Heron Therapeutics jobs - 49 jobs

This position operates on a night shift 2-2-3 schedule. The Manufacturing Associate I/II (Manufacturing Associate) is responsible for performing upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The Manufacturing Associate must follow written, approved procedures and forms to ensure all work is conducted “Right First Time” (RFT) following Good Manufacturing Practice (GMP), including good documentation practices, and/or Good Laboratory Practice (GLP). As needed, the Manufacturing Associate will work individually or on teams to author standard operating procedures (SOPs) or Master Batch Records (MBRs); write corrective and preventive actions (CAPAs); and specify, commission, and qualify new equipment. The Manufacturing Associate will be responsible for upstream unit operations (seed expansion, bioreactor operations, cell culture harvest). The Manufacturing Associate will have a working knowledge of upstream processing equipment (incubators, biosafety cabinets, bioreactors, cell counters, blood gas analyzers, metabolite testing equipment). 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). Following task execution, the Manufacturing Associate will review the executed production records and logbooks to ensure GxP compliance. The Manufacturing Associate will execute daily tasks and maintain strict accordance with manufacturing records, SOPs, and GMP. Staff will maintain a sense of ownership of the production processes, the manufacturing environment, and the facility. Staff will work cross-functionally with QA, MS&T, facilities, engineering, supply chain, IT, AFS, and other key departments to ensure startup and ongoing manufacturing operations are successful, reliable, and compliant. A proven Manufacturing Associate will demonstrate the following qualities: learning agility, orientation toward action, results driven, team player, strong attention to detail, and superior integrity and accountability. Position Responsibilities Manufacture bulk intermediates and drug substances per manufacturing batch records in compliance with quality, company policies, and current regulations Perform operations in a cleanroom environment, applying controls to ensure aseptic processing, including gowning and cleaning procedures Document each task involving manufacturing records and logbooks following GDP at the time of execution Utilize and perform maintenance on equipment per applicable SOP Ensure all materials are issued and accounted for during the execution of a record Demonstrate, apply, and ensure understanding of cGMP and how it applies to specific tasks and responsibilities Participate and be accountable for workplace organization Position Requirements Manufacturing Associate II- Bachelor's degree in a related scientific or engineering discipline and 2-5 years' experience in related cGMP manufacturing operations; or high school diploma and 4-6 years' experience, or equivalent Basic knowledge of upstream processing- cell culture or fermentation Experience in single-use platform technology is preferred *Please note: this is a night shift opportunity and will be eligible for a shift differential on top of listed salary* Salary Range: $24-$31.25/hour 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.

is Wednesday-Saturday, 2nd Shift Swing (4pm - 2am) The Microbiology Associate 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. 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. Job 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. Assures proper labeling, handling, and storage of all chemical and biohazards used in the laboratory. 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. Minimum Requirements: Minimum requirement is a Bachelor of Science degree in a scientific discipline with a minimum of 0 - 3 years of experience Salary: $21.00 - $31.00/hr. This position is also eligible for an additional shift differential. 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, Inc. (KBI) is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must either (1) have provided proof of full vaccination (as defined by the CDC) with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization; or (2) perform weekly COVID-19 testing with negative test results. 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.

is responsible for the compliance review of Biopharmaceutical Development GMP data. This includes the review and approval of release, in- is also responsible for the review and approval of method qualifications and validations. Another responsibility is the review and approval of laboratory investigations and deviations associated with the biopharmaceutical development department. JOB RESPONSIBILITIES: Performs compliance review on the following records: release, in-process, and stability data. Responsible for the review and approval of method qualifications and validations Responsible for the review and approval of deviations and laboratory investigations. MINIMUM REQUIREMENTS: BS and 11+ years experience or MS and 8+ years experience in a CGMP regulated environment within biopharmaceuticals or equivalent. Experience in QA review of analytical data (release, in-process, and stability), experience in reviewing method qualifications/validations and the review and approval of laboratory investigations and deviations. Knowledge of USP, EU and JP cGMP guidelines. 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 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. Basic math skills are required. Ability to apply concepts of basic algebra and statistics. Be able to sit for long periods of time. Ability to lift 20 pounds. Ability to use word processing, database, spreadsheets, power point, internet, e-mail, calendar, computer, telephone 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 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: The Analytical Development organization at KBI Biopharma supports early- and late-stage development programs through analytical method development, optimization, and technical leadership. The Project Leader will oversee day-to-day execution of development activities while defining analytical strategies, coordinating cross-functional efforts, and managing internal and client-facing deliverables. This role serves as a key technical and client-facing lead for assigned programs, ensuring high-quality data generation, clear communication, and adherence to company procedures and applicable quality standards appropriate for development-stage work. The Project Leader will also mentor and support scientific staff and contribute to a collaborative, solutions-driven development environment. Responsibilities: · Serve as technical and people leader for development-stage programs, providing oversight and coordination of intra-team and cross-functional efforts across analytical development, process development, and project management. Act as a primary scientific point of contact for clients and provide clear, timely communication on program status, risks, and strategy to internal leadership. · Provide technical leadership and hands-on support for analytical method development, optimization, and lifecycle advancement across development programs, including early-phase through late-phase activities, as appropriate. This includes method establishment, development, fit-for-purpose assessments, and readiness for qualification or validation as programs advance. · Oversee and review technical documentation and deliverables associated with development activities, including study plans, method development reports, technical summaries, ELNs, and client-facing reports, ensuring scientific rigor, clarity, and alignment with regulatory expectations for development-stage programs. · Maintain a broad and current understanding of state-of-the-art analytical techniques and scientific principles relevant to biologics development. Provide technical mentorship and serve as an internal subject-matter expert within key analytical disciplines, supporting troubleshooting, method strategy, and innovation. · Manage, mentor, and develop Scientists, Associates, and supporting staff, including onboarding, role clarity, performance feedback, and career development. Communicate expectations clearly and ensure team members understand departmental procedures, quality standards, and development timelines. · Support laboratory operations, including organization, supply and reagent management, and documentation practices, to ensure efficient execution of development activities in compliance with internal procedures and quality systems. · Periodically assess workload, resource needs, and staffing requirements to support current and upcoming development programs. Participate in workforce planning, preparation of role descriptions, candidate interviews, and hiring recommendations for new or evolving positions. · Ensure adherence to safety, quality, and compliance requirements, modeling safe laboratory practices and holding team members accountable to the same standards. Requirements: Education and Experience Ph.D. with 2+ years of directly related experience; or M.S. with 7+ years of related experience; or B.S. with 10+ years of related experience Prior experience must include direct people management or team leadership responsibilities. Technical Expertise Demonstrated analytical method development experience across a broad range of techniques commonly used in biologics development, including but not limited to: ELISA and other ligand-binding assays Liquid chromatography-based methods (e.g., HPLC/UPLC) SDS-PAGE and related gel-based techniques Capillary electrophoresis-based methods (e.g., CE-SDS, ic IEF) Experience supporting methods through development, optimization, troubleshooting, and advancement across program phases is required. Client and Communication Skills Strong written and verbal communication skills with the ability to clearly convey technical concepts to internal teams and external stakeholders. Client-facing experience is highly preferred, including direct interaction with sponsors, participation in technical meetings, and presentation of data and recommendations. Leadership and Work Style Proven leadership capabilities with the ability to manage, mentor, and develop scientific staff while fostering collaboration across multidisciplinary teams. Highly organized and able to operate effectively in a fast-paced, multi-program environment, balancing competing priorities while maintaining a professional and positive demeanor. Demonstrated ability to adapt productively to changing priorities and handle additional responsibilities as needed. 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, 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.

Identifies, evaluates, develops and closes new customers and expands business at existing customers. Identifies and assists in progressing biopharmaceutical business opportunities including new scientific and strategic partnerships, collaborations, licensing opportunities, joint ventures and alliances. Establishes and implements appropriate development strategies to support business objectives. Interacts with corporate contacts, facilitates communication, keeps tracks of milestones and identifies scope for enhancing these relationships. Position Responsibilities: Negotiate and successfully close contracts for KBI services with Biopharmaceutical clients in the designated accounts/areas. Assist Vice President of Business Development with activities as directed. Identify new potential clients, qualify new sales leads, develop new client relationships, solicit RFPs, and manage the proposal process; Manage existing client relationships within accounts designated by VP of BD. Assist VP of BD with key client accounts as needed. Participate in trade shows and scientific meetings as directed including coordinating preparation for trade shows with KBI marketing, setup and teardown of booth, meeting with clients/prospects in the booth, and trade show follow-up Visit client sites to deliver KBI capabilities presentations, probe for opportunities, establish personal relationships, follow-up on proposals, and otherwise advance the sales process toward closure. Coordinate client technical visits to KBI sites including developing agendas, coordinating with KBI scientific staff, and arranging hospitality. Coordinate CDA and MSA review with client and KBI legal. Facilitate client Quality Audits and Quality Agreements with KBI Quality. Maintain and update CRM with opportunities status. Maintain industry awareness on all biopharmaceutical companies in the territory with respect to potential process development and manufacturing opportunities. Coordinate with management and other business development personnel to ensure that initiatives and decisions are consistent and complimentary. Able to react to change productively and handle other essential tasks as assigned. Minimum Requirements: Technical Bachelor's degree (science preferred) with a minimum of 9 years' experience in business development in a life science industry. Track record of success in technical business development (contract services or capital equipment in a life sciences industry preferred). Experienced in business development fundamentals including prospecting for suitable clients, establishing relationships with new prospects, scheduling face-to-face meetings, delivering presentations, uncovering opportunities, soliciting RFP's, delivering proposals, gaining solid feedback on proposals, understanding and addressing client objections, and closing contracts. Experience in working on complex life science projects involving multiple internal company personnel and client personnel with relatively long lead times (3-6+ months) is an asset; Experience in dealing with corporate partners and in negotiating and completing agreements is required. Excellent communication and interpersonal skills required. Must possess the ability to build positive internal and external working relationships in a team-based environment. Familiarity with biopharmaceutical manufacturing and regulatory requirements, and/or the ability to quickly learn and understand these processes and requirements is important. Ability to travel up to 50% or more to visit client sites, travel to KBI sites for client meetings, and travel to trade shows and scientific meetings. Salary Range: $165,000-$195,000 plus a tiered commission structure 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. 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.

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 position performs 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. Responsibilities: The individual in this position will spend approximately 90% of their work time performing data review for assay categories as outlined in Job Responsibility section. Logbooks and simple assays without calculations Instrument or Solution Logbooks, Appearance, Color, Clarity, Turbidity, pH, Osmolality, particle analysis KF, Viscosity, HIAC, MFI Spectrophotometric assays UV, SoloVPE, Gel analysis SDS-PAGE, Western Blot, IEF, ELISA, BCA HPLC, plate-based assays, Capillary Electrophoresis, biophysical techniques Maintain and update knowledge of technologies and cGMP standards The Data Reviewer/Scientist I must understand principles of the technologies in scope for data review, 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. The Data Reviewer/Scientist I will make detailed observations and report required documentation corrections to analysts and their managers, as needed. This role will contribute to review-related feedback, including review group needs, to the functional management and will work with functional management to improve review cycle time. Requirements: Must have background in biopharmaceutical analytical testing, understand cGMP standards. Demonstrate strong communication and interpersonal skills. BS/BA with minimum 6 years of related experience or MS/MA with minimum 4 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: $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 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 Supervisor/Sr. Supervisor, Manufacturing, Floor Operations (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 Sr. 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 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. Sr. Supervisor Bachelor's degree in a related scientific or engineering discipline and 8 years' experience in related cGMP manufacturing operations; or high school degree and 12 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. For Supervisor, 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 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. 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 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. MS Office, ERP, EDMS, production equipment software, other Upstream or downstream bioprocessing equipment, general production equipment, in-process testing instruments, and office equipment. 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.

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 Program Control team will utilize expertise in Cost/Schedule and business management to maximize successful program performance, provide operational awareness to stakeholders and drive value creation to the enterprise. We will achieve this through the development of viable and comprehensive plans, tracking of program performance, analysis of program data, and timely and accurate reporting of program status information. To this end, we identify and reduce program risk and contribute significantly to the early identification of performance concerns. The Director, Program Control will be responsible for leading the day-to-day internal program control business functions, directly contributing to the development and implementation of new business process concepts and techniques. This position will report to the Chief Financial Officer and will work closely with Senior Leadership and all functional organizations. Responsibilities: * Manage a program control team, ensuring compliance with program control and company policies and procedures. * Ownership of all projects from a business and financial perspective. * Lead project teams in the planning, tracking, analysis, and reporting of projects of varying contract type, size, complexity, and level of risk. * Develop and deploy training and guidance for staff, develop process improvements to current policy and procedures that affect operations, manage budgets and set priorities. * Responsible for implementing company goals and objectives, facilitating effective communications and relationships with line and functional departments, interpreting policy/guidance and disseminating to program control staff. * Collaborate cross functionally with functional peer groups and senior management. * Assist with complex proposal development, contract negotiations and administration of contracting activities utilizing sound business judgement. * Ensure that the program teams establish and maintain cost/schedule baselines, develop Work Breakdown Structures (WBSs) and related dictionaries. * Guide the development of, and review of, Estimates at Completion (EACs) and possess a complete understanding of related financial policies. * Ensure Resource Loaded Networks (RLNs) and related variance analyses are accurate and complete. * Review projections of cash flow and profitability for projects and recommend options to improve. * Ensure internal and external reports on the financial status of the programs are accurate and meaningful. * Assist with risk assessments, including the development of Risk Identification and Mitigation plans. * Prepare written and verbal reports to executive level management regarding project status. Requirements: * Bachelor's Degree in Business Administration or a related discipline and 15+ years of related experience is required or a combination of education and experience. * Experience in CDMO contracting and understanding of GAAP and other contracting and finance/accounting standards. Understanding of revenue recognition standards. * Requires program control experience working with schedules, Work Breakdown Structures (WBS), cost accounting and financial management systems, work authorizations, process management systems, and/or reporting. * Comprehensive knowledge in scheduling tools such as MS Project, Primavera, Cobra or others, as well MS Office products. * Prefer experience with SAP, SharePoint and other business tools. * Prefer experience with Monte Carlo analysis and other scheduling evaluation approaches. * Ability to effectively communicate schedule status and analysis 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.

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.

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.

. The Manufacturing Quality Assurance (MQA) Supervisor is responsible for supervising the MQA team who supports the Manufacturing Process and Areas as part of a GMP Contract Manufacturing Organization. MQA Supervisors are expected to provide sound guidance to MQA team and Manufacturing with respect to process, SISPQ of product, and risk. The MQA Supervisor's team shares responsibility for the inspection readiness of the site. MQA Supervisor routinely work on the cleanroom floor directly with the MQA and Manufacturing team to provide real time guidance and support. The Supervisor must adhere to procedures and policies to work on the Manufacturing floor. MQA Supervisor routinely collaborates with Manufacturing and work on team initiatives. The MQA Supervisor is responsible for coaching and mentoring their teams as needed to foster a GMP compliant site. JOB RESPONSIBILITIES: Time Supervise MQA team supporting Manufacturing. Provides training, coaching, and mentoring as needed. Works directly with MQA team/Manufacturing to resolve deviations and other compliance issues in a timely manner. Attend relevant operational meetings as MQA representative Perform Change Control assessments for MQA Performs client support relating to Batch Record reviews MINIMUM REQUIREMENTS: Bachelor's Degree or higher degree and appropriate years of experience (at least 6 years) in a Quality or Technical role in a GMP setting required. 1-2 years of Supervisory experience preferred. Demonstrated ability to provide leadership to team. Strong understanding of technical and compliance regulations for Clinical and Commercial Biopharmaceutical Programs. Salary Range: $103,994 - $125,719 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. Language Ability: Ability to read and comprehend instructions, correspondence, and memos. Ability to write routine correspondence. Ability to respond to common inquiries or complaints from employees and/or clients. Reasoning Ability: Ability to manage and prioritize multiple efforts independently. Ability to write, follow, issue, and explain clear instructions furnished in written and oral form. Ability to use risk to make decisions. Ability to methodically solve problems to their root causes. 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 bar graphs. Physical Demands: Ability to walk job sites, gown into cleanroom areas, lift small equipment and tools. Computer Skills: Microsoft Office Programs, E-mail, Electronic Document Management Systems, Electronic Batch Record Systems. Equipment Use Computers 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.

You will find an attractive and exciting workplace KBI Biopharma Inc. In this position, you will be responsible for the development and implementation of the global procurement strategy within defined categories to maximize the benefits of strategic sourcing in close cooperation with the respective demand owners, the Global Director Procurement and other corporate functions. You will also ensure the achievement of the agreed service targets regarding quality, costs and time in scope of the responsibilities. Your area of responsibility belongs to the GSCP (Global Supply Chain Procurement Function). You will report directly to the Global Director Procurement KBI. Work Location: Hybrid schedule: Work remotely with required onsite presence at our Durham office on an as-needed basis. WHAT YOU CAN EXPECT Your main duties will include the following: Developing and regularly updating the category strategic plan and underlying policies for assigned procurement categories Developing and regularly updating the suppliers' strategy plan and policies Identifying and managing sourcing risks; and reporting them to business stakeholders Contributing to the development and implementation of procurement processes for the defined demand categories across relevant legal entities Identifying & negotiating savings potentials within the category scope, ensuring the achievement of the service targets with respect to quality, costs and time, supported by data analytics Creating spend forecast/budget for the categories in scope Contributing to developing a culture of continuous improvements on processes and tools in close collaboration with other expert positions in the company, such as Procurement Excellence, Global Process Owner P2P, IT experts, Controlling and Global Process Management Establishing and managing relationships with significant strategic suppliers Engaging, managing and supporting internal business stakeholders (budget owners) Taking up the design of complex Global Sourcing initiatives and implementing for best possible cost to source Performing Supplier search to build up and maintain the supplier list of the assigned categories, as well as certifying and validating suppliers For new sourcing initiatives, meeting sales representatives or other related partners to define and understand specifications on a specific sourcing initiative Negotiating, concluding and maintaining global contracts with a significant economic impact or with extremely significant suppliers Proactively bringing in best practice from the external network and leveraging the internal functions, applying tools such as cost trend analysis, price change analysis and target pricing Collaborating with the Global Business Services organization in order to coach colleagues and contribute to the success of the operational model for the Purchase-to-Pay process (buyers' role) WHAT WE EXPECT We are looking for a motivated team-player, who brings along the following background: Bachelor's degree in business administration or other relevant studies At least 5 years of experience in a similar position with exposure to Indirect spend categories within the Pharmaceutical or Biotech industries. Other experience considered in lieu if part of a strong overall resume. Excellent procurement expertise, including regional and global markets, purchasing guidelines, supporting legal documentation, claim management, risk management, procurement methods, market know-how in the various categories Broad international procurement know-how and experience as well as fundamental market and product know-how for the defined category Excellent analytical skills and top target pricing management Proven track record in RFX and supplier management Excellent knowledge of MS Office Knowledge of analytical and strategic procurement systems (such as SAP Business Data Warehouse, ARIBA, ASC Trac) is desirable Excellent communication and presentation skills on all levels of the organization Lateral leadership skills, paired with convincing and influencing skills Fluent English skills, spoken and written (spoken French a plus) Position Responsibility Managing Indirect Spend Categories for KBI Globally (Sourcing initiatives, contracting, negotiating with Key suppliers) Developing and implementing KBI's Category rules, procurement rules and regulations, in conjunction with Global Procurement Director, Liaising with vendor/suppliers to resolve procurement related issues and concerns. Ensure that risk management assessment and mitigation strategies are in place aligned with the Business Support centralization of P2P Buying process & establishment of Global Ops Buyer Team. Supporting definition & production of departmental and role specific KPI's & supporting other categories of spend assigned adhoc by the Global Director Procurement. Minimum Requirements: Requires more than 5 years of relevant Procurement experience with expertise in Procurement Category Management - Indirect Spend. Prior experience in biotech/pharmaceutical industry is important. Good Knowledge of related supplier markets preferred. Expertise in purchasing, sourcing, supplier performance management, supply chain and inventory strategies & practices; including demonstrated competency in P2P operations. Strategic Sourcing, negotiation expertise key. Customer Service mindset and ability to deliver independently and work well within a team. Salary Range: $118,000 - $162,800 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. 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.

Manage the QA Analytical function at the KBI Biopharma, Hamlin location, supporting analytical laboratory operations in a contract biopharmaceutical manufacturing organization. Responsible for review of certificates of analysis for both clinical and commercial programs. Works directly with AFS, QC and Microbiology laboratories to resolve lab investigations and other compliance issues in a timely manner. Communicates directly with clients to resolve issues related to GMP testing. Cultivates and maintains Quality Assurance staff by recruiting, training, and managing QA team members. Align QA Analytical organization to meet company's strategic goals. Experience managing a QA organization in both clinical and commercial operations is beneficial Job Responsibilities: Leads and directs the QA Analytical team supporting analytical testing operations. Lead, assess, coach and develop departmental specialists. Manage performance, ensure team meets expectations and objectives. Guide the professional growth of team members by providing personal guidance and training relative to responsibilities Support GMP testing activities including release and stability testing. Oversees QA review of method qualifications, transfer, and validations. Oversees QA review of deviations, lab investigations, SOPs and GMP technical documents. Works directly with AFS and Microbiology to resolve deviations and other compliance issues in a timely manner. Communicates directly with clients to resolve issues related to GMP testing. Attend relevant operational meetings in support of issue resolution and escalation and batch disposition activities. Support client audits and regulatory inspections as required. Job Requirements: Knowledge, Skills, Abilities BS in scientific field with 8+ years' experience or MS and 6+ years' experience in a QA or GMP environment or equivalent. Experience in a in a QA role supporting GMP analytical testing is required. Minimum of 2 years of supervisory experience. Strong understanding of technical and compliance requirements for clinical and commercial biopharmaceutical programs and knowledge of US, EU and Row cGMP guidelines. Experience with electronic laboratory information management systems is preferred. 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, customers, and the general public. 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 Basic math skills are required. Ability to apply concepts of basic algebra and statistics. Physical Demands Support manufacturing and warehouse operations to include movement and/or lifting of raw materials and consumables. Computer Skills Knowledge of and experience using word processing, databases, spreadsheets, Power Point, Internet, E-mail, Calendar Management Equipment Knowledge of and experience using a computer, a telephone 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, 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.

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 - Thursday [2:00 PM EST -10:00 PM 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.

Work Schedule: Night shift, hours are 7pm - 7am, working a 2-2-3 schedule A Supervisor in the Manufacturing Support Department will coordinate and supervise, Manufacturing Support operations such as Cleaning of the GMP Facilities, PAR operations, Raw Material Sampling operations, and Process Waste Operations. The Supervisor will ensure compliance in all operations that align with all regulatory guidelines, company policies, Standard Operating Procedures (SOP), and Policy Documents (PD). The Manufacturing Support Supervisor will supervise and support all Manufacturing Support operations accurately and apply their GMP knowledge and experience to troubleshoot operational issues. This includes facilitating additional support with external departments, such as responses required to maintain and ensure all Manufacturing Departments are operational which may require work schedule adjustments. The supervisor will guide, mentor, and coach Manufacturing Support personnel ensuring each associate understands their daily tasks, performs their task with extreme efficiency, and coaches them to exceed all expectations and gives each associate the tools to become successful. The Supervisor of the Support Department will maintain a sense of ownership of all Support Department operations for his/her shift and ensure the resources are available, resources are coordinated, resources are efficient, and Quality is implemented in all aspects of the Support Department. Will be required to use the Quality System (CAPA, Deviation, Change Control, and Training) to ensure compliance within the Department. The expectation of the Supervisor of the Manufacturing Support Department is to lead by example and to model the KBI Values. It is the duty as a Supervisor to ensure the safety and compliance of each personnel while on KBI property. Job Duties: Support and trains all supervised associates to complete daily tasks. Ensures learning and development of departmental associates. Responsible for and ensures manufacturing compliance with GDP's and cGMP's with logbook and record entries. Facilitate responsibilities required to support operations. Communicates with external departments to ensure required task are scheduled and completed. Initiate Compliance Quality Systems such as Deviations, CAPAs, and Change Controls that are related to the Support Department Performs/supports annual/biannual performance reviews of direct/indirect reports within the Support department. Adheres to all safety requirements and reports unsafe conditions. Ability to work outside routine schedules to maintain support operations when necessary. Write/Revise Department SOP's, TRN's, and Manufacturing Records Perform Change Control Assessments related to Support Department functions. Requires strategic planning and decision making to ensure continual operations while remaining compliant with various policies and procedures. Reviews and approves direct reports timesheets and PTO request. Requirements: High School Diploma with 8+ years of relevant manufacturing experience; or Associate Degree with 6 years of relevant manufacturing experience; or Bachelor's Degree with 4 years of relevant manufacturing experience. 2+ years of prior leadership/supervisory experience required Knowledge of Quality Assurance systems and regulatory agency guidelines is strongly preferred. Excellent written and verbal communication skills are required. Working Conditions: Hours may vary depending on business needs and unforeseen circumstances. Due to the use of Spor-Klenz, respirators (full faced and half faced respirators) are required for the job. Additionally, facial hair needs to be maintained short enough to ensure a good seal to properly wear the respirator. This position is considered “Essential Personnel” which requires 7 days a week work coverage even though the company closes, this position is required to ensure the cleaning is completed every day. Salary Range: $101,000 - $138,600/yr, based on experience. 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. 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.