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0.0 - 1.0 years
0 Lacs
Thane
Work from Office
Responsibilities: 1. Assist in formulation and pre-formulation studies. 2. Support development of stability and bio batches. 3. Help in maintaining lab records, BMR/BPR, and SOPs. 4. Coordinate with cross-functional teams (QA/QC/Production). 5. Perform basic lab tests and data recording. Who can apply: 1. Are pursuing M. Pharmacy (preferably in final year) 2. Are available for full time (in-office) internship 3. Are available for duration of 6 months 4. Have relevant skills and interests
Posted 2 months ago
3.0 - 8.0 years
3 - 7 Lacs
Hyderabad, Chennai
Work from Office
Role & responsibilities Analytical Research & Development (ARD) [API & FORMULATIONS] Experience in method validation, Method development and method transfer of new analytical methods by HPLC. Develop, optimize and validate new analytical methods for key starting materials, Intermediates and Active Pharmaceutical Ingredient products. Preparation of analytical method validation protocol, raw data and analytical method validation report as per ICH requirements. Manage and execute transfer of analytical methods from AR&D to internal QC. Analytical regular support for Process development team. Analytical regular support for Alternative vendor development projects. Perform hands on Residual solvents Unknown peak identification and quantification by GC troubleshooting. Maintenance of lab compliance such as calibration schedules etc. Performing a Qualitative and Quantitative tests which include analysis of raw materials, APIs and in process samples. Adequate Knowledge in Wet Lab Analysis. Formulations Research & Development [FRD] Entrusted with the task of conducting research and support activity In Formulation Department and handling various projects like Oral Solid Dosage forms (Tablets, Capsules), Liquid Dosage forms etc. Proactively involved in formulation of Robust, Stable. Cost effective, Time effective various enzyme preparations s/a Solid Oral Dosage Forms like Tablets (Dispersible, Film coated, and IR) & Capsules. Preparation of Product Development Report, Master Formula Card, various SOPs etc. Actively involved in planning, review of analysis related activities, Installation and calibration of various analytical instruments. Scale-up and technology transfer of Softgel capsules, Spray drying and Beadlets technology. Product improvement and cost reduction of existing products. Coordination with marketing and analytical team or successful completion of projects Trouble shooting and quality improvement of existing products Preparation and review of Master manufacturing document (MMD), NPD documents, batch manufacturing record (BMR), product development report (PDR) , HACCP plan and Technology Transfer documents. Process Research & Development (PRD) [API] Monitoring and planning of experiments with team. Recording the daily lab experiments as per cGMP and preparing weekly planning report. Preparation, identification, characterization and control of process related impurities and GTIs. Ability to complete the project with in stipulated time lines. Developing chemical processes for APIs and intermediates. Optimizing and validating the process at the lab,pilot and plant scale. Adequate response to the queries raised by competent regulatory bodies. Preparation of process development report(PDR) and technical packages. Co-ordinating with cross functional teams, collecting the data and supporting in the preparation of product development report. Identify & solve the plant related queries such as OOS OOT, CAPA. Obey & follow the safety norms. If interested, please share your resumes to jayakishore.gollapalli@srikrishnapharma.com
Posted 2 months ago
4.0 - 8.0 years
4 - 6 Lacs
Gurugram
Work from Office
: - Excellent knowledge of products Manufacturing of Colour Cosmetics personal care, Skincare, Cream, Shampoo, Hair Oil, Conditioner, Face Wash, Body Wash, Body Lotion and Foot Care ,Lipstick, Nail Polish Etc. Lay down procedure to implement GMP & GLP norms and ensure documentation & compliance Define AQL for incoming raw material and components Develop vendor base to meet cost, quality (manufacturing and product), and innovation requirements Development of new formulation as per the business demand Preparation of documents & Registration of product, label compliance with regulatory authorities - local & overseas. Skills :- Must come from the personal care background. Worked for the majority of their career in the development of formulations for personal care products. Familiar with cosmetics compliance requirements for EU, US FDA. Ready and able to work on multiple product formulations at the same time, with a view to develop potentially new products.
Posted 2 months ago
5.0 - 10.0 years
0 - 0 Lacs
Vadodara
Work from Office
Alembic Pharmaceuticals Limited is looking Sr. Research Scientist or Team Leader for Complex Injectable (Formulation & Development) based at our Injectable R&D Vadodara. Role & Responsibilities : Demonstrate expertise in drug device combination product (pen injector/auto injector/PFS) development device suitability, functionality testing as per ISO standards and comparative threshold analyses etc. Hands on experience in Peptide based injectable product development & peptide characterization to prove the sameness. Good understanding of Immunogenicity concept & bioassay for peptide. Proficient in technology transfer of device based products, Suspension products , terminally sterilized and lyophilized products bottleneck/gap identification & trouble shooting Good understanding of intellectual property with focus towards developing a non-infringing strategy for patent claims and develop a Para IV strategy for first to file products Able to evaluate and design the strategy for 505 (b) (2) products proof of concept studies and regulatory requirements Having sound understanding for regulatory query response Have good experience in - briefing book preparation, biowaiver control correspondence and Pre-ANDA meeting Understanding of QbD applicability and Statistical tool in Product development to ensure built in quality Hands on expertise in Designing & monitoring product development strategies - Literature, Patent landscape, Sourcing, Pre-formulation, Prototype development, Formulation & Process Optimization etc. Interested Candidates may share their CV to msnt@alembic.co.in with position title : "SRS or Team Leader-Injectable".
Posted 2 months ago
2.0 - 6.0 years
4 - 8 Lacs
Aurangabad
Work from Office
Role & responsibilities: Formulation and drug product development for biosimilar products with special focus on insulin and insulin analogues Design and execute the experiments for pre-formulation and formulation process development for biosimilars and optimization ensuring its stability and efficacy Conduct stability studies as per guidelines and Perform analytical testing using advanced analytical instruments such as SEC-HPLC, RP-HPLC etc. Document experimental data and preparation of SOPs, protocols and Reports Preferred candidate profile: Must have basic understanding of container closure system like vial, cartridge, PFS etc. Must be familiar with regulatory requirements (USFDA, EMA) for biologics development Must have operational knowledge of HPLC/UPLC systems for protein characterization and impurity profiling Must have good understanding of fill finish manufacturing operation
Posted 2 months ago
2.0 - 5.0 years
2 - 4 Lacs
Mumbai, Thane
Work from Office
Assist in formulation development of solid, liquid, semi-solid & parenteral/ Injectable dosage forms. Perform literature & patent search, pre-formulation studies, documentation, data compilation & ensure SOP/GMP compliance for global market products. Required Candidate profile Execution of process evaluation, optimization,scale-up and exhibit batches/Meeting product development timelines/literature survey/ICH guidelines/Injectable/Solid Oral Share CV- stuti.naik@enaltec.com
Posted 2 months ago
2.0 - 4.0 years
4 - 6 Lacs
Mumbai
Work from Office
Under general supervision of lab team leader, independently perform routine scientific research tasks using standard techniques, procedures and equipment. Adapt and optimize or develop new methods and procedures, actively contribute to technical solution finding process. Propose solutions and discuss with manager Show engineering and tech transfer proficiency Assist and support to R & D team and cross functional team in scale-up of new products technology Troubleshoot & or improve existing processes Summarize and document results in lab journal, prepare technical reports. Maintain clean working laboratory environment and suitable working equipment. Perform general lab assignments (e.g. raw material inventory review, lab instruments ) as assigned. Comply with regulations concerning safety, health and environment
Posted 2 months ago
6.0 - 11.0 years
8 - 12 Lacs
Navi Mumbai
Work from Office
Department: R&D Biotech (Downstream Process) at Airoli, Navi Mumbai Role: Downstream Process & Formulation development Opportunity: This role provides an opportunity to learn and grow to an advance level of expert in the field of downstream processing & formulation development of Recombinant Biotherapeutics Proteins. Role & responsibilities Development of non-infringing downstream purification process for cell culture based biotherapeutic proteins towards submission in India & various regulated countries. Understanding developmental requirements for India, ROW & regulated market (Phase-I & III) and their fulfilment during development of respective geographies. Responsible for end-to-end process optimization of all purification unit operations viz. chromatography (Affinity, IEX, HIC, etc.), UF/DF TFF, Nanofiltration, etc. towards optimization of overall DSP process. Should carry out troubleshooting in least possible time. Fine execution of day-to-day purification works at lab and active, productive coordination with cell culture and analytical groups for timely completion of project. Responsible for Scale up and technology transfer along with manufacturing support during troubleshooting at mfg. site. If required, ensuring the physical presence at manufacturing site during critical scale up/GMP batches like clinical batch, engineering batch, PV batches, etc. Regular biweekly updates to vertical heads with conclusion of performed experiments and way ahead. Align the overall development work, experiments with project deliverable timelines and company goals. Empower the team with frequent scientific discussions and energizing them for more productive outcome. Preferred candidates Candidate should be a good team player and comfortably connect inter & intra departmental teammates with expedited productive outcome. Need to demonstrate and continue implementing good documentation practices with data traceability. Should inculcate a scientific acumen in team members and exhibit a good leadership. Strong communication Candidate should be well versed with latest developments in purification techniques and look forward for implementing them in process. Should be expert in handling and troubleshooting of DSP related instruments including purification systems, TFF systems, Nanofiltration, etc.
Posted 2 months ago
0.0 - 1.0 years
2 - 3 Lacs
Ahmedabad
Work from Office
Formulation development of NCE projects, generic projects and line extension projects Preparation/review of literature summary and development report to the assigned product. Involve in execution and/or supervision of formulation development, process development and manufacturing of GMP batches of assigned product. Preparation/review of technical documents, which includes but not limited to MFC, BMR, BPR and Stability protocol following GDP. Representation in departmental audit Follow GxP (GMP, GDP etc.) for all processes and train the subordinates to follow the same. Execution and/or supervision of scale up/pilot scale batches in pilot plant under GMP condition. Preparation and/or review of technology transfer documents and technology transfer to manufacturing site, whenever required. Preparing/reviewing of QMS includes but not limited to change control, deviation, SOPs and OOS Communication with cross-functional team and client via mails, meetings and oral communication Qualifications M. Pharm (Pharmaceutics)
Posted 2 months ago
1.0 - 2.0 years
7 - 10 Lacs
Ahmedabad
Work from Office
Role & responsibilities 1. To develop Stable and Bioequivalent solid oral products for US, Europe, ROW and Domestic Markets. 2. Technology transfer of developed products to plant level, this includes all TTD-related works. 3. To collect and compile all data and submit to respective regulatory agencies. 4. To address DCGI/ regulatory agency queries as per requirement. 5. To extend support to plant for any commercial trouble shooting. Preferred candidate profile Only for Phd Candidates
Posted 2 months ago
2.0 - 5.0 years
4 - 5 Lacs
Chennai
Work from Office
Job Description: Job Responsibilities & Duties: Literature survey for the research area. Executing experiments in R&D for product development. Planning for daily experiments. Developing new biobased products for company in the area of cleaning agents including surfactancy products, dispersing agents, etc. Familiar with enzymes, priobiotics related product handling. Developing prototypes for range of products based on companys technology. Collaborating with marketing team to run troubleshooting experiments for market products. Handling of analytical instruments including HPLC, spectrophotometer, pH, TDS, viscometer, etc. Well aware with analytical skills including titration, preparation of standard solutions, standard calibration methods, etc. Results & data writing, Preparing reports & result summary. Job requirements: A successful candidate will have: A profound knowledge of organic chemistry, biochemistry, or biotechnology. Experience working on biobased cleaning products is preferred. A Masters degree in a scientific discipline from an accredited college/university and minimum 2+ years of experience in biotechnology/organic synthesis. An inquiring mind, intense curiosity, and strong desire to innovate in the biotech/organic synthesis field. ***** Interested Candidates can share their profile to raksha@proklean.in *****
Posted 2 months ago
3.0 - 5.0 years
60 - 84 Lacs
Navi Mumbai
Work from Office
M pharma if they have 5 years of experience or more or Ph.D. and less than 3-5 years of experience in nanoparticles, specifically lipid nanoparticles, nano emulsion,Pharma R&D Office cab/shuttle Health insurance Provident fund Annual bonus
Posted 2 months ago
2.0 - 5.0 years
4 - 7 Lacs
Bengaluru
Work from Office
Person at this position has gained significant work experience to be able to apply their knowledge effectively and deliver results. Person at this position is also able to demonstrate the ability to analyse and interpret complex problems and improve change or adapt existing methods to solve the problem. Person at this position regularly interacts with interfacing groups / customer on technical issue clarification and resolves the issues. Also participates actively in important project/ work related activities and contributes towards identifying important issues and risks. Reaches out for guidance and advice to ensure high quality of deliverables. Person at this position consistently seek opportunities to enhance their existing skills, acquire more complex skills and work towards enhancing their proficiency level in their field of specialisation. Works under limited supervision of Team Lead/ Project Manager. Roles & Responsibilities Responsible for design, coding, testing, bug fixing, documentation and technical support in the assigned area. Responsible for on time delivery while adhering to quality and productivity goals. Responsible for adhering to guidelines and checklists for all deliverable reviews, sending status report to team lead and following relevant organizational processes. Responsible for customer collaboration and interactions and support to customer queries. Expected to enhance technical capabilities by attending trainings, self-study and periodic technical assessments. Expected to participate in technical initiatives related to project and organization and deliver training as per plan and quality. Education and Experience Required Engineering graduate, MCA, etc Experience: 2-5 years Competencies Description Application Protocol & Engines - Android engineer is one: who has done one or more of the following wrt Android application framework: design, development/customization, bug fixing/sustenance who has experience in one or more of the following domains Multimedia Telephony Connectivity Sensor Security Platforms- Mandatory to have worked on one or more of the following; Android Technology Standard- NA Tools- Mandatory to have worked on one or more of the following: Android studio; Eclipse; Git; Gerrit;adb;Android emulator;DDMS; top;ps; meminfoBugzilla Languages- Mandatory to have worked on one or more of the following: Java; Java Native Interface Specialization- TELEPHONY, MULTIMEDIA, CONNECTIVITY, GENERIC FRAMEWORK
Posted 2 months ago
5.0 - 8.0 years
7 - 10 Lacs
Bengaluru
Work from Office
Person at this position takes ownership of a module and associated quality and delivery. Person at this position provides instructions, guidance and advice to team members to ensure quality and on time delivery. Person at this position is expected to be able to instruct and review the quality of work done by technical staff. Person at this position should be able to identify key issues and challenges by themselves, prioritize the tasks and deliver results with minimal direction and supervision. Person at this position has the ability to investigate the root cause of the problem and come up alternatives/ solutions based on sound technical foundation gained through in-depth knowledge of technology, standards, tools and processes. Person has the ability to organize and draw connections among ideas and distinguish between those which are implementable. Person demonstrates a degree of flexibility in resolving problems/ issues that atleast to in-depth command of all techniques, processes, tools and standards within the relevant field of specialisation. Roles & Responsibilities Responsible for requirement analysis and feasibility study including system level work estimation while considering risk identification and mitigation. Responsible for design, coding, testing, bug fixing, documentation and technical support in the assigned area. Responsible for on time delivery while adhering to quality and productivity goals. Responsible for traceability of the requirements from design to delivery Code optimization and coverage. Responsible for conducting reviews, identifying risks and ownership of quality of deliverables. Responsible for identifying training needs of the team. Expected to enhance technical capabilities by attending trainings, self-study and periodic technical assessments. Expected to participate in technical initiatives related to project and organization and deliver training as per plan and quality. Expected to be a technical mentor for junior members. Person may be given additional responsibility of managing people based on discretion of Project Manager. Education and Experience Required Engineering graduate, MCA, etc Experience: 5-8 years Competencies Description Application Protocol & Engines - Android engineer is one: who has done one or more of the following wrt Android application framework: design, development/customization, bug fixing/sustenance who has experience in one or more of the following domains Multimedia Telephony Connectivity Sensor Security Platforms- Mandatory to have worked on one or more of the following; Android Technology Standard- NA Tools- Mandatory to have worked on one or more of the following: Android studio; Eclipse; Git; Gerrit;adb;Android emulator; DDMS;top; ps;meminfoBugzilla Languages- Mandatory to have worked on one or more of the following: Java; Java Native Interface Specialization- TELEPHONY, MULTIMEDIA, CONNECTIVITY, GENERIC FRAMEWORK
Posted 2 months ago
2.0 - 5.0 years
4 - 7 Lacs
Bengaluru
Work from Office
Person at this position has gained significant work experience to be able to apply their knowledge effectively and deliver results. Person at this position is also able to demonstrate the ability to analyse and interpret complex problems and improve change or adapt existing methods to solve the problem. Person at this position regularly interacts with interfacing groups / customer on technical issue clarification and resolves the issues. Also participates actively in important project/ work related activities and contributes towards identifying important issues and risks. Reaches out for guidance and advice to ensure high quality of deliverables. Person at this position consistently seek opportunities to enhance their existing skills, acquire more complex skills and work towards enhancing their proficiency level in their field of specialisation. Works under limited supervision of Team Lead/ Project Manager. Roles & Responsibilities Responsible for design, coding, testing, bug fixing, documentation and technical support in the assigned area. Responsible for on time delivery while adhering to quality and productivity goals. Responsible for adhering to guidelines and checklists for all deliverable reviews, sending status report to team lead and following relevant organizational processes. Responsible for customer collaboration and interactions and support to customer queries. Expected to enhance technical capabilities by attending trainings, self-study and periodic technical assessments. Expected to participate in technical initiatives related to project and organization and deliver training as per plan and quality. Education and Experience Required Engineering graduate, MCA, etc Experience: 2-5 years Competencies Description Application Protocol & Engines - Android engineer is one: who has done one or more of the following wrt Android application framework: design, development/customization, bug fixing/sustenance who has experience in one or more of the following domains Multimedia Telephony Connectivity Sensor Security Platforms- Mandatory to have worked on one or more of the following; Android Technology Standard- NA Tools- Mandatory to have worked on one or more of the following: Android studio;Eclipse;Git; Gerrit;adb;Android emulator;DDMS; top;ps; meminfoBugzilla Languages- Mandatory to have worked on one or more of the following: Java; Java Native Interface Specialization- TELEPHONY, MULTIMEDIA, CONNECTIVITY, GENERIC FRAMEWORK
Posted 2 months ago
4.0 - 8.0 years
0 - 1 Lacs
Meerut, Muzaffarnagar
Work from Office
Research and development scientist Have deep knowledge about fertilizer granular manufacturing . Chemical and manufacturing knowledge Required Candidate profile NPK MANUFACTURING EXPERT
Posted 2 months ago
3.0 - 8.0 years
8 - 10 Lacs
Manesar
Work from Office
DESIGNATION: Assistant Manager-R&D FUNCTION: Research & Development REPORTING TO: Chief R&D Officer LOCATION: Manesar EMPLOYMENT TYPE: Permanent Roles and Responsibility: . Responsible for developing new products. Process developing, verifying, implementing and maintaining which leads to a safe, hygienic and quality product conforming to standards and company requirements. Carry out Shelf life studies. Ability to manage a team in order to undertake trials in manufacturing facility. Ensure all raw materials and finished good recipes created are FSSAI compliant. Manage Supervision and monitoring of cleaning and sanitation procedures of lab equipment, cleanliness of the laboratory. Responsible for adequate storage and proper disposal of materials as per company requirements Ensure the calibration of lab equipment as per company requirements. Maintaining personal hygiene of self and lab staff to maintain GMP and GHP score. Ability to find the root cause analysis & corrective action plan WHAT YOU WILL NEED: Effective Team player Adhere to company's administrative policies and procedures. Ability to understand and manage the objective and targets of the departments. Work in environment friendly manner by using resources intelligently and reducing wastages. Ability to participate in cross-functional teams to achieve specific goals and objectives. Basic Computer knowledge (MS office, Internet surfing) B.Tech. in Food Technology Minimum 3 years experience in Food Industry either in R&D or Product Application. What We Expect: Our culture is built on mutual trust, integrity, and ethical conduct. We prioritize transparency, accountability, and respect to foster collaboration. Employees are encouraged to take ownership, act responsibly, and build strong professional relationships. Together, we create a workplace rooted in trust and shared commitment. WHAT WE PROMISE At Hector Beverages, we promise an environment built on trust, fairness, and integrity, where every individual feels valued and empowered. We believe in open communication, ethical leadership, and a workplace that nurtures transparency and inclusivity. Our commitment to innovation means that employees will always have the support, tools, and freedom to experiment, take risks, and bring bold ideas to life.
Posted 2 months ago
2.0 - 5.0 years
3 - 7 Lacs
Mumbai
Work from Office
Job Responsibilities - Lead electronic laboratory notebook (ELN) software administration and management. Provide ELN trainings to new joiners. Connect with third party and internal stakeholders on regular basis for implementation and troubleshooting. - Literature survey as per order forms. - Supervision of experimental work in laboratory. - Ensure laboratory safety and compliances - Ensure availability of raw materials and equipment required for the execution of experimental planning - Understand the safety aspects of all reactions and chemicals to be used in laboratory - Play the role of ERT and shift incharge - Perform night duties as per site philosophy -To ensure 100% compliance on ERA and zero safety incidents in lab - Laboratory management: disposal of samples, disposal of chemical waste, chemical inventory - Equipment maintenance: ensure PM of allocated instruments and inventory of spares
Posted 2 months ago
12.0 - 22.0 years
14 - 24 Lacs
Greater Noida
Work from Office
Role & responsibilities: 1 -Design activity _new shade development. 2-Line troubleshooting line issue resolution (Filter chocking, patch mark). 3-NPD and Continual improvement in quality of products. 4-Robotic application of paint. 5-Handling routine activities and quality standards to meet requirements. 6-Paint formulation quality & cost optimaisation for New Customer Developement. 7-Continuously provided technical support to manufacturing function, supply chain, technical service team and customer end to ensure smooth functioning of the line. 8-Have fair Knowledge of automotive, refinish painting process, frequent defects and their remedies including PT & CED. Preferred candidate profile: 1- Process handling and documentation. 2-Plant operation controlling ability. 3-Material and equipment maintenance. 4-Planning and scheduling. 5-Quality monitoring and improvement. 6-Research & Development skill 7-Team Management experience of Technical/R&D team. 8-Excellent communication. 9-Improve Customer satisfaction & reduce Customer complaints. 10-Candidate must be only from Paint Industry.
Posted 2 months ago
5.0 - 10.0 years
5 - 11 Lacs
Gurgaon/ Gurugram
Work from Office
Role & responsibilities 1. To undertake literature search & preparation of report for a new development project. 2. To execute development trials as part of prototype development till technology transfer of new drug products at the manufacturing sites. 3. To guide & supervise development trainees or associates during development of new formulations. 4. To prepare Master documents of MFC / MFR / BMR / BPR /PVP / Development reports for submission & validation batches. 5. Material Master creation of Material code/ Vendor code in ERP. 6. MIC creation of Raw material / Packing material / Finished products in ERP. 7. Applying Test / Import / Manufacturer Licenses 8. Involving all Development QA activities & ensure compliance. Preferred candidate profile M. Pharm/ Ph.D in Pharmacy Interested Candidates can share their resumes on shikha.mishra@walterbushnell.com
Posted 2 months ago
6.0 - 10.0 years
6 - 10 Lacs
Gurugram
Work from Office
Key Responsibilities: Lead cross-functional project management activities across Quality, Regulatory, different R&D ancillary functions, and manufacturing sites. Be a bridge between development teams, QA, RA, and other key departments. Coordinate development and tech transfer projects and ensure timely completion of tasks. Identify and resolve plant/site-related issues efficiently. Ensure project timelines and quality standards are met. Ideal Candidate Profile: 6-10 years of relevant experience in pharma project management. Strong communication and stakeholder management skills. Proven ability to multitask and drive teams towards results. Relevant technical exposure to QA/RA/R&D functions is highly desirable. Experience in tech transfer will be an added advantage. Education PG: M. Pharmacy in Any Specialization Interested Candidates can share their resumes on shikha.mishra@walterbushnell.com
Posted 2 months ago
12.0 - 20.0 years
9 - 15 Lacs
Hosur
Work from Office
Greetings! We are looking for Formulation Research & Development Scientist - Injectables for a leading Pharmaceutical company based at Hosur location. Responsibility: 1. Develop robust formulations and processes for general products to various markets such as Regulatory, Semi-regulatory, ROW, and Domestic with application on QbD as needed. 2. Monitoring and supporting the formulation team for the completion of allocated projects within the timelines by trouble shooting the concerns involved. 3. Scale-up and optimization of manufacturing process; execution of pre-exhibit and exhibit batches; scale up and technology transfer from R&D to production to meet timeIines. 4. Plan and contribute to project-related scientific/technical activities (e.g., interpret results, critical assessment of data, draw relevant conclusions, and write reports). 5. Author technical documents including Product Development Report, Quality Overall Summary and other relevant documents for filing purpose. 6 Interaction with API/Excipient manufacturers, CROs and CMOs as needed. 7. Interaction with external testing laboratories as needed. 8. Work proactively with other cross-functional groups to execute all product related activities such as Manuticturing and Packaging master records, SOPs and protocols etc. 9. Co-ordination with other Dept. like Purchase. QC/QA, RA, ADD, Production Eng. etc. related to product development activity. 10. Review SOPs, as well as appropriate documentation and test results for accuracy and coin pleteness and coinpl iance with SOPs/GM P requirement. 11 . Coordinate with RA for fiI ing AN DAs and addressing deficiencies; provide relevant documents to Regulatory Affairs in a timely man ner for ANDA fil ings and Supplements filing. 1 2. Review of batch records, process characteri xation reports, validation reports and investigation reports. Interested Candidates Kindly share your updated cv to uma@bvrpc.com
Posted 2 months ago
10.0 - 15.0 years
14 - 19 Lacs
Ahmedabad
Work from Office
Job Description JOB Details Position : Manager - Formulation and Development, Dermatological OTC Products Job Location : Ahmedabad- Bhopal About the Role: We are seeking an experienced formulation professional to lead the development of dermatological OTC products across the US, Europe, Australia, New Zealand, CIS, and Rest of World markets. This role encompasses end-to-end ownership of formulation activities, including both new product development and enhancements to existing products. The ideal candidate will demonstrate a strong track record in delivering robust, stable, and cost-effective formulations that align with defined target product profiles, timelines, and budgets. Additionally, the position requires a proven ability to drive innovation in formulation approaches, contribute to intellectual property generation, and ensure seamless technology transfer from development to commercial manufacturing. Key Responsibilities: Product Development Lead end-to-end formulation development for derma OTC products, from concept creation to commercial scale-up, developing robust formulations that meet target product profiles, regulatory requirements, and manufacturing constraints. Design and execute stability studies to ensure product efficacy throughout shelf life while optimizing existing formulations to improve efficacy, stability, sensory attributes, and cost-effectiveness. Partner with packaging development to ensure compatibility between formulations and packaging components, evaluating and selecting appropriate packaging materials that consider product stability, usability, and regulatory compliance. Benchmark our existing formulations against successful reference products in international markets, ensuring our developments align with global quality standards while maintaining our competitive edge. Technical Leadership Provide scientific expertise on dermatological active ingredients, excipients, and delivery systems, while applying innovative approaches to solve complex formulation challenges. Stay current with emerging technologies and scientific advances in topical/dermatological OTC products, serving as a technical resource for cross-functional teams on formulation matters. Project Management Manage multiple development projects concurrently, prioritizing resources effectively while creating and adhering to project timelines, budgets, and resource plans. Identify and mitigate technical risks throughout the development process, documenting and communicating development progress, challenges, and solutions to stakeholders. Team Leadership Supervise and mentor formulation executives while fostering a collaborative environment that promotes innovation, continuous improvement, and capability building within the formulation team. Collaborate effectively with cross-functional teams including Regulatory Affairs, Manufacturing, Quality, and Management Team to ensure seamless product development and commercialization. Manufacturing Support Lead technology transfer of new formulations to manufacturing sites and support scale-up activities and process development for commercial manufacturing. Troubleshoot manufacturing issues related to formulation aspects and develop and maintain standard operating procedures for formulation processes. Qualifications Education & Experience Master's or PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field, with 10 years of handson experience in formulation development of topical/dermatological products. Proven expertise in developing OTC products in alignment with regulatory standards, with a strong track record of taking formulations from concept to successful commercial scale-up for the US, Europe, Australia, New Zealand, CIS markets Technical Expertise In-depth knowledge of dermatological product formulations such as creams, lotions, gels, and ointments, with a strong understanding of excipient functionality, stability, and compatibility. Familiarity with OTC monographs and regulatory requirements for dermatological products, along with experience using formulation design software and statistical design of experiments (DoE). Leadership & Strategic Skills Proven project management abilities with experience handling multiple projects simultaneously, along with strong verbal and written communication across all organizational levels. Demonstrated problem-solving skills and scientific curiosity, complemented by team leadership experience, including coaching and mentoring capabilities. Please Expedite and Send the Updated Resume Along with requested details and confirmation of interest. Regards, Pooja Raval - Sr. for detail discussion, if your Profile is relevant.
Posted 2 months ago
10.0 - 15.0 years
8 - 12 Lacs
Ahmedabad
Work from Office
Job Description JOB Details Position : Manager - Formulation and Development, Nasal-Based OTC Products Job Location : Ahmedabad- Bhopal About the Role: We are seeking an experienced formulation professional to lead the development of nasal-based OTC products including nasal sprays, throat sprays, and nasal inhalers across the US, Europe, Australia, New Zealand, CIS, and Rest of World markets. This role encompasses end-to-end ownership of formulation activities, including both new product development and enhancements to existing products. The ideal candidate will demonstrate a strong track record in delivering robust, stable, and cost-effective formulations that align with defined target product profiles, timelines, and budgets. Additionally, the position requires a proven ability to drive innovation in formulation approaches, contribute to intellectual property generation, and ensure seamless technology transfer from development to commercial manufacturing. Key Responsibilities: Product Development Lead end-to-end formulation development for nasal-based OTC products, from concept creation to commercial scale-up, developing robust formulations that meet target product profiles, regulatory requirements, and manufacturing constraints. Design and execute stability studies to ensure product efficacy throughout shelf life while optimizing existing formulations to improve efficacy, stability, sensory attributes, and cost-effectiveness. Partner with packaging development to ensure compatibility between formulations and specialized delivery systems (sprays, inhalers, etc.), evaluating and selecting appropriate packaging materials that consider product stability, usability, and regulatory compliance. Benchmark our existing formulations against successful reference products in international markets, ensuring our developments align with global quality standards while maintaining our competitive edge. Technical Leadership Provide scientific expertise on nasal delivery systems, active ingredients, excipients, and preservative systems, while applying innovative approaches to solve complex formulation challenges specific to nasal/throat administration. Stay current with emerging technologies and scientific advances in nasal drug delivery systems and formulations, serving as a technical resource for cross-functional teams on formulation matters Project Management Manage multiple development projects concurrently, prioritizing resources effectively while creating and adhering to project timelines, budgets, and resource plans. Identify and mitigate technical risks throughout the development process, documenting and communicating development progress, challenges, and solutions to stakeholders. Team Leadership Supervise and mentor formulation executives while fostering a collaborative environment that promotes innovation, continuous improvement, and capability building within the formulation team. Collaborate effectively with cross-functional teams including Regulatory Affairs, Manufacturing, Quality, and Management Team to ensure seamless product development and commercialization Manufacturing Support Lead technology transfer of new formulations to manufacturing sites and support scale-up activities and process development for commercial manufacturing of nasal sprays, throat sprays, and inhalers. Troubleshoot manufacturing issues related to formulation aspects and develop and maintain standard operating procedures for formulation processes. Qualifications Education & Experience Master's or PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field, with 10 years of handson experience in formulation development of nasal/respiratory products. Proven expertise in developing OTC nasal products in alignment with regulatory standards, with a strong track record of taking formulations from concept to successful commercial scale-up for the US, Europe, Australia, New Zealand, CIS markets. Technical Expertise In-depth knowledge of nasal drug delivery systems, formulation principles for nasal sprays, throat sprays, and nasal inhalers with special focus on isotonicity, pH, viscosity, and preservative systems. Strong understanding of excipient functionality, stability, and compatibility specific to nasal/respiratory applications. Familiarity with OTC monographs and regulatory requirements for nasal products, along with experience using formulation design software and statistical design of experiments (DoE). Experience with specialized testing methods relevant to nasal products (spray pattern analysis, droplet size distribution, delivered dose uniformity, etc.). Leadership & Strategic Skills Proven project management abilities with experience handling multiple projects simultaneously, along with strong verbal and written communication across all organizational levels. Demonstrated problem-solving skills and scientific curiosity, complemented by team leadership experience, including coaching and mentoring capabilities. Please Expedite and Send the Updated Resume Along with requested details and confirmation of interest. Regards, Pooja Raval - Sr. for detail discussion, if your Profile is relevant.
Posted 2 months ago
3.0 - 6.0 years
0 Lacs
Bengaluru
Work from Office
production management,machine maintenance,Formulationn knowledge,packing knowledge,manpower planning ,RM,PM planning,Batch manufacturing record. Preferred candidate profile
Posted 2 months ago
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