7 Pdl Jobs

Role & responsibilities To lead the OSD department team and ensure manufacturing process development and Optimization as per the regulatory requirements & technology transfer of the projects in co-ordination with Production and planning department for regulatory & ROW products. Accountabilities and mandatory requirements: Ensure composition and manufacturing process development of new as well as established products and ability to improvise if needed. Ensure manufacturing process/new process within Budget for maximizing efficiencies of Formulation Department Lab. Guide group for day-to-day activities and informing Formulation Development Department (FRD) colleagues for the schedule and timelines for the product development as well as technology transfer of Exhibit, Validation or commercial batches. Ensure group co-ordinate with other functions including Purchase, Production for the status of availability of Raw Materials, Packaging Materials required for development batches/ exhibit batches/ Validation batches at site. Ensure development and stability data generation of the new as well as trouble shooting products as per the regulatory or ROW market requirements. Guide to the for encounter the trouble shooting of legacy products and to provide the Technology transfer documents to resolve or to overcome issues related to the legacy products to provide quality products to the customer. Guide group for the smooth technology transfer of new as well as existing products or trouble shoot products for better to meet the finished product specification. Ensure the Regulatory queries to be addressed in time and guide the group leaders to work on to provide comments on the received quires to be close within provided timeline. Work closely with cross functional team for planning /execution of the Technology transfer/Exhibit/Validation batches of the individual projects to meet the timelines assigned. Provide the technical oversight (guidance), Plan, co-ordinate and oversee the work activities related to technology transfer/Exhibit batches/Validation batches of projects not limited to EU authorization but also CMO/ROW projects. Ensure Compilation of Development batches/Exhibit batches/validation batches data included with critical observations and submission of the same to R&D Head. Co-ordinate with production department for planning of tech transfer /Exhibit/Validation batches and execution/monitoring of the batches of the products starting from dispensing of the materials till packaging of the product to ensure smooth technology transfer of the products complying to the regulatory requirements. Preferred candidate profile- - 8-12 years of experience in Regulated market- OSD formulation & Development and technology transfer. - Good communication, open exchange of information and project teamwork will be required in order to meet the job performance. - Will be expected to accomplish his work assignments by interacting closely with scientific staff/Production staff and by developing the co-operative working relationships with other personnel within the company. - Must be able to work/co-ordinate with different functions within ALS and prioritize the workload to meet the predetermined timelines and need to work as a team with open communication, transparency and mutual trust. - Proper documentation pertaining to Formulation Development as per the Regulatory requirements and as per companys system.

Job Overview: The PDL Scientist - Injectable will be responsible for the development, optimization, and scale-up of sterile injectable formulations and manufacturing processes. The role demands expertise in injectable formulation science, process engineering, and compliance with regulatory and quality standards. Role & responsibilities Formulation Development: Design and optimize sterile injectable formulations, including solutions, emulsions, and suspensions. Perform compatibility and stability studies of active pharmaceutical ingredients (APIs) with excipients. Process Optimization: Develop robust, scalable manufacturing processes for injectable formulations. Define and optimize critical process parameters (CPP) and quality attributes (CQA). Sterility Assurance: Establish aseptic processes and ensure compliance with sterility requirements. Perform filtration studies, autoclave cycle development, and validation. Analytical Support: Collaborate with the analytical team for the development and validation of testing methods. Conduct particle size analysis, pH, and osmolarity evaluations, and other critical tests. Regulatory Compliance and Documentation: Prepare technical reports, batch records, and regulatory submissions in compliance with GMP, ICH, and FDA guidelines. Support regulatory inspections and audits with comprehensive process documentation. Technology Transfer: Facilitate the transfer of processes from lab-scale to manufacturing-scale environments. Work closely with cross-functional teams, including production, quality assurance, and regulatory affairs. Preferred candidate profile 3 - 5 years of experience in injectable formulation and process development. Hands-on experience with lyophilization, sterilization techniques, and aseptic manufacturing processes. Strong knowledge of GMP, ICH, and regulatory guidelines. Proficiency in using laboratory equipment such as autoclaves, lyophilizes, and HPLC systems. Excellent technical writing and documentation skills.

Warm welcome from SP Staffing Services! Reaching out to you regarding permanent opportunity !! Job Description: Exp: 4-6 yrs Location: Hyderabad/Chennai/Kolkata/Delhi Skill: Ab inito Developer Ab Initio GDE, EME, Conduct>It, Express>It, PDL, Unix, SQL Interested can share your resume to sangeetha.spstaffing@gmail.com with below inline details. Full Name as per PAN: Mobile No: Alt No/ Whatsapp No: Total Exp: Relevant Exp in Abinitio: Rel Exp in Unix: Rel Exp in PDL/GDE/EME: Current CTC: Expected CTC: Notice Period (Official): Notice Period (Negotiable)/Reason: Date of Birth: PAN number: Reason for Job Change: Offer in Pipeline (Current Status): Availability for virtual interview on weekdays between 10 AM- 4 PM(plz mention time): Current Res Location: Preferred Job Location: Whether educational % in 10th std, 12th std, UG is all above 50%? Do you have any gaps in between your education or Career? If having gap, please mention the duration in months/year:

Warm welcome from SP Staffing Services! Reaching out to you regarding permanent opportunity !! Job Description: Exp: 4-6 yrs Location: Hyderabad/Chennai/Kolkata/Delhi Skill: Ab inito Developer Ab Initio GDE, EME, Conduct>It, Express>It, PDL, Unix, SQL Interested can share your resume to sangeetha.spstaffing@gmail.com with below inline details. Full Name as per PAN: Mobile No: Alt No/ Whatsapp No: Total Exp: Relevant Exp in Abinitio: Rel Exp in Unix: Rel Exp in PDL/GDE/EME: Current CTC: Expected CTC: Notice Period (Official): Notice Period (Negotiable)/Reason: Date of Birth: PAN number: Reason for Job Change: Offer in Pipeline (Current Status): Availability for virtual interview on weekdays between 10 AM- 4 PM(plz mention time): Current Res Location: Preferred Job Location: Whether educational % in 10th std, 12th std, UG is all above 50%? Do you have any gaps in between your education or Career? If having gap, please mention the duration in months/year:

Purpose of the role: Drug Product MSAT and Technology Transfer TECHNICAL COMPETENCIES: 1. To ensure Site / Tech -transfer of products to Manufacturing site. 2. To ensure Process Performance Qualifications Role Purpose: 1. Technology transfer of in house R&D developed products. 2. Product transfers from internal and external sites to CDMO. 3. Ensure the compliance of Relevant SOPs in product transfer process. KEY DUTIES AND RESPONSIBILITIES: 1. To involve in execution of feasibility/exhibit/pre-validation/process qualification batches for 2. Technology transfer of products and site transfer products. 3. To conduct trials required to generate additional information or knowledge to support the site transfer projects. 4. Responsible to follow EHS compliance as per the site EHS policy and manual. 5. Responsible for review and approval of process performance qualification and continuous 6. process verification protocols and reports. 7. Supporting the operations team for closure of deviations by involving in investigations for commercial batches. 8. Responsible for MFR review. 9. Responsible for preparation of BMP / Trial report. 10. Responsible for Gap analysis preparation. 11. Responsible to ensure product execution checklist for new products. 12. Preparation and review of protocols or batch records for trial batch on need basis.

Role & responsibilities a. Having experience for EB /PV data compilation and report preparation and review. b. Having experience for Executed document (BMR& BPR) review and compliance in coordination with validations requirement. c. Having exposure for hold time study data review and report compilation. d. Having exposure for sampling strategy of bulk and finished product in case of exhibit and commercial launch batches. e. Coordination with stability /micro/QC validation /production team for data collection and compliance as per validation requirement. f. Having exposure for QMS for validation recommendations closure and revision for routine commercials. g. Having exposure for document readiness and submission for product filing to regulatory department or client

6+ years IT experience and exposure to tools ETL/Data warehousing technology . Experience in Ab Initio technologies including, Ab Initio graph development, EME, Co-Op, Conduct>IT, Metaprogramming PDLs. Good Knowledge in Unix and PL/SQL. Delegating tasks and achieving daily, weekly, and monthly goals. Contribute in all phases of the development lifecycle Understanding of architecture and design across all systems Working proficiency in developmental toolsets Ability to collaborate with high-performing teams and individuals throughout the firm to accomplish common goals Understanding of software skills such as business analysis, development, maintenance and software improvement Secondary Multiple years with various Ab Initio tools including Acquire>It, BRE, ACE, Express>IT, Continuous flows The ideal candidate is one with proven ability to drive agile adoption in various organizations, dealing with teams with a mix of low to none to and intermediate agile awareness and maturity. Demonstrated meet and enforce ability to deadlines while dealing with competing priorities, motivated by a positive attitude. Experience working in Agile framework and hands on experience using Agile development process, e.g., JIRA