Dr. Jeffrey M. Singer
PharmaBasics, Inc.
P.O. Box 610181
Bayside, NY 11361
Phone:
(917) 952-2506
E-mail: Jeffrey Singer
Dr. Singer is a senior R&D professional with a Ph.D. in Organic Chemistry and 20 years technical, managerial and scientific experience, gained with major pharmaceutical, multi-national companies and start-up, development stage biotech companies. He has over 15 years in the pharmaceutical industry, including parenterals, liquids, solids and semi-solids. Dr. Singer is an innovative problem-solver with expertise in robotics, analytical methods validation, technology transfer, computer validation and 21 CFR Part 11 compliance and CTD Dossier preparation for NDA/ANDA’s and Supplements.
- Excellent written and oral communications skills; excel at technical writing and preparing technical compliance documents, SOP’s, validation reports, CMC stability summary reports.
- Mutual-Benefit Leadership skills: foster a team-oriented work environment based on mutual cooperation for mutual benefit; look for Win-Win partnering outcomes.
- Excellent organizational and project management skills.
- Computer literate; familiar with development and implementation of LIMS and computer/software validation.
TECHNICAL EXPERTISE:
- Analytical Techniques: GC, HPLC, GC/LC/MS, FTIR, UV-Vis.
- Analytical Equipment Validation: IQ, OQ, PQ.
- Stability-Indicating Method Development / Validation / Transfer.
- Best Practices in Quality Management.
- CTD Dossier Preparation.
- Validation Master Plan Development.
- Stability Protocol Development.
- Cleaning Validation Strategy.
- LIMS and Laboratory Data Acquisition Computer Systems.
- Computerized Systems Validation Deliverables (UFRS, CRS, FAT, SAT, IQ/OQ/PQ, RTM, VSR).
- Part 11 Compliance and GAP Analysis.
- Proficient in Microsoft Office software, MS Project, MS Visio, Adobe Acrobat.
- Software Applications worked with: Documentum, Trackwise, ISOtrain, ERP/MRP, EDMS, Maximo.
BUSINESS STRENGTHS:
Considered “Scientifically Nimble” by virtue of the following factors:
- Broad perspective due to diverse technical background.
- Collaborative in spirit and entrepreneurial by nature.
- Offer a holistic approach to problem solving: able to integrate separate pieces of information in order to formulate a game plan [dissect/work through/arrive at solution]
- Ability to gather hard-to-find information quickly.
- Attention to detail; excellent analytical skills.
- Excel at hard-to-tackle projects.
- Excellent written and oral communications skills; excel at technical writing and preparing technical compliance documents, SOP’s, validation reports, CMC stability summary reports.
- Mutual-Benefit Leadership skills: foster a team-oriented work environment based on mutual cooperation for mutual benefit; look for Win-Win partnering outcomes.
- Excellent organizational skills; believe in delegation of tasks to best-suited individuals.
- Computer literate; familiar with development and implementation of Laboratory Information Management Systems and 21 CFR Part 11 Compliance issues.
- Proficient in Analytical Equipment and Laboratory Computer Systems Qualification.
PDF of:
PharmaBasics Corporate Description
Jeffrey Singer Resume
