Dawn Heasley Email & Phone Number

Ellenton, Fl, Us

Englishtown, Nj, Us

Écublens, Vaud, Ch

Management oversight and administrative support to 45 employees located at client sites.• Generated 20-25% yearly revenue growth• Interview and onboard new employees• Provide performance reviews, Performance Improvement Plans, and nurture employee development• Client point of contact for all employee, invoicing, and contract resolution• Complete month end client billing in Oracle system

New York, New York, Us

Managed daily activities of R&D Operations to meet project timelines.• Internal EHS audit lead• Authored SOP’s and coordinated the training through the P2L system and our internal “Read and Understand” system• Representative on the HSE Committee• Developed a Procurement Policy and Procedures manual to aid new hires and existing employees on their journey through the Ariba procurement system• Acted as the purchasing agent and procurement SME for the site, completing all catalog and non-catalog orders in Ariba• Processed all SAP Workflow issues and vendor invoice concerns • Coordinated all import/export shipments and documentation for the site • Coordinated all Dangerous Goods shipments for the site

Piscataway, Nj, Us

Managed daily activities of all R&D Operations to meet extremely aggressive timelines.• QA Operations and Document Manager• Assisted the development of the hard copy binders for FDA drug product filings• Developed electronic systems to track inventory of API and brand products as well as DMF and FDA filing documents• Scheduled/tracked the calibration of laboratory instruments and maintained qualification documents• Developed and maintained SOPs of all laboratory instruments and procedures• Assisted scientists as needed in formulation and analytical development • Set-up accounts payable and accounts receivable systems to streamline the process and provide reports to the company accountant• Provided the necessary documents upon request for a successful accounting audit by a third party• Developed a project spend spreadsheet and presented it on a monthly basis for budgeting purposes• Coordinated the purchase, set-up and maintenance of all laboratory and office facilities• Purchasing agent for all laboratory and office supplies • Maintained HSE compliance as well as waste disposal, necessary township permits and First Responder Certifications • Obtained New Jersey Public Notary License to notarize legal/immigration documents for the site• Obtained IATA Dangerous Goods shipping certification to ship dangerous goods

Ingelheim Am Rhein, Rhineland-Palatinate, De

• Coordinated with the QA group to ensure the timely preparation of clinical study test articles and shipped them to study sites worldwide to meet project timelines• Requested, dispensed and maintained inventory of raw materials, reference standards, active pharmaceutical ingredients, clinical supplies, packaging components and finished products according to cGMP guidelines• Represented the Formulation Development Department on the HSE Committee ensuring group and company compliance• Participated in project team meetings as lead formulator ensuring project timelines were met• Supported CMC filing and provided documentation for a timely registration• Evaluated solid dosage forms, pastes, topicals, injectionables and oral solutions compatibility with packaging components and manufacturing materials leading to the successful scale-up and technology transfer to the manufacturing facility resulting in successful Engineering/Registration Stability Batches• Coordinated the preparation of samples and provided a stability matrix for a successful market container program

Deerfield, Illinois, Us

• Prepared pre-clinical drug solutions for successful GLP studies• Coordinated and completed various study design activities long/short term stability studies to support the drug filing along with data presentation• Produced batch cards, drug development protocols, product development reports and technology transfer documents ensuring the product met the project timelines

Bachelor'S Degree, Biology/Biological Sciences, General

Master'S Certification, Supply Chain Management And Procurement

Certificate Of Completion, Gmp And Quality Issues

Certificate Of Achievement In Essentials Of Project Management, Project Management