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3.0 - 7.0 years
0 Lacs
ahmedabad, gujarat
On-site
Intas is a leading global pharmaceutical company dedicated to the development, manufacturing, and marketing of pharmaceutical formulations. The company's mission is to meet unmet medical and societal needs through a fully integrated pharmaceutical value chain that spans across the globe. With a presence in over 85 countries, including major markets like North America, Europe, Latin America, and the Asia-Pacific under the brand name Accord Healthcare, Intas has experienced rapid expansion through organic growth and strategic acquisitions. The company upholds high standards of quality with products approved by leading global regulatory agencies such as USFDA, MHRA, and EMA. Intas also focuses on advanced areas like Biosimilars and New Chemical Entities to excel in healthcare. At Intas, success is attributed to the strength of its people. The company is committed to attracting and retaining top talent in the industry and creating an empowering environment that fosters innovation and excellence. This ensures that every employee contributes significantly to both the company's growth and advancements in global healthcare. **Job Title:** Asst Manager-Global Portfolio & Bus Dev. **Job Requisitions No.:** 13742 **Job Description:** **Purpose of Job:** The ideal candidate should possess basic knowledge of pharmaceutical development for Dossier preparation for the Global Market, particularly for oral/injection/topical dosage forms, and US/European pharmaceutical IP and Regulatory strategy. Experience in pharmaceutical business intelligence and business case analysis for new project selection and approval is desirable. This role involves interaction with internal and external departments within a multidisciplinary matrix team, necessitating cross-functional skills, leadership, and motivation. **Roles and Responsibilities:** - Identify, evaluate, and monitor Pipeline Projects - Participate in internal and external development monitoring, Budgeting, launch calendar, and Portfolio slide preparation - Optimize Portfolio and select New Projects - Contribute to project strategy and business case analysis - Maintain internal databases related to Portfolio and Pipeline - Coordinate training sessions for the BD team to update on Product details - Assist in the preparation of Intas Launch Landscape for strategic territories (US, EU, AUS, CAN, LATAM) **Skills Required:** - Strong understanding of the subject - Excellent communication skills **Qualification Required:** - M. Pharm or B.Pharm & MBA **Relevant Skills / Industry Experience:** - Experience in Project Management or Portfolio Management **Location:** Head Office, Ahmedabad, GJ, IN, 380054 **Travel:** 0% - 25% **Life at Intas Pharmaceuticals:** Intas thrives on the exceptional talent of its people, fostering individual potential and collective success in a dynamic environment. The company values diverse skills and perspectives united under a shared purpose to drive innovation and excellence in the pharmaceutical landscape. **Date:** 16 May 2025,
Posted 3 days ago
4.0 - 8.0 years
0 Lacs
hyderabad, telangana
On-site
Job Description: As a Specialist in Process Development at Dr. Reddys Laboratories Ltd., you will play a vital role in the pharmaceutical development process. Your responsibilities will include conducting strategy evaluations, designing and optimizing pharmaceutical processes, calculating batch sizes, performing scale-up calculations, handling exhibit batches, and preparing technical documentation. Your expertise will ensure the successful development and scale-up of pharmaceutical products, with a focus on oral solid formulations and process validations. Key Responsibilities: - Conduct strategy evaluations to design and optimize pharmaceutical processes for efficient and cost-effective development. - Calculate batch sizes for early development and commercial production, considering critical parameters and quality standards. - Perform scale-up calculations and execute scale-up processes to transition from lab-scale to production-scale successfully. - Handle exhibit batches, coordinating activities and documentation to meet regulatory requirements and project timelines. - Prepare and maintain technical documentation, including development reports, process validation protocols, and regulatory filings. - Collaborate with cross-functional teams to drive process improvements, troubleshoot issues, and ensure product quality and consistency. - Stay updated with industry trends and regulatory guidelines, incorporating best practices and innovative technologies into the development process. Qualifications: - Educational Qualification: Masters in Pharma/Biotechnology/Chemical Engineering - Minimum Work Experience: 4-6 years of experience in Process Development/Manufacturing Skills & Attributes: Technical Skills: - Experience in process optimization, development, and troubleshooting in relevant dosage forms or technologies. - Hands-on experience in end-to-end scale-up. - In-depth understanding of process techniques, equipment knowledge, deficiency management, and product validations. - Experience in manufacturing process improvement and oral solid formulations. Behavioral Skills: - Excellent communication and interpersonal skills. - Strong analytical and problem-solving abilities. - Performance-oriented with the ability to build and leverage relationships. - Collaborative work approach with own team and cross-functional teams. Company Culture: At Dr. Reddys, we prioritize accelerating access to affordable and innovative medicines because "Good Health Can't Wait." Our work culture is driven by a common purpose and value system that fosters individual ability, teamwork, and shared success. We believe in empowering people to lead healthier lives through empathy, dynamism, and a culture that values diversity and common goals. For more information, please visit our career website at https://careers.drreddys.com/#!/,
Posted 3 days ago
10.0 - 14.0 years
0 Lacs
telangana
On-site
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. They prioritize equal employment opportunity and base their employment decisions on merit, considering qualifications, skills, performance, and achievements. The company aims to ensure that all applicants and employees receive equal opportunities in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions. They also provide reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) that offers end-to-end development and manufacturing solutions across the drug life cycle. The team serves customers globally through a network of facilities in North America, Europe, and Asia. Their services include drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. PPS specializes in the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. Additionally, PPS offers development and manufacturing services for biologics such as vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited's investment in Yapan Bio Private Limited. With a proven track record as a trusted service provider with experience across varied technologies, PPS is a preferred partner for innovators and generic companies worldwide.,
Posted 1 week ago
6.0 - 10.0 years
0 Lacs
hyderabad, telangana
On-site
As a Polymorph Screening Scientist at Morepen Proprietary Drug Research Pvt Ltd. (MPDRPL), your primary responsibility will be to lead the screening and selection of solid forms for drug candidates. You will play a crucial role in improving the physicochemical properties of active pharmaceutical ingredients (APIs) by overseeing polymorph screening activities. It is essential to identify the most stable and bioavailable forms of drug substances for regulatory submissions. Collaborating with cross-functional teams, you will mentor junior scientists and drive advancements in solid-state drug discovery. Your key responsibilities will include overseeing the screening of potential polymorphs, solvates, and hydrates for APIs, interpreting and analyzing solid-state data, scaling up identified novel polymorphs, collaborating with various teams to align polymorph selection with drug formulation strategies, preparing regulatory-compliant data for filings, troubleshooting any issues related to polymorph stability, and ensuring accurate documentation and reporting of experimental protocols and findings. The deliverables expected from you include the identification and characterization of stable polymorphs and crystal forms for drug candidates, detailed screening reports, regulatory-compliant data for solid-state forms, and methodologies for high-throughput screening, scaleup, and solid-state characterization. To qualify for this role, you should hold a Ph.D. in Pharmaceutical Sciences, Solid state Chemistry, Chemistry, or a related field, with a focus on solid-state chemistry or materials science. Alternatively, a Master's degree with equivalent experience will be considered. You should have a minimum of 6+ years of industry experience in solid-state chemistry, polymorph screening, or pharmaceutical development and proven expertise in solid-state characterization techniques and polymorph screening methods. Proficiency in solid-state characterization methods, high-throughput screening techniques, and knowledge of computational techniques for polymorph prediction are essential technical skills required for this role. In addition to technical skills, you should possess excellent problem-solving, troubleshooting, and decision-making skills. Effective communication skills, both written and verbal, are crucial for presenting complex data to diverse audiences. Being detail-oriented with strong organizational and documentation skills will contribute to your success in this role at MPDRPL.,
Posted 1 month ago
8.0 - 13.0 years
4 - 9 Lacs
Baddi
Work from Office
Lead the development and formulation of new pharmaceutical products, ensuring they meet regulatory standards and quality guidelines. Conduct research and feasibility studies to identify potential products and improve existing formulations. Formulate and test different dosage forms, including tablets, capsules, liquids, and topical products. Develop and optimize production processes, ensuring scalability, efficiency, and cost-effectiveness. Collaborate with R&D, quality control, and manufacturing teams to ensure smooth product development and transfer to production. Prepare and review documentation for regulatory submissions, including stability data and product specifications. Ensure compliance with Good Manufacturing Practices (GMP) and other regulatory standards in product development. Troubleshoot formulation issues and address challenges related to solubility, stability, and bioavailability. Monitor and evaluate the performance of products post-launch, gathering feedback for future improvements. Stay updated on industry trends, competitor products, and technological advancements in pharmaceutical development.
Posted 3 months ago
1 - 3 years
3 - 5 Lacs
Hyderabad, Gaddapotharam
Work from Office
a. Should have experience in the development of Solid Oral Dosage forms for general and potent products. b. Should be well versed with various regulatory guidelines. c. Should have through knowledge about fundamentals of pharmaceutical development. d. Good communication skills are must. Development of Solid Oral Dosage forms for general and potent products
Posted 4 months ago
6.0 - 10.0 years
9 - 15 Lacs
hyderabad
Work from Office
Job purpose: The Clinical Data Manager is a key member of Ocugens clinical data management team. This individual will be responsible for ensuring quality data collection and management processes, CRF development, database design, data monitoring, and validation of entered data for clinical development, and/or marketed products. This individual will work closely with the Biometrics team and the rest of the team at Ocugen to execute the data collection needs of the research studies. Duties and responsibilities: Establishes data flow from collection to final analysis through a data management plan. Ensures the accurate collection of electronic data. Collaborates on implementation and collection of data supporting for research protocols. Develops data transfer specifications and data review specifications and/or data quality review plan specifications. Develops program standard and study-specific electronic Case Report Forms (eCRFs). Develop and revise SOPs, implement DMP and strategies. Develop and implement risk management strategies. Prepare and participate in Audits. Develops edit checks, validation reports to ensure quality data. Provides input to project timelines and ensures that project timelines for database deliverables are met. Ensures that project tasks are completed with acceptable quality. Ensure all required documentation is completed in a timely manner. Lead junior Data management staff. Collaborates with other functional teams to ensure proper output of clinical data as needed for deliverables. Additional tasks and projects as requested. Qualifications : BS degree in clinical, biological or mathematical sciences, or related field or nursing qualification, or work- related equivalent. 6+ years direct clinical data management experience in pharmaceutical development or CRO environment. Experience with clinical trials. Experience with CRFs, and in the development process of EDC databases, IRT systems and diary applications for data collection. Strong knowledge of GCPs, ICH, FDA, and CDISC regulatory requirements governing clinical studies. Demonstrated attention to detail and outstanding organization skills. Self-motivated with a commitment to high quality, on-time deliverables. Excellent communication and collaboration skills with a team-oriented approach. Demonstrated ability to identify and resolve issues and effectively manage timelines. Experience in working with USA biopharmaceuticals/pharmaceuticals companies or client. Strong communications skills and a track record of accomplishment managing client relationships as well as regulatory agencies for USFDA and EMA. Working conditions : This position operates in an office setting, in person. Remote work will be limited. Job may additionally require incumbent to be available outside of these hours to handle priority business needs. Physical requirements: This is a largely sedentary role.
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