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9.0 - 17.0 years
0 Lacs
karnataka
On-site
As a Senior Team Leader / Senior Group Leader at Syngene located in Bangalore within the Biopharmaceutics department, you will be part of an innovation-focused global discovery, development, and manufacturing organization. Syngene International Ltd., established in 1993, offers integrated scientific services to various industries worldwide, including pharmaceuticals, biotechnology, nutrition, animal health, consumer goods, and specialty chemicals. Collaborating with renowned clients such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife, you will lead a team of scientists in developing preclinical and clinical formulations of new chemical entities (NCEs). Your responsibilities will include providing scientific leadership in the Pharmaceutics domain to identify clinically developable drug candidates through pre-formulation activities such as physicochemical characterization and polymorphism. You will lead projects and guide the team in developing formulations for pre-clinical studies, GLP toxicology studies, Phase I (FIH), and Phase II clinical studies. A good understanding of drug degradation mechanisms, biopharmaceutics risks, novel drug delivery systems, and analytical principles will be essential in your role. To qualify for this position, you should hold a Ph.D. or Post-Doctorate in Pharmaceutics, Industrial Pharmacy, Pharmaceutical Technology, or related fields with 9-17 years of relevant industrial experience. Your technical skills should encompass Pharmaceutics, Physical Pharmacy, Dosage Form Design, Drug Delivery, Chemical Degradation, and Biopharmaceutics. Moreover, your behavioral skills should demonstrate leadership abilities, effective collaboration in matrix teams, excellent communication skills, and the capacity to mentor team members. Syngene is an Equal Opportunity Employer committed to fostering a diverse and inclusive work environment where individuals are empowered to contribute their best towards achieving project objectives.,
Posted 3 days ago
4.0 - 10.0 years
0 Lacs
karnataka
On-site
At Lilly, the focus is on uniting caring with discovery to improve the lives of individuals worldwide. As a global healthcare leader headquartered in Indianapolis, Indiana, the organization is committed to developing and delivering life-changing medicines, enhancing disease management, and giving back to communities through philanthropy and volunteerism. The team at Lilly prioritizes putting people first and is dedicated to making a positive impact on a global scale. The Product Research and Development (PRD) organization at Lilly is instrumental in the development and delivery of quality medicines to patients. The diverse portfolio includes the development and commercialization of various medical products ranging from insulins to gene therapy systems. This multidisciplinary group collaborates closely with therapeutic business units and manufacturing teams to bring Lilly's clinical portfolio to patients worldwide. Located in Bengaluru, India, the Lilly Capability Centre India (LCCI) is a strategic investment aimed at attracting top talent from India's academic and professional landscape. The LCCI team works in tandem with the PRD team in Indianapolis to develop critical capabilities for Lilly and support the delivery of the organization's portfolio. As part of the PRD team, the role involves leveraging experience in solid drug product manufacturing unit operations to expedite the development of combination products and enhance manufacturability. Responsibilities include conducting risk assessments, defining critical quality attributes, implementing new manufacturing platforms, and designing manufacturing process control strategies. The position also entails leading development activities, collaborating with cross-functional teams, and contributing to regulatory strategies and submissions. The ideal candidate for this role possesses a Ph.D. in chemical engineering, pharmaceutical sciences, or a related field with relevant experience, or a B.S. or M.S. with extensive experience in a related field. Additional skills/preferences include familiarity with new platforms such as PAT and modeling tools, knowledge of oral drug delivery landscapes, project management experience, and demonstrated leadership abilities in a team setting. Lilly values diversity of thought and experience, encouraging creative solutions to address technical challenges. The organization is committed to engaging with the external environment and adopting innovative approaches across its drug product portfolio. The position may require some travel. Lilly is dedicated to providing equal opportunities for individuals with disabilities in the workforce. If accommodation is needed to apply for a position at Lilly, applicants can complete the accommodation request form for further assistance.,
Posted 5 days ago
6.0 - 10.0 years
0 Lacs
maharashtra
On-site
As a Medical Writer at Novartis Healthcare Private Limited, you will be responsible for writing, reviewing, and managing the production of high-quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. Your role will also involve providing authoritative documentation-related consultancy to other line functions and coaching, mentoring, and training less experienced writers. In this position, you will author, review, and independently manage complex Clinical Study Reports (CSR), Risk Management Plans (RMP), and other documents for health authorities. You will lead writing teams for complex submissions, contribute to key messaging and pooling strategy, and ensure compliance of documentation to internal company standards and external regulatory guidelines. Additionally, you will be an ad-hoc member of Clinical Trial Team (CTT) and extended member of Safety Management Team (SMT). You will provide input into planning data analyses, ensure compliance to internal company standards and external regulatory guidelines, and lead process improvement in cross-functional initiatives. Key performance indicators for this role include delivering high-quality clinical and safety documents in a timely manner and in compliance with internal and external standards, as well as completing an adequate volume of work per year according to Key Performance Indicators. To be successful in this role, you should have at least 6 years of medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge. Expert knowledge of the global regulatory environment, excellent communication skills, and the ability to prioritize and manage multiple demands and projects are essential. You should also have proven experience in managing global, cross-functional teams or complex global projects and the ability to motivate and coach people. At Novartis, we are committed to creating a brighter future by helping people with diseases and their families. We believe in collaborating, supporting, and inspiring each other to achieve breakthroughs that change patients" lives. Join our Novartis Network to stay connected and learn about suitable career opportunities as soon as they arise. If you require any reasonable accommodation due to a medical condition or disability during the recruitment process, please contact us at [email protected] Novartis is dedicated to building an outstanding, inclusive work environment that reflects the diversity of the patients and communities we serve.,
Posted 1 week ago
3.0 - 7.0 years
0 Lacs
karnataka
On-site
You are looking for a Study Director - Toxicology position at Syngene in Bangalore. As a Study Director, you will be responsible for overseeing GLP toxicology studies in compliance with global regulatory guidelines. Your role will involve coordinating with cross-functional teams, conducting in-life phases of toxicology studies in various animals, administering doses, collecting blood samples, and ensuring adherence to safety protocols and SOPs. Key Responsibilities: - Serve as a Study Director for in vivo toxicology studies, ensuring scientific, technical, and regulatory compliance - Coordinate with local cross-functional teams for the execution of toxicology studies - Conduct in-life phases of toxicology studies in rats, mice, and rabbits, including dose administration and blood sample collection - Utilize the Pristima data capture system for study documentation - Assist in necropsy activities, blood collection, and electrophysiology studies - Prepare for and participate in IAEC meetings, maintaining necessary documentation - Follow in-house SOPs, coordinate instrument maintenance and calibration, and archive materials from toxicology studies - Perform any other duties assigned by the line manager Requirements: - Experience: 3-6 years in toxicology with a preference for candidates with contract research organization experience - Skills: Good understanding and hands-on experience in toxicology, knowledge of toxicokinetics, pathology, and analytical chemistry - Education: MVSc At Syngene, safety is a top priority, and all employees are expected to adhere to safety guidelines, procedures, and SOPs to ensure a safe working environment. The company values excellence, integrity, and professionalism, and expects all employees to demonstrate these core values consistently. If you meet the specified requirements and are passionate about toxicology, this role at Syngene could be a great fit for you. Join us in our commitment to innovation and scientific excellence in contract research, development, and manufacturing services.,
Posted 2 weeks ago
2.0 - 7.0 years
2 - 7 Lacs
Bengaluru
Work from Office
Role & responsibilities: Perform commissioning & qualification and validation activities for biopharmaceutical manufacturing facilities in the BU. Responsible for timely preparation, review and approval of URS, DQ, IQ, OQ and PQ protocols, and reports along with operation staff and QA. Responsible for timely preparation, review and approval of other validation documents. Coordinate the Calibration Program, Preventive Maintenance Program and Alarm Management for the biopharmaceutical manufacturing facilities. Responsible for appropriate planning and timely execution along with review and approval of reports. Responsible for robust and optimal practices for maintenance and calibration program to upkeep the facilities. Responsible for establishment of appropriate Alarm Management system and implementation. Perform investigation for equipment failure to identify root cause and propose and implement appropriate CAPA to prevent reoccurrence. Participate in large & small capital projects; finalize conceptual design, basic design and detailed engineering design along with E&M team. Perform regular facility walkthroughs and internal audit for Manufacturing Plants and Operations Function to ensure adherence to the implemented systems and compliance with regulatory requirements including Data Integrity assessment. Perform Risk Management for Biologics Operations covering following elements and lead proposal and implementation of appropriate risk mitigation actions (CAPA). Quality and Compliance Risks Operational Risks of Data Integrity Risks • Perform and support timely preparation, review and approval of Standard Operating Procedures (EOP, IOP and SOP) and review of executed records. Preferred candidate profile: Engineering Commissioning & Qualification in Biopharmaceutical Industry.
Posted 2 weeks ago
0.0 - 5.0 years
1 - 6 Lacs
Pune, Ahmedabad, Mumbai (All Areas)
Hybrid
Sales of Filtration Products from leading Filtration brands in Pharmaceuticals (API & Formulation), Biopharma (Mabs, Vaccines, Other Biosimilars), Oil & Gas industries, Ultrapure Water, Digital Inks & Printers Visiting Industrial across the assigned region for pitching High Performance Industrial products for various applications. The candidate will undergo training and will be meeting key decision makers in the industry and do value selling. Candidate will hold Technical/Commercial discussions with R&D, Manufacturing, Production providing them product benefits, commercial offers, negotiations, order execution followed by payment collection. The candidate will adhere to the visit plans & provide regular visit report to Manager. Candidate will be empowered with data for Sales forecasting Monthly, Quarterly and Annually based on sales history and new developments. All new developments will be uploaded in Sales Funnel for Customer mapping and keeping Track of competitors activities in the region. Candidate will partner with the Sales Manager to meet and exceed sales targets and developing new accounts to grow the business. Role & responsibilities Preferred candidate profile
Posted 4 weeks ago
8.0 - 12.0 years
35 - 45 Lacs
Pune
Remote
On behalf of our client, WB India Pvt. Ltd. is looking for a Sales Manager to be based in India. Position Summary: The Sales Manager (SM) is responsible for actively growing and developing the Indian market, supporting sales efforts alongside the appointed distributor. This role involves protecting market share, selling on value, gathering market insights, increasing turnover, generating leads, and closing deals. This is a high-travel role with regular engagement with distributors and customers across India. Roles and Responsibilities: Sales & Business Development: Work closely with the Area Sales Manager in charge of Asia to plan the budget and align/adjust the local strategy Execute sales strategy to meet or exceed sales targets Drive sales activities and close deals with key target customers Identify/pursue new business opportunities Customer Relationship & Market Engagement: Build/maintain strong relationships with key decision-makers/influencers Use own extended network to reach key stakeholders and shorten the buying process Understand and respond effectively to customer need CRM Management & Reporting: Keep CRM data up to date (customer/contact information) Track leads, opportunities, and sales progress within the CRM system Provide regular sales reports and market insights to the Area Sales Manager responsible for Asia and management Support & Technical Assistance: Support all stakeholders in the daily business Act as the main contact for key customers (Key Account Management) Advise customers on bioprocess technology issues Provide support during installation and training on equipment Collaborate with internal teams to support customer needs and concerns Distributor Management: Support and guide local appointed distributor to achieve or exceed their sales objectives Maintain and strengthen relationships with existing distributor Ensure staff of distributor is regularly trained Evaluate performance and implement necessary improvements Market Analysis & Strategy: Gather market information (trends, competition, prices, customers, and customer demands, tender) Evaluate market potential and market share, strengths, and weaknesses in the different market segments Provide feedback to internal teams for product and strategy development Travels & Representation: Intensive travel within India (approx. 60-80%) for customer/distributor visits and trade shows Participate in international sales/distributor meetings Represent at industry events and conferences in the region of responsibility Deputy Role & Team Support: Support team members in cross-regional projects and initiatives Competencies: Strong sales and negotiation skills Demonstrate strong closing skills and a results-driven sales approach Excellent relationship management and networking abilities Deep understanding of the local business landscape Strategic thinking and problem-solving capabilities High level of self-motivation and ability to work independently Strong organizational and planning skills Qualifications: Job Skills: A university masters degree in life sciences A higher degree (masters or equivalent) in business administration, marketing, or related field is a plus Senior sales professional with a minimum of 8 years of experience in B2B sales in the life sciences biotech, or laboratory equipment industry with an extended network within the Indian biopharma industry Proven experience in achieving sales targets, driving new business, and managing long-term customer relationships Strong knowledge of bioreactors, incubator shakers, and bioprocessing technologies (practical expertise is a plus) Soft Skills: Self-motivated, reliable, goal-oriented, independent working style, and personal responsibility Passion for dealing with customers, business partners, and work colleagues from different cultures Organizational talent even in a hectic environment Strong interpersonal and persuasive communication skills IT Skills: Strong MS Office skills (Excel, PowerPoint, Word, Outlook) Proficiency in CRM (e.g., Dynamics 365 or equivalent) Languages: Fluency in English is essential (written and verbal) Fluency in German is an advantage Proficiency in local languages is highly beneficial Other languages are an advantage
Posted 1 month ago
0.0 years
1 - 1 Lacs
Bengaluru
Work from Office
Seeking aspirants for Apprenticeship: We are looking fresh graduates interested in gaining practical experience in a biotechnology plant environment. Required Qualification : •B.E / BTech/M.Tech (Chemical, Electrical, Electronics, Instrumentation, Automation, Mechanical, Mechatronics, Biotechnology, Biochemistry) MSc, BSc, B Pharm (Biotechnology, Microbiology, Life Science, Biochemistry) • Years of Graduation 2024 & 2025 (We are currently looking for freshers, not experienced candidates.) Departments: Manufacturing - Plant Operations, Engineering - Utility Maintenance and Plant Operations We are currently looking for candidates who are willing to work in production function in Biotechnology plant setup. Candidates should be prepared to in scheduled shift basis operations.
Posted 2 months ago
15.0 - 23.0 years
45 - 65 Lacs
Bengaluru
Work from Office
Role- AGM- International Business development- LATAM; East Europe / Russia CIS Company- A leading Biopharmaceutical Company Location- Bangalore Reporting To- VP- BD Roles and Responsibilities This role requires a dynamic individual with excellent analytical skills, strategic thinking, and the ability to manage complex projects and partnerships across semi-regulated markets, including Emerging Markets Latin America, Europe, . Expertise in sales and marketing within these regions is essential. Develop international business strategies to drive growth in overseas markets. Identify new opportunities for product launches and market expansions. Analyze market trends, competitor activity, and customer needs to inform business decisions. Deep & hands on understanding on the Documentation, Regulatory ecosystem/landscape, Dossier preparation to submission, facilitation at target market Identify and evaluate opportunities for in-licensing and out-licensing of Plasma Derived Products / Critical Care / Oncology / Vaccine / Biohpharma products across semi-regulated markets. Manage relationships with key customers, distributors, and partners. Will be responsible for managing International BD for regions such as- LATAM; East Europe / Russia CIS Desired Skills Post Graduation Degree in Business Management or Life Sciences. Total 15+ years of relevant pharmaceutical industry experience. Strong background in bio-pharmaceutical international business, particularly in semi-regulated markets such as Latin America, Europe, Emerging Market Expertise in sales and marketing within these regions. Sound knowledge of the global pharmaceutical industry (Biologics (Biopharm; Oncology. Critical Care, Vaccines. Strong analytical skills with advanced knowledge of Excel and PowerPoint. Excellent verbal and written communication skills with the ability to network effectively.
Posted 2 months ago
14.0 - 21.0 years
25 - 40 Lacs
Hyderabad
Work from Office
Job Description (Head R&D) 1) To build and direct a team for the development of processes for the commercial manufacture of plasma derived therapeutic proteins. The responsibilities will include the following; a) Identification of plasma derived products that can be developed for commercialisation. b) Review of published literature including patents to understand the existing product, process and formulation. c) Plan the development of scalable processes for the purification and formulation of proteins from human blood plasma. d) Plan for process validation, packaging material development, stability studies, alternate vendor development studies. e) Coordinate training, scale-up and technology transfer to production including trouble shooting for Production batches. f) To continue to evaluate the processes for improved yield and purity, incorporating the latest technologies so as to be able to deliver products that are in line with global quality standards. 2) To build and direct a team for the Analytical development of pharmacopoeial & in-house test methods for products developed by the process development team. The responsibilities will include the following; a) Identification of compendial methods for quality testing of plasma derived therapeutic products, human plasma bags received from blood banks, microbiological tests and chemical tests for raw materials/packaging materials. b) To develop in-house methods where suitable compendial methods are not available. c) To validate all test methods as per ICH guidelines d) To coordinate training and transfer of test methods to QC departments for routine batch testing and release. e) To continue to evaluate the methods and incorporate the latest test methods in accordance with the pharmacopoeial revisions to deliver good and safe quality products to the market. 3) To plan and direct a team for preparation, review and transfer of documents to QA and concerned departments. The documents will include the following; a) Process development reports (PDRs) for all products taken up in Process R&D b) Technology Transfer Dossier (TTD) for process / method to Production / QC c) Master Manufacturing Process & Formula d) Process Validation Reports e) Cleaning Validation Reports f) Analytical Method development/ qualification reports and STPs g) Technical documents for Regulatory submissions to Drug Offices and Product registrations for export to other countries.
Posted 2 months ago
6 - 10 years
0 - 0 Lacs
Hyderabad
Work from Office
a. Should be well versed with IVIVC concepts b. Should have excellent knowledge on product development and clinical studies. c. Should have hands on experience on operating various simulation tools necessary for IVIVC. d. Excellent communication skills are must.
Posted 2 months ago
3 - 8 years
5 - 8 Lacs
Bengaluru
Work from Office
Position Summary: As an Analytical Sciences Product Manager, you will play a pivotal role in developing, managing, and optimizing a portfolio of products and services in the field of Analytical and QC applications in Biotechnology. The key focus will be on Dynamic light scattering, Nano Particle Analysis, Raman and Fluorescence Spectroscopy. You will be responsible for understanding the needs of the Biopharmaceutical, academic and clinical divisions defining product strategies, and driving the development and launch of innovative solutions to address those needs. Key Responsibilities: - Market Research and Analysis: Conduct comprehensive market research to identify industry trends, customer needs, and competitive landscapes in Analytical and QC divisions with regards to Dynamic Light Scattering, Nano Particle Analysis, Raman and Fluorescence spectroscopy. Analyze and interpret trends in biopharma QC to identify emerging opportunities. Product Knowledge and Strategy: Previous experience in Dynamic Light scattering, nano particle analysis, Raman and Fluorescence spectroscopy is crucial. Develop a clear and data-driven product strategy that aligns with the company's goals and market demands. Define product roadmaps, feature sets, and pricing strategies. Product Launch and Promotion: Plan and execute successful product launches, including creating marketing and sales strategies. Develop product messaging and collateral to effectively communicate the value of our analytical solutions to Biotechnology customers. Customer Engagement: Build strong relationships with customers, industry experts, and stakeholders to understand their needs and gather feedback for product improvements. Address customer inquiries, issues, and concerns promptly. Performance Monitoring: Define key performance indicators (KPIs) and regularly track the success and adoption of our analytical products. Use data-driven insights to make informed decisions and iterate on product offerings. Regulatory Compliance: Stay informed about relevant regulations and ensure products comply with industry standards and legal requirements. Team Collaboration: Collaborate with various teams, including sales, marketing, and customer support, to drive product success. Lead and mentor cross-functional teams as needed. Qualifications: M.Sc./PhD degree with strong focus on biophysical and analytical techniques- biophysics, structural biology, nano sciences, analytical sciences etc. Proven experience in product management, preferably in Dynamic Light scattering, nano particle analysis, Raman and Fluorescence spectroscopy. Knowledge and experience of working in biopharmaceutical industry, trends and applications. Strong analytical and problem-solving skills. Excellent communication and presentation abilities. Familiarity with analytical technologies and trends. Demonstrated ability to lead cross-functional teams and manage product lifecycles.
Posted 2 months ago
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