• Formulation Development
• Technology Transfer
• Project Management
• Packaging Development
• Formulation Research (F&D, FRD)

1. Primary Shortlisting Criteria:

   Experienced in various dosage forms, including OSD (Immediate Release, Controlled Release, Extended Release, Modified Release, and Sustained Release), Injectable (suspension, emulsion, liposome, nanoparticles, microspheres, and peptide-based products), Pulmonary (MDI and DPI), Topical (semi-solid, powder, lotion, and cream), and Ophthalmic (solution, suspension, and gel).

2. Secondary Shortlisting Criteria:

   Experienced in regulated, semi-regulated, and domestic markets. Skilled in Design of Experiments and Quality by Design for dosage form development, including difficult Modified Release formulations. Expertise in ANDA and 505(b)(2) filings support. Proficient in technology transfer, scale-up, troubleshooting, and process validation. Project management and commercial launch experience.

Chemical Research (API & CRAMS)

• Process Development for API
• Contract Research
• Tech Transfer & Scale Up

1. Primary Shortlisting Criteria:

   Working experience in process development for API, New Chemical Entities (NCEs), contract research, and tech transfer & scale-up.

2. Secondary Shortlisting Criteria:

   Experienced in process development for regulated, semi-regulated, and domestic markets. Proficient in technology transfer and scale-up, process optimization, cost-cutting, and improving current processes. Skilled in DMF filing support and R&D laboratory design and setup. Proficient in chemistry research project management and managing teams. Experienced in developing specific products or handling sophisticated instruments and reactions.

• Analytical Method Development
• Analytical Method Validation
• Technology Transfer
• Primary Shortlisting Criteria

1. Primary Shortlisting Criteria:

   Working experience on various dosage forms such as oral drug delivery formulation, topical formulation with semi-solid, powder, lotion, and cream, plain and complex injection, pulmonary-based product for Metered Dose Inhaler (MDI) and Drug Powder Inhaler (DPI), nasal solution and nasal suspension, NDDS, and ophthalmic solution, suspension, and gel product.

2. Secondary Shortlisting Criteria:

   Analytical method development, analytical method validation, technology transfer, and characterization studies experience. Regulatory filling and FDA deficiency response experience. Quality control department support experience. Lab quality management systems experience.

• US Market
• EU Market
• Other regulated markets (Australia, Canada, Japan, New Zealand)
• ROW Market
• Securing relevant licenses/permissions from State FDA, CDSCO, DCGI, etc.

1. Primary Shortlisting Criteria:

   Experienced in preparation, dossier compilation, review, and regulatory filing for New Drug Master Files, ANDA, and NDA. Proficient in e-CTD submissions and CTD formats for regulatory submissions. Handled various dosage forms including solid oral, transdermal, inhalers, peptides, injectables, complex products (such as liposomes/microspheres), ophthalmic, semisolids, medical devices, biosimilars, and vaccine programs. Experienced in regulated, semi-regulated, and domestic markets. Skilled in securing relevant licenses and permissions from State FDA, CDSCO, DCGI, etc.

2. Secondary Shortlisting Criteria:

   Assessed candidates on their experience in addressing deficiencies/queries from regulatory agencies/customers, submitting amendments/updates/variations/supplements, handling post-approval changes, managing CMC and labeling, and life cycle maintenance. Experienced in regulatory strategy and problem-solving, providing regulatory inputs, making market strategy, and providing support during regulatory audits. Proficient in coordinating with plant QA, QC, and production to meet regulatory submission and customer requirements.

• Manufacturing
• Packing
• PPIC
• Contract and third-party manufacturing.

1. Primary Shortlisting Criteria:

   Experienced in manufacturing and/or packing various dosage forms, including solid orals (tablets, capsules, pellets, etc.), injectables/parenteral formulations (LVP/SVP, lyophilized, oncology/non-oncology), ophthalmic, nasal/inhalation formulations (MDIs, DPIs, nasal sprays), topical dosage forms (cream, ointment, gel, etc.), suppositories, vaginal softgel ovules, aerosol sprays, and dry syrups. Skilled in manufacturing of potent molecules, complex injectables, nano-particle injectables, and dry powder formulations.

2. Secondary Shortlisting Criteria:

   killed in capacity and production planning, with experience in regulated, semi-regulated, and domestic markets, and exposure to various regulatory audits. Proficient in coordinating with other departments and handling exhibit and commercial production. Experienced in technology transfer, scale-up execution, troubleshooting, and process validation batches under cGMP manufacturing, as well as contract and third-party manufacturing.

• API Production by Chemical process
• Fermentation
• Solvent Recovery
• Contract and third-party manufacturing

1. Primary Shortlisting Criteria:

   Experience in manufacturing of APIs, Intermediates, Contract Research, Tech Transfer, and Scale Up

2. Secondary Shortlisting Criteria:

   Capacity planning and Production Planning expertise

   Experience in regulated, semi-regulated, and domestic markets

   Exposure to regulatory audits by organizations such as USFDA, MHRA, TGA, ANVISA, WHO, MCC, US, EU, and ROW Markets

   Handling scale-up batches and commercial batches

   Collaborating with other departments including production planning, purchase, logistics, QA, QC, DRA, and marketing within the organization

   Transferring technologies, executing scale-up, troubleshooting, and process validation batches under cGMP manufacturing

   Expertise in equipment qualification and validation

   Experience in contract and third-party manufacturing.

• API / intermediate / chemical plant
• OSD manufacturing plant
• Injectable Manufacturing plant
• Biologicals manufacturing plant
• R&D centres

1. Primary Shortlisting Criteria:

   Experience in engineering and project management for various types of manufacturing sites, including API/intermediate/chemical plants, OSD manufacturing plants, injectable manufacturing plants, biologicals manufacturing plants, and R&D centres.

2. Secondary Shortlisting Criteria:

   Expertise in specific job functions, such as utility management, plant and equipment maintenance, and project management for both greenfield and brownfield projects.Exposure to regulatory audits and compliance with GMP standards for the engineering function.Number of regulatory audits faced and successfully passed.

• Purchase of RM, PM, KSM
• Purchase for Lab and R&D
• Purchase Engineering Capital
• PPIC / Planning
• Logistics

1. Primary Shortlisting Criteria:

   Relevant experience in the job function, including purchase and procurement, such as purchase of raw material, purchase of packaging material, sourcing of key start material, and purchase of lab and R&D equipment, purchase of engineering capital goods, Experience production planning / Demand PlanningExperience in international and domestic logistics, including transportation, distribution.

2. Secondary Shortlisting Criteria:

   Experience in the type and nature of manufacturing site, including API/intermediate/chemical plants, OSD (oral solid dosage) manufacturing plants, and R&D centres.

• Analytical Instrument handling (HPLC, GC, XRD etc.)
• Working Experience on LIMS
• Change control management
• Market complaints Handling
• OOS/OOT/INCIDENT Handling

1. Primary Shortlisting Criteria:

   Experience in analysis of various API and dosage forms, including tablets, capsules, injectables, lyophilized powder for injection, creams, gels, ointments, and foams.

2. Secondary Shortlisting Criteria:

   Proficient in various QC sections, including raw material testing, in-process quality monitoring, finished product QC approvals, packing material testing, stability studies, and microbiology lab testing. Expertise in tech transfer and method validations, change control management, market complaints/product complaint handling, OOS/OOT/incident handling, and review and approval of analytical reports and documentation. Experienced in regulatory audits, such as USFDA, MHRA, ANVISA, TGA, WHO etc. Knowledge and experience with various analytical instruments, such as HPLC, GC, dissolution test apparatus, UV spectrophotometer, and analytical balances. Proficient in lab software including Chromeleon, Empower, Chemstation, LIMS, and TrackWise.

• In process Quality Assurance
• Quality Management System
• Validation and qualification
• Analytical Quality Assurance
• Developmental Quality Assurance
• Quality Assurance Shortlisting Criteria

1. Primary Shortlisting Criteria:

   Experience in Quality Assurance of API, Biologics, and dosage forms, tablets, capsules, injectables, lyophilized powder for injection, dry syrup and dry powder pre-filled syringes, blow fill and seal, ophthalmic creams, gels, and foams.

2. Secondary Shortlisting Criteria:

   Experience in Quality Assurance including in-process quality assurance, cGMP compliance, line clearance, in-process sampling and check, calibration, SOP compliance, batch record review, quality management system, market complaints, change control, OOS/OOT/deviation/CAPA handling, validation and qualification, vendor and analytical quality assurance, GLP and QC systems, analytical document review, and regulatory query response. Regulatory audit experience includes USFDA, MHRA, ANVISA, TGA, INFARMED, GCC, Health Canada, MCC & WHO.