Manufacturing Microsoft Office

DANIEL CHRISTIAN RZEGOCKI

Quincy, MA *****

908-***-**** / *********@*******.***

EDUCATION:

B.S., Biology, University of Hartford, West Hartford, CT 06110

SUMMARY:

Senior Manufacturing Associate and has also worked as a Senior Associate Scientist in Process Development with extensive experience mainly in Bio-tech and pharmaceutical environments. Has a broad range of experience and in depth understanding of various functions of bio-tech manufacturing, engineering, process development, validation, data management and operational excellence. Conscientious and diligent team member committed to achieving consistent results.

TECHNICAL SKILLS AND QUALIFICATION:

Excellent analytical and problem solving skills

Extensive knowledge of GDP, cGMP and cGLP practices

Excellent interpersonal skills with the ability to work in either a team or individual environment.

Works well in a fast-paced environment.

Experienced in Microsoft Office applications, pH, Horiba, Malvern Zetasizer.

EXPERIENCE:

Alnylam Pharmaceuticals, Cambridge, Massachusetts

Senior Manufacturing Associate

8/14- Present

Troubleshoot and resolve process related issues and interact with support groups to ensure production targets are met and product and process comply with cGMPs, product licenses and corporate policies.

Ensure all operations and documentation conform to cGMP standards and that all SOP’s and batch records are maintained to reflect current manufacturing methods.

Use technical writing skills to own and complete deviations, CAPA’s, change controls, etc. as required.

Identify and implement continuous improvement projects utilizing independent project management skills.

Create work orders as needed, and coordinate work to prevent maintenance and calibration events from impacting schedule.

Perform Batch Record, Logbook requests and review manufacturing documentation to ensure compliance.

Propose and review document revisions.

Carry out work in a safe manner, notifying management of safety issues and risks.

Support execution of equipment and process qualification and validation and review associated protocols.

Provide technical training to employees, meet and maintain training material requirements.

Subject matter expert for manufacturing equipment.

CIP and cleaning validation experience.

Ultrafiltration/Diafiltration experience.

Alnylam Pharmaceuticals, Cambridge, Massachusetts

Senior Associate Scientist

7/12 – 7/14

RNA Formulation Process Development and Manufacture.

cGMP manufacture of lipid based nanoparticle drug product.

Process Development and scale-up of lipid nanoparticle.

Manufacture of lipid nanoparticles to support internal and external drug delivery research activities.

Key member in planning GMP manufacture capability of lipid-based RNA formulations for clinical studies and potential commercial application.

Prepared and reviewed batch records and SOP’s for lipid nanoparticle drug product manufacture.

Biophysical characterizations of lipid nanoparticles (such as HPLC, UV, Malvern Zetasizer and Horiba Particle Size Distribution Analyzer, etc.)

Celator Pharmaceuticals, Princeton, New Jersey

Process Development Associate

5/06 – 10/11

Development batch production and testing for chemotherapy drug products. Expertise in the entire production process including buffer preparation, compounding, filtration, fill and finish.

Developed novel lipid-based, nanoparticle formulations for the treatment of cancer.

Acted as a lead person to develop a lyophilization process of liposomal pharmaceutical products.

Technical transfer, scale-up and validation of pharmaceutical manufacturing processes to contract manufacturing sites.

Helped prepare CMC section to submit for US and international (FDA/EMEA) regulatory filings.

Clinical packaging receipt and shipment.

Member of team that brought two liposomal formulations from R&D through clinical development and process validation.

Responsible for selection of laboratory and manufacturing equipment. Wrote instruction manuals for manufacturing and laboratory equipment. Performed and coordinated routine maintenance, repair and qualification.

Represented process development and manufacturing teams on company’s safety committee.

Completed a cleaning validation and lyophilization courses, developed equipment validation methods and trained in cGMP.

Conducted trainings for employees new to the Celator combiplex (patented drug delivery process) platform.

Trained in the operation of equipment, including but not limited to homogenizers, extruders, ultrafiltration equipment from lab to production scale, particle sizer, large-scale mixers and lab and production equipment, UV Spectrometer.

Hoffman La Roche, Nutley, New Jersey

Associate Scientist

7/04 – 4/06

Assisted with research and development of pharmaceutical compounds in Kilo Lab.

Responsible for applying kilo techniques to scale up the chemical synthesis of drug substance in accordance with cGMP compliance.

Conducted analysis on assay, purity, impurities identity and water content for drug substance formulations.

Prepared samples, standards, reagents and mobile phases for analysis for pharmaceutical compounds.

Performed daily calibration of laboratory apparatus and analytical equipment.

Maintained laboratory equipment and materials in order to make efficient use of time easier. Effectively communicates with supervisors and discrepancies that may occur.

Conducted trainings for employees on sampling procedures and process use of the USP purified water.

Records keeping of laboratory notebooks and documents according with the current GMP compliance.

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