Urgent Hiring || Head of R and D (Long Acting Injectables and Novel Drug Delivery) || Jaipur, Rajasthan, India ||

Location:
CRAD Laboratory, Jaipur, Rajasthan, India Position
- Head of R and D (Long Acting Injectables and Novel Drug Delivery) Experience
- 15 + years Ctc Range
- upto 85 lpa (depends on interview) working Days
- 6 days Functional scope: Formulation Development and Analytical Development, technology transfer and scaleup Role mandate We are seeking a senior scientific leader to take ownership of our depot injectable and novel injectable drug delivery programs. The leader will define development strategy, guide daily scientific work and deliver projects from concept and feasibility through development, scale-up, technology transfer, regulatory support and commercialization. Our formulation and analytical development teams include scientists with 10 to 15 years of experience. The role therefore requires the scientific depth to guide experienced specialists, challenge experimental conclusions and solve difficult technical problems, alongside the leadership discipline to deliver agreed milestones. The priority portfolio includes octreotide, leuprolide (leuprorelin), triptorelin, buserelin and goserelin. Peptide-loaded polymeric microspheres are the core expertise required. Platform selection will be product specific; experience with implants, in situ forming depots and other novel injectable technologies is an advantage. Essential candidate profile
• MPharm or MS in Pharmaceutics, Pharmaceutical Sciences, Drug Delivery or a closely related discipline. A relevant PhD is strongly preferred; exceptional industrial product delivery experience may substitute for a PhD.
• Typically, 15 or more years of relevant pharmaceutical R&D; experience, including at least 8 years directly in long-acting injectable depots or polymeric microspheres and at least 5 years in scientific team or program leadership. Exceptional candidates with equivalent delivery evidence may be considered.
• Personally led at least two long-acting injectable depot product, preferably a peptide microsphere product, through development, scale-up, technology transfer and commercial launch. The candidate must clearly identify their own technical decisions and delivery responsibilities.
• Deep industrial experience with peptide-loaded PLGA or PLA microspheres, substantial formulation and process expertise, and strong analytical development judgment.
• A proven ability to lead experienced formulation and analytical scientists through strategic direction, routine laboratory engagement and practical troubleshooting.
• Willingness to travel to manufacturing facilities, development partners and other company locations as required. Scientific strategy and formulation leadership Portfolio strategy and development planning
• Define target product profiles, intended release durations, feasibility criteria, reference product evaluation and product-specific development pathways with the relevant functions.
• Build integrated development plans with clear scientific hypotheses, milestones, budgets, resources, dependencies and decision gates. Identify critical risks early and prioritize experiments that resolve them.
• Determine whether to advance, redesign, partner or discontinue a program using scientific evidence, manufacturing feasibility and business priorities.
• Ensure formulation, analytical, nonclinical, clinical, regulatory and manufacturing activities remain aligned throughout development. Microsphere and peptide depot development
• Lead selection and characterization of polymers, APIs and excipients, including polymer composition, molecular weight distribution, end groups and supplier or lot variability.
• Guide evaluation of peptide–polymer interactions, peptide stability, encapsulation efficiency, loading, drug distribution and degradation, including acylation where relevant.
• Direct microencapsulation approaches such as emulsion solvent extraction or evaporation, phase separation or coacervation and spray drying, selecting processes appropriate to the product and scale.
• Resolve burst release, lag phase, incomplete release,



undesired release duration and batch variation through mechanistic understanding and controlled experimentation.
• Optimize particle size distribution, morphology, porosity, residual solvents, moisture, drying or lyophilization, physical stability and storage conditions.
• Develop the complete presentation, including diluent or reconstitution system, resuspendability, syringeability, injectability, dose recovery, administration time and compatibility with the intended delivery components. Process understanding and reproducibility
• Apply quality by design, risk assessment, design of experiments and appropriate statistical analysis to link material attributes and process parameters with critical quality attributes.
• Establish justified operating ranges and robust laboratory processes; evaluate scale-sensitive operations such as mixing, emulsification, solvent removal, washing, separation and drying.
• Select fit-for-purpose laboratory and pilot equipment with engineering and manufacturing teams. Ensure development processes can be transferred to commercially practical equipment.
• Maintain transparent development records that explain why formulations and processes were selected, which alternatives were tested and how remaining risks will be addressed. Analytical development and product characterization Analytical strategy and technical oversight
• Own the integrated analytical development strategy and work closely with analytical leaders to select methods that support formulation decisions, product characterization, stability, specifications and technology transfer.
• Review protocols, raw data, chromatograms, calculations, method suitability and scientific conclusions. Challenge unexplained variability, inadequate recovery and unsupported interpretations.
• Guide stability-indicating assay and related substance methods, peptide extraction and recovery, drug loading, encapsulation efficiency, free or surface-associated drug and mass balance, as applicable.
• Oversee peptide degradation and impurity investigations using appropriate separation and identification techniques, including HPLC or UPLC and LC-MS where justified. Polymer and microsphere characterization
• Guide polymer characterization using appropriate techniques such as size exclusion chromatography or GPC, NMR and thermal analysis, supported by specialist expertise where needed.
• Establish orthogonal characterization of particle size distribution, morphology, internal structure or porosity, thermal properties, residual solvents and moisture, using techniques appropriate to each product.
• Connect polymer, API, excipient and product characteristics with manufacturing history and release performance. Assess the impact of supplier changes and raw material lot variability. In vitro release and in vivo performance
• Lead development of robust and discriminatory in vitro release testing, including sample preparation, drug stability in the release medium, recovery, mass balance and method reproducibility.
• Establish real-time release methods and appropriately justified accelerated methods; assess whether accelerated conditions change the release mechanism or obscure formulation differences.
• Use release testing to investigate manufacturing changes, stability effects and reference product comparisons. Set scientifically justified acceptance criteria with QA and regulatory colleagues.
• Work with bioanalytical, pharmacokinetic and clinical experts to interpret exposure profiles, initial release, sustained exposure and release duration; investigate in vitro–in vivo relationships where feasible.
• Support product-specific bioequivalence or clinical development strategies without assuming that in vitro similarity alone establishes equivalent clinical performance.



Lifecycle and transfer of analytical methods
• Oversee method qualification or validation appropriate to development stage, robustness studies, analytical transfer, stability protocols, specifications and method lifecycle improvements.
• Lead scientific input to atypical result, out-of-specification and out-of-trend investigations with QA. Ensure conclusions are evidence based and corrective actions address root causes. Scale up commercialization and team leadership Transfer and commercial delivery
• Own technical readiness for pilot, clinical or registration and commercial batches. Define scale-up risks and demonstrate reproducibility at the appropriate development stages.
• Lead technology transfer with manufacturing and engineering teams, including process descriptions, material and equipment requirements, operating ranges, in-process controls and acceptance criteria.
• Work with QA and microbiology specialists on feasible sterilization strategies, aseptic processing, contamination control, bioburden and endotoxin control, and product or process compatibility.
• Evaluate container closure systems, product contact materials and delivery components with relevant experts, including integrity and compatibility studies as required.
• Support process qualification, analytical transfer, stability commitments, regulatory batches, launch readiness and troubleshooting during initial commercial manufacture.
• Provide scientific leadership for CMC documentation and regulatory responses. Work with regulatory affairs on requirements for intended markets, including India and international markets as applicable. Day to day scientific leadership
• Conduct regular laboratory discussions and structured weekly project reviews. Set clear experimental objectives, review results promptly and resolve scientific or operational blockers.
• Coach experienced scientists without duplicating their roles; delegate execution while retaining accountability for scientific quality, decisions and project delivery.
• Build cross-functional problem-solving teams for difficult formulation, analytical and manufacturing issues. Ensure responsibilities, actions and decision dates are explicit.
• Develop scientific capabilities, training plans and succession. Recommend recruitment, equipment and external expertise based on demonstrated portfolio needs.
• Maintain rigorous data integrity, documentation, laboratory safety and quality practices; report progress, budget needs, technical risks and recovery plans clearly to senior management. Innovation and collaboration
• Identify new injectable delivery opportunities addressing a defined patient, clinical or product need, including improved microspheres, implants, in situ depots and other relevant platforms.
• Turn novel ideas into proof-of-concept programs with testable hypotheses, success criteria, resource estimates and decisions on further investment.
• Assess manufacturability, product differentiation and intellectual property opportunities with business, regulatory and IP specialists; contribute to invention disclosures and patent applications where justified.
• Manage scientific relationships with CROs, CDMOs, academic groups and material or equipment suppliers, with defined deliverables, timelines and technical review. Preferred experience and expected outcomes
• Commercial delivery of multiple depot products or presentations, especially peptide microspheres involving octreotide, leuprolide or triptorelin and different release durations.
• Relevant buserelin or goserelin development experience; implant, in situ depot or other novel injectable platform development and commercialization.
• Experience with international regulated market submissions, complex generic product characterization, bioequivalence programs and responses to technical regulatory questions.
• Evidence of recovering a delayed or technically difficult project, improving transfer reproducibility or resolving a critical commercial manufacturing problem.
• Patents, publications or internal platform innovations supported by practical development results. Industrial delivery remains central to assessment.

📌 Research And Development Specialist (Jaipur)
🏢 orbit verify
📍 Jaipur