Paithan
INR 9.0 - 10.0 Lacs P.A.
Work from Office
Full Time
We are hiring candidates for Manager - Research & Development for our plant into manufacturing of Active Pharmaceutical Ingredients (APIs) and Pharmaceutical Intermediates. Interested candidates can mail their resume at admin@bioaltuslabs.com Post : Manager -Research & Development, Active Pharmaceutical Ingredients (APIs) and Pharmaceutical Intermediates. Experience : Minimum 12-18 years Location : Paithan (Chhatrapati Sambhaji Nagar) Educational Qualification : PHD in Organic Chemistry, M. SC (Organic Chemistry) Job Responsibilities : * Develop robust process for APIs & Pharmaceutical intermediates considering factors such as stability & manufacturing feasibility as per plant scale. * Optimize manufacturing process for APIs & Pharmaceutical intermediates synthesis to enhance efficiency, reduce cost & improve product quality meeting as per ICH guideline. * Ensure compliance with regulatory guidelines & standards throughout the PDL including the preparation of documentation for regulatory submissions. * Excellent analytical, problem-solving & decision making skills. * Effective communication & interpersonal skills, with the ability to collaborate effectively in a team environment. * Developing different route of synthesis which enhance product quality and reduces costing for active pharmaceutical ingredients (APIs) & Pharmaceutical intermediates. * Passionate of developing the new APIs and Pharmaceutical intermediates.
Paithan
INR 1.75 - 2.25 Lacs P.A.
Work from Office
Full Time
We are hiring candidates for Sr. Executive - Research & Development for our plant into manufacturing of Active Pharmaceutical Ingredients (APIs) and Pharmaceutical Intermediates. Interested candidates can mail their resume at admin@bioaltuslabs.com Post : Sr. Executive -Research & Development, Active Pharmaceutical Ingredients (APIs) and Pharmaceutical Intermediates. Experience : Minimum 6-8 years Location : Paithan (Chhatrapati Sambhaji Nagar) Educational Qualification : M.SC (Organic Chemistry) Key Responsibilities Develop and optimize synthetic routes for APIs with a focus on safety, cost-effectiveness, scalability, and sustainability. Conduct lab-scale experiments to support process development and validation. Transfer developed processes from R&D to pilot and production scale, including preparation of technical transfer documents. Collaborate with cross-functional teams (QA/QC, Production, etc.) during process scale-up and commercial manufacturing. Ensure adherence to all regulatory and safety standards (ICH, cGMP, GLP). Troubleshoot technical issues during development and commercial production stages. Prepare and review technical documents such as process development reports, MMRs, BMRs, and SOPs. Support filing activities for regulatory submissions (e.g., DMFs, ANDAs) with the required data and documentation. Evaluate and introduce new raw materials, solvents, or process technologies to improve yield and quality. Maintain proper documentation and data integrity for all R&D activities. Monitor and ensure compliance with EHS (Environmental, Health, and Safety) standards.
Mumbai, Pune, Paithan
INR 25.0 - 30.0 Lacs P.A.
Work from Office
Full Time
Job Description To provide the leadership with a capacity of site head for smooth functions of plants. To meet the manufacturing targets within the norms and budget To establish, implement and maintain quality management and associated system. To ensure all the section heads are executing their responsibilities review daily, weekly, monthly, quarterly planning and budgeting. To ensure compliance of systems including regulatory and customers requirements. To coordinate between production, Engineering, Quality Control, Quality Assurance, Warehouse and Dispatch department for smooth functioning of the site. To interact with external agencies on technical matter including customer s representatives, regulatory authorities, certification bodies etc. To provide support in evaluation of techno/commercial feasibility of new products. To provide support/ guidance for successful transfer and scale up of new technologies for commercialization. To provide both technical and managerial guidance to the team members. Responsible to operate the plant as per EHS norm.
Mumbai, Pune, Paithan
INR 25.0 - 30.0 Lacs P.A.
Work from Office
Full Time
Job Description: To lead a team of Production chemists from the Production Team for the Pilot Batches, Scale-up & Technology Transfer and Projects To develop and produce cost-effective, non-infringing, safe and eco-friendly technologies for the synthesis of reliable APIs and intermediates. Creative capabilities in the areas of organic chemistry in designing and conducting multi step organic synthesis that is very much attractive from commercial aspects, To Identifying and select API molecules based on developing Non-infringing process for API molecules Support in transformations in synthetic organic chemistry aimed at target molecule from the Pilot scale to Plant scale. Good skills in interpretation of NMR, Mass spectra,, IR, GC, HPLC and XRD. Strongly self motivated, believing in team work and efficient problem solver, having good skills for development of subordinate potentials. Exhibit Good Laboratory Practice. Efficient handling of High pressure, Hazardous, Highly moisture sensitive and other specialized reactions. API- cost effective process development. Optimizing the process by considering the yield, quality, cost and safety operations of the process. Data generation for DMF filing of final APIs. Preparation of Process Development Report/TTD to transfer technology . Impurity impact on process, identification & synthesis Development of new API molecules and technology transfer of the same. Process improvement for cost reduction and easy technology transfer.
Thane
INR 2.0 - 2.25 Lacs P.A.
Work from Office
Full Time
JOB OVERVIEW : we are seeking a detail oriented and organized accountant with 0-2 years of experience to join our finance team in a fast paced pharmaceutical company. The ideal candidate will be responsible for managing day to day accounting functions, maintaining accurate financial records, and ensuring compliance with relevant regulations and industry standards. this role provides a great opportunity to grow within the pharmaceutical industry while contributing to the financial growth of the organization. KEY RESPONSIBILITIES: General Ledger Maintenance: Manage and update the general ledger, ensuring all transactions are recorded accurately and in a timely manner. Accounts Payable & Receivable: Process invoices, payments and receipts and manage accounts payable and receivable processes. ensure that payments are made on time and accordance with company policies. Bank Reconciliations: Perform regular reconciliations of bank accounts to ensure all financial transactions are accurately recorded and discrepancies are promptly addressed. Financial Reporting: Prepare monthly, quarterly, and annual financial reports, including balance sheets, income statements, and cash flow statements. support the senior team in financial analysis and budgeting. pharmaceutical stock, and ensuring accurate cost of goods sold calculations Audit Support: Assist in both internal and external audits by providing necessary documentations and explanations for financial transactions and records. Month End and Year End Closing: Support the month end and year end closing processes, ensuring that all entries are accurate and deadlines are met. Process Improvement: Identify opportunities for process improvements in accounting procedures and systems, and work to enhance operational efficiency.
Paithan
INR 0.6 - 0.8 Lacs P.A.
Work from Office
Full Time
Post : Maharashtra FDA Approved - QC Chemist Active Pharmaceutical Ingredients (APIs) and Pharmaceutical Intermediates Manufacturing Facility. Experience : Minimum 2-3 years’ experience in a Quality Control laboratory, preferably in the APIs Industry Willingness to work flexible hours or shift work if required. Location : MIDC Paithan, Chhatrapati Sambhaji Nagar. Educational Qualification : B.Sc. / M.Sc. (Analytical Chemistry) Job Description: Perform routine Quality Control testing on raw materials, in-process samples, and finished API products to ensure compliance with specifications. Utilize standard analytical techniques such as HPLC, GC, Spectroscopy, titration, IR, and dissolution testing. Conduct tests for purity, potency, identity, and impurities in accordance with official monographs (e.g., USP, EP) or internal specifications. Assist in the development, validation, and qualification of analytical methods, ensuring they are suitable for their intended purpose and meet regulatory standards. Participate in method transfer from development to manufacturing. Optimize existing methods to improve efficiency and accuracy. Maintain accurate, clear, and complete laboratory notebooks and test records following Good Laboratory Practices (GLP) and Good Documentation Practices (GDP). Prepare detailed test reports with data analysis and conclusions, highlighting any deviations or issues. Review and approve laboratory data, ensuring the correctness of the results and interpretation. Ensure compliance with SOPs (Standard Operating Procedures) and GMP (Good Manufacturing Practices) documentation Ensure all testing activities comply with FDA, EMA, ICH, USP, and other regulatory guidelines. Maintain awareness of industry trends, regulations, and changes in API quality control requirements. Support audits and inspections by regulatory bodies or internal teams to ensure adherence to compliance standards. Support stability studies for raw materials and API products by monitoring and testing products over time under various conditions. Analyse stability data to ensure product shelf life and quality. Prepare stability protocols and reports. Work closely with the Quality Assurance (QA) department to investigate deviations, out-of-specification (OOS) results, and corrective/preventive actions (CAPA). Assist in the investigation of non-conformities and participate in root cause analysis for issues related to product quality. Ensure proper maintenance, calibration, and performance verification of laboratory equipment. Monitor reagents and chemicals inventory to ensure availability for testing, and ensure proper storage and labelling. Adhere to safety protocols in the lab and ensure compliance with health and safety regulations. Participate in internal training on quality control procedures, new testing techniques, and regulatory updates. Assist in training junior QC chemists or new staff as required. Contribute to the ongoing improvement of Quality Control processes, laboratory procedures, and testing methods.
Paithan
INR 0.9 - 1.5 Lacs P.A.
Work from Office
Full Time
Post: Officer Production (Maharashtra FDA Approved) Location: Paithan, Chh. Sambhaji Nagar Educational Qualification : B.sc / M. Sc. Experience: 2-3 Year Job Summary: We are seeking a highly motivated and detail-oriented Maharashtra FDA Approved, Production Officer with 2-3 year of experience in API (Active Pharmaceutical Ingredients) manufacturing. The successful candidate will be responsible for overseeing and ensuring the efficient operation of the production processes, ensuring product quality, and maintaining compliance with regulatory requirements. This position requires a strong understanding of production operations and good manufacturing practices (GMP). Key Responsibilities: Production Monitoring: Oversee the daily production activities, ensuring that the manufacturing processes are running smoothly and efficiently. Ensure all production activities are conducted according to the Standard Operating Procedures (SOPs), batch records, and GMP guidelines. Quality Control and Compliance: Ensure the manufactured products meet quality standards, conducting in-process checks and inspections. Document all production activities, including deviations, and work with the quality team to resolve any non-conformance issues. Maintain proper documentation to ensure compliance with internal and regulatory audit requirements. Process Optimization: Participate in the continuous improvement of production processes by identifying inefficiencies and recommending solutions. Monitor raw material usage and optimize resource utilization. Team Coordination: Collaborate with other production team members and departments (e.g., maintenance, quality control, and logistics) to ensure smooth workflow. Provide training and support to junior production staff as necessary. Safety & Maintenance: Follow all safety procedures and protocols, ensuring the production area remains safe and in line with health and safety regulations. Assist in troubleshooting and resolving minor equipment malfunctions and coordinate with maintenance teams for major repairs. Familiarity with GMP, FDA, and other regulatory standards governing pharmaceutical manufacturing.
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