Careers

Title: Sr. Prin­ci­pal Engi­neer I

Depart­ment: GMP Manufacturing 

Exemp­t/Non-exempt: Exempt 

Job Loca­tion: South San Fran­cis­co, CA 

Job Descrip­tion 

Kan­vas Bio­sciences is look­ing for an out­stand­ing Sr. Prin­ci­pal Engi­neer to join our grow­ing team of micro­bial spe­cial­ists. You will:

• Uti­lize State-of-the-Art Tech­nol­o­gy: Engage with the lat­est advance­ments in micro­bial imag­ing and sequenc­ing to push the bound­aries of research. 
• Work with a Dynam­ic Team: Work in a vibrant envi­ron­ment teem­ing with moti­vat­ed pro­fes­sion­als, work­ing togeth­er towards achiev­ing excellence. 
• Assist in Nov­el Devel­op­ment Pro­grams: Work direct­ly with senior sci­en­tists to build com­plex LBPs as part of a new fron­tier in health and biology. 

Descrip­tion of Role

We are seek­ing a high­ly moti­vat­ed and detail-ori­ent­ed Process Engi­neer with hands-on expe­ri­ence with tech trans­fer and/​or GMP man­u­fac­tur­ing to sup­port our clin­i­cal and com­mer­cial pro­duc­tion oper­a­tions. The ide­al can­di­date will be respon­si­ble for imple­ment­ing, exe­cut­ing, and improv­ing nov­el man­u­fac­tur­ing process­es for drug sub­stance and drug prod­uct man­u­fac­tur­ing. This role will be crit­i­cal to ensure com­pli­ance, process robust­ness, and oper­a­tional effi­cien­cy in a reg­u­lat­ed environment.

Key Respon­si­bil­i­ties

This role is lab-based and col­lab­o­ra­tive, with an empha­sis on exper­i­men­tal exe­cu­tion, data inter­pre­ta­tion, and com­mu­ni­ca­tion. You will:

• Lead the tech trans­fer and exe­cu­tion of micro­bio­me-based GMP drug sub­stance and drug prod­uct man­u­fac­tur­ing processes.
• Sup­port scale up and tech trans­fer of micro­bio­me-based drug sub­stance and drug prod­uct processes. 
• Lead GMP-readi­ness activ­i­ties for batch production
• Tech­ni­cal SME for GMP man­u­fac­tur­ing oper­a­tions and equip­ment (e.g., sin­gle use biore­ac­tors, tan­gen­tial flow fil­tra­tion, blend­ing, encap­su­la­tion, etc).
• Lead the design and pro­cure­ment of GMP man­u­fac­tur­ing equipment
• Lead facil­i­ty, equip­ment, and process start up (e.g., CQV activ­i­ties, pilot batches/​engineering batch­es, etc)
• Lead the design, pro­cure­ment, and imple­men­ta­tion of a sin­gle use tech­nol­o­gy plat­form for GMP manufacturing
• Author and revise batch records, SOPs, and work instructions.
• Col­lab­o­rate with Qual­i­ty, Process Devel­op­ment, and Engi­neer­ing teams to trou­bleshoot and resolve man­u­fac­tur­ing issues.
• Mon­i­tor and ana­lyze man­u­fac­tur­ing data to iden­ti­fy process improve­ments and CAPAs.
• Pro­vide on-the-floor sup­port dur­ing batch exe­cu­tion, devi­a­tions, and audits.
• Lead or sup­port inves­ti­ga­tions for devi­a­tions, OOS/OOT, and non-conformances.
• Ensure com­pli­ance with all applic­a­ble GMP reg­u­la­tions and inter­nal qual­i­ty standards
• Lead teams dur­ing batch cam­paigns or facil­i­ty start­up projects and serve as a men­tor to junior team members.

Key Qual­i­fi­ca­tions

We are seek­ing a sci­en­tif­i­cal­ly curi­ous, hands-on researcher with the fol­low­ing background:

• Bachelor’s or Master’s degree in Engi­neer­ing (Chem­i­cal, Bio­chem­i­cal, or relat­ed dis­ci­pline) with 6 – 8 years of expe­ri­ence in GMP man­u­fac­tur­ing oper­a­tions and/​or process engi­neer­ing in biotech, phar­ma, or CDMO settings.
• Expe­ri­ence supporting/​leading tech trans­fer and clin­i­cal man­u­fac­tur­ing for fer­men­ta­tion-based bio­phar­ma prod­ucts. Hand-on expe­ri­ence with sin­gle use biore­ac­tors (Bioflo, Cyti­va), TFF sys­tems, and sin­gle use mix­ing sys­tems preferred.
• Expe­ri­ence author­ing GMP doc­u­ments such as batch records and SOPs.
• Expe­ri­ence with equip­ment start up and/​or facil­i­ty start up is preferred. 
• Expe­ri­ence with the design and imple­men­ta­tion of sin­gle-use man­u­fac­tur­ing tech­nolo­gies (e.g., tub­ing sets, bag designs, con­nec­tor technology)
• Expe­ri­ence with equip­ment start up and/​or facil­i­ty start up is preferred
• Expe­ri­ence with asep­tic pro­cess­ing, anaer­o­bic fermentation/​processing, and/​or oral solid/​liquid dosage forms is a plus.
• Famil­iar­i­ty with qual­i­ty sys­tems such as devi­a­tions, inves­ti­ga­tions, CAPAs, and change control.
• Under­stand­ing of cGMP, FDA, and ICH guidelines.
• Excel­lent com­mu­ni­ca­tion, orga­ni­za­tion­al, and cross-func­tion­al col­lab­o­ra­tion skills.
• Demon­strat­ed abil­i­ty to lead ini­tia­tives, man­age junior staff, or serve as the tech­ni­cal lead in cross-func­tion­al man­u­fac­tur­ing activities.

Addi­tion­al Information

• This is a ful­ly onsite, lab-based role in South San Fran­cis­co, CA.

• Start date is imme­di­ate upon com­ple­tion of the inter­view process.
• Salary will be com­men­su­rate with local indus­try stan­dards and expe­ri­ence ($150,000+) and includes benefits.
• The role reports to the VP of Process Devel­op­ment and Manufacturing.

How to Apply:

Please send your resume or CV to colleen@​kanvasbio.​com

Title: Process Engi­neer I

Depart­ment: GMP Manufacturing 

Exemp­t/Non-exempt: Exempt 

Job Loca­tion: South San Fran­cis­co, CA 

Job Descrip­tion 

Kan­vas Bio­sciences is look­ing for an out­stand­ing Process Engi­neer to join our grow­ing team of micro­bial spe­cial­ists. You will:

• Uti­lize State-of-the-Art Tech­nol­o­gy: Engage with the lat­est advance­ments in micro­bial imag­ing and sequenc­ing to push the bound­aries of research.
• Work with a Dynam­ic Team: Work in a vibrant envi­ron­ment teem­ing with moti­vat­ed pro­fes­sion­als, work­ing togeth­er towards achiev­ing excellence.
• Assist in Nov­el Devel­op­ment Pro­grams: Work direct­ly with senior sci­en­tists to build com­plex LBPs as part of a new fron­tier in health and biology. 

Descrip­tion of Role

We are seek­ing a high­ly moti­vat­ed and detail-ori­ent­ed Process Engi­neer with hands-on expe­ri­ence with scale-up and/​or tech trans­fer to sup­port our clin­i­cal and com­mer­cial pro­duc­tion oper­a­tions. The ide­al can­di­date will be respon­si­ble for scal­ing up fer­men­ta­tion-based micro­bio­me drug sub­stance and drug prod­uct process­es in close part­ner­ship with the process devel­op­ment and man­u­fac­tur­ing teams. This role will be crit­i­cal to ensure com­pli­ance, process robust­ness, and oper­a­tional effi­cien­cy in a reg­u­lat­ed environment.

Key Respon­si­bil­i­ties

This role is lab-based and col­lab­o­ra­tive, with an empha­sis on exper­i­men­tal exe­cu­tion, data inter­pre­ta­tion, and com­mu­ni­ca­tion. You will:

• Lead the scale up and tech trans­fer of micro­bio­me-based GMP drug sub­stance and drug prod­uct man­u­fac­tur­ing process­es for clin­i­cal manufacturing.
• Sup­port GMP man­u­fac­tur­ing by pro­vid­ing on-the-floor sup­port dur­ing man­u­fac­tur­ing cam­paigns, includ­ing off-shift or week­end cov­er­age as needed.
• Tech­ni­cal SME for GMP man­u­fac­tur­ing process­es (e.g., fer­men­ta­tion, tan­gen­tial flow fil­tra­tion, blend­ing, encap­su­la­tion, etc).
• Author and revise GMP doc­u­men­ta­tion such as batch records, SOPs, and work instructions.
• Col­lab­o­rate with Qual­i­ty, Process Devel­op­ment, and Engi­neer­ing teams to trou­bleshoot and resolve man­u­fac­tur­ing issues.
• Mon­i­tor and ana­lyze man­u­fac­tur­ing data to iden­ti­fy process improve­ments and CAPAs.
• Sup­port inves­ti­ga­tions for devi­a­tions, OOS/OOT, and non-conformances.
• Ensure com­pli­ance with all applic­a­ble GMP reg­u­la­tions and inter­nal qual­i­ty standards.

Key Qual­i­fi­ca­tions

We are seek­ing a sci­en­tif­i­cal­ly curi­ous, hands-on researcher with the fol­low­ing background:

• Bachelor’s or Master’s degree in Engi­neer­ing (Chem­i­cal, Bio­chem­i­cal, or relat­ed dis­ci­pline) with 2 – 4 years of expe­ri­ence in GMP man­u­fac­tur­ing oper­a­tions, process devel­op­ment, and/​or process engi­neer­ing in biotech, phar­ma, or CDMO set­tings. A min­i­mum of 2 years of expe­ri­ence work­ing in sup­port­ing a GMP man­u­fac­tur­ing envi­ron­ment is required.
• Expe­ri­ence supporting/​leading tech trans­fer and clin­i­cal man­u­fac­tur­ing for fer­men­ta­tion-based bio­phar­ma prod­ucts. Hand-on expe­ri­ence with sin­gle use biore­ac­tors (Bioflo, Cyti­va), TFF sys­tems, and sin­gle use mix­ing sys­tems preferred
• Expe­ri­ence with the design and imple­men­ta­tion of sin­gle use man­u­fac­tur­ing tech­nolo­gies (e.g., tub­ing sets, bag designs, con­nec­tor tech­nol­o­gy, etc).
• Expe­ri­ence with anaer­o­bic fermentation/​processing, and/​or oral solid/​liquid dosage forms
• Work­ing knowl­edge of GMP doc­u­men­ta­tion (e.g., batch records, SOPs, work instruc­tions, etc) and com­pli­ance expec­ta­tions. Famil­iar­i­ty with qual­i­ty sys­tems such as devi­a­tions, inves­ti­ga­tions, CAPAs, and change control.
• Expe­ri­ence with facil­i­ty and equip­ment start up is a plus.
• Expe­ri­ence sup­port­ing spray dry­ing or lyophiliza­tion is a plus.
• Excel­lent com­mu­ni­ca­tion, orga­ni­za­tion­al, and cross-func­tion­al col­lab­o­ra­tion skills.

Addi­tion­al Information

• This is a ful­ly onsite, lab-based role in South San Fran­cis­co, CA.

• Start date is imme­di­ate upon com­ple­tion of the inter­view process.
• Salary will be com­men­su­rate with local indus­try stan­dards and expe­ri­ence ($110,000 – $135,000) and includes benefits.

How to Apply:

Please send your resume or CV to colleen@​kanvasbio.​com