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18.0 - 25.0 years

40 - 60 Lacs

Bengaluru

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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

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10.0 - 20.0 years

15 - 25 Lacs

Bengaluru

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Job Description We are looking for an experienced and dynamic Team Leader to head our Analytical Research team within the Pharmaceutical R&D division, focused on complex injectable products and 505(b)(2) submissions . This role is ideal for a candidate with a strong background in pharmaceutical R&D , robust team management skills , and deep understanding of injectable formulation analytics . Key Responsibilities Lead and manage the analytical research team supporting complex injectable development. Supervise daily lab operations, resource allocation, and project timelines. Drive method development, validation, and troubleshooting for injectable formulations. Provide scientific leadership and ensure data quality and regulatory compliance. Maintain high team morale and cultivate a positive, collaborative work environment. Guide preparation of analytical documents for regulatory filings (505(b)(2), ANDA, etc.). Impart training, develop team capabilities, and mentor junior scientists. Collaborate closely with formulation, quality, and regulatory teams. Ensure compliance with cGMP, GLP, and internal SOPs. Desired Candidate Profile Qualification: M.Pharm / Ph.D. in Pharmaceutical Sciences, Analytical Chemistry, or related field. Experience: 8+ years in Pharmaceutical R&D , minimum 3 years in a leadership/supervisory role . Hands-on experience in analytical method development for complex injectables (liposomes, suspensions, emulsions, etc.). Sound knowledge of 505(b)(2) regulatory pathway . Strong command of analytical techniques: HPLC, GC, spectroscopy, particle size analysis, etc. Proven track record in team leadership, project coordination , and technical problem-solving . Excellent communication and interpersonal skills. Key Skills Analytical R&D, Complex Injectables, Injectable Formulations, Team Management, 505(b)(2), Method Development, HPLC, GC, Troubleshooting, Pharmaceutical R&D, Training & Mentoring

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8.0 - 12.0 years

8 - 15 Lacs

Ahmedabad

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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

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4.0 - 9.0 years

4 - 9 Lacs

Nalagarh

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Greetings from Immacule Lifescience Pvt. Ltd! We are seeking experienced professionals for multiple positions in our Engineering department at our sterile injectable formulations manufacturing plant located in Nalagarh, Himachal Pradesh. Department : Engineering - Sterile Formulations Experience : 4 - 8 years Qualification : B. Tech (Electrical & Instrumentation) / Diploma (Electrical & Instrumentation) Positions Available: Officer / Executive : Plant Maintenance Engineering Executive / Senior Executive : Engineering QMS (Quality Management System) Officer : Building Management System (BMS) & Environmental Management System (EMS) Key Requirements: For plant Maintenance & QMS Hands-on experience with injectable equipment, including: - Vial Washing Machine - Vial Filling Line - Tunnel - Autoclave - Pre-Filled Syringe (PFS) Machine - Strong understanding of engineering principles and practices in a sterile manufacturing environment. How to Apply: Interested candidates can send their updated resumes to Eswar.reddy@immacule.in

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2.0 - 6.0 years

3 - 6 Lacs

Bengaluru

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Production : Associate /Senior Associate Qualification : B. Pharmacy / M. Pharmacy Experience : 2 to 6 years Must have Injectable and Regulatory Knowledge in any of these areas: Aseptic processing activity (Vial/PFS), Bulk compounding, sterilization,Vial washing & Depyrogenation,Lyophilization & Terminal sterilization process. Infusion bags processing activities, In-process checks and Line Clearance activities, Handling of shift activities and manpower. Computer Proficiency: TW, Documentum , MES & SAP, GEP

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3.0 - 8.0 years

5 - 15 Lacs

Hyderabad

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Job Description Roles & Responsibilities You will be responsible for end to end Formulation development of Injectable including development, execution, filing and approval. You will be responsible to co-ordinate closely with analytical team to devise effective Proof of Concept (POC) for developing generic equivalent of Reference Listed Drug (RLD)/generic Injections. You will be responsible to support in scale-up to pilot/plant scales for Injectable Products. You will be responsible to monitor the development for robust, effective and bioequivalent drug product in timely manner adhering to safety and quality standards. Also provide support in documentation for regulatory submissions. You will be responsible for technology transfer and execution of the batches. You will be responsible for performing pre-formulation studies for material characterization, drug-excipient compatibility and Reference Listed Drug (RLD) characterization (including reverse engineering, formulation designing and optimization, processes designing and scale up). You will be responsible for preparation of risk evaluation and risk mitigation documents, Scale-up batch documents, and filing documents for drug product at every stage of development. You will be responsible to review data generated and participate in discussions with experts to conclude on prototype(s). Participate in strategizing the sourcing of Active Pharmaceutical Ingredient (API), raw materials and ensure development studies are performed related to regulatory and internal system requirements. You will be responsible for designing and implementing stability studies for injectable formulations to ensure product quality and shelf life. You will be accountable for troubleshooting formulation and process-related issues during development and manufacturing stages. You will collaborate with cross-functional teams to ensure alignment of formulation development with regulatory requirements and commercial objectives. You will be responsible for staying current with emerging technologies and regulatory guidelines in injectable drug development and incorporating them into your work. You will mentor junior scientists and contribute to the continuous improvement of the formulation development process. Qualifications Educational qualification: Masters in Pharmaceutical/M.Tech in Chemical Engineering Minimum work experience: 5 to 8 years of experience in pharmaceutical company in Injectable products. Skills & attributes: Technical Skills Have work experience on Formulation Development and expertise in inhalation/injectable dosage form. Experience in areas of product development for Generic Injectable Experience in Quality by Design (QbD). Experience in Process Optimization and scale up. Experience in Operational Excellence. Knowledge on Good Manufacturing Practice and Good Laboratory Practice. Experience in Technology Transfer. Behavioral Skills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams.

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2.0 - 6.0 years

2 - 5 Lacs

New Delhi, Hyderabad, Puducherry

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Roles & Responsibilities: Position: Area Business Manager Therapy- Injectables/Gynecology/IVF Job Description: Sales Target Achievement: 1. Drive sales performance in the assigned area to meet or exceed revenue and growth targets. Implement sales strategies and initiatives to expand market penetration and boost product sales. Monitor daily, weekly, and monthly sales to track progress toward targets. 2. Team Management: Lead, manage, and develop a team of Territory Sales Executives/Managers to achieve sales goals. Conduct regular performance reviews, provide coaching, and address any performance gaps. Ensure the team follows company policies, guidelines, and ethical sales practices. 3. Customer Relationship Management: Build and maintain strong relationships with key healthcare professionals (doctors, pharmacists, hospitals) to promote product awareness. Collaborate with distributors, stockists, and retailers to ensure product availability and timely supply. Resolve customer issues and inquiries promptly to ensure high satisfaction levels. 4. Market Analysis & Strategy: Analyse market trends, competitor activities, and sales data to identify opportunities for growth. Provide feedback to senior management on market dynamics, customer preferences, and product performance. 5. Recommend adjustments to sales strategies to capitalize on market opportunities. New Product Launches: Plan and execute successful new product launches within the area. Train the sales team on new product details and competitive positioning. 6. Ensure promotional campaigns and initiatives are effectively rolled out in the field. Reporting & Compliance: Prepare and submit timely sales reports, forecasts, and market insights. Ensure compliance with industry regulations and company standards, maintaining high ethical practices in all sales activities. If Interested and have relevant experience, requesting you to share your CVs on priya.tripathi@emcure.com

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2.0 - 5.0 years

4 - 7 Lacs

Mumbai, Tarapur, Ahmedabad

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Kamla Homes is looking for Officer - Sterile Ointment to join our dynamic team and embark on a rewarding career journey Oversee sterile ointment production in cleanroom settings Monitor batch records and ensure GMP compliance Perform in-process checks and manage documentation Ensure safety and quality in operations

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4.0 - 8.0 years

2 - 7 Lacs

Shamirpet, Hyderabad

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Greetings From SP Accure Labs!!! We are conducting Walk-In Interview for Production Injectables formulation department for Compounding Chemist on 30/05/2025 Friday @ our Shamirpet Plant facility. Roles and Responsibilities Conduct quality control tests on injectable products using techniques such as SIP, CIP, TOFFLON, PFS, ISOLATORS, LYOPHILIZATION. Ensure compliance with cGMP guidelines during production activities. Department - Production Role - Compounding activities like CIP, SIP Mixing & Filling Vessels. Desired Candidate Profile 4-8 years of experience in a similar role with (M.Pharmacy, M.Sc, B.Pharma / B.Sc). Strong understanding of chemistry principles applied to pharmaceuticals. Proficiency in compounding, parenteral production, sterile processing, and lyophilization techniques. Experience working with injectable products including oncology treatments. Thanks & Regards, Archana Reddy Team HR

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3.0 - 6.0 years

10 - 20 Lacs

Hyderabad

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Job Summary We are seeking a dynamic and experienced Formulation Scientist in Topical division for designing and development of formulation process, ensuring quality by design (QbD) implementation, scaling up for manufacturing of batches, coordinating manufacturing readiness, overseeing plant execution, and facilitating seamless technology transfer. Roles & Responsibilities You will be responsible for end to end Formulation development of Topical formulations (Creams, Ointment, Gels, Sprays and Foams) including development, execution, filing and approval. You will be responsible to co-ordinate closely with analytical team to devise effectiveProof of Concept (POC) for developing generic equivalent of Reference Listed Drug (RLD). You will be responsible to support in scale-up to pilot/plant scales for topicals. You will be responsible to monitor the development for robust, effective and bioequivalent drug product in timely manner adhering to safety and quality standards. Also provide support in documentation for regulatory submissions. You will be responsible for technologytransfer and execution of the batches. You will be responsible for performing pre-formulation studies for material characterization, drug-excipient compatibility and Reference Listed Drug (RLD) characterization (including reverse engineering, formulation designing and optimization,processes designing and scale up). You will be responsible for preparation of risk evaluation and risk mitigation documents, Scale-up batch documents, and filing documentsfor drug product at every stage of development. You will be responsible to review data generated and participate in discussions with experts to conclude on prototype(s). Participate in strategizing the sourcing of Active Pharmaceutical Ingredient (API), raw materialsand ensure development studies are performed related to regulatory and internal system requirements. you will be responsible on preparation of assessments for impurities including Nitrosamine impurities and should be well versed with guidelines of India market, Russia market and US market requirements. Qualification Educational qualification: Masters in Pharmaceutical Technology/Pharmaceutics Minimum work experience: Approx. 5 years of experience in pharmaceutical company topical products. Skills & attributes: Technical Skills Have work experience on Formulation Development and expertise in Topical dosage forms Experience in areas of product development for Generic topical dosage forms Experience in Quality by Design (QbD). Experience in Process Optimization and scale up. Experience in Operational Excellence. Knowledge on Good Manufacturing Practice and Good Laboratory Practice. Experience in Technology Transfer. Behavioral Skills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams. Additional Information About the Department Integrated Product Development Organisation We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

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16.0 - 24.0 years

20 - 30 Lacs

Ahmedabad

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Greetings from Kashiv Biosciences!!!! We are looking for Validation and QMS Engineer for our Engineering Team in our Biosimilar Manufacturing facility based out of Ahmedabad. Below are the roles and Responsibilities. Roles and Responsibilities: Responsible for Engineering compliance , Validation and QMS activity. , Timely escalation of any challenge bottle necks pertaining to engineering compliance to the management (site leadership team) to ensure proper planning and solutions. Representing as a Subject Matter Export of Engineering department in front of regulatory auditors. Responsible for engineering investigations pertaining to equipment failures and ensure for proper root cause identification and CAPA effectiveness. Responsible for technical agreements with vendors who have work at Plant premises. Responsible for preparing and review the master list of equipment, instrument along with the preventive maintenance & calibration scheduled. Responsible for change control/deviation management/CAPA Through Track wise management System. Facing the Regulatory, Customer, Internal Audits and preparation of compliance. SOPs and Protocols Training for the new personnel and refreshment training for existing team members. Co-ordination with CFT line Production, QC & QA department to execute any engineering documentation related works. Candidate Details The candidate should be from Pharma industry only having exposure to Parenteral/ Injectables. The candidate should be aware of GDP/ GMP Process. The candidate should have exposure to equipment qualification, Validation and QMS . The candidate should have good communication skills. Interested candidate please share the resume on my mail id manan.hathi@kashivindia.com Regards HR Team Kashiv Biosciences

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2.0 - 7.0 years

2 - 7 Lacs

Hyderabad

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Walk In Drive For Production Injectables In Formulation Division @ Jadcherla Department:- Production Injectables Qualification :-ITI| BA | Diploma |B Com | BSC | B Pharmacy Experience :- 2 To 8 Years Division :- Formulation Interview Date:- 01-06-2025 Interview Time :- 9.00AM TO 2.00PM Venue Location:- ELITE HOTELS & RESORTSNH44,Bangalore Hyderabad Hwy Jadcherla, Telangana 509301 Contact No:- 040-304338701 | 8954 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card We are looking for candidate those who have experience in Lyo, Compounding, Autoclave,Vial Filling, Vial Washing, Sealing,Aseptic Processing Area, Tunnels, Labelling, About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.

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9.0 - 14.0 years

5 - 15 Lacs

Ahmedabad

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Role & responsibilities To meet the production schedule both in quality and quantity. To maintain good discipline in the Packaging area and department. To ensure the implementation of EHS practices during the work To plan the activities of the area as per daily basis schedule To plan & allocate different jobs on daily basis to workmen/ machine operators of Packing area. To check and verify the transfer of Packing Material to the finished goods store in coordination with Section Manager - Production. To ensure implementation of Good Packaging Practices and SOP during work. To maintain and improve quality of the products as per standards. To ensure the effective control on usage of men, machine and material in the department. To participate and co-ordinate various ongoing validation activities of equipment and system. To supervise the Packing activities under the supervision of Packing Manager. To ensure training completion of all employees working in packing area activities. To conduct investigation of OOS, monitor CAPA and handle deviations. To ensure instruction of validation protocols, change controls, deviations, SOPs and specifications relating to packaging and ensure their strict implementations.. To maintain department and equipment in neat and tidy condition all the time. To control the rejection during packaging operations. To do counselling and grievance handling of the subordinates. To review the BPR after its completion. To perform any other related work allotted by the superior as per the production requirement. To work for the control of wastages during Packaging and to achieve higher yields of product. To perform all the trackwise and SAP related work. Any other responsibility to be completed that may be assigned for time to time. To perform investigation for Market Complaint and Deviations & handling of change controls. Completion of all the record work on daily basis.

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2.0 - 7.0 years

2 - 7 Lacs

Ahmedabad

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Working Experience in Production/Packing : 2 to 10 years in Parenteral Manufacturing unit *For Production (Parenteral/Injectable exposure only) : > Process Incharge/Sr. Process Incharge : - To ensure the cleanliness, environmental norms and other process of various area like Dispensing, Mixing, Filling and Terminal Sterilizer. -To complete CIP, SIP and batch manufacturing process timely. -To ensure the batch manufacturing process is done as per Batch Manufacturing record. -To co-ordinate with other departments like QA, QC, Stores, Engineering, etc. as and when required. *For Packing (Parenteral/Injectable exposure only) : >Process Incharge/Sr. Process Incharge: - To make sure that issued material is as per requirement and the material quality is as per specification. -To check the availability of packing material with proper labels and status. -To ensure that the packing activity does not start without line clearance. -To check, verify and destroy the rejection generated during packing and ensure recording of all such material. -To update the Batch Packing Record online. -To check the packing online at frequent intervals as defined in the Standard Operating Procedure. -To train personnel for the critical operations like visual inspection and labeling. Candidate Profile: Ready to work in rotational shifts. Excellent understanding about working area. Initiator and Learner. Decision making ability. Team player and if required, can provide training to other team members. Good communication. -The above positions are for shift (rotational) operations for the plant location (Vasana-Chacharwadi) and only for experienced candidates. -Fresher candidates can share their profile on hrm.opmf-amd@otsukapharma.in Note: Otsuka Pharmaceutical India Pvt Ltd does not hire any such consultants/agents who promise interviews/jobs for monetary consideration/registration fees. Beware of such fraudulent calls.

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2.0 - 7.0 years

2 - 5 Lacs

Ahmedabad

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"Hiring Event Announcement" MFG Production Operators (ITI): 3 to 8 Experience in Injectable production, filling, dispensing, sterilization, autoclave, batch record review etc., activity MFG Packing Operators ( ITI): 3 to 8 Experience in Injectable packing activity. Date & Time : 31st May 2025 || 09 AM to 3 PM IST Venue : Ahmedabad (Invites will be shared based on your shortlisting) Registration Link copy : https://talentcommunity.baxter.com/flows/manufacturing-packing-operators-31st-may-25-gqengvlfs EEO (Equal Employment Opportunity) This is where Baxter International Inc. is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.

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3.0 - 6.0 years

10 - 20 Lacs

Hyderabad

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Roles & Responsibilities You will be responsible for end to end Formulation development of Injectable including development, execution, filing and approval. You will be responsible to co-ordinate closely with analytical team to devise effective Proof of Concept (POC) for developing generic equivalent of Reference Listed Drug (RLD)/generic Injections. You will be responsible to support in scale-up to pilot/plant scales for Injectable Products. You will be responsible to monitor the development for robust, effective and bioequivalent drug product in timely manner adhering to safety and quality standards. Also provide support in documentation for regulatory submissions. You will be responsible for technology transfer and execution of the batches. You will be responsible for performing pre-formulation studies for material characterization, drug-excipient compatibility and Reference Listed Drug (RLD) characterization (including reverse engineering, formulation designing and optimization, processes designing and scale up). You will be responsible for preparation of risk evaluation and risk mitigation documents, Scale-up batch documents, and filing documents for drug product at every stage of development. You will be responsible to review data generated and participate in discussions with experts to conclude on prototype(s). Participate in strategizing the sourcing of Active Pharmaceutical Ingredient (API), raw materials and ensure development studies are performed related to regulatory and internal system requirements. You will be responsible for designing and implementing stability studies for injectable formulations to ensure product quality and shelf life. You will be accountable for troubleshooting formulation and process-related issues during development and manufacturing stages. You will collaborate with cross-functional teams to ensure alignment of formulation development with regulatory requirements and commercial objectives. You will be responsible for staying current with emerging technologies and regulatory guidelines in injectable drug development and incorporating them into your work. You will mentor junior scientists and contribute to the continuous improvement of the formulation development process. Qualification Educational qualification: Masters in Pharmaceutical/M.Tech in Chemical Engineering Minimum work experience: 5 to 8 years of experience in pharmaceutical company in Injectable products. Skills & attributes: Technical Skills Have work experience on Formulation Development and expertise in inhalation/injectable dosage form. Experience in areas of product development for Generic Injectable Experience in Quality by Design (QbD). Experience in Process Optimization and scale up. Experience in Operational Excellence. Knowledge on Good Manufacturing Practice and Good Laboratory Practice. Experience in Technology Transfer. Behavioral Skills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams. Additional Information About the Department Integrated Product Development Organisation We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

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1 - 3 years

5 - 10 Lacs

Hyderabad

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Job Summary We are seeking a dynamic and experienced Production Shift Chemist in Active Pharmaceutical Ingredient (API) to support the development of robust and cost effective API's by executing scale up batches for all new and existing APIs at GMP Kilo Lab. Roles & Responsibilities You will be responsible for Equipment Operations of Reactors (GL, SS & All Glass), Mobile Receivers & tanks, ANFD, PNF & VTD, Isolators (Reactor Charging, ANFD Discharge, Dispensing/packing, sifter & multimill), Air jet mill, Multimill, Blender & Sifter, Spray dryer, TCU, Vacuum Pumps, AODD Pumps, centrifugal pumps & peristatic pumps, VNS sealing machine, RLAF & dispensing booth, Refrigerators and Deep freezers etc. You will be responsible to Execution of Batches, Equipment product change over & General cleaning of equipment. Batch production record filling as per SOP & as per Good documentation practices. You will be responsible for Filling of Equipment Logs, daily production monitoring records like Temperature, Humidity & RH, weighing balance calibrations, reviewing of house keeping records, Printing Data logger records and Updating status boards etc as per site SOPs. Collection of Records/books, submission of completed BPRs/Records to QA. You will be responsible for In process sample collection from Reactors, ANFD & VTD etc. Raw Material, Solvents handling, material moments & dispensing and maintaining records as per SOP. You will be responsible to reduce the accidents in the plant by following safety principles, install earth rods to remove static electricity from material, Handling different chemicals with appropriate PPE & following SHE Norms. Monitor adherence of behavioral safety of contract persons. You will be responsible to meet the production schedules and reduce breakdowns by planning the equipment for idle condition to prepare for preventive maintenance, issue work order to maintenance to carry on with maintenance, follow up with maintenance on problem rectification. You will be responsible for Handling of Production waste & Detoxification batches execution. Support the engineering team in equipment qualification activities to meet the batch planning. You will be responsible for handling, initiation of deviations, incidents and support for closure of deviation & Incident reports Qualification Educational qualification: B.Sc Chemistry, M.Sc Chemistry & Diploma in Chemical engineering Minimum work experience: 2-6 years of experience in Pharma industry Skills & attributes: Technical Skills Experience on Process of Product Development Knowledge in API chemical Process & equipment. Knowledge of unit operations. Knowledge in Safety, Health and Environment guidelines (SHE) guidelines. Experience in data entry in SAP system. Behavioural Skills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams. Additional Information About the Department Integrated Product Development Organisation We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

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2 - 7 years

5 - 15 Lacs

Ahmedabad

Work from Office

Job Description : - Department - Injectable Mfg & Packing Position - Technician / Officer / Sr. Officer Exp - 2 to 6 Education - ITI / Diploma Eng / D.Pharma / B.Pharma / M.Pharma Skill Set - Require good knowledge in Complex Skid / NDDS / Aseptic (PFS / Vials Liquid) / Autoclave/ Lyopholizer / Batch Manufacturing, Sterile Secondary Packing and track and trace activity + visual inspection activity. Department - QC ( QC FG / Stability / AMV ) Position - Officer to Executive Exp - 2 to 7 Education - M.Sc / B.Pahrma / M.Pharma Skill Set - Analyst : Finished, AMV & Stability Section. knowledge of Instrument - HPLC / GC. Preferably know-how of Chromeleon Software Department - Engineering ( Plant Maintenance Sterile / Instrumentation Sterile ) Exp - 2 to 15 Position - Technician / Executive / Assistant Manager / Manager Education - Diploma Eng / ITI / B.Tech Skill Set - Have good exposure in Plant Maintenance & Instrumentation related work in sterile facility Department - QA ( IPQA / Qualification (Sterile Background Only) Position - Officer to Executive Exp - 2 to 7 Education - B. Pharmacy / M.Pahrma / M.Sc Skill Set - Have good exposure in Sterile IPQA & Sterile Qualification Related activity Department - Lab QA Position - Officer to Sr. Executive Exp - 2 to 9 Education - B. Pharmacy / M.Pahrma / M.Sc Skill Set - Having good exposure of QC QMS handling , Lab instrumentation & audit trails. Have strong background of Lab QA activity. Department - Solid Oral Packing Position - Technician / Officer / Sr. Officer Exp - 2 to 5 Education - ITI / Diploma Eng / D.Pharma / B.Pharma Skill Set - Require good knowledge in Primary & Secondary Packing, Track & Trace, Carton Packing Machine (CAM HV1 Model), Online Documentation BPCR / Logbook etc.

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- 2 years

2 - 3 Lacs

Nadiad, Ahmedabad, Anand

Work from Office

Roles and Responsibilities Assist in production activities such as BMR, sterilization, dispensing, mixing, formulation, and parenteral operations. Monitor and control process parameters to ensure compliance with quality standards. Maintain accurate records of production data and batch logs. Collaborate with team members to resolve issues and improve productivity. Ensure adherence to cGMP guidelines and company policies. Desired Candidate Profile Strong understanding of BMR, sterilization techniques, dispensing procedures, mixing processes, formulation development, and parenteral manufacturing principles. Ability to work effectively in a fast-paced environment with attention to detail and ability to multitask.

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4 - 9 years

5 - 12 Lacs

Vapi, Ratlam, Thane

Work from Office

Help in Day To Day Production Of Pharmaceutical Products Manpower Allocation For Smooth Working In Shift Supervision Of Production Activity BMR And BPR Report Preparation Data Preparation For Internal And External Audit -IE. US FDA - EU GMP Etc Required Candidate profile B. Pharm - M. Pharm - B.Sc - M. Sc Experience In Production Or Packaging Working Experience US FDA Approved Plant is Desirable FDA Approval in Tablet - Capsule Or Any will be an added advantage

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4 - 9 years

5 - 12 Lacs

Dahej, Panaji, Mumbai

Work from Office

Help in Day To Day Production Of Pharmaceutical Products Manpower Allocation For Smooth Working In Shift Supervision Of Production Activity BMR And BPR Report Preparation Data Preparation For Internal And External Audit -IE. US FDA - EU GMP Etc Required Candidate profile B. Pharm - M. Pharm - B.Sc - M. Sc Experience In Production Or Packaging Working Experience US FDA Approved Plant is Desirable FDA Approval in Tablet - Capsule Or Any will be an added advantage

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4 - 6 years

5 - 7 Lacs

Hyderabad/Secunderabad

Work from Office

Roles and Responsibilities Review of technical regulatory documents for drug substance and drug products Compilation of CMC data for submission to regulatory authorities Review and approval of master documents for CMC segments Preparation and review of annual reports, amendments, supplements etc. Assist with CMC responses to regulatory authorities queries during development, registration, and product lifecycle. Evaluation and co-ordination of change controls Liaison with various departments like R&D, QC, QA, Production, stability departments for obtaining documents. Prepare response to regulatory deficiencies letters according to US regulatory requirements. Desired Candidate Profile The candidate should have adequate knowledge in regulatory affairs (Injectable or Ophthalmic formulations) for US market. He/ She should have 3 - 5 years of experience with B. Pharm./ M. Pharm./ M. Sc. as a educational qualification. Candidate should possess excellent verbal and communicational skills.

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