Heron Therapeutics jobs

The incumbent will support GMP manufacturing operations for late-phase and commercial mammalian Cell Culture programs and oversee compliance activities for the department. The individual will support operations during the planning stages by releasing electronic manufacturing logbooks and records, as needed. The employee will support operations during the execution stage by tracking manufacturing records and logbooks in execution. They will also support manufacturing record and logbook reviews and track them through their post-execution life cycle. The individual will monitor GDP execution and provide feedback, coaching, and training to ensure ‘Right the First time' execution of manufacturing documentation. They will also track metrics for executed manufacturing records and logbooks throughout their entire lifecycle. This person will also ensure the manufacturing training plan is set appropriately and track training metrics and compliance for the department. The individual will oversee the departmental compliance activities and metrics as it pertains to deviations, capas, and change controls. They will initiate and complete deviations, capas, and change controls, as needed, to support operations. Lastly, the individual will author, train, and review manufacturing procedures as needed and perform additional duties as assigned. Position Responsibilities Release electronic manufacturing records and logbooks. Perform reviews of electronic logbooks and manufacturing records. Prepare and track departmental manufacturing records and logbooks throughout entire lifecycle and support executed record reviews and comment resolution Author, train, review manufacturing procedures Oversee and execute against departmental compliance activities associated with QA Systems such as deviations, CAPAs, and change controls Develop and oversee manufacturing training plan, and training compliance for department. Other duties as assigned Position Requirements Bachelor's degree in a related scientific or engineering discipline preferred and 2-4 years' experience for specialist in related GMP manufacturing operations or QA; or 4-6 years' experience with a high school degree, or equivalent. Demonstrated knowledge of cell culture or fermentation unit operation is preferred. Experience in single-use platform technology is preferred. Excellent written and verbal communication skills are required. Strong attention to detail, as well as, presentation, written, and verbal communication skills required. Energetic, motivated and dynamic individual. Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor. Experience working with electronic QA Systems such as documentation, deviations, capas, and change control systems is preferred. Salary: Manufacturing Specialist I: $55,000-$70,000 Manufacturing Specialist II: $65,000-$80,000 Manufacturing Specialist III: $75,000-$100,000 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

The Microbiology Associate II will be part of the Microbiology Department responsible for the testing and support for the Microbiology Laboratory in support of a Contract Manufacturing biotechnology facility and Process Development. The position will be a first shift, 10-hour/shift position, located at the Hamlin Road facility. Responsibilities include laboratory support, program testing, reporting of results, execution of protocols. This person is responsible for the aspects of the following programs as directed by management: Environmental Monitoring (Air Viable, Total Air Particulate, Surface Viable) Clean Utility Monitoring (Water Sampling, Bioburden, Conductivity, TOC, Coliform and Nitrates) Compressed Gas Monitoring (Collection, Air Viable, Total Air Particulate, Dragger Tests and specific ID tests) Product Testing (Bioburden, Endotoxin, Host Purity, or Non-Host) Media Release Laboratory Support It is the expectation that this position is required to be onsite full time. Addition, this position should be in the laboratory/facility for a minimum of 75% time daily. The normal working hours for this position are Wednesday through Saturday from 8:00 am to 6:30 pm. Responsibilities include: Executes routine Microbial Laboratory work. Utilizes technical discretion in the execution and interpretation of experiments that contribute to program goals. Makes detailed observations and carries out elementary data analysis. Understands monitoring programs and methods and conducts troubleshooting analysis. Working knowledge of sampling equipment and testing instruments. Documentation and technical writing skills. Knowledge of current regulations and scientific literature. Ensures proper labeling, handling, and storage of all chemical and biohazards used in the laboratory. Ensures proper labeling and disposition of hazardous waste in satellite areas; adheres to all safety requirements and follows safe procedures and attends all required safety and health training, including handling hazardous waste. Requirements: .Minimum requirement is a Bachelor of Science degree in a scientific discipline with a minimum of 2 - 3 years of technical management experience; or a master's degree with 1 year or a Doctorate degree in Microbiology study and 0 years related experience and/or equivalent training preferred. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, and governmental regulations. Ability to write reports, business correspondence, and procedures. Ability to effectively present information and respond to questions from groups of managers and peers. Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables Ability to apply advanced mathematical concepts such as exponents, logarithms, statistical analysis, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis. Must be able to lift up to 50lbs. Ability to stand for periods of time greater than 3 hours. Position requires donning PPE. Knowledge of and experience using computers, Word processing, Spreadsheets, Internet, E-mail Knowledge of and experience using telephone, sampling equipment and laboratory instruments. Range: Microbiology Associate II: $26.44 / hr. - $36.49 / hr. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

This position operates on a 2-2-3 schedule, with 7:00 pm-7:00 am shifts. The Manufacturing Supervisor leads a team of manufacturing associates to perform upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The Supervisor will plan, assign, and monitor daily tasks to ensure timely “Right First Time” execution and strict compliance with safety and quality regulations, e.g., current Good Manufacturing Practice (cGMP). As needed, the Supervisor will also lead teams on projects to author standard operating procedures (SOPs) or Master Batch Records (MBRs); implement corrective and preventive actions (CAPAs); and help specify, commission, and qualify new facilities and/or equipment. A proven and qualified Supervisor will use knowledge and experience in upstream processing (seed expansion, bioreactor operations, cell culture harvest), downstream processing (purification and bulk filling) to teach others, troubleshoot, and continuously improve daily operations, and/or manufacturing support operations (solution preparation, assembly preparation, parts wash, and autoclave) activities. The Supervisor will have a working knowledge of upstream processing equipment (incubators, biosafety cabinets, bioreactors, cell counters, blood gas analyzers, metabolite testing equipment), downstream processing equipment (mixing vessels, chromatography, tangential flow filters, virus filters), and/or manufacturing support equipment (mixing vessels, parts washers, and autoclaves). Additionally, the manufacturing associate will have knowledge of general bioprocessing equipment such as filters, filter integrity testers, balances, pumps, pH/conductivity meters, and disposable technologies (disposable bags, sterile tubing welders, tubing sealers). Additionally, the Manufacturing Support supervisor manages the staff who clean the GMP facilities. The Supervisor will review manufacturing procedures and train manufacturing personnel to ensure that manufacturing operations are conducted accurately, safely, and compliantly. The Supervisor will maintain a sense of ownership of the production processes, manufacturing environment and facility. Following task execution, the Supervisor will review executed production batch records and production orders to ensure a comprehensive and accurate set of actions have occurred. It is management's expectation that all deviations/events are documented and escalated according to KBI internal notification processes. The Supervisor will use leadership and technical expertise to drive process improvement initiatives, monitor processes and equipment, troubleshoot issues, and track/trend metrics. Position Responsibilities Plan, schedule, and support daily production tasks to ensure schedule adherence while maintaining a successful and cGMP compliant execution. Facilitate additional manufacturing activities and process support with other manufacturing groups, MS&T, PD, QA, Maintenance, Facilities, AFS and Microbiology. Ensure timely execution and review of batch documentation and logbooks, initiation of deviations, and execution and completion of ERP orders. Ensure timely corrections to batch documentation and logbooks. Supervise, coach, mentor, and train team members to maintain educated, qualified, and motivated employees. Ensure staff maintain a high level of compliance to procedures and quality expectations. Ensure equipment and manufacturing facilities remain in working order by overseeing maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair. Author, train, review manufacturing procedures Drive process improvement initiatives; troubleshoot issues; track and trend metrics; and author, review, and approve manufacturing deviations, CAPAs, and change controls, as needed. Position Requirements Supervisor: Bachelor's degree in a related scientific or engineering discipline and 4 years' experience in related cGMP manufacturing operations; or high school degree and 10 years' experience, or equivalent. 2+ years prior leadership/supervisory experience. Demonstrated knowledge of upstream (cell culture or microbial fermentation) or downstream unit operations for production of biopharmaceuticals is preferred. Experience in single-use platform technology is preferred. Prior experience in a leadership/supervisory role is preferred. Knowledge of quality systems and regulatory expectations is preferred. Excellent written and verbal communication skills are required. Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor. Salary: Supervisor: $105,000-$125,000 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Primary Responsibilities: Manufacture cell culture products according to manufacturing batch records while ensuring compliance with quality standards, company policies, and current regulations. Perform cleanroom operations, adhering to aseptic processing controls, including gowning and cleaning procedures. Document manufacturing procedures (e.g., SRs, EPRs, BRs) in compliance with Good Documentation Practices (GDP) at the time of execution. Ensure proper issuance and accountability of items used in manufacturing records (SR, EPR, BR). Demonstrate and apply knowledge of current Good Manufacturing Practices (cGMP) in daily tasks and responsibilities. Maintain and uphold 5S standards in the manufacturing environment. Operate and perform maintenance on equipment per applicable Standard Operating Procedures Minimum Requirements: Manufacturing Associate 1: Bachelor's degree in a related scientific or engineering discipline with 0-2 years of GMP manufacturing experience; OR high school diploma with 3-5 years of related GMP manufacturing experience. Manufacturing Associate II Bachelor's degree in a related scientific or engineering discipline with 2-5 years of GMP manufacturing experience; OR high school diploma with 4-6 years of related GMP manufacturing experience. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

The Manufacturing Support Associate I position is designed as an introduction to the environment of cGMP manufacturing. This position performs all routine/nonroutine cleanings of the GMP Facilities, manages Process Waste, and continuously supports the manufacturing operations. This position requires a 12-hour shift schedule. Aseptic and Gowning Qualifications are required for this position. Must be able to document and maintain records to comply with regulatory requirements, cGMP's, Policy Documents and SOPs. Job Responsibilities: Performs and Maintains Manufacturing facilities by routine/nonroutine cleanings. (Daily, Weekly and Monthly Cleanings) - Requires Aseptic and Gowning Qualifications. Cleans, operates and maintains the Process Waste area. Ensures cleanliness of the area and discards waste materials within the area. Cleans drums and dollies as required. Prepare, build and complete processing assemblies (PAR) for production. Completes Facilities response forms and ensures communication to inform other departments requiring EM sampling if required. Stock general supplies in the manufacturing production areas. Handling and discarding of hazardous and nonhazardous waste. Job Requirements: Knowledge / Skills: High School Diploma or Associate Degree with 0+ years of experience. Language Ability: Ability to read and interpret English documents such as safety rules, standard operating procedures, and procedure manuals. Ability to write routine reports and correspondence. Ability to communicate with coworkers and supervisors. Reasoning Ability Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Math Ability Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute ratio and percent. Physical Demands Must be able to stand, walk, wear steel toe shoes and have the ability to push, pull, squat, lift, reach and carry waste as needed, Computer Skills Knowledge of and experience using Word, Excel, E-mail Equipment Use Knowledge of and experience using a computer, a telephone, a copy machine, a fax machine KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary: Join a highly technical analytical team in a dynamic work environment where you will participate in contracted client analytical programs as a member of the Analytical Development (AD) Department. The individual in this position will be responsible for executing experimental protocols and performing data analysis in biopharmaceutical laboratories. Position Responsibilities: Performs testing on in-process, drug substance/drug product, or formulation samples using bio-analytical techniques such as (but not limited to) HPLC, SDS-PAGE, SDS-CGE, ELISA, UV-Vis, and/or biophysical characterization techniques. Regularly exercises technical discretion in the execution and interpretation of experiments that contribute to project goals Makes detailed observations and carries out elementary data analysis. Understands experiments and conducts troubleshooting analysis. Maintains and updates knowledge of instrumentation. Electronic notebook upkeep and writing skills. Maintains familiarity with current scientific literature; maintains professional expertise through familiarity with scientific literature. Assures proper labeling, handling, and storage of all chemicals used in the area; assures proper labeling and disposition of hazardous waste in satellite areas; adheres to all safety requirements and follows safe procedures, and attends all required safety and health training, including handling hazardous waste. Reacts to change productively and handles other essential tasks as assigned. Minimum Requirements: Research Associate I requires a Bachelor's degree in chemistry, biochemistry or related area (or equivalent training) with 0+ years of relevant experience Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables. Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. Salary Range: Research Associate I: $55,000-$70,000 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit ********************* KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

The MQA Supervisor/Senior Supervisor is responsible for leading the MQA batch record review team. Responsible for the review, approval and posting of manufacturing batch records, internal support records, and related client records. Supervisor level loads work across the group and coordinates the support for external client reviews and timely resolution of comments. They will collaborate directly with the MQA Floor Support and Manufacturing teams to complete timely reviews and support dispositions. They are to collaborate with Manufacturing on team initiatives and provides ongoing feedback in order to improve overall efficiency. The MQA Supervisors is responsible for coaching and mentoring their teams as needed to foster a GMP compliant site. As part of a GMP Contract Manufacturing Organization. MQA Supervisors are expected to provide sound guidance to internal MQA team and customers with respect to batch record review process. The MQA Supervisor's team shares responsibility for the inspection readiness of the site. Position Responsibilities: Performs and coordinates the compliance review of master batch records, executed batch records, and internal support records. Maintains timely resolution of batch record comments for Manufacturing and Clients. Responsible for coordination and tracking of all records from review to closure. Documents and reports out metrics to relevant operational meetings as needed. Collaborates with functional areas to improve cycle time for batch record review and subsequent disposition. Attends relevant operational meetings in support of record disposition. Develops and supports training program for QA review of batch records. Provide oversight of training and certification to staff. Supports department related Deviations and CAPAs Supports Client Audits and Regulatory Inspections as area Subject Matter Expert. Minimum Requirements: BS and 6+ or MS and 4+ years' experience (Supervisor), BS and 8+ or MS and 6+ years' experience (Senior Supervisor) experience in a QA or cGMP environment in Biopharmaceuticals or equivalent. Experience in QA Batch Record review and disposition and/or related Quality Systems, with 1-3 years of supervisory experience. Prefer experience in providing QA shop floor support or prior MFG experience, facilitating real-time reviews, guiding the MFG team in compliant documentation. Demonstrates strong interpersonal skills, ability to work in a team environment, attention to details, and excellent problem resolution skills. Strong understanding of FDA, EU, and ROW cGMP regulations. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

The Sr. Director, Manufacturing, oversees the management of all areas of the Manufacturing department, including the upstream processing (cell culture and harvest), downstream processing (purification and bulk filling), and manufacturing support teams. The overall aim is to produce bulk intermediates and/or bulk drug substances while achieving quality, schedule, and cost objectives. Responsibilities: · Oversees hiring, training, and performance management for all Manufacturing staff. Develops an engaged and high-performing team. Provides clear direction and balanced performance feedback by coaching, developing, and challenging direct reports. As necessary, takes timely corrective action in accordance with company policy. Ensures compliance with current federal, state, and local regulations. Consults with Human Resources Department as appropriate. · Serves as a mentor in developing direct reports and other leaders across the site. Serves as a role model for KBI's Values. · Directs department managers and monitors performance against manufacturing goals consistent with established manufacturing and safety procedures. Acts as liaison between department management/subordinate levels, as well as executive/department manager levels to inform personnel of communications, decisions, policies, and all matters that affect their performance, attitudes, and results. · Supports achievement of optimum employee headcount while minimizing overhead and raw material costs to meet annual budgetary plan and client budgets. · Manages the establishment of procedures for maintaining high standards of manufacturing operations to ensure that products conform to established customer and company quality standards. · Assists managers, supervisors, and other senior staff members in the development and formulation of long and short-range plans, policies, programs, and objectives. · Identifies, recommends, and implements changes to improve productivity and reduce cost and waste. · May lead major projects needed to add capabilities or manufacturing capacity, e.g., workstream lead. · Serves as a subject matter expert (SME) as required during regulatory inspections for deviations, change controls, and process documentation. Makes decisions as an SME on large-scale production processes. · Performs miscellaneous duties and projects as assigned and required. Requirements: Bachelor's degree in a related scientific or engineering discipline with 18+ years biopharmaceutical industry experience and/or training; or equivalent. Broad based knowledge of upstream and downstream processing techniques and equipment. Experience with technical transfer is desired. Experience working in a cGMP manufacturing environment is required. Language Ability Fluent in reading and writing the English language. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, and customers. Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Math Ability Ability to perform process calculations to complete technical transfer analysis including but not limited to mass balances, cycle analysis, feed rate calculations, ratio determinations, and step yields. Computer Skills MS Office Applications, ERP systems, EDMS systems, Electronic Quality Management Systems, statistical software Equipment Use Upstream and downstream bioprocessing equipment, general production equipment, in-process testing instruments, and office equipment. Working Conditions While performing the duties of this job, the employee is maybe exposed to moving mechanical parts. The employee is occasionally exposed to high, precarious places; toxic or caustic chemicals; and risk of electrical shock. Salary Range: $189,000 - $262,900 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit ********************* KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary: Perform data review for contract services projects, including GMP testing for internal and external manufacturing and stability studies, as well as analytical and formulation development programs for monoclonal antibodies, proteins, and peptides. Responsibilities: Data review for assay categories: Particle Analysis, Spectrophotometry, Gel Analysis, Plate Based Assay, Binding Assay, HPLC, Trace Analysis, Capillary Electrophoresis, Biophysical Techniques, Method Qualification and Validation. Maintain knowledge of instrumentation and GMP standards Employ data review software (Empower, 32 Karat, Softmax, Compass, Chemidoc). Verify that calculations, electronic data, and documented information are compliant and accurate. Make detailed observations and report documentation corrections as needed. Demonstrate strong communication and ability to work independently and as part of a team. Requirements: 3 years of experience following cGMP documentation practices. 3 years of experience working with formulas, scientific equations, and graphs; 3 years of experience in analytical software, including Empower , SoftMax, or Compass. 3 years of experience with GMP testing, stability studies, analytical and formulation development of monoclonal antibodies, proteins, or peptides. 3 years of experience within a pharmaceutical setting completing weekly analytical data review assignments in cGMP environment and independently handling Method Qualification and Method Validation reviews. 3 years of experience with Biopharmaceutical regulatory agency (FDA/EMA) inspection readiness for data integrity ALCOA+ and 21 CFR part 11 regulatory compliance requirements in cGMP environment. Salary Range: $84,000 - $105,000 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting upon hire and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit ********************* KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary: Join a highly technical analytical team in a dynamic work environment. Participate in contracted client analytical programs as a member of Analytical and Formulation Sciences (AFS) in the cell-based assay (CBA) team. Perform analyses and evaluate data from bioassays, including cell-based assays and ELISAs. Responsibilities: Regularly exercises technical discretion in the execution and interpretation of experiments that contribute to project goals. Makes detailed observations and carries out elementary data analysis. Understands experiments and conducts troubleshooting analysis. Maintains and updates knowledge of instrumentation. Notebook upkeep and writing skills. Maintains familiarity with current scientific literature; maintains professional expertise through familiarity with scientific literature. Assures proper labeling, handling, and storage of all chemicals used in the area; assures proper labeling and disposition of hazardous waste in satellite areas; adheres to all safety requirements and follows safe procedures, and attends all required safety and health training, including handling hazardous waste. Reacts to change productively and handles other essential tasks as assigned. Performs 96-well cell-based assays with absorbance, luminescent, or fluorescent readouts, requiring experience with plate readers and flow cytometers, as well as curve fitting software. Maintains multiple cell lines concurrently with no cross-contamination or microbiological contamination, requiring familiarity with aseptic technique and cell passaging and banking. Requirements: Bachelor's degree in chemistry, biochemistry or related area (or equivalent training) with 6+ years' experience or Master's degree and 4+ years' experience Demonstrated expertise in cell-based assay analytical techniques Good oral presentation and technical writing skills Able to record (accurately, clearly, and consistently) information, facts, and measurements that are required by cGMP, GLP, GCP, and/or by co-workers to understand situations and to perform their assignments Understanding of biotherapeutic regulatory requirements and expectations Strong communication skills Salary Range: $84,000-$115,000 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting upon hire and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit ********************* KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

We are seeking a highly motivated QA Manufacturing Specialist I/II at our state-of-the-art commercial manufacturing facility in Patriot Park, Durham, NC. You will have the unique opportunity to help build our site processes and culture as we ramp up to full manufacturing capacity. We embrace KBI's values of learning and growth, high standards, collaboration, and trust and respect to solve problems and continuously improve. As a center of excellence, our site enables real-time quality and process monitoring through paperless records with integrated automation. We are looking for a critical thinker who is comfortable tackling new challenges / unknowns and utilizing a risk-based approach. We hope you join us! Position Responsibilities: Be an on-the-floor quality partner working with the manufacturing team during operations Work with manufacturing and other groups to escalate and resolve deviations and other compliance issues Conduct QA walkthroughs Participate in safety walkthroughs Participate in process improvements Attend relevant meetings in support of manufacturing operations Review electronic batch records and logbooks Provide feedback on facility response for unplanned events Other tasks and projects as assigned Work 12-hour shifts (2-2-3 schedule, day shift) Position Qualifications: MQA Specialist I High School diploma or equivalent. Degree progression preferred. GMP / regulated industry / laboratory experience is required (approximate 1-3 years). Demonstrated ability to work in a team environment. Demonstrated ability to understand the manufacturing process. Ability to perform routine core MQA responsibilities. MQA Specialist II Associate degree / bachelor's degree strongly preferred or appropriate years of experience (approximate 3-5 years). Demonstrated ability to work in a team environment and strong communication skills within all levels of an organization. Demonstrated ability to represent Quality on interdepartmental meetings. Demonstrated knowledge of technical documents. Ability to support internal and external audits. Demonstrated ability to train employees on Quality subjects. Ability to track and trend department metrics Salary Ranges: MQA Specialist I: $54,000 - $74,300 MQA Specialist II: 66,966 - 92,077 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Principal Process Engineering is responsible for all Manufacturing process equipment and ensures the equipment and site infrastructure is in an active state to support cGMP operations. As a Principal Process Engineer, you will act as member of a cross-functional team to support implementation of new systems and improvements to existing manufacturing processes and equipment. You will apply sound scientific and engineering principles to successfully define upstream and downstream process equipment requirements, specifications and standards for facility fit, and assess equipment design and operation in a commercial cGMP production facility. This may include upstream activities such as cell culture and harvest, and/or downstream processes such as chromatography, purification, and filtration. You will be at the forefront of existing best practices and evaluating technologies. Provide system ownership for Upstream Biopharmaceutical process equipment. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of process equipment. Key Responsibilities You will support equipment commissioning and qualification activities related to new or modified processes. Collaborate with MS&T and Manufacturing teams to troubleshoot and resolve equipment and process-related issues in manufacturing systems. Act the technical subject matter expert (SME) for upstream and/or downstream equipment and the site clean utilities ensuring proper installation, qualification, and maintenance of these systems. Lead process engineering related projects to improve manufacturing operations or implementation of new processing equipment. As the project lead you will ensure on time delivery, compliance with project requirements, and project budget. Lead the development, scale-up, and optimization of upstream (cell culture, fermentation) and/or downstream (purification, filtration) processes for biologics or advanced therapies Design and execute experiments to improve process robustness, yield, and product quality Collaborate with Engineering, Quality, Regulatory, and Manufacturing teams to ensure seamless tech transfer and GMP compliance Author and review process documentation including SOPs, and Engineering Studies protocols Serve as a technical lead in cross-functional project teams and represent process engineering in regulatory filings and audits Evaluate and implement new technologies (e.g., single-use systems, PAT tools, continuous processing) to enhance scalability and efficiency Support capital projects including facility design, equipment selection, and commissioning Lead risk assessments, and root cause investigations for process deviations Communicate with other KBI sites for problem solving and consistency of processes through the organization. Contribute to developing a culture of continuous improvements on processes and tools in close collaboration with other. You will perform facility fit activities for various production scenarios. You should be able to apply engineering principles in-order to problem-solve and drive projects to successful completion within defined timelines. The ability to manage multiple concurrent projects and resources. Lead and support CAPA, Change Control, Deviation, Risk Analysis, Root Cause Analysis, and other Quality Systems. Providing technical support for equipment modifications, deviations, change controls, and CAPAs. Develop and maintain equipment SOPs (Standard Operating Procedures), training, and other process documentation. Requirements: Bachelor's, Master's, in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field. 10+ years of experience in bioprocess engineering within the biotech or biopharmaceutical industry. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary: This individual will direct microbiology activities at Patriot Park. Responsible for the development, maintenance and harmonization of microbiology procedures and systems related to Quality Control oversight. Provides strategic and technical expertise in all cGMP compliance related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the KBI internal requirements. Responsible for the directing and overseeing of microbiology monitoring and product testing at Patriot Park. Responsibilities: · Develop strategy and drive harmonization of microbiology programs. · Provide strategic and technical expertise to Patriot Park and Hamlin Rd. KBI sites to ensure microbiology procedures, and decisions meet regulatory and KBI requirements and are based on documented scientific rationales. · Lead, assess, coach and develop departmental associates. Manage performance; ensure team meets company, site and personal expectations and meets objectives; · guide the professional growth of team. · Ensure all personnel at both facilities are trained to appropriately perform expected duties. · Encourage a quality culture of inclusion and high standards to ensure a high performing team. · Expert understanding of regulations and industry expectations. Support regulatory and client audits. Requirements: BS and 12+ years' experience or MS and 10+ years' experience in a QA or GMP environment or equivalent. Experience leading and managing microbiology laboratories in an FDA regulated manufacturing environment. Demonstrated expert knowledge of relevant FDA and EU regulations as well as hands on experience in a low bioburden and aseptic processing setting. Language Ability Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedures. Ability to effectively present information and respond to questions from staff, colleagues, managers and clients. Ability to read, analyze and author complex documentation. Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Math Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Computer Skills Word processing, Database, Spreadsheets, Power Point, Internet, E-mail, Calendar Management, quality management electronic systems Salary Range: $173,000 - $238,700/yr. Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit ********************* KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary: The Specialist has responsibility for the implementation of the Environmental, Health, Safety, and Sustainability (EHSS) program. This includes leadership to maintain EHSS compliance and continuous improvement. EHSS supports operations of biologic contract development and manufacturing organization. Responsibilities include incident response, reporting and investigations; environmental permit management; and risk management. Implements all applicable EHSS programs for the site such as: LOTO, confined space entry, industrial hygiene, hazard communication, PPE, workers compensation, emergency management, etc. Coordinates with operations to identify and mitigate risks with effective engineering controls, procedures, and training. Responsibilities: Interface with KBI staff: Maintain productive working relationships with EHS&S and site staff. Collaborate on ways to enhance the Safety culture. EHS&S General Compliance: Provide input on EHS&S assessments. Define additional action items where compliance gaps exist. Offer guidance on compliance improvement initiatives. EHS&S Management Systems: Assist with maintenance of the Benchmark EHS&S Management system. Actively facilitate closure of open action items. Help track metrics associated with all modules. Aid in execution of Compliance Calendar tasks by identifying appropriate actions to take including completion of regulatory reports. EHS&S Written Programs: Draft new written programs and/or revise existing programs where needed. EHS&S Training: Develop training presentations and deliver training to affected groups. Assist with implementation ofexisting training programs. Work with Global Training to maintain and track accurate records. Waste Management: Oversee compliance with hazardous waste management and propose plans to enhance proficiencies surrounding waste management. Other duties as assigned. Requirements: Bachelor of Science degree in an occupational health and safety related field and a minimum of 5 - 10 years of industry experience as a safety professional, or Bachelor of Science in a technical discipline and minimum of 7 - 12 years' experience as a safety professional in R&D and/or manufacturing. Relevant training and/or certification in regulated safety and environmental activities such as: RCRA Hazardous Waste Management DOT hazardous materials shipping First Aid/CPR/AED 30 Hr General Industry OSHA Certification, 40 Hr HAZWOPER certification, etc. Preferred: Experience in a cGMP manufacturing environment (biotech, pharmaceutical or medical device industries) Knowledge of the operations typical to the biotechnology/pharmaceutical industry. Language Ability Ability to concisely write reports and to effectively communicate information to executive management, managers, technicians, government agencies and customers. Reasoning Ability Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, musical notes, etc.,) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables. Math Ability Strong math and analytical skills required. Ability to apply mathematical operations to such tasks as frequency distribution, variance analysis, and determination of reliability and validity. Equipment Use Computer, smartphone, copy machines, EHS&S and industrial hygiene instruments such as a noise dosimeter, gas monitor, light meter, etc. Working Conditions Incumbents may work with toxic materials, toxic gases, electrical hazards, and dangerous tools and equipment. Must comply with all applicable rules and regulations of the company and the Pharmaceutical / Biotech industry including FDA regulations such as cGMP, GDP, Environmental, Health, Safety & Sustainability regulations and company regulations such as the employee handbook. Salary Range: $101,000 - $138,000 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit ********************* KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

This role contains the following responsibilities covering 2nd shift hours (2:00 pm through 10:30 pm), Monday through Friday: The Senior QC Analyst (2nd Shift) will be trained to execute analytical test methods and their corresponding analytical techniques. The core function is composed of completing QC testing for in-process, characterization, release, or stability samples. Additionally, when need arises, Senior QC Analyst will assist with troubleshooting and support In-process Support Associates with STAT samples during 2nd shift. Responsibilities include: In-process, characterization, stability, and/or release testing as assigned. Capabilities include (but not limited to) HPLC, ELISA, qPCR, SoloVPE, other spectrophotometric techniques, capillary electrophoretic techniques, and compendial testing per USP with near-zero error and minimal guidance or direction Execution of method transfer, method qualification, and/or method validation testing performed under protocol Solution preparation Organizes and processes samples according to GxP standards Independent analysis and collation of data to draw conclusions Enter data into control charts and LIMS, if applicable Supports lab investigation and deviation reports Supports implementation of Corrective and Preventive Actions Revises SOPs and technical documents Supports team to troubleshoot testing or project challenges with comfort in presenting and communicating data Tracks department metrics upon request; actively engages in improvement of department metrics Partakes in continuous improvement projects or leading simple improvement projects Ensures state of safety and regulatory audit readiness at all times Maintains work to current Good Manufacturing Practices (cGMP) Ensures Trainer qualification status to expand team matrix Laboratory support - ensures areas are neat, clean, organized, and equipment is functioning Participates in data review activities Duties may include support in STAT testing coordination It is the expectation that this position is required to be onsite full time with a minimum of 75% of time in the laboratory/facility Minimum Requirements: Relevant degree and 4-8 years' biopharmaceutical industry experience, preferably in protein analytics Salary: $63,000-$86,900 KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

The Manufacturing Supervisor, Solution Prep leads a team of manufacturing associates to perform both upstream and downstream preparation of solutions and growth media used for processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The individual will plan, assign, and monitor daily tasks to ensure timely “Right First Time” execution and strict compliance with safety and quality regulations, e.g., current Good Manufacturing Practice (cGMP). As needed, the Supervisor may also support core production operations (cell culture or purification), lead teams on projects to author standard operating procedures (SOPs) or batch and solution records; implement corrective and preventive actions (CAPAs); support continuous improvement and other initiatives involving safety, quality, delivery, engagement, & cost in accordance to KBI/JSR business objectives. A proven and qualified supervisor will use knowledge and experience to execute production operations, coach staff, troubleshoot, and continuously improve daily operations and/or manufacturing support operations. The Supervisor will have a working knowledge of bioprocessing equipment. including but not limited to, filters, filter integrity testers, balances, pumps, analytical instruments, and disposable technologies (disposable bags, sterile tubing welders, tubing sealers). The Supervisor will review manufacturing procedures and instruct manufacturing personnel to ensure that manufacturing operations are conducted accurately, safely, and compliantly. The Supervisor will maintain a sense of ownership of the production processes, manufacturing environment and facility. Following task execution, the Supervisor will review executed production documents to ensure accuracy and completeness. It is management's expectation that supervisors uphold the company's core competencies and departures from specifications and/or policies are reported according to KBI internal notification processes. Job Responsibilities Support daily production tasks to ensure schedule adherence while maintaining a successful and cGMP compliant execution. Facilitate additional manufacturing activities and process support with other manufacturing groups, MS&T, PD, QA, Maintenance, Facilities, AFS and Microbiology. Ensure timely execution and review of batch documentation and logbooks, initiation of deviations, and execution and completion of ERP orders. Ensure timely corrections to batch documentation and logbooks. Supervise, coach, mentor, and train team members to maintain educated, qualified, and motivated employees. Ensure staff maintain a high level of compliance to procedures and quality expectations. Ensure equipment and manufacturing facilities remain in working order by overseeing maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair. Author, train, review manufacturing procedures. Drive process improvement initiatives; troubleshoot issues; track and trend metrics; and author, review, and approve manufacturing deviations, CAPAs, and change controls, as needed. Minimum Requirements Bachelor's degree in a related scientific or engineering discipline and 4 years' experience in related cGMP manufacturing operations; or high school degree and 10 years' experience, or equivalent. Demonstrated knowledge of mammalian cell culture (or microbial fermentation) or purification operations for production of biopharmaceuticals is preferred. Experience in single-use platform technology is preferred. Knowledge of quality systems and regulatory expectations is preferred. Excellent written and verbal communication skills are required. Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor. Language Ability Fluent in reading and writing the English language. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch, and production records. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Math Ability Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret graphs. Computer Skills Knowledge of and experience using MS Office, ERP, EDMS, production equipment software is required Equipment Use Knowledge of and experience using upstream or downstream bioprocessing equipment, general production equipment, in-process testing instruments, and office equipment is required Working Conditions The job requires working 12-hour shifts (2-2-3 schedule) which include working weekends and holidays and may include working overnight. The job requires working within a cGMP manufacturing biotechnology facility which requires clean room operations. Clean room operations require donning clean room attire when entering clean room areas and maintaining good personal hygiene. While performing the duties of this job the employee regularly utilizes equipment and materials which include mechanical hazards, chemical hazards, electricity hazards, and tripping and falling hazards. The noise level in the environment is moderate to high. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Testing and support for the Microbiology Laboratory in support of a Contract Manufacturing biotechnology facility and Process Development. Responsibilities includes laboratory support, program testing, reporting of results, execution of protocols. This person is responsible for the aspects of the following programs as directed by management: • Environmental Monitoring (Air Viable, Total Air Particulate, Surface Viable) • Clean Utility Monitoring (Water Sampling, Bioburden, Conductivity, TOC, Coliform and Nitrates) • Compressed Gas Monitoring (Collection, Air Viable, Total Air Particulate, Dragger Tests and specific ID tests) • Product Testing (Bioburden, Endotoxin, Host Purity, or Non-Host) • Media Release • Laboratory Support It is the expectation that this position is required to be onsite full time. Addition, this position should be in the laboratory/facility for a minimum of 75% time daily. Second Shift: Sunday - Wednesday [2:00 PM EST -12:00 AM EST ] Responsibilities: Executes routine Microbial Laboratory work. Utilizes technical discretion in the execution and interpretation of experiments that contribute to program goals Makes detailed observations and carries out elementary data analysis. Understands monitoring programs and methods and conducts troubleshooting analysis. Working knowledge of sampling equipment and testing instruments. Documentation and technical writing skills. Knowledge of current regulations and scientific literature. Ensures proper labeling, handling, and storage of all chemical and biohazards used in the laboratory. Ensures proper labeling and disposition of hazardous waste in satellite areas; adheres to all safety requirements and follows safe procedures and attends all required safety and health training, including handling hazardous waste. Requirements: Bachelor's/Master's degree in Microbiology, Biology or related technological field of science. Minimum years of experience 0 years of experience. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, and governmental regulations. Ability to write reports, business correspondence, and procedures. Ability to effectively present information and respond to questions from groups of managers and peers. Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables. Ability to apply advanced mathematical concepts such as exponents, logarithms, statistical analysis, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis. Must be able to lift up to 50lbs. Ability to stand for periods of time greater than 3 hours. Position requires donning PPE. Word processing, Spreadsheets, Internet, E-mail. Computer, telephone, Sampling equipment and Laboratory instruments. Salary Range: $21.97 - $30.21/hr. Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit ********************* KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

The incumbent will oversee tech transfer activities for Upstream or Downstream Manufacturing and serve as the technical leader for the department. The Specialists' Manager will oversee the Upstream or Downstream Manufacturing specialist team to ensure that Manufacturing tech transfer responsibilities are met to ensure ‘On-Time” and “Right the First time' execution of production activities. The individual will oversee manufacturing record generation, equipment enrollment, operation, and maintenance, manufacturing projects and studies, and drive operational excellence initiatives for the department. The Specialists' Manager will oversee Manufacturing Specialists and will report to the Director of Manufacturing Technical Operations. The individual will be responsible for managing mid-term and long-term manufacturing readiness planning and be the primary point of contact for daily issue escalation with respect to tech transfer and readiness tasks. The individual will ensure their team maintains strict accordance with SOPs and Good Manufacturing Practices. The individual will also be responsible for ensuring their staff work cross-functionally to ensure operations are both reliable and successful. This requires a drive for continuous improvement and simplicity and looking for opportunities to ensure equipment operation is reliable. This proven and qualified candidate will use their past experiences, depth and knowledge of fundamentals in media/buffer preparation, seed expansion, bioreactor operations, cell culture harvest operations, chromatography, ultrafiltration/nanofiltration and drug substance filling operations to teach, troubleshoot and continuously improve the production operations of Manufacturing. The ideal candidate will be both technically sound as well as an experienced team motivator and coach. The Specialists' Manager will use their leadership and technical expertise to drive process improvement initiatives, monitor processes and equipment and troubleshoot issues, trend and track metrics and author, review and approve procedures, deviations, CAPAs, and change controls as needed. Job Responsibilities Oversee manufacturing tech transfer activities including: Manufacturing record generation, MRP BOM and work order generation, and enrollment of materials and equipment Drive process improvement initiatives, troubleshoot issues, trend and track metrics and author, review and approve procedures, deviations, CAPAs, and change controls as needed Supervise, coach, mentor and train team members to maintain educated, qualified and motivated employees. Ensure staff maintain a high level of compliance to procedures and quality expectations. Drive process improvement initiatives, troubleshoot issues, trend and track metrics and author, review and approve procedures, deviations, CAPAs, and change controls as needed Ensure equipment and Manufacturing facilities remain in working order by overseeing manufacturing specialists and ensuring vendor repairs as needed, maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair. Job Requirements Bachelor's degree in a related scientific or engineering discipline and 10+ years' experience in related GMP manufacturing operations; 6+ years prior leadership/supervisory experience. Demonstrated knowledge of cell culture, fermentation, or purification unit operation is preferred. Experience in single-use platform technology is preferred. Excellent written and verbal communication skills are required. Energetic, motivated and dynamic individual. Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary: This is a Data Reviewer position in Analytical and Formulation Sciences department reporting to Project Leader. Responsibilities: Perform data review for contract services projects, including GMP testing for internal and external manufacturing and stability studies, analytical and formulation development for monoclonal antibodies, recombinant proteins and peptides. Follow manager's instructions to complete job responsibilities and spend approximately 95% time on data review for assay categories as outlined in Job Responsibility section. Understand principles of the technologies in scope for data review at respective job title level. Verify that calculations and documented information are correct, complete and accurate in accordance with guiding documents and internal procedures. Maintain and update knowledge of relevant instrumentation and cGMP standards. Make detail observations and report documentation corrections required to analysts and their managers, as needed. Contribute to review related feedback, including review group needs, to the functional management. Work with functional management to improve review cycle time. Data reviewer job responsibilities and approximate percent of time are allocated based on the assay complexity level are: 1. Logbooks and simple assays without calculations Instrument or Solution Logbooks, Appearance, Color, Clarity, Turbidity, pH, Osmolality, particle analysis KF, Viscosity, HIAC, MFI - 20% 2. Spectrophotometric assays UV, SoloVPE, Gel analysis SDS-PAGE, Western Blot, IEF, ELISA, BCA - 75% 3. Maintain and update knowledge of technologies and cGMP standards 5% Requirements: Must have background in biopharmaceutical analytical testing, understand cGMP standards. Demonstrate strong communication and interpersonal skills. BS/BA with minimum 5 years of related experience or MS/MA with minimum 3 years of related experience. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, percent, molarity and other common calculations used in biochemistry. Ability to generate and interpret graphs and plots. Salary Range: $78,000 - $95,000 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit ********************* KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.