8 Stability Protocols Jobs

Job Position: Product development Associate Location: Mumbai HURC Business Context and Main Purpose of the Job This is an opportunity to work as an R&D Associate with Glow & Lovely (previously Fair & Lovely), the biggest skin care brand in India based in Mumbai. With this opportunity, as you work to make a real impact on business and the world, we'll work to help you become a better you! About Glow & Lovely Glow & Lovely is a leading skin care brand which serves millions of people around the world by offering safe, effective and affordable products which deliver glowing, even toned and radiant skin. Previously called Fair & Lovely, we changed our brand name to Glow & Lovely to embrace a more inclusive vision of beauty. The new name reflects the progressive changes we have been making to the brand over the years and our ongoing evolution to celebrate the diversity of beauty in India and other countries. The Glow and Lovely's, Global Product Design team (located at Mumbai) is a highly ambitious team works on the development of high impact brand innovations for our global markets across South Asia, Southeast Asia, NAMET, Africa, etc. covering 32 countries. We encompass expertise on a large range of products across the benefits platforms like Skin Brightening, Even Tone Management, Healthy Resilient Skin and Moisturisation, Face Cleansing, Protection through innovative formats and technologies benchmarked to international brands and compete them in Global marketplace. We offer an agile and open-minded environment with strong, proactive, passionate thinkers who are constantly seeking to independently work to deliver innovative technologies for business growth. In this role, you will have an opportunity to work as formulation workstream Lead, extending the end-to-end experience to design the formula and craft the product story and claims. Deliverables The incumbent would be responsible for Product Design and Development for Global Glow & Lovely R&D in skincare. S(he) would be working on various global & regional projects. The job needs continuous interaction with Global & regional R&D teams, Marketing teams, Legal, Regulatory teams as well as external agencies as part of innovative product developments. It is expected that the incumbent, during the course of his/her work, will need to achieve the following key goals: . Understand the consumer habits & needs and translate to develop formulations and product solutions as needed by the business project briefs. . Deliver to new product development briefs by designing experiments, prototyping and lab experiments, and delivering finished product. . Formulation design to fit insight, meet benchmarks, sensory, assess product stability, efficacy, formulation interaction with packaging and scale up for manufacturing. . Design of stability testing and monitoring, interfacing with analytical laboratory, execution of basic analytical tests, in line with the global stability protocol . Write formulation and process specifications and support the Technology Roll-out to the Sourcing Units. . Preparation of product technology dockets and development reports. . Operational interactions with Factories/Suppliers, Global R&D teams, etc. . Generate product/raw material specifications in PLM/Interspec. . Monitor competitor activity in terms of product quality and composition and make technical recommendations to counter competitive threats. . Contributes to patents and publications as per the need of the work/research. . Contribute proactively to identifying & supporting value improvement opportunities for portfolio of products. . Ensuring compliance with Internal Unilever protocols while developing product solutions with respect to commitment to safety, environment, claim support, specification management etc. . Work on raw material resilience initiatives. Relevant Experience post-graduate with knowledge of chemistry (preferably Pharmaceuticals/chemical engineering) with 2-4 years experience, preferably on Skin care/ Personal care product development. . Well versed with the Product Development Principles - Formulation science, material science, claims, consumer testing. . Well versed with R & D Processes and Protocols - stability protocols and formulation assessments with basic laboratory tools, analytical tests and instrumentation. . Tech Savvy - Well versed with handling digital tools and platforms. Required Professional skills . Good knowledge of Biology, experience in formulation design. Claims/CTI experience for personal care products would be an added advantage. . Digital Savviness and the data driven approach would be essential. . Basic understanding of analytical methods and microbiology. . Excellent spoken English & presentation skills a must. . Good interpersonal skills and a team player, . Agile, proactive and enthusiastic working style . Design thinking & Creativity Critical SOL (Standards of Leadership) Behaviors PERSONAL MASTERY : Sets high standards for themselves. Has emotional intelligence to take feedback, manage mood and motivations, and build empathy for others. PASSION FOR HIGH PERFORMANCE: Generates intensity and focus to motivate people to deliver results at speed. Takes personal responsibility and accountability for execution and results. TALENT CATALYST: Invests in people - coaches individuals and teams to realize their full potential. Creates an inclusive climate, empowering everyone to be at their best. PURPOSE & SERVICE: Has humility, understanding that leadership is service to others, inside and outside Unilever. CONSUMER LOVE: Invests time inside and outside to understand the needs of consumers. BUSINESS ACUMEN: Creates sustainable growth with purpose, engaging different partners across the system for change. Our commitment to Equality, Diversity & Inclusion Unilever embraces diversity and encourages applicants from all walks of life! This means giving full and fair consideration to all applicants and continuing development of all employees regardless of age, disability, gender reassignment, race, religion or belief, sex, sexual orientation, marriage and civil partnership, and pregnancy and maternity.

As a Quality Control Laboratory Specialist, your primary responsibility will be to ensure compliance with Standard Operating Procedures (SOPs) and regulatory requirements within the laboratory. You will be required to provide training to QC Associates on SOPs and current regulatory standards based on review observations. Additionally, your role will involve reviewing a variety of analytical data including Finished, Intermediate, Raw Material, and Stability samples. It will be your duty to meticulously review electronic data and compare it with hard copies to guarantee the accuracy of the analytical results. You will also be responsible for examining Stability Protocols, schedules, data sheets, as well as master lists of instruments and equipment, along with their respective Qualification documents. Furthermore, you will play a crucial role in reviewing Preventive Maintenance and Calibration schedules, along with the Calibration data of all Analytical Instruments housed within the Quality Control laboratory. You will also be tasked with reviewing Method transfer/verification/validation protocols and reports, including the raw data, as well as evaluating Reference Standards/Working Standards and their respective Certificates of Analysis. In order to ensure the consistency of analytical trends, you will be expected to prepare quality comparison sheets for all dispatched materials. Your role will also involve reviewing monthly comprehensive assessment reports, laboratory errors, invalidations, and Analyst Qualification raw data. Additionally, you will need to conduct an audit trail review of all standalone instruments and Empower systems within the Quality Control department, as well as reviewing certificate of analysis documents. Key Competencies required for this role include excellent verbal and written communication skills, persuasiveness, strong inter-personal skills, adaptability, foresight, and a solid understanding of business processes. If you possess these competencies and are ready to take on the responsibility of maintaining quality standards within the laboratory, we encourage you to apply for this position.,

Azurity Pharmaceuticals is a specialty pharmaceutical company dedicated to providing innovative products for underserved patients. With a focus on unique, accessible, and high-quality medications, Azurity continuously expands its commercial product portfolio and late-stage pipeline through integrated capabilities and a vast partner network. The company's patient-centric products cover various markets including cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan, benefiting millions of patients globally. As an inclusive workplace and Equal Opportunity Employer, Azurity attributes its success to a talented and dedicated team committed to improving patients" lives with a strong emphasis on science and quality. We are looking for individuals who are highly motivated, possess integrity, dedication, and a creative spirit to excel in our organization. **Job Responsibilities:** - Design, supervise, and conduct formulation development, process optimization, scale-up, and manufacturing of products. - Prepare and review essential documents including batch records, SOPs, stability protocols, specifications, and reports. - Analyze test results, identify variances, and recommend solutions to achieve project goals. - Schedule experiments, prioritize assignments, and meet project objectives and deadlines. - Maintain laboratory equipment and adhere to company safety standards. - Conduct laboratory experiments, prepare detailed reports with conclusions, and recommendations. - Develop and follow laboratory procedures to meet project objectives efficiently. - Identify and manage potential risks within complex projects promptly. - Maintain accurate documentation of experimental methods and results as per good documentation practices. - Serve as the primary scientific contact for external collaborators. - Manage inventories of supplies and raw materials. - Ensure completion of all required training on time. **Qualifications And Education Requirements:** - M. Pharm or Ph.D. in Pharmacy with a minimum of 3 to 6 years of industrial experience in pharmaceutical development and product scale-up. - Expertise in oral dosage forms, particularly in Modified Release, Extended Release, Targeted Release, Immediate Release solid/suspensions/solutions. - Experience in Global Product Development across markets like US, EU, China, and ROW. - Experience in developing branded and differentiated products, preferably in the 505(b)(2) category. - Familiarity with working with CROs/CDMOs is preferred. - Proficiency in Microsoft Office applications. By applying for this role, you confirm your ability to fulfill the job responsibilities outlined in the job description without any restrictions. If you have any concerns or disabilities that may affect your performance, please inform HR in advance.,

The Associate, Regulatory Affairs is responsible for supporting regulatory efforts related to the submission of supplemental ANDAs, ANDA Annual Reports, Drug Listing, SPL/PLR (labeling), and other regulatory compliance matters to assist the company's approved product portfolio, both internally and externally. Key responsibilities include: - Compiling and submitting Post Approval Supplements such as PAS, CBE-0, CBE-30. - Preparing, reviewing, and submitting amendments and supplements for assigned products. - Preparing, reviewing, and submitting responses to the Agency's queries for assigned products. - Compiling and submitting Global Annual Reports. - Reviewing stability protocols and reports. - Reviewing analytical method validation protocols and reports. - Reviewing raw material, packaging material, finished product specifications, finished product stability specifications, and testing procedures. - Reviewing batch records. - Reviewing Process Validation Protocols, hold time study protocols, and reports. - Reviewing Product Development Reports. - Reviewing executed documents including executed BMR, Certificate of Analysis to ensure compliance with regulatory requirements.,

As a remote analytical support specialist at PPL sites, your main responsibility will be reviewing analytical data and preparing essential documents such as specifications, test methods, and protocols. You will be uploading documents for review in ENSURE and initiating QMS elements in TrackWise/eDMS. Additionally, you will also prepare and review stability protocols and reports, as well as perform stability data trending and analysis. Your day-to-day tasks will involve reviewing analytical data generated in the analytical lab, including cleaning verification data, IPC, raw materials, intermediates, finished products, stability, and method validation data in compliance with cGMP, GDP. You will also review various reports for accuracy and completeness, such as method validation reports, stability reports, and lab equipment calibration reports. It is essential to have knowledge of analytical data review tools like Empower, Chromeleon, Open-Lab, Lab-Notebooks, and LIMS/QMS module. Furthermore, you will be responsible for creating and revising working test methods to support analytical testing and managing Change Request Forms via the TrackWise system. You will perform data trending and out-of-trend analysis to identify OOT results and ensure compliance with specifications and quality standards for external data generated by laboratories. Collaboration with the site team to address review deficiencies and developing, revising, and reviewing stability protocols in accordance with ICH guidelines will also be part of your role. Qualifications required for this position include a degree in B. Pharm / M. Pharm / M.Sc. Chemistry / B.Sc. Chemistry or equivalent. Additionally, you will be expected to participate in customer audits, regulatory inspections, and handle any other tasks assigned by the Head of Department. This is a full-time position located at Project: Piramal Agastya, PRL Agastya Pvt Ltd., LBS Marg, Kamani Junction, Mumbai, Maharashtra, 400070, IN. The job identification number is 8774, with the posting date set for 06/03/2025, and the application deadline on 06/30/2025.,

As a Formulation Scientist at BacAlt, you will be responsible for conducting research and development activities, performing laboratory experiments, and developing formulations in the field of transforming post-harvest waste into valuable biopolymers. Your role will be based in Bengaluru and will involve hands-on work in the laboratory, problem-solving, and meticulous documentation of research findings. Additionally, you will play a key role in the technology transfer processes to scale up formulations from the lab to production. To qualify for this position, you must hold an M.Sc. or Ph.D. in Cosmetic Science, Chemical Engineering, Polymer Chemistry, or a related field. You should have a minimum of 4-8 years of hands-on formulation experience in personal care, pharma, or advanced materials, with at least 2 years of experience in sourcing or qualifying novel ingredients. Proficiency in global cosmetic or medical-device regulations such as REACH, FDA OTC, BIS, ISO 10993/16128 is essential. You should also possess a strong analytical toolkit including experience with instruments like rheometer, DSC/TGA, FT-IR, HPLC, and accelerated-stability protocols. A proven track record of successfully taking a lab concept to pilot or commercial launch will be an advantage. It would be beneficial if you have a network of sustainable ingredient suppliers in SAPMENA or EU, experience in the procurement of new materials and ingredients, authorship on patents or peer-reviewed papers in biopolymers, and familiarity with life-cycle analysis and eco-label criteria. In return, we offer early-stage equity along with a competitive salary, direct ownership of breakthrough projects that influence global beauty brands, access to a state-of-the-art lab and pilot trays, and a rapid decision-making culture. You will also have a learning budget, opportunities for conference travel, and mentorship from industry veterans.,

The responsibilities for this role include reviewing raw and finished product specifications, ensuring good laboratory practices in the Quality Control department, reviewing audit trial records, analyzing analytical records, reviewing instrument calibration and equipment qualification documents related to QC, validating analytical methods, verifying samples, handling reserve sample room, ensuring analyst qualification, reviewing working standards, managing deviations, change control, OOT, OOS, laboratory incidents, investigations, and annual trends, coordinating CAPA implementation verification and closure, reviewing instrument and equipment preventive maintenance, monitoring and recording temperature and humidity in the laboratory area, and managing document control. The ideal candidate should possess skills in audit trial, OOT, deviation handling, OOS, backup and restoration data management, sample handling, instrument maintenance, quality assurance, instrument calibration, laboratory practice, laboratory incidents management, change control, method edit forms, working standards review, analytical records analysis, quality control, document management, equipment qualification, stability protocols, analyst qualification, analytical method validation, CAPA implementation, and temperature monitoring.,

The Regulatory Affairs Senior Associate role involves being responsible for the preparation, compilation, evaluation, and submission of ANDAs & Amendments to USFDA. This position also entails handling deficiencies and ensuring the timely submission of responses to the agency. Your main responsibilities will include coordinating with cross-functional teams and stakeholders such as R&D, Quality, manufacturing, SCM, IP, and PM, along with vendors when necessary. You will be tasked with evaluating documents in accordance with current regulatory requirements. Additionally, you will need to review various documents including Product Development Reports, Batch Records, Specifications, Analytical Procedures, Validation Protocols and Reports, Certificates of Analysis, stability protocols, and reports. You will also be responsible for reviewing vendor documents related to API, Excipients, and Packing materials to ensure adequacy and compliance. Furthermore, you will be involved in the preparation, review, and compilation of ANDAs, Amendments, and Supplements in eCTD format. Collaboration with the Regulatory Operation team member for uploading submissions in eCTD software and reviewing exported submissions for submission will be part of your routine tasks. It is also essential to monitor the FDA website for any updates. To qualify for this role, you should possess a Master of Pharmacy in the Department of Pharmaceutics and have at least 3-5 years of experience in Regulatory Affairs.,