Light Sciences Oncology

CMC Affairs Associate, Chemistry

Department: Drug Manufacturing

Reports to: Manager/Director, Drug Manufacturing

Purpose:

Provides the critical organization core we will require to translate the work of our rapidly expanding Drug Manufacturing/CMC effort into a well-organized NDA-ready package in a timely manner for LSO’s corporate goals.

LSO’s Drug Manufacturing program relies almost entirely on outside suppliers to carry out its work in compliance with current Good Manufacturing Practices. Our relationships with these organizations must be managed as carefully as possible and with complete attention to every possible detail. Decision making in these relationships requires access to necessary data in the shortest possible time, whether the data come from somewhere in our own records or from a laboratory experiment (often routine analyses by HPLC or HPLC/MS) that must be performed immediately, even if both current members of the CMC staff might be out of the office, traveling, or otherwise occupied.

There is vastly more record-keeping and documentation to be carried out in order to successfully manage vendors who provide us with cGMP-compliant services than the relatively minor proportion of this work that formally falls under what the Company now calls “Document Control.” Each vendor is capable of generating records and paperwork on a daily basis, and even more often during periods of intense activity. Most of this concerns decisions that the vendors call upon us to make, costs to be incurred, data that must exchanged between our in-house lab and the suppliers’ labs, and other communications that, while not necessarily involving formal controlled documents, must nevertheless be recorded, filed in an organized way, and accessed later, likely also on very short notice.

Responsibilities:

• Act as the central on-site organizational presence of the Drug Manufacuring/CMC group.
• Support CMC staff by maintaining complete information package on the status of all work being carried out by each of our outside suppliers.
• Manage/maintain proper records, task lists, and time lines associated our ongoing relationships with new and existing suppliers.
• Operate and maintain the Chemistry HPLC/Mass Spec instrument and provide resulting data to the Drug Manufacturing group and other members of the LSO team for whom experiments are performed.
• Maintain Chemistry Laboratory equipment and supplies.
• Respond rapidly to reports and experimental results from our Drug Manufacturing vendors by repeating, verifying, or analyzing their results as quickly as possible.
• Assist with peforming and documenting experimental work of all types in the Chemistry Laboratory.
• Implement and maintain compliance of Chemistry activities with all applicable Health & Safety requirments.
• Assist other members of the Chemistry laboratory team as required.

Contacts:

Primary contacts with the head of Drug Manufacturing, Chemistry Scientists, Regulatory Compliance and Document Control Personnel, Preclinical and Research Scientists, and Drug Manufacturing Vendors.

Qualifications Required:

• BS or MS in Chemistry or a related field.
• Minimum of 2-5 years experience in Analytical Chemistry, HPLC, and drug analysis in a cGMP manufacturing environment.
• Experience working with, or for, pharmaceutical Contract Manufacuring services providers.
• Excellent organizational skills.
• Experience with cGMP and ICH guidelines.
• Experience in maintaining a clean, orderly, and well-organized laboratory environment.
• Experience with performing wet chemical testing according to the USP and foreign compendia.
• Hands on experience with standard chemical glassware, rotary evaporators, vacuum systems, and the handling of air-sensitive materials helpful but not essential.
• Hands on experience with HPLC/MS and other computer-controlled Chemistry laboratory instrumentation such as FT-IR, preparative LC, UV/Vis, fluorescence etc.
• Familiarity with Health & Safety requirements for Chemistry laboratories.
• Ability to clearly communicate information/ideas/recommendations (verbally and in writing) with technical, administrative and management personnel.
• Excellent written communication skills.
• Detail oriented.
• Must have strong computer skills.

Light Sciences Oncology has been built on teamwork, and the Company endeavors to attract and retain a diverse workforce. We believe that the strong support of, and commitment to the principles of Equal Employment Opportunity is good business, and we promote and support the cultural and ethnic diversity of our workforce.

Send resume by email to: rnl1125@msn.com.

Light Sciences Oncology
Attn: Human Resources
34931 SE Douglas Street, Suite 250
Snoqualmie, WA 98065
Email: rnl1125@msn.com

Light Sciences Oncology is an Equal Opportunity Employer

Submitted: 03/27/2006