Dynamic leader with a proven track record at Orbicular Pharmaceutical Technologies, excelling in method development and cross-functional management. Spearheaded innovative analytical projects, enhancing laboratory efficiency by 30%. Renowned for exceptional communication skills and expertise in GLP and GXP, adept at driving teams towards regulatory success and operational excellence.
Hi, I’m
SAIKIRAN ANUMANDLA
14+ Years Experienced Manager Analytical Research Complex Injectable And Peptides And MAbs
Hyderabad,Telangana
Summary
Overview
15
years of professional experience
2
Years of post-graduate in chemistry education
Work History
Orbicular Pharmaceutical TechnologiesHyderabad
Manager
01.2021 - Current
Job overview
- Working as lead for Peptide injectable and mAbs Analytical development and project Execution.
- Design and plan Analytical development of Peptides injections and mAbs
- Assay, RS development, Sequence and Mass confirm, High molecular weight species or Aggregates and SEC study design, Primery , secondary structures, Physio chemical Development for peptide injectables, PEQ study report design and approval.
- Impurity profiling and unknown and Know impurity identification through Mass spectrometry and data interpretation and Sameness assessment with Reference listed drug.
- Analytical feasibility for Monoclonal antibodies and methods development lead to determine physico chemical parameters Potency, purity, Glycans, IEX, SEC methodologies and its orthogonal techniques.
- API Source finalization through data evolution, Peptide and protein degradation path ways monitoring and post transitional modifications assessment through UPLC HRMS Synapt.
- Release and Orthogonal methodologies finalization sameness implementation for Q1/Q2 and Q3 targets
- Physico chemical Characterization and structure identification data evolution and interpretation.
- Coordinate with CRO's and Data evolution, interpretation.
- Responsible for Alcoa+ and GLP and GXP implications in the Laboratory
- Coordinate with the Cross-functional teams like Validation lab and technology transfer and Quality control and Regulatory affairs,QA, CRO's.
- Involves in Scientific meeting for the data presentation and answerable for query responses.
- Responsible for Spec approval and STP Review and change in the methodologies and impact assessment through out product lifecycle.
- Introduction of new systems and Technologies to the lab.
- Led cross-functional teams to execute projects on time, within budget, and with high-quality outcomes.
- Empowered team members by delegating responsibilities according to individual strengths and areas of expertise.
- Supported cross-functional teams in achieving project goals through effective collaboration on procurement-related tasks.
- Performed data analysis and provided recommendations for Lab scale and scaleup and Exhibit and Commercial batches.
- Proficiency in filing and get approval approval for the product to FDA and EU and Global markets.
Gland Pharma LimitedHyderabad
Deputy Manager
07.2019 - 02.2021
Job overview
- Supervised day-to-day operations to meet performance, quality and service expectations.
- Chemical method development Monitoring through HPLC, GC and Coordinate scientifically Justified Methodologies.
- Development and Validation and Technology transfer Data evolution, Protocols and Report signing
- Characterization methodologies finalization Like Particle size distribution, Viscosity, Rheology, XRD, DSC,Tg,Glass Delamination studies through SEM
- Analytical Stability data evolution and decisions making justify the scientific sinario.
- Evaluated suppliers to maintain cost controls and improve operations.
- Partnered with upper management in executing functional strategies and reporting capabilities.
- Conferred with customers each day to maintain current understanding of needs and preferences, resolve issues, and promote brand loyalty.
- Functioned as point of contact for project administrators and managers focused on timely and successful completion of full lifecycles of assigned projects.
- Interviewed, performed background checks, hired, and trained morethan 10 no of associates.
- Eliminated functional bottlenecks by streamlining communication channels between management and employees.
- Performed statistical analyses to gather data for operational and forecast team needs.
- Worked collaboratively with QC,RA, Validation, Product departmental team and served on health and safety committee.
- Coordinated unloading merchandise from delivery truck.
- Mentored team members to enhance professional development and accountability in workplace.
Dr. Reddy's LaboratoriesHyderabad
Scientist R1B
02.2017 - 07.2019
Job overview
- Working for Emulsion and Microspheres formulations As Analytical scientist
- Responsible for Method development and Method validation and Technology transfer and Stability studies
- Experienced in Discriminated Dissolution development
- Drug distribution in Different phases
- Related substances Method development and Validation
- Particle size distribution by Malvern 3000 and Zeta sizer
- Viscosity method development and validation (SEM) Scanning electron microscopy analysis
- Protocols for Method Development and Method Validation preparation and Review
- Stability studies Monitoring and Data presentation
- Handling of Out of specifications and Out of trend(OOS&OOT) Handling of Incidents and Change Controls
- Pre formulation and development formulation study
- Viscosity Development and Rheology experienced
- Residual solvents by Gas chromatography
- Experienced in USP type 4 Dissolution studies.
Mylan Laboratories Ltd.Hyderabad
Research Associate
02.2014 - 02.2017
Job overview
- In vitro Method Development for NDDS Microspheres (Depot injections) and Liposomes
- Liable for Analytical Method Development and Method Validation and Stability Studies of Injectable Dosage forms
- Performed Pre-formulation studies
- Execution of polymer characterization
- Actively participating in project meetings about Data Discussions of Assigned projects
- Stability study, compilation and data review of drug products
- Working under Strong GLP system Communicate and address problems in methods perform safety and literature searches under moderate guidance from more experienced team member
- Actively contribute to team goals
- Development and validation of various analytical method like Assay, Related substance, Dissolution
- Having good comprehension on LIMS and Newgenesis systems
- Working for Regulatory US FDA projects Expertise in Microspheres (Depot Injection), liposomes, Sterile Injections, Ophthalmic and Nasal Sprays development
- Checking and Maintaining of LNBs and related documents as per GLP.
Celon LabsHyderabad
Research Associate
12.2011 - 02.2014
Job overview
- Analytical Method development Method validations for parenteral drug products
- Worked as a team member and supported for stability analysis as Research officer AR&D Handling of Liposomal injection and Microspheres analytical development and stability analysis
- Supported project management efforts, resulting in timely completion of research tasks and deliverables.
- Maintained detailed records of experiment protocols, ensuring consistency and reproducibility across studies.
- Utilized advanced laboratory techniques to produce reliable and accurate data for ongoing studies.
- Expanded professional knowledge by attending relevant workshops and seminars regularly.
- Contributed to the development of research proposals, securing funding for multiple projects.
- Assisted senior researchers with experimental design, contributing to the successful completion of various studies.
- Spearheaded troubleshooting efforts for instrumentation issues, minimizing downtime and maintaining efficient laboratory operations.
Vijayasri OrganicsHyderabad
Quality Control Executive
02.2010 - 12.2011
Job overview
- Worked as a Trainee level Handling of HPLC,GC,Potentiometry, and Wet lab analysis Supported to QC under seniors guidence
- Support for Raw material analysis Support for Reaction monitoring Daily and Monthly Calibration of the instruments
- To attend GLP and GXP trainings.
Education
Acharya Nagarjuna University
Masters Degree in Chemistry
01.2007 - 04.2009
University Overview
Skills
Method development
Timeline
Manager
Orbicular Pharmaceutical Technologies
01.2021 - Current
Deputy Manager
Gland Pharma Limited
07.2019 - 02.2021
Scientist R1B
Dr. Reddy's Laboratories
02.2017 - 07.2019
Research Associate
Mylan Laboratories Ltd.
02.2014 - 02.2017
Research Associate
Celon Labs
12.2011 - 02.2014
Quality Control Executive
Vijayasri Organics
02.2010 - 12.2011
Acharya Nagarjuna University
Masters Degree in Chemistry
01.2007 - 04.2009
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