Senior QC/R&D Scientist

Marcus Ajesh Nykan

Senior QC/R&D Scientist

***********@*****.*** • 925-***-****

LinkedIn • Oakley, CA 94561

Accomplished professional with over decade of experience in driving innovation and ensuring product excellence through quality control and advanced research methodologies; recognized for leading high-impact projects, optimizing lab operations, and enhancing product development processes to consistently exceed regulatory standards and market expectations.

Proven track record of conducting analytical experiments to test new and existing biosensor concepts and materials, including small molecules, organometallics, traditional polymers, and biologics. Proficient in utilizing and interpreting results from advanced analytical instrumentation such as HPLC, LCMS, GCMS, UV, GPC, viscometer, cyclic voltammeter, NMR, MS, and elemental analysis. Skilled in constructing and testing electrochemical biosensors for R&D, leveraging techniques such as laser cutting and automated liquid dispensing. Adept at accessing chemical, biological, and engineering literature to address technical issues and presenting experimental results in group meetings. Strong history in maintaining lab equipment, QA records, and purchasing documentation, with proven ability to manage material procurement and liaise with contract suppliers. Excellent coordination skills with internal functions, including safety, purchasing, and accounting, while guaranteeing seamless operations and compliance.

Areas of Expertise

Analytical Experimentation

Project Management

Research and Development (R&D)

Operational Excellence

Assay Method Transfer

Method Validation

Equipment Installation

Instrument Equivalency Testing

Technical Research & Analysis

Risk Assessment & Mitigation

Data Migration & Interpretation

Quality Assurance & Control

Regulatory Compliance

Process Improvement

Product Development

Laboratory Management

Staff Training & Leadership

Client & Stakeholder Engagement

Cross-functional Collaboration

CDS1 (Chromatography Data System)

EDMS3

DR/CAPA2

LIMS

Advanced Instrumentation

Accomplishments

Recipient of Special Recognition Award (SRA-Delivering Results) from Bayer Healthcare in 2009 for pivotal contributions as core team member in M-Building to ESE labs relocation project, while proactively overseeing validation and qualification of equipment for QC Chromatography group.

Attained Special Recognition award for pivotal contribution as core team member in IFN-β Complex study project at Bayer Healthcare, as well as recognized by FDA, 2010.

Selected by Genentech Leadership as Project Team Lead for inaugural installation and qualification of Waters Aquity UPLC systems, while playing pivotal in increasing testing capabilities.

Led technical assay transfers from Genentech's South San Francisco Development labs to Quality Control labs in Vacaville, CA, while confirming seamless integration of new UPLC assays on advanced UPLC systems.

Managed pioneering installation and qualification of first-ever UPLCs at Genentech Vacaville, while effectively expanding to four UPLCs through successful project team collaboration in 2018.

Professional Experience

Polaris Pharmaceuticals, Inc., Vacaville, CA 2023 – 2024

Quality Control / Research & Development Scientist I, Analytical Technologies, Quality

Analyzed and validated data against stringent criteria and specifications, while proactively guaranteeing accuracy and reliability. Spearheaded, identified, supported, and documented OOS/OOE/OOT and deviation investigations with prompt resolution. Maintained laboratory in inspection-ready state in adherence to regulatory and quality standards. Updated and refined written procedures for confirming clarity and compliance. Prepared inclusive study protocols and reports for routine and non-routine tests. Conducted peer reviews and archived analytical data for maintaining data integrity. Managed reagent and equipment inventory for verifying availability and operational efficiency.

Key Accomplishments:

Achieved specified timelines by planning and initiating comprehensive biochemical, physical, and chemical analyses of test samples, such as process development, lot release, and stability samples under cGMP guidelines.

Ensured operational readiness and compliance by procuring and facilitating qualification of analytical equipment (IQ/OQ/PQ).

Supported routine laboratory functions and chores, leading to smooth QC laboratory operations.

Enhanced laboratory capabilities by attaining exceptional proficiency in broad spectrum of test methods.

Improved team competency by effectively diagnosing technical issues and providing advanced training to analysts.

Cultivated in-depth knowledge of cGMP, 21CFR, USP, EP, ICH, and other regulatory requirements.

Elevated testing accuracy by creating and refining Liquid Chromatography analytical test methods and equipment.

Aided audits and investigations by reviewing and approving technical content, while ensuring scientific merit and regulatory compliance in SME role.

Eidos Therapeutics, a BridgeBio Company (Real Staffing), San Francisco, CA 2022 – 2023

QC Specialist, Analytical Chemistry, Quality Control, CMC (Chemistry, Manufacturing, and Controls)

Directed Quality Control operations in commercial Quality Control group, while supporting late-stage small molecule Acoramidis program and subsidiary programs. Conducted thorough review of analytical test packages for release, in-process, and stability testing of clinical/commercial supplies (DS and DP), while verifying current specifications, test methods, and documentation accuracy. Submitted test packages to QA for further review and managed data entry into electronic storage systems. Supervised laboratory operations, while executing investigations into out of specification, out of trend, and anomalous results.

Key Accomplishments:

Ensured adherence to Current Good Manufacturing Practices (cGMP) at analytical Contract Manufacturing Organizations (CMO) laboratories.

Maintained timely data review and fostered collaboration with Quality Assurance (QA) and analytical contract laboratories.

Leveraged advanced expertise in analytical techniques: HPLC, GC, GC/MS, LC/MS, ICP, dissolution, IR, NMR, XRPD, Karl Fischer titration, DSC, TGA, PSD, and wet chemistry.

Demonstrated excellence in Good Documentation Practices (GDP) and effective communication, including verbal and written.

Guaranteed prompt resolution of deficiencies/omissions in test packages by overseeing review and approval of analytical data for release, stability, and in-process testing.

Genentech Roche, Vacaville, CA 2013 – 2022

QC Associate II, Product Analytical Testing, Quality Control, Biotechnology

Managed lab supply inventory and procurement, while optimizing reagent preparation for complex assignments. Developed and validated multiple HPLC and UPLC methods, while transferring globally across in-network sites. Revised SOPs and authored technical reports, while collaborating with internal and external stakeholders to support operational activities. Led analytical method validation and transfer assays, while verifying accurate data analysis and statistical evaluations. Drafted and revised comprehensive analytical test methods, validation and transfer protocols/reports, deviations, CAPA, and other analytical documentation.

Key Accomplishments:

Achieved significant on-time performance by verifying adherence to GMP and GDP guidelines in testing routine and non-routine samples, such as in-process, intermediates, finished product, stability for lab operations.

Trained and mentored new HPLC and UPLC analysts within Genentech Roche network, while gaining expertise in troubleshooting and minor repair of equipment.

Maximized analytical testing methods for medical devices by conducting and reviewing diverse HPLC and UPLC assays.

Identified and resolved technical issues, while achieving continuous process improvements and adhering to GMP policies.

Additional Experience

Senior Scientist, Analytical Operations, Research & Development, PDM (Pharmaceutical Development and Manufacturing), Eurofins PSS (Gilead Site) Foster City, CA

QC Associate II, Liquid Chromatography, Quality Control, Biopharma, Bayer Healthcare, Emeryville, CA

QC Associate II, Liquid Chromatography, Quality Control, Biopharma, Novartis Corporation, Emeryville, CA

QC Analyst I, Liquid Chromatography, Quality Control, Biopharma, Chiron Corp, Emeryville, CA

QA Technical Reviewer I, Complaint Administration, Blood Testing, Biopharma, Chiron Corporation Emeryville, CA

Education

Bachelor of Science in Biology, Cal State Hayward (East Bay) University

Key Projects

Turbo Chrome v.4 (TC4) to Turbo Chrome Client Server (TCCS) with Chiron Corp (11/03 – 01/07).

Waters Empower 1 Chromatography Data System (CDS) to Waters Empower 2 (CDS) with Novartis Corp. (01/07 – 09/07).

Waters Empower 2 (CDS) to Waters Empower 3 (CDS) with Bayer Healthcare (09/07 – 07/11).

Waters Empower 3 (CDS) to Waters Empower 3 (CDS) v.5 Firmware Upgrade with Genentech Roche (12/13 – 08/22).

Cross company QC training project manager with Chiron (provided assay training to partner companies).

Chiron QC provided training to Novartis QC and BI QC.

Reference Standards/Critical Reagents Project: Project manager with Novartis. Responsible for inventory control and expiry extension technical reports.

HPLC Lab Transfer Project: Acted as Project manager with Bayer Healthcare, while moving all equipment from old HPLC lab to new HPLC lab as well as coordinated and performed OQ/IQ/PQ testing for all equipment in new HPLC lab.

Assay Method Transfer Project: Project manager with Genentech. Responsible for the transfer of new HPLC and UPLC assays from one Genentech site to my Genentech location in Vacaville, CA.)

New Product Transfer Project: Led as Project manager with Genentech and transferred new products from one Genentech site to Genentech location in Vacaville, CA.

Method Validation Project Experience with Multiple Products: Performed method validation with Genentech on several test methods for several products.

Equipment Installation and Qualification Project Manager: Management of installation and qualification of first 3 UPLCs at Genentech, Vacaville, CA. Management of installation and qualification of the Wyatt DynaPro NanoStar II Dynamic Light Scattering equipment and software.

Instrument Equivalency Transfer Testing: Performed testing per protocol to transfer analytical methods from Agilent HPLC to Waters HPLC at Genentech Vacaville.

Prepared MV (method validation) protocols for execution (state acceptance criteria and parameters to meet, most of comes from characterization study), step by step instructions and approved before execution. Designed method validation reports to summarize data from the method validation experiments.

Quality Assurance Experience: Served as Quality Assurance Technical Reviewer for Chiron, while creating and reviewing customer complaint records for the Blood Testing division. Offered investigation reports for the closure and resolution of corrective and preventive actions (CAPAs).

Technical writing and review of assay data packets for batch records release and product stability program requirements at Chiron, Novartis, Bayer, and Genentech.

Technical writing and review of testing protocols, method development reports, method validation reports, assay standard operating procedures (SOPs), deviation reports, and more at Chiron, Novartis, Bayer, Genentech, Eurofins/Gilead, and Polaris.

Possess twenty years of experience in quality assurance, quality control, and research and development environments.

Technical Proficiencies

Microsoft Word/Works, Microsoft Excel, Microsoft Power Point, Turbochrom Client Server, Turbochrom V4, Waters Empower (CDS)1 v1, 2, 3, 4, & 5, ChemStation (CDS)1, Sentry/Trackwise (DR/CAPA)2, Veeva Vault (DR/CAPA)2 (EDMS)3, Atlas (EDMS)3, DocLink (EDMS)3, Condor (EDMS)3, Livelink (EDMS)3, SAP, SQL LIMS4, Labware LIMS4, and Electronic Laboratory Notebook (ELN)

Laboratory Skills

High Performance Liquid Chromatography Specialist (HPLC)

Ultra-High Performance Liquid Chromatography Specialist

UHPLC also known as UPLC

Hydrophobic Interaction Chromatography (HIC) HPLC

Gel Permeation Chromatography (GPC) HPLC

Reverse Phase (RP) HPLC

Cat ion Exchange (CEX) HPLC

Size Exclusion (SEC) HPLC

Ion Concentration (IC) HPLC

Anion Exchange (IEX) HPLC

Peptide Mapping (RP) HPLC

Reverse Phase (RP) UPLC

Size Exclusion (SEC) UPLC

Peptide Mapping (RP) UPLC

HILIC Glycan UPLC

Capillary Electrophoresis (CE)*

Waters, Agilent, and Thermo Fisher HPLC and UPLC Specialist

UV-VIS

Karl Fischer (KF)

Wyatt DynaPro NanoStar II Dynamic Lighting Scattering System, Instrument, and Software (DLS)

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