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Posted: Monday, January 8, 2018 6:17 AM

The Analytical Development Scientist will be responsible for developing and utilizing wet chemistry, chromatographic, and characterization techniques to enable small molecule drug substance (API) and drug development from pre-clinical to commercial filing. The primary responsibilities include analytical method development/optimization, method transfers, method validations, analytical investigations/troubleshooting, process and product characterization for development and clinical drug products. The Scientist will also review data, protocol and reports related to method validation and release testing of small molecule drug substance and drug product. The successful candidate should be familiar with USP/NF analytical procedures and have a thorough understanding of cGMP's and ICH guidelines. The successful candidate will work in a team environment with members of medicinal chemistry, process chemistry, chemical development, formulation, QA and manufacturing CMOs.

Responsibilities:

* Responsible for method development/qualification/troubleshooting and assay transfer to Contract Testing Labs

* Support characterization of new chemical entities; identify process impurities and degradants using state of the art techniques such as HPLC, LC-MS, GC-MS, IC, FTIR, Dissolution, UV-Vis and KF

* Responsible for hands-on and technical support to medicinal chemistry, process chemistry and pharmaceutical sciences research and development activities

* Provide technical support for analytical sections of regulatory filings

* Provide technical support for OOS/OOT deviation investigations and trouble shoot analytical or manufacturing issues in a timely manner

* Plan and organize experiments to meet specific technical objectives

* Work with process chemistry, manufacturing and QA to propose and/or modify specifications with justification for DS/ DP intermediates and reference standards

* Prepare and/or review written technical reports, SOPs and regulatory filings

* Use good scientific judgment in all activities

* Participate in group and individual meetings to establish priorities and organize activities and communicate results

Qualifications:

* A PhD (preferred) in the field of chemistry or pharmaceutical chemistry, with minimum 2-4 years of experience (10+ years with BS/MS) in the biotechnology/pharmaceutical industry

* Experience in analytical test method development, transfer, qualification and validation of small molecule pharmaceutical products

* Hands on experience with analytical methodologies used for analysis and characterization of small molecule pharmaceuticals, such as HPLC, GC, UV, LC-MS, FTIR and dissolution

* Knowledge of Quality Systems and current FDA regulations and ICH guidelines

* Experience writing analytical characterization related sections of IND/NDA submission a plus

* Proficient with instrument trouble-shooting for HPLC, GC and LC-MS

* Must be highly organized and have the ability to communicate effectively with internal and external organizations

* Highly motivated team player willing to contribute to a growing biopharmaceutical company

SDL2017


Associated topics: antibody, diet, drug, drug development, healthcare, immunology, metabolism, nephrology, therapy, trauma

Source: http://www.jobs2careers.com/click.php?id=4780068131.96


• Location: San Francisco

• Post ID: 93171902 sf
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