.
- Define formulation strategies based on target product profiles (TPP), product specifications, and development objectives.
- Develop new pharmaceutical products and recommend suitable formulation approaches.
- Provide technical recommendations for product development and commercialization.
B. Hands-on Formulation Development
- Personally conduct and guide practical formulation development activities at the client's laboratory.
- Develop and optimize pharmaceutical formulations, particularly:
- Tablets (Immediate Release, Modified Release, etc., as applicable).
- Capsules.
- Pharmaceutical powders and granules.
- Oral liquids and suspensions.
- Semisolid formulations such as creams, gels, and ointments.
- Conduct laboratory trials, prototype preparation, and formulation optimization.
- Perform excipient selection, concentration optimization, and process parameter evaluation.
- Troubleshoot formulation and manufacturing-related challenges.
- Evaluate formulation performance and recommend improvements.
C. Preformulation & Compatibility Studies
- Conduct feasibility assessments and preformulation studies.
- Evaluate the suitability of APIs and pharmaceutical excipients.
- Perform preliminary API-excipient compatibility studies.
- Recommend appropriate excipients based on formulation requirements.
- Assess physicochemical properties and their impact on formulation performance.
D. Formulation Laboratory Setup & Development
- Plan, establish,
and optimize pharmaceutical formulation development laboratory facilities.
- Recommend laboratory infrastructure, equipment, instruments, and utilities.
- Identify suitable equipment for different dosage form development activities.
- Support equipment selection, installation planning, and operational readiness.
- Establish laboratory workflows, operating procedures, and experimental practices.
- Guide laboratory personnel in formulation techniques and equipment operation.
E. Analytical Development & Product Evaluation
- Coordinate with analytical teams for analytical method development and validation.
- Guide physical, chemical, and performance evaluations of developed formulations.
- Support product quality assessments and preliminary specifications.
- Evaluate formulation performance and identify areas requiring optimization.
F. Stability Studies & Quality Assessment
- Develop and guide stability study plans.
- Support accelerated and long-term stability studies in accordance with applicable guidelines.
- Evaluate stability results and recommend necessary formulation improvements.
- Support documentation of stability protocols, observations, and reports.
G. Scale-Up & Technology Transfer
- Support scale-up activities from laboratory batches to pilot or commercial manufacturing.
- Recommend suitable manufacturing processes and critical process parameters.
- Guide process optimization and manufacturing readiness.
- Support technology transfer from R&D; to production.
- Troubleshoot scale-up and process-related challenges.
H. Documentation & Regulatory Compliance
- Prepare and review formulation development reports and technical documentation.
- Document laboratory trials, observations, formulation compositions, and optimization results.
- Develop or review relevant SOPs and laboratory records.
- Ensure formulation development activities follow applicable GMP principles and pharmaceutical quality requirements.
- Coordinate with QA, QC, Regulatory Affairs, Manufacturing, and Procurement teams.
3. Mandatory On-Site Laboratory Engagement
This is a critical requirement of the assignment.
The selected consultant must be willing to physically visit the client's formulation laboratory and personally participate in the practical execution of pharmaceutical formulation development activities.
The consultant is expected to:
- Visit the designated laboratory as per the mutually agreed project schedule.
- Personally perform formulation trials and experimental activities.
- Participate in dispensing, blending, granulation, compression, coating, and other relevant manufacturing processes, depending on the dosage form.
- Prepare laboratory prototypes and conduct formulation optimization.
- Guide laboratory personnel in practical formulation development techniques.
- Demonstrate the operation and application of relevant formulation development equipment.
- Review experimental results and recommend corrective actions.
- Support laboratory setup and establish practical R&D; workflows.
Important: This is not a work-from-home, remote consulting, or purely advisory assignment.
The consultant must be practically capable of executing formulation development activities at the laboratory.
4. Required Technical Knowledge & Experience
Candidates should possess:
- Strong knowledge of pharmaceutical formulation development and NPD.
- Minimum 2+ years of hands-on experience in pharmaceutical formulation development.
- Practical experience in developing tablets and other pharmaceutical dosage forms.
- Experience in pharmaceutical R&D; laboratory operations and setup.
- Knowledge of API and excipient selection.
- Experience in preformulation and compatibility studies.
- Understanding of formulation optimization and process development.
- Knowledge of stability testing and product evaluation.
- Understanding of scale-up, process validation, and technology transfer.
- Familiarity with GMP, pharmaceutical quality systems, and relevant regulatory requirements.
- Ability to independently assess project requirements and execute development activities.
- Willingness to physically visit the laboratory and undertake practical formulation work.
5. Educational Qualifications
- Master's degree (M.Pharm) in:
- Pharmaceutics.
- Pharmaceutical Technology.
- Industrial Pharmacy.
- Relevant pharmaceutical specializations.
- PhD in Pharmaceutics, Pharmaceutical Sciences, or a related specialization will be an added advantage.
- Relevant pharmaceutical industry experience in formulation development and NPD is essential.
6. Expected Deliverables
The consultant will be expected to provide the following deliverables based on project requirements:
- Pharmaceutical product development strategy and formulation development plans.
- Formulation laboratory setup plans and equipment requirements.
- Practical prototype formulations and laboratory trial batches.
- Formulation optimization reports and technical recommendations.
- Preformulation and API-excipient compatibility study reports.
- Stability study protocols, plans, and supporting documentation.
- Analytical development coordination and product evaluation recommendations.
- Scale-up and technology transfer recommendations.
- Laboratory SOPs and technical documentation.
- Recommendations supporting manufacturing readiness and product commercialization.
7. Ideal Consultant Profile
The ideal candidate should be a pharmaceutical formulation development professional who:
- Has worked in a pharmaceutical formulation R&D; laboratory.
- Has personally developed pharmaceutical products through practical laboratory trials.
- Has experience in tablet formulation and other dosage forms.
- Can independently establish and guide formulation laboratory activities.
- Can identify formulation challenges and provide practical solutions.
- Is confident in handling formulation development equipment and laboratory processes.
- Is willing to work directly at the client's laboratory rather than providing only remote technical advice.
8. Engagement Expectations
The engagement will be based on the client's product development and laboratory requirements.
- The consultant must be available for physical laboratory visits.
- The frequency and duration of visits will be mutually agreed upon based on project scope.
- Hands-on formulation execution is an essential part of the engagement.
- Project deliverables, timelines, and consulting fees will be mutually finalized.
- Additional visits may be required during critical formulation trials, optimization, and scale-up activities.
Contact person:
Gray-+91-XXXXXXXXXX
Job Types: Part-time, Freelance, Volunteer
Pay: From ₹10,000.00 per month
Work Location: Remote
📌 Pharmaceutical Consultant – NPD & Formulation (Chennai) (India)
🏢 Guires Solutions Private
📍 India