Artsiom Nnumolu Email & Phone Number

• Effectively managed six unique projects, ensuring on-time completion of milestones and deliverables, critical for IND filings of innovative molecules. Provided weekly progress reports and updates, facilitating clear.
• Lead and mentor a small analytical team, focusing on skill development and cohesive teamwork, which contributed to enhanced project outcomes and team performance.
• Spearheaded the transformation of two complex residual ADC payload analytical methods using LC-MS-MS. Overcame technical challenges to develop and validate these methods within stringent timelines, significantly.

Bristol, Pennsylvania, United States

• Conducted research, optimization, and validation of analytical methods for both small and large molecules using various instruments and techniques, validating over 16 methods across six projects.
• Supported downstream bioconjugation and chemistry processes for Phase I, Phase II and early phase IND projects.

Bethlehem, Pennsylvania, United States

• Effectively managed three client projects, ensuring the timely completion of all milestones and deliverables, alongside delivering weekly progress reports and meeting updates to facilitate IND and ANDA filings for.
• Successfully validated over ten analytical methods for injection suspensions and various medical devices utilizing extended delivery and nano-vehicle technology.

Plymouth Meeting, Pennsylvania, United States

• Led, supervised, inspired, nurtured, and trained an analytical team of six scientists, conducting performance evaluations.
• Authored the analytical section of the Bioequivalence Studies with Pharmacokinetic Endpoints report, submitted under an Abbreviated New Drug Application (ANDA) to the FDA for approval.
• Successfully helped to prepare the facility and laboratory for an FDA audit, maintaining cGMP readiness.

Plymouth Meeting, Pennsylvania, United States

• Planned, and executed a bioequivalence study as per FDA guidelines, while completing the study within company set deadline (which saved the company over $450,000).
• Maintained, performed routine analyses, and developed methods on GC-MS.
• Successfully authored and implemented an OOS/OOT investigation SOP/system.

Horsham, Pennsylvania, United States

• Introduced and drove the impurity program for analytical methods per ICH Q3A(R2) and Q3A(R2), utilizing RRF values to accurately calculate impurities and related compounds of APIs.
• Optimized and validated over 10 analytical methods on HPLC across several product lines.
• Reviewed data, identified trends, performed, and authored OOS/OOT investigations.

Bristol, Pennsylvania, United States

• Researched, developed, optimized, and validated analytical methods across multiple instruments and techniques.
• Initiated and created a database/dashboard (in Microsoft access) to manage all the functions of the lab, which saved the company ~$200,000 from having to invest in database software.
• As a safety officer, created a monthly safety inspection and maintained overall laboratory safety as per OSHA guidelines.

Levittown, Pennsylvania, United States

• Trained QC Chemists in routine testing areas, including dissolution, HPLC, and GC, resulting in significant time and cost savings for the company through the reduction of incidents, deviations, and rework, leading to a.
• Validated and transferred methods from R&D to QC.
• Lead/supervise stability team; manage scheduling and assign testing to QC Chemists. Ensured all the product stability time points were pulled and executed on time.

Levittown, Pennsylvania, United States

• Produced precise and accurate analytical results: in-process, finished, stability products and raw materials following in-house and USP methods in cGMP environment.
• Created and maintained chemical inventory of expired chemicals; purchased chemicals, analytical instrumentation, and columns.
• Performed comprehensive cleaning validations to ensure adherence to quality standards and regulatory requirements.

King Of Prussia, Pennsylvania, United States

• Authored and edited SOPs and Test Methods.
• Calibrated analytical instrumentation.
• Routine analyses on GC-FID, HPLC, IC, and IPC-OES.