200 Formulation Development Jobs - Page 4

Job Title: F&D Executive Experience: 23 Years Department: Formulation & Development (F&D) Location: Prahladnagar, Ahmedabad Reporting To: F&D Manager / R&D Head Job Description: We are looking for a skilled and detail-oriented F&D Executive with 2–3 years of hands-on experience in pharmaceutical formulation development. The ideal candidate should possess a solid understanding of global regulatory guidelines (e.g., ICH, USFDA, EMA) and strong expertise in dissolution method development. The role involves supporting product formulation, optimization, and technology transfer activities in line with international quality and compliance standards. Key Responsibilities: Develop and optimize formulations for new and existing products across various dosage forms. Conduct pre-formulation studies, compatibility studies, and stability evaluations. Design and execute dissolution method development and validation as per international guidelines (USP, Ph. Eur., JP, etc.). Prepare and maintain technical documentation including MFRs, BMRs, development reports, and validation protocols. Ensure compliance with global regulatory requirements (ICH, USFDA, EMA, WHO) throughout development stages. Support scale-up, exhibit batch preparation, and technology transfer to manufacturing. Collaborate with cross-functional teams including QA, QC, Regulatory Affairs, and Production. Required Skills & Knowledge: In-depth knowledge of worldwide regulatory guidelines related to formulation and dissolution. Hands-on experience with analytical instruments and dissolution testing (e.g., USP Apparatus I & II). Familiarity with cGMP, GLP, and ICH Q8/Q9/Q10 guidelines. Strong technical writing, documentation, and data interpretation skills. Ability to work in a fast-paced, cross-functional environment with attention to detail.

Amneal Pharmaceuticals is looking for Officer, Process Development to join our dynamic team and embark on a rewarding career journey Develop and optimize manufacturing processes Support trials, validation, and scale-up activities Analyze data to improve yield and efficiency Ensure compliance with regulatory standards

Role & responsibilities Formulation Research And Development (FRD): Executes and supports formulation research & product development activities of the company to meet the pre-determined goals. Develops the formula based on information collected through literature search, innovator product details, pre-formulation studies and requirements as applicable for product and process design. Studies the effect of changing levels of key excipients such as taste masking agents, film formers, disintegrants, plasticizers etc. to establish the robustness of formulation. Finalization of excipients along with specifications and the finalized formula to yield a satisfactory physical and chemical properties including alternate excipient sourcing for optimization. Prepares SOP for the relevant R&D activities and documents like PIF, PDP, PDR, MFR. Supports the documentation of Test license NOC, Test license, Product filing for DCGI and FSSAI Product license. Supporting for execution of Pre-exhibit (Feasibility/ Scale-Up/optimization/ Pilot BE/ Placebo) batches. Raw materials sourcing Performs daily calibration of analytical/weighing balances and pH meter as per requirement. Environment, Health & Safety (EHS): Key Skills and Qualifications: Knowledge of EHS Regulations and Standards: Understanding and applying relevant regulations, such as ISO 14001, ISO 45001, and OSHA regulations. Risk Assessment and Hazard Identification: Identifying potential hazards in the workplace, including chemical, physical, biological, and ergonomic risks. Safety Program Development and Implementation: Creating and implementing safety programs, policies, and procedures. Training and Education: Providing training to employees on safety procedures, emergency response, and relevant regulations. Inspection and Monitoring: Conducting regular inspections of equipment, facilities, and work processes to ensure compliance with safety regulations. Incident Investigation: Investigating incidents, accidents, and near misses to identify root causes and implement preventative measures. Record Keeping and Documentation: Maintaining accurate records of EHS-related activities, inspections, training, and investigations. Compliance with Regulations: Ensuring compliance with environmental, health, and safety regulations and standards. Reporting and Communication: Preparing reports, communicating EHS information to management and regulatory bodies. Emergency Response: Developing and implementing emergency response plans and conducting drills. Promoting a Safety Culture: Fostering a positive safety culture within the organization. Staying Updated on Best Practices: Keeping abreast of the latest EHS regulations, standards, and technologies. Mechanical Engineering: Hands on experience on maintenance of HVAC and utility systems For maintenance of equipment's like Air handling units, process equipments, chillers, water plant, boiler, ETP & STP, Compressors, lab gases and all other utilities Perform installation, maintenance, and repair of pharmaceutical machinery. Troubleshoot and resolve technical issues promptly. Conduct regular inspections and preventive maintenance. Ensure compliance with safety and industry regulations. Collaborate with production teams to optimize machinery performance. Document service activities and generate detailed technical reports. Provide training to end-users on machinery operation and maintenance. Preferred Male candidates.

Position of Formultion and developments for Nutraceutical and probioceuticals in different dosages forms (Powder / Tablet/capsule/liquid doses form). To perform trials for new products ,Preformulations studies, In process development and testing,

Role & responsibilities To formulate and conduct evaluations and due diligences related fragrancing products including deos, perfumes, talcs and emulsion products. Product Development Activities: Literature Survey, Batch Making, Stability Studies, Product Analysis, Sensory Evaluation, Documentation Preferred candidate profile Qualifications : Masters in Chemistry/ Bio Chemistry/Cosmetic Technology Work Experience : 2-4 Experience in personal care FMCG industry & Experience in formulation development of fragrancing products/ personal care (alcoholic base, emulsions and coloured products) including Deos, perfumes, antiperspirants, fine fragrances etc. Skills : Sound understanding of Personal Care Products formulation, Willingness to learn, Good at Communication, Clarity in thoughts, Enthusiastic, Self-driven Hands-on experience in formulating fragrancing products, and emulsions in relevant delivery formats of fragrancing products. Experience in olfactive evaluations Knowledge : Raw Material Analysis and Qualification, Prior knowledge on Fragrancing Product Development an Advantage. Exposure to Good Lab Practices, Safe Handling of Chemicals in a Laboratory Environment and Scale Up Operations of batches a plus. Should have an appreciation of the regulatory landscape applicable to the category such as BIS, IFRA, EU, CIR, etc.

Purpose of the job Accountable for: Efficient contribution to Tender execution (including TT Agreements) over Transfer Activities (S,D). Efficient contribution to Project execution over Transfer Activities (S,D,R). TT processes and tools deployment and improvement (S,D,R) . Efficient Data sharing with Transfer Stakeholders (Donor/Receiver; Project/Metiers/Sites) (S,D,R). Position in the Organization Organization Structure See standard PME organization chart. Organizational Reporting Reports hierarchically to the Site PME Manager Reports operationally to the Project Manager Reports functionally to the TT Process Owner Team (*depends on scope) People (*): 0 direct report Network and links Industrial Community from Donor and Receiver Sites. Site TT Process representative. Tender and Project Core teams Mission & Responsibilities Objectives Achieve Project and Tender QCD objectives for TT. (D,R) Manage TT Team, IMP, Transfer Document, Manage Training and Assistance. (D, R) Support site construction on demand (for greenfield or brownfields). (S, D) Contribute to improve process efficiency and active data sharing (best practices, REX ). (S, D, R) To ensure TT common way of working and to use of TT best practice. (S, D, R) To develop and maintain common TT data Library (processes, tools, contract) (S, D) Responsibilities Set-up, execute and maintain TT Plans (D). This covers all Industrial activities (PME, Production, Testing, Quality, Supply Chain, Assistance to Sub-Contractor). Analyze Transfer Risk and Drive Related Action Plan (D). Connect and coordinate Donor and Receiver mtier stakeholders (D, R). Manage IMP (R) . Ensure IMP validation by Donor (D). Manage TT Data/Documents (DML, Transmittal Sheet, RFC, translation..) (D, R) Define and Execute relevant Training and Assistance Plans (D, R) Ensure Transfer activities are performed within AT EHS standards. Deploy and propose improvement of TT Standards and Processes. (S, D, R) Develop TT understanding and competencies over sites and mtiers (S, D, R). Key Performance Indicators KPI n1: Project Transfer success (QCD & KPIs): (D) Transfer Gate reviews, IMP completion and verification , Documentation List, RFC, Work Package Reviews, Workload (ADEL) Consolidated Planning (Facilities, Documentation batches, Industrial Master Plan milestones, Receiver Staffing plan, Training, Assistance). KPI n2: Training and assistance evaluations. (D) KPI n3: Data sharing (best practices, relevant reporting) (R,D) KPI n4: Audits status (Customer/Internal) (D,R) KPI n5: Central weekly reporting for (S). Ref TT SharePoint Indicator (S). KPI n6: Site process reviews report shared on TT SharePoint (S). Candidate requirements Educational Requirements Graduate in engineering. English fluent mandatory. Desired Knowledge / Experience Industrial background with 5 to 10 years experience preferably in the railway industry (rolling stock or component business). Experience in Project or Industrial QCD management. Familiar with IS common tools. Behavioral Competencies Conscientious. Commits and delivers. Good leadership. Team Player. Spirit of Team Trust Action Decisive. Obtains and uses necessary information to make decisions. Refers decision to others when appropriate. Self-Motivation, anticipation and autonomy. Logical and organized. Good communication to interface organisation and customer. International and network mindset. Availability for travels

Role & responsibilities Prepare, review and submit regulatory documents for new drug applications, product registrations, amendments and renewals to the US, Brazil, EU, India and State Level authorities. Regulatory Submissions : Prepare and submit regulatory documents, including INDs (Investigational New Drug Applications) and NDAs (New Drug Applications) to regulatory authorities. Compliance and Licensing: Ensure compliance with regulatory requirements of US, Brazil, EU & India. Liaise with regulatory authorities for drug licensing, including product registrations, renewals and manufacturing licenses for local and international markets. Ensure timely submission of import licenses and NOcs (No Objection Certificates) for imported pharmaceutical products. Regulatory Strategy: Provide strategic input on regulatory requirements for new product development, lifecycle management and post-market activities, including regulatory intelligence gathering and competitive landscape analysis. Cross Functional Collaboration: Collaborate with R&D, Clinical, Quality, Manufacturing and Marketing teams to ensure alignment with regulatory strategies and compliance. Regulatory Health Authority Communication: Act as a liaison between the company and regulatory agencies to address questions or requests regarding regulatory fillings and approvals. Documentation and Reporting: Maintain accurate and up-to-date records of regulatory agencies submissions, communications with regulatory authorities and product approval status. Regulatory Training: Assist in training internal teams on regulatory requirements and best practices to ensure overall compliance across departments. Audit and Inspection Management: Coordinate with regulatory bodies in the event of audits, inspections or investigations. Preferred candidate profile Education: Bachelor's degree in Life Sciences (Pharmacy, Biology, Chemistry or related field). Advanced degrees (e.g. Master's or Ph.D.) are a plus. Experience: Minimum 05 -07 Years of experience in Regulatory Affairs, with a focus on regulatory submissions and drug licensing in the pharmaceutical industries. Knowledge: In-depth knowledge of regulatory requirements (FDA, EMA, ICH, etc.) drug development processes and regulatory submission strategies.

Key Responsibilities: Product Development & Sensory Innovation Lead the formulation, pilot trials, and commercialization of innovative premix and dry-mix nutraceuticals. Develop and refine flavour profiles using botanicals, bioactives, and natural essences. Conduct structured sensory evaluations and reduce rejection rates through scientific feedback integration. Scientific Research & Market Insight Track global and regional market trends to drive innovation and new product ideas. Conduct literature reviews, ingredient functionality studies, and competitive benchmarking. Generate a robust product pipeline aligned with functional and clean-label trends. Process Optimization & Scale-Up Lead process development from lab to plant, ensuring optimal scale-up and production efficiency. Collaborate with QA, manufacturing, and marketing teams to address formulation challenges and improve go-to-market timelines. Regulatory Compliance & Documentation Ensure 100% adherence to quality, safety, and documentation protocols (GMP, FSSAI, ISO). Support regulatory dossier preparation and coordinate with compliance bodies. Maintain accurate formulation, testing, and process documentation. Scientific Communication & IP Support Draft technical reports, whitepapers, and assist in patent strategy. Liaise with academic/research institutions and international collaborators. Must Have: Education: B.Sc/M.Sc- Food technology, Phd food technology is preferable. Experience: Minimum 10 years of relevant experience in NPD, scientific formulation, and nutraceutical innovation . Expertise in premix and dry-mix formulation , sensory evaluation, and ingredient functionality. Strong knowledge of GMP, FSSAI, USFDA, EMA, and SOPs . Hands-on experience in pilot-scale development and commercial scale-up . Proven success in managing cross-functional product development teams . Good to Have: Exposure to international collaborations or academic-industry partnerships. Experience with patent filing , IP strategy, or tech-transfer documentation. Knowledge of clean-label formulation , plant-based nutrition, or botanical actives. Familiarity with QbD frameworks , regulatory dossier compilation, or functional claims substantiation. Proficiency in market research, competitor analysis , and innovation forecasting tools.

Role & responsibilities Company : RSPL Group is more than 6,000 Cr diversified conglomerate, which is committed to value for money propositions & credited with several innovations over last 3 decades. The sagacity to weave its business around consumer needs has conferred RSPL Group with a distinct value and identity. Efficient capital structure, cutting edge technology, operational discipline and a widespread distribution network, have together attributed to enhance RSPL Group and enabled the organization to deliver value to consumers. Diversified Group having product category in FMCG, Dairy Products, Hygiene Care, Foot wear, Real Estate, Renewable Energy. This position belongs to HCD Vertical Job Responsibilities: 1) Lead overall raw materials, product lab tests process and the present the results in a right format and time. 2) Perform the validation tests for new test methods. 3) Regularly evaluate market samples and maintain proper records for the same. 4) Responsible for the preventive maintenance, calibration and proper functioning of the lab equipment. 5) Document knowledge, make the clear report and maintain the security of the result as required by RSPL policy. 6) Maintain expertise in at least one area of the company's technology as a Researcher for Feminine Care products. 7) Skillful handling of critical lab test equipment especially for those of Sanitary Napkin testing and evaluation. 8) Experience into pulp, paper & Non- woven. Number of positions : 1 Job Location- Kasna Industrial Area, Greater Noida Office Timings- 09:30 am to 06:00 pm 2nd & 4th Saturday are off. Contact HR: Ms. Nancy Goyal Email- nancy.goyal@rsplgroup.com

Work Experience (Total number of years/ experience/ background or equivalent) : Total experience (in years): 15 Experience in current role (in years): 6.5 Years Work Background: Formulation Development, Technology Transfer, Root Cause Investigations, Project Management Primary Job Function - To drive technology transfer for Third party manufacturing, Loan license projects, Abbott s own manufacturing plants. To support Abbott site MS&T team as per requirements. To support Alternate supplier qualification of raw materials & API. To comply with the regulatory, quality, statutory, EHS and Pharmacovigilance requirements. Core Job Responsibilities - To perform effective gap analysis between sender & receiving site in process & equipment and to provide solution for smooth technology transfer. To prepare Master formula record & Technology transfer protocol for products identified for transfer. To Review receiving site s draft documents pertaining to manufacturing, process validations & analysis of product under transfer & executed documents post validation. To execute validation batches and to ensure validation batch reproducibility is demonstrated in commercial batches. To review executed process validation batch documents & support FLQR approvals. To service, trouble shoot and solve production process problems at manufacturing site. To acquire sufficient process understanding at current manufacturing site to enable effective investigations of commercial batch failure or market complaints and to contribute towards appropriate CAPA. To carry out due diligence of new sites with focus on formulation and required infrastructure and support new product acquisitions & product certifications. To work towards improving knowledge base for handling of Parenteral products in addition to the other dosage forms such as Oral solids, Oral liquids, Topicals, etc. To extend technical support and batch execution (as applicable) to activities like Alternate Supplier Qualification and Material Harmonization. To initiate, review & approve change controls in Soltraq. To author, review & approve technical documents in Darius. To extend support to NPI activities like Dossier review, Product certification & FLQR approval. To extend support to I&D for new product launches, review & approval of technical documents, batch monitoring & FLQR approval. To keep track of ongoing projects and update senior management beforehand.

Role & responsibilities 1. Formulation & Development for emerging & regulated market. 2. Execution of Lab Trial batches & Tech Transfer activities at site. 3. Lab note book writing & documentation ensuring compliance with regulatory guidelines \ Preferred candidate profile - Experience in Tablets, Capsule, Pellets, ER, SR, and DR product development for emerging market.

KEY RESPONSIBILITIES: Develop new processes, or refine existing ones, to optimize the scale up of lab batches in factory. plan, carry out and supervise process trials in laboratories & pilot trials. Develop tech transfer documents along with formulation team. Plan the scale up batches aligning with stakeholders. scale up the production process via trials, making changes to raw materials or components, and process parameters to ensure quality is maintained during large-scale production. To run the stability studies of pilot batches, assist the lab team in running stability studies. work with product pipelines at various stages of development and provide guidance on scalability. develop formulae specifications by taking pilot trials. advise on equipment modification to enable process changes for new product development. read and write technical reports and specifications, maintaining appropriate records. initiate and generate ideas based on reading and research. Adhere to GMP practices. Adhere to safety & quality standard operating procedures. Identify and Implement Process improvement projects. Follows and supports current Good Manufacturing Practices and current Good mfg/Laboratory Practices Cross-functional collaboration: to work closely with R&D, Quality Assurance, Quality Control and Manufacturing SKILLS: a. scale up of lab batches in factory. b. Read and write technical reports and specifications. c. Experience in cosmetic production facility, worked as manufacturing chemist handled production d. Having good exposure on ISO 9001-2015 & ISO 22716 requirements e. Mastery of office tools such as Excel, Word, Power Point, and Sharepoint f. Problem-solving mindset g. Excellent communication

Role & responsibilities New Product Development/ R&D: Provide expert insights regarding the new formulations from AYUSH pharmacology with reference of scientific literature, standard textbooks & new scientific developments. Evaluate and analyse drug drug interaction if the ingredients are used from ayurveda, Unani, homeopathy or Nutraceuticals. Detailed knowledge of all classic ayurvedic formulations & good acumen of new Nutraceutical types with high bioavailability. Production: Conduct sample batch for human testing in the inhouse lab Technical Documentation: To make RM & FG specifications. To create label drafts, SOPs, Label content for ayush products and SOPs and regulations related to food products (FSSAI) Preferred candidate profile Clinical experience in Ayurveda/ Herbal medicines, with a focus on holistic and preventive care. Proven expertise in managing complex health conditions using Ayurvedic principles. Email : monisha.lahiri@randstad.in

Job Title: Management Associate MPD – AMA Contract Resource Department: MPD-BB, AMA PHC Location: Andheri East Chakala, Mumbai Position Type: Full-Time, Contractual Vacancies: 1 Job Description: We are seeking a Management Associate to support the MPD – AMA team on a contractual basis. This role involves key responsibilities in pharmaceutical documentation, data management, and coordination to ensure efficient support to formulation and analytical development teams. Key Responsibilities: Setup of Enovia DSM for formulation parts and documentation. Compilation and tracking of stability study data for review and approval in Enovia. Raise and manage Change Controls in Veeva QA system for MPD department (CCPs in scope). Maintain status trackers for ongoing/pending CCPs and ensure timely closure and action item follow-ups. Support the MPD Process and Analytical teams with preparation of batch records and other regulatory documentation. Create Coupa Purchase Orders (POs) based on verified quotations. Perform QC Soft entries for reports on stability data, raw material samples, and protocol documentation. Coordinate with the MPD lab team for: Disposal of laboratory waste. Dispatching samples for external testing with accurate documentation. Updating records for destruction of leftover stability samples. Assist in TT document and supplier qualification reviews . Liaise with RM suppliers for collection and review of material qualification and safety documents . Perform additional tasks as assigned by the MPD team. Qualifications: B. Pharm / M. Pharm from a recognized institution. Experience: Minimum 2 years of relevant experience in Formulation Development (F&D) and Technology Transfer functions in a reputed pharmaceutical company. Key Skills: Familiarity with Veeva QA, Enovia DSM, QC Soft, and Coupa Strong knowledge of pharmaceutical documentation and stability study processes Experience in Change Control and Regulatory Compliance Good communication and coordination skills Proficient with MS Teams, SharePoint, and Email correspondence

Role & responsibilities Conduct pre-formulation and formulation development of new pharmaceutical dosage forms (solid, liquid, semisolid, etc.). Perform compatibility studies for Drug-Excipient interactions. Design and execute laboratory-scale and pilot-scale trials . Develop and optimize manufacturing processes , ensuring scalability and reproducibility. Maintain batch manufacturing records (BMRs) and development reports . Support analytical development teams with stability and validation studies. Assist in technology transfer to production and contract manufacturing sites. Ensure adherence to GMP, GLP, and regulatory guidelines (e.g., USFDA, MHRA, WHO). Collaborate with cross-functional teams: QA, QC, Regulatory Affairs, and Production. Troubleshoot formulation and process-related issues. Participate in product lifecycle management and cost optimization initiatives. Preferred candidate profile Strong knowledge of formulation principles and pharmaceutical excipients . Experience in process optimization and scale-up . Familiarity with equipment like granulators, tablet presses, blenders, etc. Attention to detail and documentation accuracy . Good communication, problem-solving, and team collaboration skills.

Role & responsibilities Formulation development of Injectable FORMULATION for regulated market, USA and Europe. To carry out product development trials, process optimization trials, scale up trials and exhibit batches at manufacturing plant. Literature search of new products, to conduct pre formulation studies, other studies like Tubing studies, compatibility studies and filter studies. Preparation of development protocols, QbD/Risk assessment documents, technology transfer documents and product development reports. Ability to carry out investigations, troubleshooting exercises related to development, scale up and exhibit batches. Preferred experience on Lyo product and colloidal Iron product development.

Key Responsibilities: Search and review scientific information / literature Drafting, submitting applications with all necessary information to RA for related Licenses required for Product Development. Identify and propose formulation strategy for product development. Read, discuss and plan Developmental activities, bring Innovation in work and adopting Digital Initiatives while doing scientific work. Visualize the developmental needs of the product. Work along with Cross functional team towards to meet project milestones as per timelines. Use Scientific approach to mitigate challenges during development, scale up and Technology transfer of the product. Qualification M.Pharm/Phd(Pharmaceutics): Experience- 2-6 years Additional Information

Role & responsibilities 1. Literature Search, Pharmacopoeia and Patent Search, Review and Discussion and Documentation. 2. Application of NOC, Test License, Manufacturing and Import License 3. Reference product Characterization, Manufacturing and Import License. 4. Reference product Characterization, Reverse Engineering and prototype development. 5. Preformulation study, Manufacturing of bench scale trials for formulation development. 6. Manufacturing of process optimization batches, scale up batches and submission batches. 7. Preparation of Bill of Material, Master Formula Record for manufacturing of submission batches. 8. Preparation of Product development Report for regulatory filing of products. 9. Should have knowledge on product development requirements for Regulated market (EU/UK/Canada). 10. Should have knowledge on QbD and DOE, formulation development and Process development of drug products. 11. Coordination with CFTs like: DQA, Clinicals, Regulatory, Technology transfer and production for smooth development and transfer of product from laboratory to Production floor. 12. Knowledge on IR/MR solid oral drug products. Preferred candidate profile Male candidate only

Off Targets is a leader in pharmaceutical innovation, committed to developing advanced therapeutic solutions that address unmet medical needs. We are looking for an experienced and dynamic professional to lead our Formulation Development department, driving the development of cutting-edge injectable drug products. Job Description We are seeking an accomplished R&D leader to head our Injectable Formulation Development function. The ideal candidate will bring deep technical expertise in complex injectable products and a strategic mindset aligned with 505(b)(2) development, regulatory planning, and IP differentiation. Key Responsibilities: Lead end-to-end formulation development of complex injectable drug products (liposomes, emulsions, depot injections, suspensions, etc.). Design and drive a robust R&D pipeline focused on 505(b)(2) opportunities . Provide strategic input into USFDA regulatory planning (CMC sections, QbD, stability). Contribute to patent strategy and product differentiation from early development. Collaborate with analytical, regulatory, IP, and business development functions. Mentor a high-performing R&D team and build scientific leadership. Solve scale-up and technology transfer challenges. Maintain strong compliance with global quality and documentation standards. Key Skills: Injectable Formulation, 505(b)(2), Liposomes, Emulsions, Depot Injections, Formulation R&D, CMC, USFDA, Drug Delivery, Intellectual Property, Team Leadership, Innovation Strategy Desired Candidate Profile: Qualification: Ph.D. / M.Pharm in Pharmaceutics or related field Experience: 15+ years in pharmaceutical R&D with at least 5 years in a strategic leadership role Proven expertise in injectable formulations and 505(b)(2) development Strong knowledge of USFDA CMC expectations, IP evaluation , and regulatory submission processes Excellent leadership, innovation, and cross-functional collaboration skills Perks and benefits Opportunity to lead a key department in a forward-thinking pharmaceutical company. A collaborative and supportive work environment that encourages professional growth and innovation. Competitive salary and benefits package, with opportunities for advancement. Access to state-of-the-art facilities and cutting-edge technology. How to Apply: Interested candidates are invited to submit their resume and a cover letter outlining their experience and qualifications to business@offtargets.com

Role & responsibilities 1. Responsible to lead a team of 4-5 scientist for the development of drug products of Regulated Market (EU and UK) 2. Responsible for drug product development to exhibit batch execution and to support for regulatory filing. 3. Conduct Literature survey and compile the scientific data per product. Development of Rubust, bioequivalent formulation and processes through optimization by applying QbD principles. 4. Compilation and review of developmental data and exhibit batch stability data. 5. Should have good understanding on Reference Product Characterization, reverse Engineering, Bioequivalent Prototype development, Stability studies, Scale up activities. 6. Coordination with different cross functional team like ADL, IP, Project Management, SCM, Clinical and regulatory for smooth execution of the projects. 7. Execution of Tech Transfer and monitoring scale up / Exhibit batches. 8. Having well verse knowledge on Regulatory Guidelines for EU, Canada and TGA 9. Lab activities and team management experience is must. Preferred candidate profile Team Management, Formulation Development, Scale Up and Technology Transfer

Essential Duties and Responsibilities: Actively Support launch and sustenance of Baxter commercial products globally by following the Baxter Quality Management Systems. Assist in the management of the Baxter product design throughout the product lifecycle and maintenance of the product DHF, or similar product design governance documents for a particular product family. Identify and analyze design problems to achieve optimal solutions that satisfy cost and technical requirements. Formulate new, innovative approaches to solve technical problems on a consistent basis. Actively involve in commercialized product investigation, execute batches in laboratory, prepare report to support the investigation. Involve in compendial product change/proposal discussion, assess the proposed change impact on the product quality & patient safety. Provide support to analytical team by providing the required product solution/placebo solution samples. Execute batches in laboratory, assess the study outcome to support the compendial product change requirement. Ensure response to customer queries, agencies query, market compliance. Design and execute batches/experiments in laboratory, prepare report to support queries/market compliance. Responsible for ensuring the availability of required licenses and materials (raw material, packaging materials) in laboratory. Qualifications: Educational Qualification: Masters in Pharmaceutics or equivalent Hands on experience in laboratory batch execution and drive the towards the expected result. Good communication skills for effective liaison and teamwork Problem-solving skills, analytical skills and attention to detail Excellent organizational skills and the ability to work on several tasks or projects concurrently Presentation skills - for presenting ideas and findings to colleagues and customers Ability to work well independently, with minimum supervision Drive, enthusiasm and self-motivation

Role & responsibilities Actively supports launch and sustenance of Baxter commercial product globally. Support all commercialized project related requirements related to Baxter manufacturing sites and CMOs Globally. Assist in the management of the Baxter product design throughout the product lifecycle and maintenance of product design governance documents for a particular product family. Make sure the relevant documents for various product families are available to support risk management, change control processes and design integrity. A very good understanding of Quality Risk Management for pharmaceutical products is required per ICH Q9 and ensure sustenance of Baxter commercial products globally by following Baxter Quality Management Systems. Respond to customer queries regarding safety aspects of the product after consultation with Clinical affairs and other relevant functions. Manage Platform core team performance, product life cycle, project schedule, execution, budget commitments and spend. Review weekly, monthly/yearly progress of the projects and send report to the governance team to implement the improvements suggested by the governance. Drive the discussion and ensure the implementation of VIP/ MIP projects, alternative vendor projects. Own supplier notification of change (SNC) or change control to support the implementation of change on time. Preferred candidate profile Educational Qualification: Masters in Pharmaceutics or equivalent Data Analysis and Good communication skills for effective liaison and teamwork Problem-solving skills, analytical skills and attention to detail Excellent organizational skills and the ability to work on several tasks or projects concurrently Presentation skills - for presenting ideas and findings to colleagues and customers Ability to work well independently, with minimum supervision Drive, enthusiasm and self-motivation An aptitude for mathematics and statistics and highly developed IT and technical skill Project management skills and having knowledge of MS office and project management tracking software (Microsoft project, primavera and Planisware) to track and monitor the project progress will be an added benefit.

Role & responsibilities RM and PM receiving and documentation of the same. Proper arrangement of the Received COA of RM and PM. Sampling of Received RM and PM, sending the samples to ADL for analysis. Preparation of indent for trial activity and ensure the availability in defined time. Taking of daily trial batches, discussion of issue with immediate supervisor. Entry of trial batch data in lab notebook and preparation of BMR for stability batches. Maintaining the files of individual products like RM and PM COA, Trial COA and Stability Reports after updation in Excel Sheet. Ensure GMP practice in Laboratory routinely. Documentation of stability batches. Calibration of instruments in the laboratory. Literature search and review for the newly identified products for EU/UK/Raw market. SOP preparation and submission to DQA. Ensure utility in good condition in laboratory during all development batches. Adhere Good Manufacturing Practice and Good Laboratory Practice throughout lifecycle of the product. Preferred candidate profile Should have exposure to Formulation & Development of Injectable products knowledge for regulatory market preferable along with regulatory documents preparation like PDR, MFR etc. If having basic knowledge of injectable products is added advantage.

Responsibilities: Review IP landscape reports, non-infringement& FTO analysis Devise strategies for patent non infringement and invalidations Collaborate with R & D Scientist to explore design around strategies for P-IV & NCE products Conduct IP due diligence for product selection/ new opportunity identification. Support RA for patent certification, PIL clearances and declaration Monitor, review and manage ANDA litigations Conduct patentability searches, draft and file patent applications and manage prosecutions Ensure timely and effective task delivery through strategic planning prioritisation and execution.

PDR . ; SOPs.; CHANGE controls, deviations , incidents ; Master formula card, drug excipient study reports ; regulatory and customer audits. .Apply the Test Licenses and Narcotic-related licenses. Provident fund