606 Formulation Development Jobs - Page 10

About Us We are a pioneering exosome manufacturing company branching into the dermacosmetic space. Our goal is to develop next-generation skincare products featuring exosome-based actives for regenerative, anti-aging, and barrier-restorative benefits. Role Overview Reporting to the Head of R&D, you will lead the formulation and development of exosome- infused cosmetic products. You will design, prototype, and optimize formulations using exosomes and complementary biotech actives, ensuring product safety, stability, regulatory compliance, and scalability. Key Responsibilities • Formulation Development: Design creams, serums, gels, and emulsions incorporating exosomes and related advanced actives. • Lab Trials & Testing: Conduct stability, compatibility, sensory, and performance studies (e.g. efficacy, bioavailability). • Delivery System Optimization: Develop particulate or encapsulation systems for enhanced exosome and bioactive delivery. • Raw Material Collaboration: Work with suppliers for sourcing and testing new actives and packaging solutions. • Regulatory Compliance: Ensure formulations adhere to global standards (e.g. GMP, ISO, COSMOS, regional norms). • Scale-Up Process Development: Transition lab batches to pilot/production scale, troubleshoot manufacturing issues. • Documentation & Reporting: Maintain detailed R&D protocols, batch logs, SOPs, and technical reports. • Innovation & Market Awareness: Stay updated on ingredient trends and literature; propose novel formulation concepts. • Cross-functional Collaboration: Partner with marketing, quality assurance, production, and regulatory teams. • Issue Resolution: Address formulation challenges related to compatibility, texture, stability, and cost. Required Expertise • Must-have formulation experience with exosomes and at least some of the following biotech ingredients: 1. Polydeoxyribonucleotide (PDRN) 2. Exosomes (plant-derived, marine, recombinant) 3. Peptides & Proteins 4. Tremella Mushroom Extract 5. Ectoin 6. Polyglutamic Acid 7. Tranexamic Acid 8. Glutathione 9. Smart Hydration Polymers 10. Epigenetic Modulators / DNA Repair Enzymes 11. Oleyl Adapalenate 12. Gold Nanoparticles Academic Qualifications: BSc / MSc / PhD in Cosmetic Science, Chemistry, Biochemistry, Chemical Engineering, or related discipline. Technical Competence: Hands-on experience in cosmetic R&D (5 years). Proficiency in analytical techniques (HPLC, GC, FTIR, rheology, etc.). Understanding of ingredient compatibility and formulation challenges. Knowledge of delivery technologies and bioactive stabilization. Experience with regulatory compliance and product safety assessments. • Soft Skills: Strong project management, problem-solving, attention to detail. Excellent documentation and report drafting abilities. Effective collaboration and technical communication across departments.

Role & responsibilities To perform the Technology transfer of Product from R&D to Site receiving activities and QMS related activities at the manufacturing plant . To perform alternate vendor batch execution, process improvement, change in batch size, trouble shooting at shop floor, equipment change activities of product after technology transfer completion along with production team. To finalize batch sizes of scale up, exhibit and commercial batches to meet the equipment capacities and regulatory requirements with consent of R&D and production. To prepare/review relevant documents like SOP, Batch Manufacturing Record, Sampling Protocol, hold time study protocol/ report, stability study protocol/report, Process validation protocol and Report for the scale up, exhibit and validation batches. To provide technical support for change management, investigations of deviations or OOS, CAPA identification and QMS related activities at plant. Ensure cGMP and Regulatory compliance.

Hello, Position : Head Research & Development Location : Navi Mumbai Experience : Export Oriented Pigment Skills : Customize products to end-use specifications. Email : rghrsolutions2@gmail.com Thanks, Vijay G Shinde RG HR Solutions 09373815433

Good knowledge on packaging works for RD and commercial activities Knowledge on artworks designing software and coordinate between cross functional teams and also external vendors Reviewing and finalization of all level artworks as per machine trials Ensuring all the serialisation and artwork guidelines as per country regulations Handling of changecontrols, Artwork pack profiles, SOPs, specifications and other Masterpackaging records.

Develop tablet/capsule formulations for regulated markets (US/EU). Conduct pre-formulation, prototype trials, and scale-up. Execute lab, exhibit, and validation batches. Prepare technical documents for ANDA filings. Support tech transfer and respond to regulatory queries.

End-to-end formulation and development of injectable dosage forms (Liquid, Lyophilized, Emulsion, etc.) Handling of scale-up, exhibit batches, and tech transfer Cross-functional coordination with ADL, RA, QA, and Manufacturing

1.Responsible for giving line clearance between startup of various finished product formulation and filling operations. 2.Responsible for performing in process checks during finished product operations as per respective established procedures. 3.Responsible for Monitoring and Coordination of process validation, Hold time studies, media fill and cleaning validation activities. 4. Responsible for preparation of IPQA SOPs and review of finished product SOPs. 5. Responsible for preparation of Annual Product Review Reports. 6. Responsible for continued process verification reports. 7.Responsible for compliance to GMP in finished product area. 8.Responsible for review of all finished product log books. 9.Responsible for review of master MFR and executed BFRs. 10.Responsible to attend training programs and SOP trainings. 11.Responsible for preparation of media fill BFR, protocol and report. 12.Responsible for monitoring of stability samples. 13.Responsible for preparation and review of visual inspection qualification protocol and report. 14.Day to Day Manufacturing observations Report to Manager QA.

Design and execute experiments related to the formulation development of oral solid dosage forms using HME techniques. Operate and maintain HME equipment including twin-screw extruders, feeders, and associated downstream processing units (milling, compaction, etc.). Conduct pre-formulation studies, including excipient compatibility and thermal analysis (DSC, TGA). Perform process optimization and scale-up studies for HME-based formulations. Prepare solid dispersions, amorphous systems, and evaluate physical and chemical stability. Perform solid-state characterization using tools such as XRPD, FTIR, Raman spectroscopy, and microscopy.

Lead formulation and process development of HFA-based MDI products for regulated markets (US, EU, etc.). Manage drug-device combination product development , including coordination with device vendors for CMC and regulatory compliance. Coordinate cross-functionally with analytical, regulatory, clinical, and manufacturing teams to ensure timely project execution. Drive process optimization at the lab scale using QbD principles; establish control strategies for successful scale-up. Design and define product specifications in compliance with current global regulatory guidelines. Review Product Development Reports, Technology Transfer Reports , and Deviation/Investigation Reports for technical accuracy. Support regulatory query responses related to product development and manufacturing in collaboration with relevant departments. Lead technology transfer of HFA-based MDIs to contract manufacturing organizations (CMOs) for domestic and international markets. Provide technical and regulatory support for submissions including NDA, ANDA, and 505(b)(2) applications. Troubleshoot formulation-related issues during manufacturing to ensure smooth and compliant commercial production.

1. Aseptic handling. 2. Media and feeds preparation for shake flasks experiment and bioreactors batches. 3. Shake flasks handling for clone, media and feed selection. 4. Bioreactors preparation (1L,5L,20L). 5. Batch execution in small scale bioreactors and large-scale bioreactors. 6. In process sample analysis like cell count, viability, metabolites (glucose, lactate, ammonia, glutamine etc. 7. SOP preparation related to instruments and process. 8. Shift duties for batch monitoring. 9. Able to work in a team.

The candidate would be developing various analytical method (such as CD, Fluorescence spectrscopy ,CE UH/HPLC etc..)for CQA to support biosimilarity and analytical studies. Qualify method for biosimilarity and analytical studies. Responsible for performing biosimilarity, characterization and analytical studies for various molecules across lifecycle . Evaluation, interpretation and graphical representation of the measurement data as well as presentation of the results obtained from multiple experiments. Author technical documents such as MoA,MQR,SOP,study protocol and report.

Development and validation of analytical methods for injectable dosage forms Stability study execution and data interpretation Support for formulation development and regulatory submissions (US/EU) Instrument handling: HPLC, GC, UV, KF, etc. Preparation of method validation reports, protocols, and SOPs

1. Responsible for operation and cleaning of PFS/Vial filling stoppering and Sealing machine. 2. Responsible for operation and cleaning of Lyophilizer machine. 3. Responsible for involvement in aseptic media fills formulation and filling activities in aseptic areas. 4. Responsible for operation and cleaning of HPHV steam sterilizer. 5. Responsible for cleaning, preparation of machine parts and loads as per load pattern. 6. Preparation and filtration of disinfectants, IPA etc., 7. Responsible for area and equipments cleaning in FP facility. 8. Handling of APA equipments and to be involved in personnel gowning qualification. 9. Online Execution of Batch documents and related logbooks. 10. Handling of various types of filters and filter integrities. 11. Execution of preventive maintenance plan for equipments in coordination with engineering. 12. Maintaining of day to day activities in manufacturing areas. 13. Performing DQ, IQ, OQ, and PQ for the equipments in aseptic processing area and other associated areas.

1. Operation and maintenance of Instruments. 2. Receipt, storage and usage of microbiological dehydrated media and other microbiology laboratory consumables. 3. Reconciliation and maintenance of sterile media. 4. Preparation of dilute disinfectants, cleaning, reagents solutions / indicator solutions. 5. Responsible for handling of Bio-waste in Microbiology department. 6. Monitoring of temperature, DP and RH of the Microbiology laboratory. 7. Preparation, sterilization and maintenance of sterile media and reagents. 8. Review, checking and verification of all types Microbiology laboratory documents. 9. Verification of cleaning in the Microbiology laboratory. 10. Responsible for compliance to cGLP. 11. Performing the isolation, identification and confirmation tests for test organisms and Isolates. 12. Responsible for Growth promotion, inhibition test of Microbiological culture media. 13. Responsible for Biological indicator qualification, usage and testing. 14. Culture maintenance in Microbiology department. 15. Preparation and usage of disinfectants. 16. Any job allotted by Department head.

Message to applicants applying to work in the U.S. and/or Canada: When available, the salary range posted for this position reflects the projected hiring range for new hire, full-time salaries in U.S. and/or Canada locations, not including equity or benefits. For non-sales roles the hiring ranges reflect base salary only; employees are also eligible to receive annual bonuses. Hiring ranges for sales positions include base and incentive compensation target. Individual pay is determined by the candidates hiring location and additional factors, including but not limited to skillset, experience, and relevant education, certifications, or training. Applicants may not be eligible for the full salary range based on their U.S. or Canada hiring location. The recruiter can share more details about compensation for the role in your location during the hiring process. U.S. employees have access to quality medical, dental and vision insurance, a 401(k) plan with a Cisco matching contribution, short and long-term disability coverage, basic life insurance and numerous wellbeing offerings. Employees receive up to twelve paid holidays per calendar year, which includes one floating holiday (for non-exempt employees), plus a day off for their birthday. Non-Exempt new hires accrue up to 16 days of vacation time off each year, at a rate of 4.92 hours per pay period. Exempt new hires participate in Cisco s flexible Vacation Time Off policy, which does not place a defined limit on how much vacation time eligible employees may use, but is subject to availability and some business limitations. All new hires are eligible for Sick Time Off subject to Cisco s Sick Time Off Policy and will have eighty (80) hours of sick time off provided on their hire date and on January 1st of each year thereafter. Up to 80 hours of unused sick time will be carried forward from one calendar year to the next such that the maximum number of sick time hours an employee may have available is 160 hours. Employees in Illinois have a unique time off program designed specifically with local requirements in mind. All employees also have access to paid time away to deal with critical or emergency issues. We offer additional paid time to volunteer and give back to the community. Employees on sales plans earn performance-based incentive pay on top of their base salary, which is split between quota and non-quota components. For quota-based incentive pay, Cisco typically pays as follows: .75% of incentive target for each 1% of revenue attainment up to 50% of quota; 1.5% of incentive target for each 1% of attainment between 50% and 75%; 1% of incentive target for each 1% of attainment between 75% and 100%; and once performance exceeds 100% attainment, incentive rates are at or above 1% for each 1% of attainment with no cap on incentive compensation. For non-quota-based sales performance elements such as strategic sales objectives, Cisco may pay up to 125% of target. Cisco sales plans do not have a minimum threshold of performance for sales incentive compensation to be paid.

Experience : Minimum 7-10 years of hands-on experience in formulation and technological process development of various solid oral dosage forms for regulated markets such as the US, EU, and Canada. Formulation Strategy & Execution : Expertise in designing formulation and process development strategies, planning and executing activities to develop robust, scalable products within defined timelines. This includes literature reviews, pre-formulation studies, laboratory trials, and detailed documentation in electronic lab notebooks (eLNs). Product & Process Optimization : Skilled in formulation and process optimization, execution of pilot bioequivalence (BE) batches, and application of Quality by Design (QbD) principles. Familiar with bio study requirements and timelines for sample submissions. Cross-functional Coordination : Strong coordination with departments such as Analytical, Regulatory Affairs, Production, QC, Procurement, and other cross-functional teams to ensure efficient product development and execution. Involved in drafting and reviewing in-process and finished product specifications. Documentation & Compliance : Responsible for preparing protocols, technology transfer documents, stability and interim reports, and comprehensive product development reports with a focus on accuracy, compliance, and regulatory requirements (Module 3). Technology Transfer : Proficient in executing technology transfer to manufacturing sites by applying scale-up principles and supporting smooth execution at commercial scale. Regulatory Support : Experience in supervising and addressing regulatory queries is an added advantage. Additional Responsibilities : Willing to undertake additional tasks as assigned to support project success. Project Alignment : Works closely with cross-functional teams (CFTs) and aligns effectively with Project Management to meet project goals. Must have experience in working in oncology ( anti cancer ) OSD formulation.

Hands on experience in Formulation development in oral solid dosage forms on regulated markets Planning and execution of Lab scale experiments, Formula and process parameter optimization employing the concept of Quality by Design and DoE Prepare documents related to the product development such as Product development plan, Stability protocols, Product development reports

Lead global industry marketing programs Drive and execute sponsorship & participation in industry events Develop marketing artefacts and collateral along with messaging for the website Formulate & work with Inside Sales & external vendors on demand-gen programs Support the analyst relations program & garner mentions by driving participation in relevant studies

Role & responsibilities Responsible for Pre-formulation studies for lab formulation development trials of solid orals, Oral Liquid, injectable, products, and Nutraceuticals product. To design strategy for projects through literature surveys. Respective API characterization, excipients characterization, drug and excipient study and its ratio. Worked on different manufacturing strategies for the development of products. To evaluate product for stability in manufacturing, monitor and review the stabilized batches. To study on existing formulations. Responsible for co-ordination, execution and monitoring of scale up activity, Responsible for Trial batches, Scale up batches, Optimization batches, Exhibit batches. Co- ordination with all cross-functional teams. TT sites and LL Sites To design/assist/support/ review for documents such as SOP, LNB, QQ, Risk assessment, PDR, MFR, Scale up BMR, stability protocol, qualification, validation documents, change controls, deviations, investigations and CAPAs etc. Preferred candidate profile pharma THANKS YOU REGARDS MILAP RATHOD (7486829377) any time call me or whtup HR DEPARTMENT OPES HEALTHCARE PRIVATE LIMITED

Food Technology / Bio Technology / similar qualifications. 8-15 years experience in Research and Development in a food manufacturing company Required Candidate profile Experience in Research and development, New Product development, Food safety, Quality Control, Quality Assurance, Regulatory activities etc.

We are a Pharma Mfg located in Dabaspet. We are looking to hire QA Executive for our Tablets mfg and pkg dept. who will be dedicated full time. B.Pharma. Minimum Exp. (3-5 years OSD formulation). Interested send resume to watsapp 9739978848

Original Application submission Labeling development for original applications (NDA/ANDA) in accordance with RLD labeling, current FDA guidance (s) and carve outs based on patents and exclusivity claims Labeling Query responses/ REMS and Patent Amendments/ PNP Requests Thorough review/interpretation of FDA comments. Review of revised labeling and response. Tracking/ Review for Completeness/ Timely Submission of REMS correspondence/ Amendments Review of patent amendment & proprietary name review request Submission of Final Approval Requested Life Cycle Management Track RLD labeling changes Initiate labeling revision activity as per RLD label revision/safety labeling change SLC notification from FDA Submission of Labeling Supplements (CBE 0/ CBE 30/ PAS) Timely submission of REMS Review of revised artworks

- New Product Development (NPD) in Topicals - Documentation (Product Dossiers, Manufacturing SoPs, Regulatory etc) - Pilot Scale Productions - Customer Side Communications - Project Management

Dear Applicants, Greeting from Biophore India pharmaceutical Pvt Ltd, We have opening for Formulation R&D Department (OSD) Position : Executive or Sr Executive Experience : 4 - 9 Yrs Job Description: 1) Candidate must have knowledge Prototype & Product Development. 2) Must have Literature Search. 3)Scale-up Batches, Exhibit Batches, DOE Experiments. 4) PDR Preparation & Development related documentation. 5) Experience in US ,EU Markets. 6) Preparation of documents form development stage to Technology Transfer Stage. Preparation and Review of SOP,S related to formulation R&D. 7) Good Communication Skills. Ref to Friends or colleagues. Please Share me update resume: careers@biophore.com Total Exp: Current CTC: Exp CTC : Notice Period: Designation:

Job Title R&D Head (Food & Nutraceuticals) Eligibility Criteria (Experience, Qualification, Skills) Qualification: Advanced degree (Masters or Doctorate) in Food Science, Nutrition, Biochemistry, or B.Tech. in Biotechnology, food technology, or related field Experience: Minimum 15 years of experience in research and development within the food industry, with a significant focus on Ayurvedic products. Proven track record of leading successful product development projects and teams. Skills required Expertise in Ayurvedic principles and their application in food product development. Knowledge of food science, formulation, and product innovation. Leadership and strategic planning abilities. Communication and stakeholder management skills. Problem-solving and decision-making capabilities. Project management and organizational skills. Ability to inspire and motivate a multidisciplinary team. Market knowledge Key Responsibilities Lead and oversee all R&D activities related to Ayurvedic food and wellness products Provide technical expertise and guidance to the R&D team Oversee all aspects of product development in the food segment Collaborate with internal (cross-functional team) and external stakeholders Manage R&D budgets and resources effectively Ensure regulatory compliance and quality standards Establish KPI metrics and benchmarks Drive continuous improvement and innovation Job description Provide visionary leadership and direction for the R&D function, setting strategic priorities and objectives in alignment with the company's mission and business goals. Develop and implement R&D strategies aligned with business objectives, to address market needs and capitalize on emerging opportunities Lead, mentor, and inspire a multidisciplinary team of scientists, researchers, and technicians, fostering a culture of excellence, innovation, and collaboration. Oversee the entire product development lifecycle, from conceptualization and formulation to testing, validation, and commercialization. Drive collaborative research initiatives, joint ventures, and technology transfer agreements to enhance the company's R&D capabilities and accelerate innovation Ensure that all R&D activities comply with applicable regulatory requirements, quality standards, and industry best practices. Develop and manage the R&D budget, allocating resources effectively and efficiently to support priority projects and initiatives. Establish key performance indicators (KPIs), metrics, and benchmarks to monitor and evaluate the performance and impact of R&D initiatives. Stay abreast of market trends, consumer preferences, competitor activities, and technological advancements in the sector.