HETERO LABS LIMITED - India is a pharmaceuticals company

Company Overview: Hetero Drugs&nbsp;is an Indian&nbsp;<a href="https://en.wikipedia.org/wiki/Pharmaceutical" rel="noopener noreferrer" target="_blank">pharmaceutical</a>&nbsp;company and the world's largest producer of anti-retroviral drugs. Hetero's business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics. Job Summary: We are looking for a proactive and detail-oriented IPM professional with a strongbackground in pharmaceutical formulation R&amp;D. The candidate will be responsible formanaging patent-related activities including drafting, filing, and prosecution, conducting FTO(Freedom to Operate) analyses, and supporting product development with robust IPstrategies. Key Responsibilities: <ul><li>Drafting and filing patent applications related to formulation and pharmaceutical</li></ul>products.<ul><li>Conducting patent invalidation studies and preparing oppositions.</li><li>Preparing IP landscape and competitive intelligence reports to support R&amp;D and</li></ul>business decisions.<ul><li>Performing FTO (Freedom to Operate) analyses for new and existing products.</li><li>Reviewing patent certifications (Para IV filings, etc.) and handling label clearances in</li></ul>compliance with regulatory frameworks.<ul><li>Collaborating with formulation scientists, regulatory, legal, and business teams to</li></ul>align IP strategies with product goals.<ul><li>Monitoring and assessing third-party patent activity and alerting stakeholders to</li></ul>potential risks or opportunities.<ul><li>Assisting in response to patent litigation or regulatory queries as required.</li></ul> Desired Candidate Profile: <ul><li>M. Pharm (Pharmaceutics – mandatory) with 3–8 years of experience in IPM within a</li></ul>formulation R&amp;D environment.<ul><li>Sound understanding of pharmaceutical patent law, Hatch-Waxman provisions, patent</li></ul>life-cycle management, and regulatory pathways.<ul><li>Experience in drafting, filing, and prosecuting patents in India, US, and EU.</li><li>Knowledge of patent databases and tools (e.g., Derwent, PatBase, USPTO,</li></ul>Espacenet).<ul><li>Strong analytical and communication skills with attention to detail.</li></ul> Job Title: Executive/ Sr ExecutiveDepartment: Intellectual Property Management / R&amp;DReports To: General ManagerExperience: 3–8 YearsQualification: M. Pharm (Pharmaceutics – Must)Location: Jeedimetla, Hyderabad

Company overview: Hetero Drugs&nbsp;is an Indian&nbsp;<a href="https://en.wikipedia.org/wiki/Pharmaceutical" rel="noopener noreferrer" target="_blank">pharmaceutical</a>&nbsp;company and the world's largest producer of anti-retroviral drugs. Hetero's business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics. Job Title: Scientist II - Formulation Research and Development (Injectables)Department: Formulation R&amp;D (FR&amp;D)Location: Jeedimetla, HyderabadExperience: 7-10 YearsReports To: Group Leader / Manager - FR&amp;D Job Summary: We are seeking a highly experienced and motivated Scientist II to join our Formulation R&amp;D team focused on the development of sterile injectable formulations including aqueous, non-aqueous, lyophilized, and peptide-based oncology products. This role is critical to advancing product development for regulated markets (US, Europe, and ROW) and involves comprehensive formulation design, process optimization, regulatory documentation, and interdepartmental coordination. Key Responsibilities: <ul><li>Independently lead the development of sterile injectable products: aqueous, non-aqueous, lyophilized, and peptide-based formulations.</li><li>Conduct formulation studies, process optimization, and scale-up activities to develop robust and reproducible manufacturing processes.</li><li>Perform material compatibility studies including container-closure components (filters, tubing, rubber stoppers).</li><li>Prepare critical product development documents including:</li><li>Test/Manufacturing license applications</li><li>Master Formula Cards (MFCs)</li><li>Exhibit batch procurement packages</li></ul> Job Description - Scientist II (FR&amp;D) <ul><li>Stability study protocols and notes</li><li>Process evaluation protocols</li><li>Product development reports</li><li>Conduct and support filter validation and terminal sterilization studies.</li><li>Prepare technology transfer documentation for successful transfer to commercial manufacturing.</li><li>Collaborate with Analytical Development, Regulatory Affairs, and Tech Transfer teams throughout the development lifecycle.</li><li>Contribute to regulatory submissions (ANDA, EU dossiers) and actively participate in responding to regulatory queries.</li><li>Ensure compliance with cGMP and ICH guidelines, and support audits and inspections as required.</li></ul> Required Qualifications: <ul><li>M.Pharm / M.S. in Pharmaceutics, Pharmaceutical Technology, or related field.</li><li>7-10 years of industry experience in formulation development of sterile injectables.</li><li>Hands-on expertise in oncology injectables, peptide formulations, and lyophilization process development.</li><li>Strong working knowledge of USFDA, EMA, and ROW regulatory requirements.</li><li>Proven experience in technology transfer, scale-up, and regulatory documentation.</li><li>Excellent communication, problem-solving, and cross-functional collaboration skills.</li></ul>

Company overview: Hetero Drugs&nbsp;is an Indian&nbsp;<a href="https://en.wikipedia.org/wiki/Pharmaceutical" rel="noopener noreferrer" target="_blank">pharmaceutical</a>&nbsp;company and the world's largest producer of anti-retroviral drugs. Hetero's business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics. Job Title: Scientist II - Formulation Research and Development (Injectables)Department: Formulation R&amp;D (FR&amp;D)Location: Jeedimetla, HyderabadExperience: 7-10 YearsReports To: Group Leader / Manager - FR&amp;D Job Summary: We are seeking a highly experienced and motivated Scientist II to join our Formulation R&amp;D team focused on the development of sterile injectable formulations including aqueous, non-aqueous, lyophilized, and peptide-based oncology products. This role is critical to advancing product development for regulated markets (US, Europe, and ROW) and involves comprehensive formulation design, process optimization, regulatory documentation, and interdepartmental coordination. Key Responsibilities: <ul><li> Independently lead the development of sterile injectable products: aqueous, non-aqueous, lyophilized, and peptide-based formulations.</li><li> Conduct formulation studies, process optimization, and scale-up activities to develop robust and reproducible manufacturing processes.</li><li> Perform material compatibility studies including container-closure components (filters, tubing, rubber stoppers).</li><li> Prepare critical product development documents including:</li><li> Test/Manufacturing license applications</li><li> Master Formula Cards (MFCs)</li><li> Exhibit batch procurement packages</li></ul> Job Description - Scientist II (FR&amp;D) <ul><li> Stability study protocols and notes</li><li> Process evaluation protocols</li><li> Product development reports</li><li> Conduct and support filter validation and terminal sterilization studies.</li><li> Prepare technology transfer documentation for successful transfer to commercial manufacturing.</li><li> Collaborate with Analytical Development, Regulatory Affairs, and Tech Transfer teams throughout the development lifecycle.</li><li> Contribute to regulatory submissions (ANDA, EU dossiers) and actively participate in responding to regulatory queries.</li><li> Ensure compliance with cGMP and ICH guidelines, and support audits and inspections as required.</li></ul> Required Qualifications: <ul><li> M.Pharm / M.S. in Pharmaceutics, Pharmaceutical Technology, or related field.</li><li> 7-10 years of industry experience in formulation development of sterile injectables.</li><li> Hands-on expertise in oncology injectables, peptide formulations, and lyophilization process development.</li><li> Strong working knowledge of USFDA, EMA, and ROW regulatory requirements.</li><li> Proven experience in technology transfer, scale-up, and regulatory documentation.</li><li> Excellent communication, problem-solving, and cross-functional collaboration skills.</li></ul>

Accomplished HR nearly 18 TO 30 years of rich work experience in managing diverse HR functions including, Employee Lifecycle Management, Payroll Management, Learning &amp; Development, Statutory Compliances, Performance Management, Contract Labor Management, Industrial Relations, Employee Welfare and Manpower Management. Contract Labor Management:Ensuring timely compliances of various returns by the contractors.Ensuring timely renewal of labor license, insurance policy by the contractors.Monitoring &amp; ensuring that the contractors are properly depositing PF, ESIC etc. contributions to the concerned authorities under various statutory departments and maintain the records for the same.Monitoring whether the contractors are maintaining various registers like muster roll, wage register, Over Time register etc. under act. Employee Welfare:Managing the administration of facilities such as administration, housekeeping,Coordinating periodic medical checkups and managing Mediclaim Policies for employees.Organizing sports and games events for annual celebrations and festivals, fostering a positive work culture.Collaborating with the Safety Department to ensure safety and well-being of employees working in Manufacturing plant/unit. POSH, Grievance, canteen, safety committees HR Best Practices:Formulating and implementing company policies, systems, procedures and employee welfare schemes that align with industry best practices and organizational values. Emphasizing the significance of teamwork and promoting a healthy work environment where every individual thrives and contributes optimally Added advantage Pharmaceutical experience