Danielle Melvin Email & Phone Number

United States

(Previously Center for Breakthrough Medicines role) In this role I participate in Upstream suspension processes and maintain proficient aseptic technique and sterile gowning. I regularly perform suspension cell expansion through the use of shake flasks and single use rocking motion and suspension bioreactors. I participate as an SME for upstream processes, ensuring all required materials have been ordered/received, and that the required equipment is ready for use. I am trained and proficient on cell analysis equipment as well as any required upstream ancillary equipment. I assist with reviewing batch records and participating in water runs, collaborating with MSAT to improve our guiding GMP documents. I helped implement the use of LIMS for manufacturing sample management and trained the MFG team on the software before use. I assist with goods movement and consumptions in SAP for process materials. I also assist with initiation and authoring of deviations and CAPA plans when required. I am a firm believer in helping set up the team for success and being confident in the work we do to help patients by safely manufacturing these life saving treatments!

King Of Prussia, Pennsylvania, United States

(Previously Center for Breakthrough Medicines role) In this role, I helped develop and stand up the gowning, aseptic technique, and Viral Vector training programs. I am responsible for the creation and maintenance of all Viral Vector Manufacturing, MSAT, and Support Services curricula, and training documentation. I work hand in hand with MFG leadership to ensure training needs are met and with our Quality Training Team to ensure all training is functional and visible in our LMS system. I work to ensure training readiness of MFG personnel for GMP operations. I also assist in the creation, delivery, and coordination of various Instructor Led Trainings, OJTs, Vendor Trainings, and other required trainings. I also assist with Gown Training/Qualifications and Aseptic Manipulation Qualifications sitewide. I maintain all curricula and documentation for Gowning and Personnel Flow for the Manufacturing Areas and Aseptic Manipulation Qualifications. I also perform hands on training for both Basic and Advanced Gowning and Personnel Flow as well as Aseptic Technique. I am constantly searching for ways to improve our current training program and have a passion for helping personnel develop and learn in their careers!

Baltimore, Maryland, United States

I managed the on the job training program for the Emergent Manufacturing team as well as help create, deliver, or coordinate instructor led trainings, computer based trainings, vendor trainings, gown trainings/qualifications, remediation trainings, etc. I helped author and manage training procedures, guides, and other miscellaneous training documents. I also oversaw the onboarding of all new Manufacturing personnel and developed their training plans. I am constantly searching for ways to help improve our current training program!

Baltimore, Maryland

In this role I am a part of a team manufacturing vaccine products, including vaccines for the current Covid-19 pandemic. My daily responsibilities include working in a clean room environment and performing cell culture techniques under a biological safety cabinet and in various sized bioreactors. I am trained to operate various manufacturing equipment needed for successful production. I also assist with improving current SOPs and On the Job Trainings, writing and carrying out CAPA plans, as well as implementing 6S systems to clean room areas. Currently, one of my main roles is also as a trainer for new employees on different equipment and roles needed during the manufacturing processes.

As a Manufacturing Technician II I am part of a team that processes and packages human birth tissue for the manufacturing of wound covers. I work daily in a clean-room environment and am responsible learning and carrying out various SOPs as well as training newer technicians on them inside and outside of the clean-room. I am also responsible for assisting with batch record/document preparation and review.

Columbia, Maryland

Baltimore, Maryland Area

As a Clinical Research Coordinator, I was responsible for helping carryout clinical research trials for post operative pain medications. I was responsible for following study protocols and collecting data during the trials such as pain scales, PK samples, vital signs, ECGs, blood draws, documenting side effects, etc.

Mansfield, Pa

Thawed, cultured, and counted tumor cells and calculated doubling times for the specific cell line under the guidance of Dr. Kristen Long

Mansfield, Pa

- Examined factors that affect the passive transfer of immunity in dairy calves under Dr. Sarah Hazelton and Dr. Jeanne Kagle- Collected colostrum and blood samples, used a digital refractometer to measure blood proteins and immunoglobulins, created media plates, operated an autoclave machine, identified bacterial colonies - Won second place award in the session of Ecology, Evolution, and Organismal Biology at the 2017 Commonwealth of Pennsylvania Biologists Conference

Mansfield, Pa

Answered prospective student and parent questions over the phone, gave campus tours to prospective students, filed student files, copied documents, created folders, input into prospective student database.

Paxinos, Pa

Served food and beverages to gold club members and guests attending events held at the country club. I was also responsible for keeping the bar stocked and neat.

Tioga County, Pensylvania

- Searched for Mycoplasma bovis in the milk of dairy cattle - Performed DNA extraction, PCR, gel electrophoresis