Careers

Title: Direc­tor of IT 

Depart­ment: IT 

Exemp­t/Non-exempt: Exempt 

Job Loca­tion: South San Fran­cis­co, CA OR Mon­mouth Junc­tion, NJ 

Job Descrip­tion 

We are seek­ing an expe­ri­enced and hands-on Direc­tor or Asso­ciate Direc­tor of IT to join our grow­ing team. This is a crit­i­cal role as the first IT hire at our com­pa­ny, report­ing direct­ly to senior lead­er­ship, and with a title com­men­su­rate with the candidate’s lev­el of expe­ri­ence. The Direc­tor of IT will man­age all aspects of IT infra­struc­ture and oper­a­tions, help define and imple­ment the cor­po­rate IT strat­e­gy, and serve as the pri­ma­ry liai­son for IT con­trac­tors. The ide­al can­di­date will pos­sess a deep under­stand­ing of the IT require­ments in the biotech/​biopharma indus­try and have a proven track record of work­ing col­lab­o­ra­tive­ly with sci­en­tif­ic and busi­ness teams to meet company’s needs. You should be a fast learn­er and self-moti­va­tor, have the abil­i­ty to effec­tive­ly mul­ti-task to meet short dead­lines, pos­sess a high lev­el of atten­tion to detail and should thrive in a busy, fast-paced envi­ron­ment. The suc­cess­ful can­di­date will play a crit­i­cal role in main­tain­ing the sys­tems that sup­port our live bio­ther­a­peu­tic prod­ucts (LBPs) and help ensure com­pli­ance with indus­try and reg­u­la­to­ry guidelines. 

Key Respon­si­bil­i­ties: 

As Direc­tor of IT, your respon­si­bil­i­ties will include: 

• Devel­op and imple­ment the com­pa­ny’s IT strat­e­gy, includ­ing sys­tem design, deploy­ment, con­fig­u­ra­tion, and maintenance. 
• Man­age and over­see the oper­a­tional aspects of hybrid cloud/on-premis­es com­pute and data stor­age infrastructure. 
• Ensure the reli­able and secure oper­a­tions of company’s IT core sys­tems and infra­struc­ture, includ­ing desk­tops, servers, print­ers, net­work, telecom­mu­ni­ca­tions and AV. 
• Ensure har­mo­nized, con­sis­tent IT Oper­a­tions and reli­able end user sup­port expe­ri­ences for local and remote users. 
• Col­lab­o­rate close­ly with engi­neers, sci­en­tists, busi­ness lead­ers, and oth­er stake­hold­ers to under­stand and ful­fill tech­ni­cal requirements. 
• Iden­ti­fy and serve as the pri­ma­ry point of con­tact for IT con­trac­tors and con­sul­tants, ensur­ing high-qual­i­ty deliv­ery of out­sourced services. 
• Estab­lish, main­tain, and enforce IT poli­cies and pro­ce­dures to ensure data integri­ty, secu­ri­ty, and compliance. 
• Plan and man­age the IT bud­get, includ­ing pro­cure­ment and main­te­nance of hard­ware and software. 
• Imple­ment and man­age cor­po­rate soft­ware solu­tions, ensur­ing align­ment with busi­ness objectives. 
• Stay cur­rent with tech­nol­o­gy trends and pro­pose inno­v­a­tive solu­tions to enhance oper­a­tional efficiency. 
• Pro­vide end-user sup­port and train­ing as needed. 

Ide­al Can­di­date Pro­file 

We are seek­ing can­di­dates who have a Bach­e­lor’s degree in Com­put­er Sci­ence, Infor­ma­tion Sys­tems, or a relat­ed field and a min­i­mum of 8 years of expe­ri­ence in IT, with at least 4 years in the biotech/​pharmaceutical indus­try and 3 years in a man­age­ment role. The role requires the fol­low­ing qual­i­fi­ca­tions and experience: 

• Proven expe­ri­ence build­ing and man­ag­ing IT infra­struc­ture in a hybrid cloud/on-premis­es envi­ron­ment, includ­ing hands-on expe­ri­ence with AWS, Azure, etc. 
• Expe­ri­ence build­ing and man­ag­ing HPC clus­ters, includ­ing archi­tec­ture, deploy­ment, and main­te­nance of asso­ci­at­ed infra­struc­ture such as stor­age sys­tems and net­work configurations. 
• Proven abil­i­ty to build and man­age IT teams or over­see exter­nal contractors/​vendors. 
• Strong knowl­edge of IT com­pli­ance, data secu­ri­ty, and best prac­tices, espe­cial­ly as they relate to biotech/​pharma envi­ron­ments. This may include expe­ri­ence with reg­u­lat­ed envi­ron­ments, such as FDA/EMA com­pli­ance require­ments, GxP, and data secu­ri­ty protocols. 
• Hands-on exper­tise in IT sys­tems and tools rel­e­vant to biotech oper­a­tions, such as LIMS, ELN, and data stor­age solu­tions for large data sets such as imag­ing and genom­ic data. 
• Exper­tise in IT sys­tem val­i­da­tion and com­pli­ance frame­works (e.g., 21 CFR Part 11, GDPR, HIPAA) 
• Strong prob­lem solv­ing and project man­age­ment skills for deploy­ing and main­tain­ing IT sys­tems to meet the sci­en­tif­ic and busi­ness needs of a grow­ing organization. 
• Strong project man­age­ment skills with a focus on col­lab­o­ra­tion and stake­hold­er engagement. 
• Excel­lent writ­ten and ver­bal com­mu­ni­ca­tion skills. 
• Abil­i­ty to man­age mul­ti­ple pri­or­i­ties in a fast-paced, dynam­ic environment. 

We expect the can­di­date fill­ing this posi­tion to be phys­i­cal­ly present at our offices in the Bay Area and/​or NJ as need­ed, which may also require occa­sion­al travel. 

At Kan­vas, we offer a com­pet­i­tive salary (range for this posi­tion $190,000 to $250,000, depend­ing on loca­tion and expe­ri­ence) and ben­e­fits pack­age that includes full med­ical, den­tal, and vision insur­ance pack­ages for employ­ees and their fam­i­lies, and paid time off. 

If you’re pas­sion­ate about IT and want to join a dynam­ic and inno­v­a­tive team, we encour­age you to apply for this excit­ing oppor­tu­ni­ty. Please send your CV and a brief para­graph about why you think you’d be a good fit for the job to kyle+​jobs@​kanvasbio.​com. 

Title: Asso­ciate Direc­tor, Qual­i­ty Assur­ance GMP 

Depart­ment: Qual­i­ty Assurance 

Exemp­t/Non-exempt: Exempt 

Job Loca­tion: South San Fran­cis­co, CA 

Job Descrip­tion 

We are seek­ing an expe­ri­enced and high­ly moti­vat­ed Asso­ciate Direc­tor of Qual­i­ty Assur­ance to join our dynam­ic team. Report­ing to the Head of Reg­u­la­to­ry and Qual­i­ty Assur­ance, the Asso­ciate Direc­tor will be respon­si­ble for the qual­i­ty func­tion at Kan­vas and will over­see and man­age all GxP activ­i­ties inter­nal­ly and exter­nal­ly with ven­dors. The ide­al can­di­date will have exten­sive qual­i­ty assur­ance expe­ri­ence with­in the biotech/​pharmaceutical sec­tor, will be a fast learn­er and self-starter, have the abil­i­ty to effec­tive­ly mul­ti-task to meet short dead­lines, pos­sess a high lev­el of atten­tion to detail and should thrive in a busy, fast-paced envi­ron­ment. The suc­cess­ful can­di­date will play a crit­i­cal role in main­tain­ing the qual­i­ty stan­dards of our live bio­ther­a­peu­tic prod­ucts (LBPs) and ensur­ing com­pli­ance with indus­try and reg­u­la­to­ry guidelines. 

Key Respon­si­bil­i­ties: 

As Asso­ciate Direc­tor in GMP Qual­i­ty Assur­ance, your respon­si­bil­i­ties will include: 

• Man­ag­ing the QA over­sight of GMP man­u­fac­tur­ing ven­dors, includ­ing involve­ment and review of method val­i­da­tion doc­u­men­ta­tion, sta­bil­i­ty pro­to­cols and reports, GMP drug sub­stance and drug prod­uct spec­i­fi­ca­tions, GMP drug sub­stance and drug prod­uct mas­ter and exe­cut­ed batch records, and GMP drug sub­stance and drug prod­uct release. 
• Main­tain­ing the Qual­i­ty Man­age­ment Sys­tem and assist­ing in the devel­op­ment and main­te­nance of GxP SOPs and elec­tron­ic systems. 
• Review­ing and approv­ing val­i­da­tion pro­to­cols, qual­i­ty agree­ments, and oth­er tech­ni­cal documents. 
• Col­lab­o­rat­ing with cross-func­tion­al teams to address and resolve qual­i­ty issues promptly. 
• Assist­ing in estab­lish­ing and ongo­ing man­age­ment of ven­dor relationships. 
• Over­see­ing the devel­op­ment and imple­men­ta­tion of qual­i­ty assur­ance poli­cies and pro­ce­dures to ensure prod­uct qual­i­ty and reg­u­la­to­ry compliance. 
• Pro­vid­ing qual­i­ty assur­ance input for the devel­op­ment and man­u­fac­tur­ing of our LBPs products. 
• Prepar­ing and pre­sent­ing qual­i­ty reports to senior management. 
• Per­form­ing oth­er duties as assigned by the Head of Reg­u­la­to­ry and Qual­i­ty Assurance. 

Ide­al Can­di­date Pro­file 

We are seek­ing can­di­dates who have a Bachelor’s degree in a sci­en­tif­ic dis­ci­pline and a min­i­mum of 10 years of expe­ri­ence in Qual­i­ty Assur­ance with­in the biotech­nol­o­gy or phar­ma­ceu­ti­cal indus­try, with a min­i­mum of 6 years with­in GMP. The role requires the fol­low­ing expe­ri­ence and key qualifications: 

• Expe­ri­ence with an elec­tron­ic qual­i­ty man­age­ment sys­tem, ACE Essen­tials being pre­ferred but not necessary. 
• Strong knowl­edge of FDA, EMA, and ICH guidelines. 
• Proven lead­er­ship and team man­age­ment skills. 
• Excel­lent prob­lem-solv­ing and deci­sion-mak­ing abilities. 
• Abil­i­ty to man­age mul­ti­ple pri­or­i­ties in a dynam­ic, fast-paced devel­op­ment environment. 
• Expe­ri­ence in a start-up environment. 
• Strong com­mu­ni­ca­tion and inter­per­son­al skills. 

We expect the can­di­date fill­ing this posi­tion to be phys­i­cal­ly present at our office to best be an inte­gral part of our team’s ongo­ing research efforts. 

At Kan­vas, we offer a com­pet­i­tive salary and ben­e­fits pack­age that includes full med­ical, den­tal, and vision insur­ance pack­ages for employ­ees and their fam­i­lies, and paid time off. 

If you’re pas­sion­ate about biotech and want to join a dynam­ic and inno­v­a­tive team, we encour­age you to apply for this excit­ing oppor­tu­ni­ty. Please send your CV and a brief para­graph about why you think you’d be a good fit for the job to marguerite@​kanvasbio.​com.