Sunil Kumar Akkena

• Managing External Supply Operations (CDMO) of Sandoz Large Molecule platform (Biosimilars).
• Managing Quality Operation teams under the QMS domain, where I deal with the Product Release team, Change Control Management Team, APQR team, MAH Team, and Market Complaint Management Team.
• Managing a team of 80 associates, accountable for the business acumen, and Health and Culture of the team.
• Drove team to consistently exceed critical Key Performance Indicator (KPI) targets by up to 100%.
• Responsible for the management of FTEs versus approved SLAs.
• Representing the organization in Extended Leadership connects and working on business partnering with Manufacturing sites across the globe.
• Led performance reviews and tailored employee feedback to facilitate professional development.
• Provided leadership and direction for employees, supervising activities to drive productivity and efficiency.
• Fostered positive employee relationships through communication, training and coaching.
• Resolved employee relations issues and navigated disciplinary proceedings.
• Maintained accurate employee records and updates on performance, absence and HR conversations.
• Undertook regular performance reviews to identify areas for improvement.
• Promoted professionalism and effective communication among staff to develop productive relationships.
• Influenced business change and success through collaborations with different stakeholders

Sandoz spun from Novartis, during Spinoff, I opted to move with Sandoz, for the same roles and responsibilities from Novartis.

• Managing Quality Control Lab, a team of ~70 members, where I am accountable for all lab operations, Compliance with quality systems, deliverables, infrastructure, resources, revenue generation, and culture of the team.
• Responsible for representing the health of QMS, highlights/concerns of QC, monthly revenue targets, and milestone deliverables to senior leadership (COO and CQO) weekly-wise
• Syngene is a CDMO, I am responsible for managing multiple clients (~24 projects), and internal CFTs and meeting the committed timelines on the scope of the work
• Capable of successfully providing advisory, technology & quality solutions as per the organizational requirements; strengthening all laboratories, documentation of data.
• Designed and implemented quality assurance training programs for improved staff understanding.
• Analyzed quality metrics and performed managerial reviews, recommending action plans to close operational gaps.
• Reduced cases of non-conformance through impactful deviation management.
• Defined and implemented quality standards across production processes, enabling improved outcomes.
• Improved customer satisfaction ratings by addressing product shortfalls through detailed root-cause analysis.
• Resolved varied quality issues, aiding project delivery within quality, budget, and deadline targets.
• Identified corrective and preventative action for quality issues through complete failure investigations.
• Presented monthly key metrics to management through detailed, informative technical reports.
• Spearheaded strategic development plans to instigate departmental change, adding value and innovation to business decision-making.
• Adhered to national and international standards for full product compliance.

• Managed operations as head of the Analytical section (Biochemical, HPLC Lab & Bioassays) and took care of all product analysis and release (including all in-process, DS, and DP analysis)
• Representing QC for deliverables as a single point of contact for all the projects (2 Small proteins and 5 mAbs) of the Organization
• Designing stability studies for the pre-clinical, clinical material, forced degradation studies, and studies as per management and regulator body requirements
• Reviewing the development reports and qualification reports and leading the technology transfer activities between the Development teams and Quality Team
• Identifying organizational requirements, hiring required resources & evaluating them on the required parameters
• Monitoring analytical method validations for all the projects (7 projects) that are transferred to QC
• Facing Audits: Internal Audits, Client Audits, and from Regulatory bodies
• As I was one of the Generation Zero hires for the company, hence worked from the initial phase of establishing the R&D labs, QC labs, and manufacturing suits.
• Part of the design of the lab (made a few changes to ease the workforce and smooth movement of the workflow)
• Established the lab from construction to a fully set (functional) Lab for operations
• Management of the support staff activities, Monitoring Engineering schedules and other related service providers for timely readiness of lab
• All system-related documentation, hiring resources, and continuous follow-up with different vendors for all the equipment Installation and Qualifications
• Highlights:
• Accomplished development and troubleshooting of process-related issues for a few molecules.
• Finished & submitted complete validation for 2 projects in 2 months.
• Developed Method, and performed validation and monitoring of the performance of the method by trending all the related data
• Streamlined processes by analyzing product lifecycles and recommending appropriate improvements.

• As a section head of the Analytical Lab, felt the need to coach the analysts with core technicalities like chromatography techniques and PAGE techniques, and successfully trained the team to become SMEs for respective methods with time.
• Managed a group of 12 who are part of Biochemical and HPLC analysis of the Quality control at Kemwell
• As an Ad hoc, I took care of the sample management team and Stability management team.
• Project coordinator for 3 major projects (mAbs) of the Organization
• Received appreciation from internal stakeholders for meeting the TAT for batch release and stability data submissions
• Built and trained quality team through stronger recruitment and coaching programs
• Enhanced the productivity of QC including the GLP compliance improvement
• Recognized for completing CQA Audits, DCGI audits, and QP Audit with no critical observations in QC labs
• Appreciated for on-time batch release for consecutive months, Quality Control -(Instrumentation Section Head)
• Drove client interactions over calls and visits, discussions with internal stakeholders, representing the client requirements between cross-functional groups, and communicating the discussion in brief to the peers and subordinates
• Executed Internal audits, client audits, and from Regulatory bodies
• Introduced a technical training module for all the QC folks, it's an initiative to build a few basics and logical interpretations of the analytical data.

• Senior Scientist in Analytical and formulation development lab and Product Characterization team.
• Planning of routine operations like in-process analysis, DS, and DP releases.
• Planning of stability studies and extracting samples as per protocol for analysis.
• Troubleshooting analytical methods like SEC, IEX RP etc.
• Developed methods like Glycan by HPLC/UPCL/KIT based, SEC methods, IEX methods etc, Qualified and transferred to QC
• Established Instrumentation Support Team which further grew to a team of 12 members which includes all levels of experience, who will be the first contact points for any instrument-related trouble in the lab (especially HPLCs and UPLCs).
• Successfully led a team & brought required changes in the maintenance of lab instruments, instruments handling, training new people in the lab about handling critical equipment
• Introduced the concept of troubleshooting dairy/manual in the lab

• As part of the Analytical Operations team, all in-process analyses were taken care of as routine support to Downstream and Upstream studies.
• Developed SEC methods for different mAbs (3 mAbs).
• Developed IEX and RP methods for mAbs (3 mAbs).
• Awarded for an innovative method for quantifying polysorbate excipient, by RP and SEC method.
• Optimized the Glycan analysis, as each sample analysis is a huge cost to the company and time-consuming too. Significant work on this method successfully optimized the glycan method and made as a platform technique for all N-glycan analysis.
• Worked on a project to evaluate all kind of leachates that comes with different consumables that get in contact with DS / DP during routine operations.
• Optimized the in-process sampling matrix for different small proteins and mAbs, to decrease the cost to the company and for improved efficiency on the TAT.

• Supporting in-process analysis for different small molecules and mAbs (3 small proteins and 4-5 mAbs)
• Developed physiochemical assays like pH measurement, UV 280, CZE Analysis, and different HPLC methods.
• During this period was also part of the Manufacturing Support lab (MSL, as an ASAT)
• Worked in the downstream lab, part of end-to-end development of the process for small proteins (2 Small proteins and 1 mAb).
• Worked with PEGylated molecules, established IEF and SDS PAG methods, and also the SEZ methods.
• Worked under Downstream Process development for one of the protein molecules, worked end to end on the robustness of the process as part of a special study where worked on a few vendors' products to cut down the cost to the company (significant cost reduction for the company, and was awarded for this achievement)

I was a trainee research associate in the Analytical Development lab.

For the 6 months, I was on rotation into different development labs.

Learned fermentation techniques, cell culture techniques, process chromatography techniques, and Analytical development lab techniques.

Supported all development batch analysis for physico chemical analysis in the initial phase of career, later progressed into the handling separation techniques.