Research Associate
Genentech Research and Early Development
Small Molecule Analytical Chemistry
ID 00408544
Job Description
Genentech is seeking a highly talented Associate Scientist to join its world class Research and Early Development organization as an analytical development chemist within the Small Molecule Pharmaceutical Sciences department.
This laboratory-based position focuses on analytical characterization, method development and GMP release of formulated drug product, drug substance, intermediates, starting materials, and functional excipients to support clinical and pre-commercial CMC drug development. You will be a key team member working within an analytical project group to support development, scale up, and tech transfer of synthetic processes and pharmaceutical products. You will be a contributor to regulatory filings and assist group leaders in defining regulatory strategy. The successful candidate will also be able to conduct and publish novel research in analytical chemistry as it relates to core job responsibilities. You will also collaborate functionally and technically with partners in Medicinal Chemistry, Safety Assessment, and Internal and External Quality Assurance. The successful candidate will accomplish our mission through open communication, innovation, teamwork, creative problem-solving, and use of state-of-the-art technology, including chiral and achiral (U)HPLC, (HS)GC, MS (SQ, TQ, IT, TOF, LTQ-OrbiTrap), IC, KF, DSC/TGA, FTIR, UV, XRPD, particle size testing, dissolution as well as myriad of automation instrumentation.
Qualifications
A Ph. D. degree in a relevant scientific discipline (analytical chemistry preferred) is required. Relevant experience of 0-3 years in the pharmaceutical industry will be considered. Candidates must have a strong fundamental knowledge of analytical chemistry and organic chemistry and be able to apply it to drug development. Hands-on experience in organic spectroscopy, chromatography and other separation techniques will be beneficial to your application. Experience with automation is desirable. A strong publication and presentation record with evidence of the potential to augment scientific and strategic competencies as your career grows to support evolving therapeutic platforms is essential. You will gain knowledge of current FDA regulations, ICH guidelines, GMP quality systems and regulatory filing strategy. Candidates should have advanced problem solving skills, the ability to think strategically, excellent communication skills and sound scientific judgment.
Research Associate/Senior Research Associate
Genentech Research and Early Development
Small Molecule Analytical Chemistry
ID 00407644
Job Description
We seek outstanding candidates to join Small Molecule Analytical Development and Quality Control efforts in Small Molecule Pharmaceutical Sciences. Responsibilities include characterization of small molecule candidates, method development and qualification, supporting process scale-up and formulation development, and release testing of clinical trial materials. The successful candidate will develop chiral and achiral HPLC methods, conduct assays, document studies in notebooks, summarize and interpret the data, troubleshoot instrument and method problems, present findings at team meetings and contribute to IND/NDA filings. The successful candidate will accomplish our mission through innovation and teamwork, creative problem-solving, and use of state-of-the-art technology including HPLC, ultra-high-pressure LC, Prep LC, HSGC, MS (SQ, IT, TOF, LTQ-OrbiTrap), IC, KF, DSC/TGA, FTIR, UV, dissolution as well as myriad automation instruments.
Qualifications
BS/MS in a relevant scientific discipline (analytical chemistry preferred) and a minimum of 2 – 6 years experience in pharmaceutical industry. Candidates must have good theoretical knowledge of analytical chemistry, hands on practical experience on chromatography (HPLC, GC, data handling) and other analytical techniques (MS). Knowledge of current FDA regulations/guidance and strong background in organic chemistry, pharmaceutics or drug discovery are desirable. Candidates should have good problem solving, written and oral communication skills. Outstanding candidates with more than 4 years of relevant industrial experience and a strong publication record will be considered as a Senior Research Associate.