PROFESSIONAL EXPERIENCE

Confidential, Clinton, New Jersey

Technical Specialist Quality and CMC

Responsibilities:

• Perform/assist Quality and Compliance audits of CMOs, GLP labs, Computer system vendors (ViewPoint®, StartingPoint®), Medical Device vendors and Pharmaceutical drug distributor vendors to ensure cGMP, cGLP compliance according to 21 CFR Parts 11, 58, 205, 210, 211, 820; OECD guidelines, where applicable
• Coordinate/manage client audits, distribute audit reports/responses, and reviewing audit responses
• Manage/oversee Confidential Vendor/Supplier Audit files and program
• Author/review Standard Operating Procedures (SOPs) to ensure compliance wif GMPs and industry standards
• Assist in preparing Quality technical agreements wif vendors/suppliers
• Support QA management in establishing systems and procedures to ensure product quality and compliance wif cGMP, ICH Guidelines and ISO 13485
• Pull together required information to write, maintain, and update technical documentation such as CMC or Tech Transfer packages
• Review and/or approve batch records, product specifications, SOPs, deviation requests, method changes, change control requests, and other cross functional documentation
• Hold meetings wif work teams as needed to manage the process of compiling and writing CMC sections as part of IND, Annual Report, IMPD
• Manage product sections and contribute to the preparation of the Annual Product Review
• Collaborate and facilitate discussions wif the CMC source areas, Quality and Regulatory Affairs on CMC submissions content and requirements
• Generate SOPs to ensure the regulatory compliance areas of responsibility as needed for Quality and Regulatory Affairs
• Tracking and reporting progress of projects against established timelines

Confidential, Princeton, New Jersey

Medical Writer

Responsibilities:

• Collaborate wif Sponsors, Confidential Project Managers, and Physicians (Radiologists/Oncologists) in reviewing protocols and proposals prior to authoring, editing and revising study - specific Independent Review Charters (i.e., Clinical studies, Oncology, Phase: I-IV)
• Collaborate wif Sponsors, Confidential Project Managers and Physicians in reviewing the Medical Components of study related documents such as Radiology Technical Manuals, Study Coordinator Manuals, Radiology Referral Forms (e.g., PET, CT, MRI)
• Review of study related documents such as Protocols, Charters, IQA/Read Summaries, Radiology Technical Manuals, Study Coordinator Manuals
• Collaborate wif Sponsors, Confidential Project Managers and Physicians in authoring, editing and revising study-specific Quality Plans
• Participate in the development, review and evaluation of Medical Affairs Standard Operating Procedures
• Assist in the clerical duties associated wif Charter Development i.e., file conversion to PDF format, data archive to CDs, etc, as necessary
• Other functions as assigned by the Sr. MA Specialist and the Vice President, Medical Affairs and Oncology

Confidential, Princeton, New Jersey

Documentation Specialist

Responsibilities:

• Support Wyeth regulatory submission management team in the preparation of pre-clinical reports, for IND, IB, IMPD, Annual Report in CTD format
• Supervise, train and assist administrative personnel in Regulatory Submission Systems
• Work across Confidential areas and/or on multiple projects
• Implements updates to data filing and storage systems to secure regulatory records
• Provide guidance to investigational product development teams in regulatory submissions for Company and partner sponsored global regulatory submissions
• Interact wif contracted vendors, CROs, consultants and in support of investigational drug development and regulatory submissions
• Responsible for editing and completing the quality control of regulatory documentation prior to submission
• Act as liaison wif departments for preparation of documentation providing input to time lines for completion of pre-clinical documents, and ensuring delivery of documents to meet the time lines
• Accurately tracks up-to-date status of investigational products progress and development
• Initiate/Assist in the development and improvement of the clinical documentation process

Confidential, Branchburg, New Jersey

Technical Writer

Responsibilities:

• Prepare CMC sections for regulatory submissions for investigational and marketed products for IND, NDA, BLA, sBLA, IMPD, DMF, Annual Reports, IB
• Communicate wif cross-functional teams from research, product development, manufacturing, and QA/QC to ensure timely preparation of high priority regulatory submissions are consistent wif FDA, ICH and cGMP guidelines for US and Global submissions
• Utilize and work wif data information and managment tools like Documentum, PILGRIM and SLIM to compile data for the compilation of CMC stability reports and sections, as part of submissions
• Ensure regulatory submissions for post-approval changes are complete, in proper Common Technical Document (CTD) format, and comply wif applicable regulatory requirements
• Participate in change control meetings to provide support and input to determine the impact on regulatory submissions and for implementation of new processes in the manufacturing facilities

Confidential, Princeton, New Jersey

Technical Writer

Responsibilities:

• Prepare, review scientific content and document format of pre-clinical reports for IND/IMPD/ filing/publishing (in CTD)
• Verify structure of documents/reports in compliance wif FDA/ICH guidelines
• Work closely wif authors, Regulatory Management, and technical staff in the preparation of document submission
• Participate in Regulatory Submissions Systems meetings and actively ensure QC of clinical documents meets industrial standards guidelines
• Contribute to the revision/update of Submission Style Template/Guides
• Supervise, train and assist administrative personnel in Regulatory Submission Systems

Confidential

Quality Controller

Responsibilities:

• Review/assess/perform calibration on instruments: NMR, HPLC, GC, FPLC, SDS-PAGE, FTIR, and MS
• Run instrument performance, accuracy and repeatability checks and communicate significant findings to the Laboratory Management
• Perform preventive maintenance of instruments
• Assess and perform inventory control and purchase parts for the instrument systems

Confidential

Chemist Associate

Responsibilities:

• Perform analysis of chemical waste, before and after operations for prizing and logistic approach (for FAAS, Karl-Fischer, Dr Lange-instruments, HPLC, GC, MS, UV/Vis).
• Perform processes per SOP to meet the regulations and requirements established by the Environmental Authorities and in accordance wif ISO 14001.
• Validate existing chemical processes for the entire facility
• Facilitate and notify any upcoming annual revisions carried out by the authorities to the department
• Serve as an acting Team Leader in the absence of the Supervisor

Confidential

Chemical Analyst/Process Operator

Responsibilities:

• Reception control of incoming waste, labeling, and packing materials in accordance wif existing environmental legislation.
• Assure the chemical waste correspond to the documentation given by client
• Initiate and propose improvements to streamline the facilities and processes
• Assess, document, and communicate to the Team Leader for approval of suitable process and approach of the chemical waste
• Waste product management: to be destructed or recycled internally and/or externally
• Assist in decontamination of industrial sites, train new employees, and maintain inventory control
• Participate and follow-up the established budget for the facilities in the department