STEPHEN A. TELLES

(***)- ***-**** adh9z9@r.postjobfree.com

CAREER PROFILE:

Biotechnology professional with 5 years experience producing high quality products, completing processes efficiently, leading and training new employees in the pharmaceutical and medical device industries. Led other team members in achieving high yields, identifying and segregating nonconforming raw and intermediate materials and ensuring training of new hires on manufacturing and quality processes.

EDUCATION:

Franciscan University of Steubenville, Steubenville, OH

Bachelor of Arts in Biology - May 2015

EXPERIENCE:

Genmark Dx – Carlsbad, CA

Formulations Specialist II

March 2020 – Present

Initiating non-conformance reports and assisting with writing and executing validation protocols

Supporting team managers with product formulations to ensure development processes are followed and deadlines are met in a timely manner

Supporting development team with formulating Research Use Only (RUO) and Emergency Use Authorization (EUA) products

Leading and training new employees on manufacturing processes and good lab practices

Identifying and reporting non-conforming products

Maintaining a safe and clean work environment in compliance with best practices and standard operating procedures

Tracking inventory to ensure new production lab is fully equipped with necessary raw materials and equipment

Evaluating manufacturing forms and work instructions for lab tests

Quality Control testing of depos solutions and lyophilized magnetic bead products.

Contributed to company achievement of becoming cash flow positive in Quarter 2 of 2020

Formulations Specialist

July 2018 – February 2020

Formulated reagents and performed line clearance

Identified and documented errors in products labels, obtained approval and successfully relabeled product

Created reports to gather and analyze data from product testing

Collaborated with team members to identify and resolve customers’ complaints

Performed tests to ensure product tubes were sealed to proper specifications

Coordinated between departments to schedule calibration and preventative maintenance on lab equipment

Manufacturing Technician I

September 2017 – July 2018

Adhered to the requirements of working in Food and Drug Administration regulated workplace

Assisted team lead while following standard operating procedures & guidelines

Completed manufacturing batch records while maintaining good documentation practices

Genentech – Oceanside, CA

Manufacturing Bioprocess Technician

December 2015 – September 2017

Worked with highly integrated and fast-paced interdisciplinary teams on process troubleshooting and manufacturing of clinical and commercial drug substance

Purified product; set up and monitored large scale chromatography columns

Performed fixed tank and filtration systems cleaning using clean-in-place (CIP) and steam-in-place (SIP) procedures

Operated production equipment via Syncade and DeltaV software to produce active pharmaceutical ingredients

Documented production procedures by completing forms, reports, logs, and records of equipment

Tested new equipment during facility expansion to adhere to manufacturing industry standards

Collaborated with groups to implement procedures and processes to increase efficiency

Cleaned, assembled, and sterilized equipment using glass washers and autoclaves

Downstream processes related to purification of Mammalian Cho Cell products in a GMP Biologics Environment

TECHNICAL SKILLS: Microsoft Word, PowerPoint, Excel

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