Manager/Sr. Mgr. - Q.C. Laboratory

<body topmargin=0 leftmargin=0 marginheight=0 marginwidth=0> <table cellpadding=0 cellspacing=0 border=0><tr> <td valign="top" colspan=2 height=82 BGCOLOR="#9900CC" TEXT="#080000"> <div> <FONT SIZE="6" COLOR="#FFFFCC" FACE="Book Antiqua" ><B>The Artac Seel Company, Inc.</B></FONT><FONT SIZE="3" COLOR="#FFFF99" FACE="Book Antiqua" ><B> </B></FONT><FONT SIZE="3" COLOR="#FFFF80" FACE="Book Antiqua" ><B> </B></FONT><B>   </B><A HREF="index.htm" TARGET="_top" TITLE="TASC Home Page"><U><B>Home Page</B></U></A><B> </B></div> <div> <A HREF="id45.htm" TARGET="_top" TITLE="FULLTIME POSITIONS"><U>FULL-TIME POSITIONS</U></A>   |   <A HREF="id56.htm" TARGET="_top" TITLE="CONTRACT POSITIONS"><U>CONTRACT POSITIONS</U></A>   |   <A HREF="id48.htm" TARGET="_top" TITLE="RECRUITING"><U>RECRUITING</U></A>   |   <A HREF="id46.htm" TARGET="_top" TITLE="CONSULTING"><U>CONSULTING</U></A>   |   <A HREF="id49.htm" TARGET="_top" TITLE="ABOUT US"><U>ABOUT US</U></A></div> <div> </div> </td> </tr><tr> <td valign="top" width=340 BGCOLOR="#999980" TEXT="#080000"> <div> <B>Ellen Capito-Wightman, President</B></div> <div> <B>Corp. Phone  (860) 535-4419</B></div> <div> <B>FAX (860) 535-1842</B></div> <div> <A HREF="mailto:info@artacseel.com" TARGET="_top" TITLE="mailto:info@artacseel.com"><U><B>info@artacseel.com</B></U></A></div> <div> <A HREF="mailto: ellen@artacseel.com" TARGET="_top" TITLE="mailto: ellen@artacseel.com"><U><B>E-Mail to Ellen</B></U></A></div> <bR> <div> <B><U>FULL-TIME POSITIONS</U></B></div> <div> <A HREF="id108.htm" TARGET="_top" TITLE="Director, Compliance Regulatory Affairs"><U>Director, Compliance & Regulatory Affairs</U></A></div> <div> <A HREF="id107.htm" TARGET="_top" TITLE="Scientist II, DMPK "><U>Scientist II, DMPK </U></A></div> <div> <A HREF="id106.htm" TARGET="_top" TITLE="Exec. Dir., Early Clinical Development "><U>Exec. Dir., Early Clinical Development - Inflam. & Immunology</U></A></div> <div> <A HREF="id105.htm" TARGET="_top" TITLE="Global Medical Affairs Disease Leader (E"><U>Global Medical Affairs Disease Leader (Exec. Dir)</U></A></div> <div> <A HREF="id103.htm" TARGET="_top" TITLE="Exec. Dir., Clinical Research Physician,"><U>Exec. Dir., Clinical Research Physician, Leukemia</U></A></div> <div> <A HREF="id104.htm" TARGET="_top" TITLE="Global Exec. Dir/VP Phase 1 Leader"><U>Global Exec. Dir/VP "Phase 1 Leader"</U></A></div> <div> <A HREF="id102.htm" TARGET="_top" TITLE="Dir., Multiple Myeloma Marketing"><U>Dir., Multiple Myeloma Marketing</U></A></div> <div> <A HREF="id101.htm" TARGET="_top" TITLE="VP Clinical and Medical Affairs"><U>VP Clinical and Medical Affairs</U></A></div> <div> <A HREF="id100.htm" TARGET="_top" TITLE="Senior Dir., Translational Medicine"><U>Senior Dir., Translational Medicine</U></A></div> <div> <A HREF="id99.htm" TARGET="_top" TITLE="Director Medical Affairs Oncology"><U>Director Medical Affairs -- Oncology</U></A></div> <div> <A HREF="id98.htm" TARGET="_top" TITLE="Clinical Submission Manager"><U>Clinical Submission Manager</U></A></div> <div> <A HREF="id97.htm" TARGET="_top" TITLE="Senior BiostatisticianProgrammer Pharma"><U>Senior Biostatistician-Programmer - Pharmacovigilance </U></A></div> <div> <A HREF="id96.htm" TARGET="_top" TITLE="Senior Medical Reviewer, Drug Safety "><U>Senior Medical Reviewer, Drug Safety </U></A></div> <div> <A HREF="id95.htm" TARGET="_top" TITLE="Director, Solid Tumor Marketing"><U>Director, Solid Tumor Marketing</U></A></div> <div> <A HREF="id94.htm" TARGET="_top" TITLE="Director, Regulatory CMC"><U>Director, Regulatory CMC</U></A></div> <div> <A HREF="id93.htm" TARGET="_top" TITLE="Director IM Forecasting and Planning"><U>Director IM Forecasting and Planning</U></A></div> <div> <A HREF="id92.htm" TARGET="_top" TITLE="Senior Mgr., IVRS Central Management"><U>Senior Mgr., IVRS Central Management</U></A></div> <div> <A HREF="id91.htm" TARGET="_top" TITLE="Manager, Safety Quality Assurance, Globa"><U>Manager, Safety Quality Assurance, Global Drug Safety</U></A></div> <div> <A HREF="id90.htm" TARGET="_top" TITLE="Research Scientist I / II"><U>Research Scientist I / II</U></A></div> <div> <A HREF="id88.htm" TARGET="_top" TITLE="Associate Director/Director, Regulatory "><U>Associate Director/Director, Regulatory Affairs, Oncology</U></A></div> <div> <A HREF="id75.htm" TARGET="_top" TITLE="AD/Trail Management, Translational Medic"><U>AD/Trail Management, Translational Medicine(TM)</U></A></div> <div> <A HREF="id72.htm" TARGET="_top" TITLE="Associate Director, Regulatory Affairs, "><U>Associate Director, Regulatory Affairs, Oncology</U></A></div> <div> <A HREF="id71.htm" TARGET="_top" TITLE="Associate Director, Manufacturing Operat"><U>Associate Director, Manufacturing Operations</U></A></div> <div> <A HREF="id53.htm" TARGET="_top" TITLE="Compliance Project Sr. Specialist "><U>Compliance Project Sr. Specialist </U></A></div> <div> <A HREF="id65.htm" TARGET="_top" TITLE="Senior Director, Lead Global Product Saf"><U>Senior Director, Lead Global Product Safety Physician </U></A></div> <div> <A HREF="id76.htm" TARGET="_top" TITLE="Senior Medical Reviewer, Drug Safety"><U>Senior Medical Reviewer, Drug Safety</U></A></div> <div> <A HREF="id52.htm" TARGET="_top" TITLE="Director, Lead Global Product Safety Phy"><U>Director, Lead Global Product Safety Physician </U></A></div> <div> <A HREF="id86.htm" TARGET="_top" TITLE="Clinical Research Scientist, Oncology"><U>Clinical Research Scientist, Oncology</U></A></div> <div> <A HREF="id85.htm" TARGET="_top" TITLE="Associate Director, GLP Quality Assuranc"><U>Associate Director, GLP Quality Assurance </U></A></div> <div> <A HREF="id84.htm" TARGET="_top" TITLE="Medical Writer, Scientific Communication"><U>Medical Writer, Scientific Communications</U></A></div> <div> <A HREF="id81.htm" TARGET="_top" TITLE="Director/Sr. Director, Regulatory Affair"><U>Director/Sr. Director, Regulatory Affairs</U></A></div> <div> <A HREF="id80.htm" TARGET="_top" TITLE="Associate Director, Manufacturing Ops"><U>Associate Director, Manufacturing Ops</U></A></div> <div> <A HREF="id79.htm" TARGET="_top" TITLE="Manager, Nonclinical Development Q.A."><U>Manager, Nonclinical Development Q.A.</U></A></div> <div> <A HREF="id78.htm" TARGET="_top" TITLE="Clinical Research Physician Oncology/Hem"><U>Clinical Research Physician- Oncology/Hematology</U></A></div> <div> <A HREF="id77.htm" TARGET="_top" TITLE="Clinical Research Physician Inflammation"><U>Clinical Research Physician- Inflammation</U></A></div> <div> <A HREF="id59.htm" TARGET="_top" TITLE="Quality System Application Specialist"><U>Quality System Application Specialist</U></A></div> <div> <A HREF="id87.htm" TARGET="_top" TITLE="Assoc Director DMPK"><U>Assoc Director DMPK</U></A></div> <div> <A HREF="id83.htm" TARGET="_top" TITLE="Mgr., Global Project Mgt. Admin."><U>Mgr., Global Project Mgt. Admin.</U></A></div> <div> <A HREF="id82.htm" TARGET="_top" TITLE="Project Manager Clinical Supplies"><U>Project Manager Clinical Supplies</U></A></div> <div> <A HREF="id73.htm" TARGET="_top" TITLE="M.D. Medical Safety Expert"><U>M.D. - Medical Safety Expert</U></A></div> <div> <A HREF="id64.htm" TARGET="_top" TITLE="Sr. Manager, Manager Pharmacokinetics"><U>Sr. Manager, Manager Pharmacokinetics</U></A></div> <div> <B><IMG BORDER="0" SRC="Symb075c00b700f0ccffff00.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Manager/Sr. Mgr. - Q.C. Laboratory</B></div> <div> <A HREF="id74.htm" TARGET="_top" TITLE="Investigation Mgr., Devel. Quality"><U>Investigation Mgr., Devel. Quality</U></A></div> <div> <A HREF="id47.htm" TARGET="_top" TITLE="Clinical Pharmacology Scientist"><U>Clinical Pharmacology Scientist</U></A></div> <div> <A HREF="id55.htm" TARGET="_top" TITLE="Global Product Safety Physician"><U>Global Product Safety Physician</U></A></div> <div> <A HREF="id63.htm" TARGET="_top" TITLE="Assoc. Director Global Drug Safety"><U>Assoc. Director - Global Drug Safety</U></A></div> <div> <A HREF="id61.htm" TARGET="_top" TITLE="Sr. Prin/Assoc. Dir. Biostatistics"><U>Sr. Prin/Assoc. Dir. - Biostatistics</U></A></div> <div> <A HREF="id57.htm" TARGET="_top" TITLE="Manager Regulatory Affairs"><U>Manager - Regulatory Affairs</U></A></div> <div> <A HREF="id69.htm" TARGET="_top" TITLE="Senior Director Clinical Ops"><U>Senior Director - Clinical Ops</U></A></div> <div> <A HREF="id70.htm" TARGET="_top" TITLE="Senior Research Scientist"><U>Senior Research Scientist</U></A></div> <div> <A HREF="id68.htm" TARGET="_top" TITLE="Senior Mgr., Med. Sci. Writing"><U>Senior Mgr., Med. & Sci. Writing</U></A></div> <div> <A HREF="id66.htm" TARGET="_top" TITLE="Senior Clinical Research Scientist"><U>Senior Clinical Research Scientist</U></A></div> <div> <A HREF="id67.htm" TARGET="_top" TITLE="Clinical Research Manager"><U>Clinical Research Manager</U></A></div> <div> <A HREF="id62.htm" TARGET="_top" TITLE="Clinical Trial ManagerOncology"><U>Clinical Trial Manager-Oncology</U></A></div> <div> <A HREF="id50.htm" TARGET="_top" TITLE="Clinical Research CRA"><U>Clinical Research CRA</U></A></div> <div> <A HREF="id51.htm" TARGET="_top" TITLE="Senior Director Oncology"><U>Senior Director - Oncology</U></A></div> <div> <A HREF="id54.htm" TARGET="_top" TITLE="Data Manager II"><U>Data Manager II</U></A></div> <bR> </td> <td valign="top" height=398 BGCOLOR="#FFFFCC" TEXT="#080000"> <div> <B><U>Manager/Sr. Mgr. - Q.C. Laboratory</U></B></div> <bR> <div> <TABLE BORDER="6" CELLPADDING="7" CELLSPACING="7" WIDTH="677" BORDERCOLORLIGHT="#660099" BORDERCOLORDARK="#660099" FRAME="BOX" RULES="ALL" HSPACE="0" VSPACE="0" > <tR> <tD VALIGN=TOP BGCOLOR=#FFFFFF HEIGHT= 1216 ><NOBR><bR> <bR> <bR> <div> <B>Manager/Senior Mgr.</B></div> <div> <B>Q.C. Laboratory</B></div> <bR> <div> <B>Posted Feb. 26, 2007</B></div> <bR> <bR> <div> <B><IMG SRC="0e396330.jpg" border=0 width="150" height="51" ALIGN="BOTTOM" HSPACE="0" VSPACE="0"></B></div> <bR> <div> <B>Minimum 8-10 Years Exp.</B></div> <bR> <bR> <bR> </NOBR></tD> <tD VALIGN=CENTER BGCOLOR=#FFFFFF WIDTH="386"><div> <B>JOB DESCRIPTION: </B></div> <div> Responsible for leading and supervising the QC Laboratory that performs analytical release and stability testing of clinical and commercial products according to approved test methods and protocols, cGMPs (current Good Manufacturing Practices) and current SOPs.  The QC Laboratory Manager is responsible for the review and approval of raw data and results from the OC laboratory and approved contract laboratories.  He/she monitors the stability program including protocols, set-up and sampling according to ICH/FDA guidelines and regulatory submissions/commitments.  This person assures laboratory personnel are trained, qualified and properly equipped for safe and effective performance of their assigned duties.  The job function includes encouraging a team environment to promote quality while continuously improving efficiency and productivity within the laboratory The position involves establishing communication with contract laboratories starting with qualification and analytical method transfer and continuing with routine testing to ensure that quality laboratory standards are maintained.</div> <bR> <div> <B><U>Responsibilities will also include, but are not limited to, the following:</U></B></div> <div> <IMG BORDER="0" SRC="Symb075c00b700c833000000.png" HEIGHT="13" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Manages all activities associated with release and stability testing of clinical and commercial APIs and finished products.  This includes scheduling/coordination of laboratory testing, data  review and QC approval of results within specified timelines.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700c833000000.png" HEIGHT="13" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Supervises 9 laboratory analysts and 1 lab technician including performance evaluations/development, training on SOPs and approved test methods and hiring/promotion recommendations.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700c833000000.png" HEIGHT="13" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Responsible for the stability testing program including establishing stability protocols, sample set-up, monitoring and performing all testing according to defined schedules, guidelines and the required timelines.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700c833000000.png" HEIGHT="13" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Supervises method transfer and validation activities according to approved protocols.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700c833000000.png" HEIGHT="13" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Manages reference standards testing and recertification program.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700c833000000.png" HEIGHT="13" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Authors/reviews SOPs and analytical test methods, method transfer protocols/reports and stability reports.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700c833000000.png" HEIGHT="13" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Responsible for interacting with contract laboratories to ensure successful method transfers and that routine testing is performed to the same standards as in the OC laboratory.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700c833000000.png" HEIGHT="13" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Leads OOS investigations and initiates corrective/preventive action.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700c833000000.png" HEIGHT="13" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Participates in safety committee meetings and ensures compliance with all laboratory regulations including cGMPs, DEA and OSHA regulations and SOPs.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700c833000000.png" HEIGHT="13" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Monitors lab supplies budget and makes recommendations for capital equipment purchases.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700c833000000.png" HEIGHT="13" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Ensure laboratory readiness for and participate during regulatory inspections (FDA and DEA) and audits.</div> <bR> <bR> <div> <B>JOB REQUIREMENTS:</B> </div> <div> <IMG BORDER="0" SRC="Symb075c00b700c833000000.png" HEIGHT="13" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Minimum 8 - 10 years' pharmaceutical laboratory experience in quality control or analytical departments including prior supervisory experience.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700c833000000.png" HEIGHT="13" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">BS/MS Chemistry or relevant discipline with equivalent experience</div> <div> <IMG BORDER="0" SRC="Symb075c00b700c833000000.png" HEIGHT="13" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Demonstrated communication skills</div> <div> <IMG BORDER="0" SRC="Symb075c00b700c833000000.png" HEIGHT="13" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Strong decision making & problem solving capability</div> <div> <IMG BORDER="0" SRC="Symb075c00b700c833000000.png" HEIGHT="13" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Demonstrated management skills including delegation, time management, work allocation and people leadership</div> </tD> </tR> </TABLE></div> <div> <B><U>The Artac Seel Company</U></B></div> <div> --Effectively Delivering Talent in Pharmaceuticals & Biotech--</div> </td> </tr></table></body>