Diana Chan Email & Phone Number

Mumbai, Maharastra, In

Princeton, Nj, Us

• Manages drug development projects and commercial operations for various drug dosage forms. Conducts presentations for senior management and facilitates regular meetings with internal and external parties. Coordinates customs and FDA clearance for imports and exports. Executes business agreements including contracts, leasing, maintenance, insurance and state licensing. • Led cross-functional teams in submission of 6 Abbreviated New Drug Applications (ANDAs) to the FDA within one year, resulting in 5 approvals.• Managed cross-functional teams and contract sites in timeline and deliverables for commercial launch of 3 products. Achieved early delivery of product due to extreme coordination between internal and external production, quality, regulatory, serialization and supply chain teams. • Managed 15 projects with budgets ranging from $300,000 to $1M. • Coordinated multinational bioequivalence clinical trials in vivo and in vitro, including international controlled substances studies. Conducted CRO selection and evaluation.

Princeton, Nj, Us

Conducted analytical testing including dissolution, assay, impurities, and content uniformity using HPLC. Managed all accounting, legal, human resources, and office documents. • Procured all active pharmaceutical ingredients, excipients, chemicals and supplies. Saved over $40,000 in first year. Negotiated with vendors to implement blanket discount pricing of at least 10% and obtained discount of at least 40% on commonly-ordered items. • Trained new team members in several test methods, Empower 2 software, UV/Vis spectroscopy, good laboratory practices (GLP) and good documentation practices (GDP), ensuring a knowledgeable and FDA-compliant team. Developed new test methods for drug products.

Huntsville, Al, Us

• Conducted analytical testing including dissolution, assay, related compounds/impurities, and content uniformity using HPLC. Reported results using good documentation practices. Maintained clean laboratory.• Trained new team members in several test methods, Empower 3 software, Loss on Drying and water content by Karl Fischer, boosting departmental work capacity. • Procured all chemicals and lab supplies for Analytical R&D department, saving up to 50% per order. Reduced cost of HPLC vials by 20% through implementing recurring-order initiative. • Created electronic inventory for chemicals and reference standards, eliminating all out-of-stock issues.• Managed sample respository, resulting in increased locational organization and meeting of testing deadlines.

Waltham, Massachusetts, Us

· Earned position as deputy department head. Scheduled formulation and ordered chemicals and materials. Trained new team members, resulting in greater departmental output.· Formulated various buffers and media in support of upstream and downstream processes.· Revised over 125 documents including specifications and SOPs, updating methods to prevent documents becoming obsolete. Reviewed batch records and reduced the number of errors sent to QA.· Calibrated pH and conductivity meters on daily basis, ensuring that buffers were within specification. Performed sterile gloving into BSC using aseptic technique.· Worked closely with QA, QC, and QC Microbiology regarding documentation and samples. Used interdepartmental communication, confirming availability of chemicals and meeting tight production schedule.

St. Louis, Mo, Us

Gallus BioPharmaceuticals was acquired by Patheon Biologics.

Whittier, Ca, Us

· Interviewed and evaluated prospective students. Conducted over 100 informative presentations.· Scheduled appointments and coordinated with Financial Aid department. Gained over 200 hours phone experience by contacting prospects.

Waltham, Ma, Us

· Worked in fast-paced high throughput laboratory performing DNA synthesis and other functions on 3 different software programs. Verified process paperwork and reviewed logs.· Conducted bi-weekly preventative maintenance and cleaning of manufacturing equipment, ensuring smooth machine operation and unhindered production schedule.· Performed product packaging and final quality control on finished oligonucleotides. Inspected vials, ensuring they were counted and placed accurately on 96-well plates.

Bachelor Of Science, Biology

Associate Of Science (A.S.), Accounting