Manufacturing associate jobs in Chapel Hill, NC

This position is on a 2-2-3 shift, 6p-6a. The Manufacturing Associate I/II - Downstream is responsible for the execution of production activities for early and late-phase Cell Culture programs within a GMP environment. The Manufacturing Associate I/II - Downstream must follow the instructions depicted in SR's, EPR's, BR's, SOP's and forms. Additionally, must ensure all work is conducted following Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP); including ‘Right the First Time' (RFT). Downstream is responsi ble for the execution of purification activities for early and late-phase Cell Culture programs within a GMP environment. The candidate will maintain a sense of ownership of the production processes, manufacturing environment and facility. They will be exposed to cell culture clarification, chromatography operations using the Cytiva UNICORN software application, viral inactivation, ultrafiltration/diafiltration systems, various other filtration techniques utilizing single use technologies. Various analytical tools (SoloVPE, pH/Conductivity meters) and general biotechnology auxiliary equipment (pumps, sterile tubing welders and sealers, scales) are used on a daily basis. Following task execution, the Manufacturing Associate I/II will review the executed production records (SR's, ERP, and BR's) to ensure GxP compliance. Position Responsibilities Purification of cell culture products per manufacturing batch records in compliance with quality standards, company policies and current regulations. The duties required include, but are not limited to, purification processing using various chromatography, filtration, and viral reduction techniques up through bulk fill of drug product/intermediate. Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures. Document each task involving manufacturing procedures (i.e. SR's, EPR's and BR's) following GDP at the time of execution. Ensure all materials/items are issued and accounted for during the execution of a record (i.e. SR, EPR and BR) Demonstrate and apply understanding of current Good Manufacturing Practices (cGMP) and how they apply to specific tasks and responsibilities. Participate and be accountable for room 5S. Utilize and perform maintenance on equipment per applicable SOP's. Position Requirements High school diploma. Experience in a regulated industry or demonstrated knowledge of downstream or purification unit operations. Ability to follow written instructions. Excellent written and verbal communication skills. Must be organized and able to focus in a fast-paced, multi-tasked environment and maintain operational efficiency and positive demeanor. Energetic, motivated and dynamic individual. Must have high attention to detail. Ability to work a 12-hour schedule to include weekends, nights and Holidays. Preferred Qualifications Associates or Bachelor's degree in a related scientific or engineering discipline Biowork certification. Experience in single-use platform technology. Experience in a CDMO. Salary: $24.00-31.25/hour, plus a 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, 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.

This role can sit anywhere in the US as long as it is near an Accenture Corporate Office We Are: Looking to be part of a transformational digital engineering and manufacturing practice? How about an opportunity to help world-class clients solve their biggest challenges and create products and services that customers love - quickly, efficiently, and sustainably? Industry X combines Accenture's powerful digital capabilities with deep engineering and manufacturing expertise . We use the power of data and digital to help our clients reimagine the products they make, and how they make them. By connecting engineering and manufacturing operations every step of the way - from how products are designed and engineered, sourced and supplied, manufactured, to how they are serviced and renewed, we help them achieve greater productivity, drive growth and meet their sustainability commitments. Find out more about Industry X. (********************************************************************************* You are: A leader in the manufacturing space with deep knowledge of the Siemens portfolio, experienced with consulting, and able to help large organizations solve their most complex manufacturing issues by properly adopting technology. The Work: + Suggest/evaluate system architecture options + Estimate and plan project work + Help sales teams during opportunity pursuits + Support delivery teams on large and global programs + Develop internal capability onshore and offshore Travel may be required for this role. The amount of travel will vary from 0 to 100% depending on business need and client requirements Here's what you Need: + Bachelor's Degree or equivalent work experience (12 years); or an Associate's Degree with 6 years of work experience. + 10+ years of experience with OpCenter Electronics/Camstar or OpCenter Discrete + 10+ years of experience in consulting or technical advisory role with MES solutions + 10+ years of technology sales experience Bonus points if you have: + 10+ years of experience in non-Siemens platforms + 10+ years of exposure to Automotive, Industrials, and Aerospace and Defense manufacturing processes Compensation at Accenture varies depending on a wide array of factors, which may include but are not limited to the specific office location, role, skill set, and level of experience. As required by local law, Accenture provides a reasonable range of compensation for roles that may be hired as set forth below.We accept applications on an on-going basis and there is no fixed deadline to apply. Information on benefits is here. (************************************************************ Role Location Annual Salary Range California $132,500 to $302,400 Cleveland $122,700 to $241,900 Colorado $132,500 to $261,300 District of Columbia $141,100 to $278,200 Illinois $122,700 to $261,300 Maryland $132,500 to $261,300 Massachusetts $132,500 to $278,200 Minnesota $132,500 to $261,300 New York/New Jersey $122,700 to $302,400 Washington $141,100 to $278,200 #LI-NA-FY25 Requesting an Accommodation Accenture is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Accenture and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired. If you would like to be considered for employment opportunities with Accenture and have accommodation needs such as for a disability or religious observance, please call us toll free at **************** or send us an email or speak with your recruiter. Equal Employment Opportunity Statement We believe that no one should be discriminated against because of their differences. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. For details, view a copy of the Accenture Equal Opportunity Statement (******************************************************************************************************************************************** Accenture is an EEO and Affirmative Action Employer of Veterans/Individuals with Disabilities. Accenture is committed to providing veteran employment opportunities to our service men and women. Other Employment Statements Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States. Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration. Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process. Further, at Accenture a criminal conviction history is not an absolute bar to employment. The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Additionally, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the Company's legal duty to furnish information. California requires additional notifications for applicants and employees. If you are a California resident, live in or plan to work from Los Angeles County upon being hired for this position, please click here for additional important information. Please read Accenture's Recruiting and Hiring Statement for more information on how we process your data during the Recruiting and Hiring process.

The manufacturing associate in Drug Product Manufacturing will have a primary task for operation of filling line including all tasks related. This role will also support projects which influence manufacturing processes for DPM including training of others. This position will also support and assist in scheduling daily manufacturing activities for the team. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours or shift rotation. Job Description What You'll Do During the project phase * Participate and support testing activities, such as FAT, PQ etc. as well as other related activities * Support and contribute to the preparation of the documentation package as e.g., Standard Operating Procedures, Work Instructions * Contribute to the preparation for operational readiness related to bulk drug product manufacturing * Possible assignments include: Supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes as well as testing and commissioning support * Travel up to 0-25% (international or domestic) may be required during the project phase In operations * Lead, execute and document manufacturing processing steps and/or manufacturing support activities as well as process monitoring and control * Perform operations of the Drug product filling line * Execute validation protocols according to cGMP Standard Operating Procedures (SOPs) * Own the establishment of processes and trainings to become a trainer for coworkers * Maintain compliance of GMP documents and ensure own training level is complaint and maintained * Support and/or assist senior level associates or supervisor with scheduling daily activities on drug product manufacturing floor, as needed * This role requires shift work (weekend and potential for nights) * Perform other duties as assigned Basic Requirements * High School Diploma or GED * 6+ years of direct experience in a manufacturing environment Preferred Requirements * Associate's Degree + 4 years of direct experience in a cGMP manufacturing environment OR * BA/BS + 2 years of direct experience in a cGMP manufacturing environment * Equivalent Military training or experience * Experience on specific unit operations (ex: Viral Filtration and Bulk Dispensing) * Understanding of manufacturing run cadence and order of shift activities * Knowledge of cGMP, safety and operational procedures * A high degree of knowledge and expertise of the operation of specific production equipment WORKING CONDITIONS & PHYSICAL REQUIREMENTS * Be exposed to an environment that may necessitate respiratory protection * Be exposed to noisy environments * Have a normal range of vision * Climb ladders and stairs of various heights * Experience prolonged sitting, standing, walking, bending, stooping and stretching throughout the shift, up to 12 hours * Use hand-eye coordination and manual dexterity sufficient to operate a computer keyboard, telephone, calculator, and other office equipment is required * May be required to lift up to 50 pounds on occasion To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

About the Department At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk's innovative oral products. At API, you'll join a global network of manufacturing professionals who are passionate about what they do. What we offer you: * Leading pay and annual performance bonus for all positions * All employees enjoy generous paid time off including 14 paid holidays * Health Insurance, Dental Insurance, Vision Insurance - effective day one * Guaranteed 8% 401K contribution plus individual company match option * Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave * Free access to Novo Nordisk-marketed pharmaceutical products * Tuition Assistance * Life & Disability Insurance * Employee Referral Awards At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. The Position Operate API manufacturing equipment to achieve production goals. Relationships Reports to Shift Manager, Operations - API. Essential Functions * Work in a safe & environmentally responsible manner * Follow instructions listed in GMP documentation & product quality * Review SOP's & other documents, as required * Real-time review of electronic batch records ensuring compliance to Standard Operating Procedures (SOPs) & current Good Manufacturing Practices (cGMP) standards * Manage individual training plan * Participate in qualification & validation activities as required * Setup, operate, monitor, & control highly automated processes & systems * Load & unload product from trucks, tankers & ISO containers, as required * Execute production schedule to achieve production goals * Utilize investigation skills during troubleshooting & assist during equipment maintenance, including restoration of lost function, predictive & preventative maintenance * Maintain clean room areas & perform environmental monitoring, as required * Other accountabilities, as assigned Physical Requirements Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role. Qualifications * High school graduate or equivalent required * Associate's Degree or higher in Tech, Science, or Engineering preferred * BioWork or equivalent industrial, military or vocational training combined with experience preferred * Minimum two (2) years of manufacturing experience in FDA regulated environment preferred * Experience demonstrating a systematic approach to problem solving & troubleshooting based on data & facts. Actively participated in & driven event response activities. Documented problems & worked on ensuring rapid resolution & preventing recurrence preferred * Experience following SOPs to perform tasks & raising issues if errors are found preferred * Experience following established safety guidelines when performing tasks preferred * Computer literacy including, but not limited to, ability to operate computer driven manufacturing/production equipment & efficient use of Microsoft Office suite programs required * Ability to read & understand complicated product documentation & standard operating procedures with attention to detail required * Ability to perform basic material handling tasks, safely & effectively use material handling equipment required * Ensure compliance with corporate/local SOPs, regulations & ISO standards required * General knowledge in cGMP manufacturing & production processes associated with pharmaceutical companies required * Basic knowledge of biology/chemistry preferred * Mechanical aptitude, ability to follow use tools to perform tasks, basic troubleshooting of mechanical components & systems preferred * Experience working with work permits/Lock Out Tag Out systems preferred We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We're not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at **************. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

The Manufacturing technician will be responsible for production and post-processing of medical devices. Common secondary processes include deburring, media blasting, polishing, filing, cleaning, and packaging. Essential Duties and Responsibilities: Perform production activities for equipment set-up/line clearance, processing, labeling, and record completion while following quality system guidelines and Good Manufacturing Practices (GMP) Support equipment maintenance activities as needed Participate in continuous improvement projects Perform inspections for components and product at all stages of manufacturing process Compliance to safety (OSHA), GMP, GDP, GLP and 21 CFR 820. Qualifications: High school diploma or GED required Associates or post-secondary education preferred Experience in the use of basic machine shop tools and equipment is required Mechanically inclined Working knowledge of GMP, GLP, and GDP is required Strong verbal and written communication Experience in FDA 21 CFR 820 Quality system is preferred TOOLS AND EQUIPMENT Basic hand tools Rotary tools Polymeric 3D printers Media blasting cabinet Furnace or ovens Materials testing frames Cleaning and inspection equipment Sealing and packaging equipment Respirator, protective clothing, eye protection, and hearing protection MATERIALS HANDLING / EXPOSURE Position may involve handling of or exposure to metallic powders and other powder materials, polymeric resins, cleaning solutions, inert gases, and acids. Skills, Abilities, Competencies Required: Position requires the ability to intermittently lift and carry up to 50 pounds PPE including eye protection, hearing protection, and gowning required depending on task performed May require extended periods of standing, extensive work with the operator's hands and tools, as well as occasional squatting, kneeling, and working with a ladder Working conditions include standard conditions of a machine shop. Machine shop conditions may include noise, dust, and temperature extremes. Work environment may also include a controlled environment requiring the technician don PPE such as gown, hair net, shoe covers and nitrile gloves. restor3d is an equal opportunity employer

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA. Responsibilities: Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR] with strict adherence to safety and compliance. Ensure proper gowning and aseptic techniques are always followed. Perform hands-on operation including set-up, cleaning, sanitization, monitoring of equipment and assigned area. Buffer and Media preparation and transfer. Weigh and dispense of materials to be used in the preparation of Buffers and Medias. Complete washroom activities: cleaning equipment, small to large scale, use in production activities. Run and monitor critical process per assigned procedures. Perform documentation for assigned function (i.e., equipment logs, EBRs). Maintain an organized, clean, and workable space. Qualifications: High school diploma / GED + 1 year of manufacturing and/or other regulated experience OR Associate's degree Experience in a regulated industry such as biotechnology or pharmaceutical Basic understanding of GMP principles Strong verbal and written communication skills Proficient Microsoft Office skills Ability to follow detailed work instructions (SOPs) Initial schedule will be Monday-Thursday or Tuesday -Friday, 10 hours days. The schedule will transition to shifts (rotating 2-2-3, 12 hour shifts) upon completion of startup activities and as business needs dictate. Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

The Manufacturing Associate 3, Drug product is responsible for Component/Parts Preparation, Thawing and Formulation of Drug Substance, Sterile Filling and Visually Inspecting of Drug Product (DP). This role supports projects which influence manufacturing processes for Drug Product Manufacturing including training of new colleagues. Maintains compliance of cGMP documents and to assist in qualification of equipment and all aspects of startup of the DPFG facility. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description What You'll Do • Leads, executes and documents manufacturing processing steps and/or manufacturing support activities, process monitoring and control • Performs in-process testing (pH, conductivity, visual inspection) • Executes validation protocols according to cGMP Standard Operating Procedures (SOPs) • Maintains training to perform all required manufacturing activities • Assists and/or lead cycle counts and manage materials for the assigned manufacturing functional area • Performs Operations for all aspects of Drug Product (e.g., Parts Washer, Autoclave, Formulation, Filling, and Visual Inspection) • Assists the lead with tasks in manufacturing activities • Assists with the coordination of daily shift activities • This role may require shift work (weekend and potential for nights) • Performs other duties as assigned Basic Requirements • High School Diploma or GED with 4+ years of direct experience in cGMP manufacturing environment • Associate's Degree + 2 years direct experience in cGMP manufacturing environment OR • Bachelor's Degree, preferably Life Sciences or Engineering OR • Equivalent Military training or experience Preferred Requirements • Qualified Experience on unit operation (e.g., Parts Washer, Autoclave Operation, Compounding/Formulation, Filling with Isolator Technology, or Manual/Automated Visual Inspection) • BioWorks or BTEC Capstone cGMP coursework preferred WORKING CONDITIONS & PHYSICAL REQUIREMENTS Be exposed to an environment that may necessitate respiratory protection May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program Will work in environment operating a motor vehicle or Powered Industrial Truck Ability to discern audible cues Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color Ability to ascend or descend ladders, scaffolding, ramps, etc Ability to stand for prolonged periods of time Ability to sit for prolonged periods of time Ability to conduct activities using repetitive motions that include wrist, hands and/or fingers Ability to operate machinery and/or power tools Ability to conduct work that includes moving objects up to 33 pounds Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions Will work in heights greater than 4 feet To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Purpose and Scope: The Associate III, Downstream Manufacturing, will be a key contributor to manufacturing readiness and future operational output of the manufacturing facility. The role will initially support ongoing commissioning and validation activities as the site works towards GMP production readiness and will provide overall manufacturing operations support that includes yet is not limited to; equipment testing, SOP/batch record generation, validation protocol execution support, as well as cross site tech transfer collaboration. Once commissioning and validation is complete, the role will be responsible for executing a combination of engineering and GMP clinical batches with supporting staff. This role, as part of the Manufacturing division, will be an integral contributor tasked with building a diverse and technically strong team for future successful GMP operations. Essential Job Responsibilities: Perform all manufacturing operations under cGMP/ISO requirements while displaying a proficient understanding of downstream process theory (e.g., tangential flow filtration, chromatography) equipment operation, and aseptic processing Assist with the installation, commissioning, and validation of equipment within single use facility Adhere to manufacturing GMP documentation guidance (e.g., standard operating procedures) with a proven ability to identify clarifications / updates as well as assist with document updates / generation when required Perform legible, clear, and concise data entry into batch records, logbooks, and all other ancillary controlled forms used in a cGMP process and maintain a high level of quality and compliance with regards to all aspects of manufacturing in both personal actions as well as through the training of other manufacturing associates Ability to identify and escalate process non-conformances based on process guidance documents, specified operating limits, and performance metrics tracking Able to contribute cross departmentally through upstream operation support assignments that fall outside of downstream responsibilities Often assigned in a support role to internal and cross-functional project teams Lead the completion of routine non-process operations including, but not limited to, preventative maintenance work order execution and safety walkthrough audits Available to participate in flexible shifts (Day, Swing, Weekends, Holidays) as directed by the facility start up and future production schedules Quantitative Dimensions: The Associate III, Downstream Manufacturing, will contribute to manufacturing readiness and operational output. The role is responsible for executing a combination of engineering and GMP Clinical batches, along with building a diverse and technically strong team. Organizational Context: The Associate III, Downstream Manufacturing, will typically report to the Supervisor or Sr Supervisor, Manufacturing. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization.

Job Title: Production Operator Reports to: Production Supervisor 6:00 AM - 2:30 PM, Monday through Friday with occasional overtime hours required including Saturdays. Essential Tasks * Process orders for labeling * Label un-labeled inventory based on customer orders * Print labels that are required for daily work * Pack products based on customer orders * Manage label inventory * Assist in the management of un-labeled cartridge inventory * Set up, operate, and clean up filling machines. * Checks cartridges for proper fill level/piston depth with micrometer. * Insert pistons in filled cartridges using manual or semi-automatic piston insertion tools. * Replenish cartridges and packaging components (cartridges, pistons, labels, boxes) * Perform basic preventative maintenance tasks on equipment. * Perform general cleaning and organizing of the warehouse as necessary * Any other duties or responsibilities as assigned by management Essential Duties and Responsibilities * Maintains clean and safe working area/working environment in line with company policies. * Follow all site safety rules. * Detects and reports unsafe conditions, equipment or situations * Reports issues with equipment immediately to maintenance and supervision. * Inspects filled containers to ensure that product is packaged according to specifications. * Observe all company work rules, policies and procedures to ensure optimum safety and successful attainment of task objectives. * Complete all assignments with accuracy, neatness and thoroughness. * Maintain harmonious working relationships with team members, co-workers and other departments. * Flexibility to changes in assignment and workload and contribute to the growth of the organization. * Actively strive to enhance knowledge, skills and abilities related to present position or assignment. * Experienced workers may be tasked training responsibilities with new employee(s) * Comply with company safety policies and PPE requirements Required Knowledge/Skills: * Attention to detail * Process focused * Must be able to follow standard work instructions * Manual dexterity * Ability to work independently * Analytical and problem solving skills * Good interpersonal skills and ability to work with different departments. * Strong safety orientation Education/Experience: * High school diploma/GED strongly preferred. * Manufacturing or warehouse experience preferred Physical Demands/Work Environment * Typical workday would range from 50%-80% standing/walking. * Lifting of up to 40 lbs. Required lifting is primarily moving boxes of filled cartridges from the end of packaging line, at waist level, onto pallet, from ground level to chest level, 1 to 2 steps from end of the line at a maximum frequency of about 7-8 boxes per hour. (No overhead lifting required). * Piston insertion and hand labeling are manual processes that are repetitive. These tasks could be performed up to 80 times per hour for maximum continuous duration of 2 hours. * There may be bending, stooping, stretching, reaching or carrying of light items such as papers, books small parts, etc. No special physical demands other than an average amount of dexterity are required to perform the work.

Full-time Description We want you on our team! Opportunities to grow within the company! Schedule: 12 hours shifts days 7am-7pm (may work over) nights Overtime is Mandatory Only work 7 days in a 14-day rotation Essential Duties and Responsibilities: Remove air from bags and seal Make sure bags are sealed completely and placed in correct bin Check for proper identification on sealed bags Print product name on chemical setup sheet at the start of each production run Assist lead operator as needed during setup of each production run Check the first bag of every bin and document the weight Correct problems on the line caused by chemical over/under weighments Notify lead operator or supervisor when errors on production line happen repeatedly Correct problems caused by chemical over/under weight's/calibrate scales Needs to be aware of the lines needs so it does not run out of material Communicates with lead operator as to what he/she needs to keep line running Make sure materials are put on line in the right place for each hopper/feeder Keeps hoppers filled and helps empty them on changeovers Perform a physical set up check using recipe sheet used by the line leader Keep feeders/product properly tagged at all times Report to lead operator any nonconforming material or excessive waste Work any line/area as assigned by supervisor Makes sure work area stays clean Understands, promotes, and utilizes risk opportunity management theories/processes relevant to their position. Our Benefits Include: Health Insurance Dental Insurance Vision Insurance 401(K) (with company match) Company paid Short-term and Long-term Disability Company paid Life Insurance 9 Paid Holidays Employee Assistance Program Immediate PTO Accrual 2 Annual Personal Days Optional Paid Shower Time at the End of Each Shift Starting Pay: $14.30/hour, plus $1.25 for off shift schedules This job describes the general nature and level of work performed by employees assigned to this position. It does not state or imply that these are the only duties and responsibilities assigned to the job. Employees may be required to perform other job-related duties as requested by management. All requirements are subject to change over time and to possible modification to reasonably accommodate individuals with a disability. Requirements Required: Must have basic working skills Required: High school diploma or equivalent Required: Must be 18 years of age or older MUST HAVE RELIABLE TRANSPORTATION - Excellent attendance is a part of your essential job responsibilities. Must pass pre-employment testing. Must provide Steel Toed work shoes. Physical Activity May Include But Is Not Limited To: Operation of Fork Truck if certified Must be able to repeatedly lift up to 56 pounds Repeated twisting, bending and lifting. Job Specifications: Operators must be able to read and perform simple computations. Accuracy in following intricate instructions within time limits is critical. The employee is expected to follow all safety procedures and use appropriate personal protective equipment. If you require alternative methods of application or screening, you must approach the employer directly to request this as Indeed is not responsible for the employer's application process.

The Company Open Book Extracts is an industry leading source for all your hemp-derived cannabinoids, including wholesale raw ingredients, finished goods, and custom solutions - the singular destination for excellence in cultivation, extraction, processing, manufacturing, R&D, traceability, and fulfillment. We believe in harnessing the healing powers of cannabinoids to improve lives and are looking for passionate candidates who share our enthusiasm. Job Summary Production Associate, Bulk Ingredients (Day & Night shifts) will perform tasks and operate equipment for the production and purification of cannabinoid ingredients, such as cannabidiol (CBD). Primary responsibilities include preparation of materials for production, general use of production equipment and recording of production data as outlined by standard operating procedures. The qualified candidate will work with their supervisor to ensure production timelines are met. Responsibilities Closely follow supervisor instructions in assigned tasks and responsibilities Clean and maintain processing equipment Monitor ongoing production runs, gather data, noting any differences Complete batch records in line with Good Documentation Practices (GDP) with necessary guidance from senior production staff members Perform quality control tests in the lab as needed Assist with testing and calibrating lab equipment in preparation for specific tasks Follow all company policies and procedures to ensure product integrity and quality control Analyze retrieved data and prepare reports for laboratory management Recognize and report any production safety issues Basic troubleshooting of all equipment Work together with supervisor to maintain production timeline Maintain a clean and organized work environment Read and follow standard operating procedures and department protocols Additional tasks as assigned by management Skills and Abilities Must be able to meet production standards in a fast paced work environment by performing tasks quickly and efficiently High degree of attention to detail Effectively manage time by balancing multiple tasks simultaneously Effective communication skills Flexibility to work occasional days/evenings/weekends depending on production schedules Work effectively and cohesively with others Understanding of proper and safe handling of hazardous materials Responsible for completing batch records to a cGDP standard Manufacturing quality adherence and thoroughness in carrying out standard operating procedures (SOP's). Experience working with manufacturing or lab equipment is a plus Mathematic and measurement skills Ability to keep detailed records Education and Experience HS Diploma or equivalent. Additional Details: This is a full-time position based out of Roxboro, NC. OBX Ingredient Production Department operates 7 days a week, (12 hour shifts, 3 days per week, and 4 days every other week) covering both day & night shifts, & evenings/weekends depending on production; premium pay rate offered for night shift Current vacancies are for the Day and Night shift. Background and reference checks required. Physical Demands and Working Environment: May be required to stand and/or walk for extended periods of time. Must be able to lift, carry and balance up to 50 pounds While performing the duties of this job, the employee is regularly required to perform grasping, talking, hearing, seeing and repetitive motions. Ability to walk and stand for long periods of time (10-13 hours) with frequent kneeling and bending. Working in limited climate-controlled facilities and experiencing extreme heat or cold. Work with heavy fumes, plants, airborne particles and chemicals requiring use of a respirator Must be comfortable working with and around heavy machinery May experience moderately high noise levels Equal Employment Opportunity (EEO) Statement Open Book Extracts is proud to be an equal opportunity employer. We embrace diversity and are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.

**Why Us?** We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. ** Summary** SUMMARY OF POSITION: This position is responsible for operating large scale manufacturing equipment to produce bulk organic chemicals in accordance with Company standards and operating procedures. He/she will be responsible for reports and documentation. Must be able to pay attention to detail due to the nature of chemicals and environment he/she will be working in on a daily basis. **Job Description** **ESSENTIAL FUNCTIONS** **:** + Operates in a regulated environment and complies with all cGMP and OSHA regulations applicable to manufacturing responsibilities. This includes wearing appropriate personnel protection equipment (PPE), understanding and following all applicable standard operating procedures, work instructions, and standard work practices applicable to job responsibilities + Operates and monitors dryers, mills, sifters, and other miscellaneous equipment through manual operations, panel boards, indicators, PLC displays, and DCS screens following applicable batch records, procedures and good documentation practices + Packages, weighs, samples, and labels finished and intermediate products following applicable procedures and good manufacturing practices + Maintains detailed operating reports and logs, including notes on problems and records on added weights, volumes, measured temperatures, pH levels, pressures, and flow rates following applicable procedures and as directed by supervisor + Delivers samples to laboratory and retrieves operating supplies from storeroom + Cleans and maintains work area, process equipment, tools and safety supplies according to regulatory and Company standards and operating procedures. + Other duties as assigned by Management **DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:** + Monitors environmental and safety devices (scrubbers, ruptured discs, etc.) to insure that the equipment is functioning properly. + Performs Lock Out/Tag Out (LOTO) independently. + Operates fork lifts, hoists, and other material handling devices to physically move bulk raw materials, WIP, and packaged goods to and from pick-up points + Participate in various employee involvement teams and committees, such as Area/Site Safety Teams, kaizen events, Hazmat and/or Cost Savings Teams, to improve the workplace, increase efficiency, and improve productivity **MINIMUM REQUIREMENTS** **:** _Education:_ High School Diploma, GED, or equivalent required. Associate or Technical degree preferred. _Experience:_ Previous GMP/ISO manufacturing experience preferred _Skills/Qualifications:_ _Skills/Competencies:_ _Other Skills:_ Must be able to read and follow detailed instructions and procedures, and effectively communicate in both verbal and written formats. Must be able to perform basic math. Must have a working knowledge of chemical processing equipment and associated safety requirements. Possess sound decision making skills. Action Oriented, Informing, Computer Skills (MS Office and E-mail), Problem Solving, and Teams Must work in a team environment to cover work stations during breaks and lunches Must be able to wear the required Personal Protective Equipment (PPE) required for the job or task. Sound decision making skills. Action Oriented, Informing, Computer Skills (MS Office and E-mail), Problem Solving, and Teams **RELATIONSHIP WITH OTHERS/ SCOPE:** + Performs diversified duties following standard procedures and under the direction of a production supervisor or lead operator. Requires a high level of safety awareness and ability to determine when equipment is not performing to standards or expectations. + Responsible for proper operation of processing equipment to ensure optimum production of high quality products. Mistakes and errors normally result in unacceptable product and or mechanical equipment damage. As a result, impacts our product status in the market place. + Understands the misuse of processing equipment could result in serious injuries to self and others due to the potentially dangerous nature of the equipment and the chemicals being processed. + No direct responsibility for the work of others; however, the team approach is emphasized in order to cover work stations during breaks and lunches. Furthermore, the "buddy system" for training new operators creates additional responsibility. **WORKING CONDITIONS:** + The plants open-air construction exposes operators to the normal year-round outside climate. Some relief from the elements is available in the control rooms and break area. + Dirty conditions and chemical fumes are occasionally present in the work areas. + Must handle average to heavy weight materials by hand. Material handling devices (e.g., hand truck, for truck, and conveyors) are used when possible but use of proper lifting and movement techniques is necessary to prevent injury. + Must be able to physically climb stairs and evacuation ladders, rolling drums, lifting and pouring bags of raw materials, driving forklifts, climbing and entering reaction vessels and perform first aid. + Injuries could result from spills or leaks of corrosive flammable, and toxic material, all of which are normally handled in the plant + Must be able to work rotating 12 hours/day shift and occasional overtime as needed. **DISCLAIMER** **:** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. **EEO Statement:** We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Job Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Responsibilities:• Adhere to RTP Plant safety policies and procedures, contribute to a safe work environment. • Setup and operate highly automated equipment in the Packaging area. • Adhere to standard operating procedures and current Good Manufacturing Practices to ensure quality of product. • Document process steps on appropriate batch documentation (Electronic Ticket, SAP, Cleaning Logs, etc.). • Attain and maintain qualification for the operation of assigned process equipment and duties in the area. • Identify opportunities for operational improvements. • Proactively monitor documentation and product quality, promptly documenting all activities and reporting issues to supervision. • Contribute to the achievement of key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance. Qualifications Requirements/Knowledge/Education/Skills:• High School Diploma/GED required Previous experience working in a GMP environment preferably in the pharmaceutical industry• Strong ability to multitask • Ability to develop independence in performing daily tasks • Collaborative work ethic with a strong bias for action Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Powered by JazzHR Fm7A4wnMRI

************************************************* xmlns="********************************* The PCX Manufacturing Technician supports a variety of engineering and production activities including equipment set-up and validation of new equipment, development and implementation of process improvements, process troubleshooting, monitoring of process data, assistance with creating and updating of process documentation, prototype execution, and assistance with preparation for new product introductions. The Manufacturing Technician is responsible for completing all assigned work according to specifications in a high quality and safe manner. The Manufacturing Technician assists and advises other employees in the assembly and production of switchgear and other electrical systems. Manufacturing Technicians understand and participate in the PCX quality program, to include KANBAN inspection scheduling and in-process inspections, and are knowledgeable in the project process flow, working with the engineering department during project planning and execution. They are required to follow the instructions of the electrical supervisor and suggest improvements. Specific Position Requirements: Must follow PCX safety guidelines and requirements Able to read, interpret, and understand blue prints and electrical schematics Develop detailed understanding of processes and equipment to identify and solve process issues through troubleshooting, data analysis, and collaboration with stakeholders across the Engineering, Operations, Maintenance, and Quality teams Support process validation projects by aiding with set-ups, engineering studies, and related testing Provide administrative support such as developing and updating manufacturing documentation and tracking and reporting on process performance Support execution of projects including DMAIC, LEAN, 5S, cost reduction and process improvement initiatives Install and connect power supply wiring, control wiring, cables, conduit, and electrical apparatus for machines and equipment following diagrams, schematics, or blueprints Inspect jobs upon completion and ensure areas are clean Ensure that equipment is in safe operating condition Follow established safety procedures and techniques to perform job duties Must verify conformance of work to specifications Must exhibit quality workmanship that adheres to engineering and customer specifications Adheres to PCX Quality Management System and ISO9001 standards Works in a timely, efficient manner to meet all daily performance objectives Maintains tools and equipment in proper working condition Must be able to read and understand posted bulletins, regulations, rule books, manufacturer manuals, and work instructions Must be able to work in a team environment which requires cooperating with others, offering help when needed, and maintaining positive work relationships Complete Time Reporting Sheets Report inventory use as required Able to lift 50# consistently Ability to work 10 hours per day and weekends as required Must have a valid Driver's License Background check and drug-screen are required

The Manufacturing technician will be responsible for production and post-processing of medical devices. Common secondary processes include deburring, media blasting, polishing, filing, cleaning, and packaging. Essential Duties and Responsibilities: Perform production activities for equipment set-up/line clearance, processing, labeling, and record completion while following quality system guidelines and Good Manufacturing Practices (GMP) Support equipment maintenance activities as needed Participate in continuous improvement projects Perform inspections for components and product at all stages of manufacturing process Compliance to safety (OSHA), GMP, GDP, GLP and 21 CFR 820. Qualifications: High school diploma or GED required Associates or post-secondary education preferred Experience in the use of basic machine shop tools and equipment is required Mechanically inclined Working knowledge of GMP, GLP, and GDP is required Strong verbal and written communication Experience in FDA 21 CFR 820 Quality system is preferred TOOLS AND EQUIPMENT Basic hand tools Rotary tools Polymeric 3D printers Media blasting cabinet Furnace or ovens Materials testing frames Cleaning and inspection equipment Sealing and packaging equipment Respirator, protective clothing, eye protection, and hearing protection MATERIALS HANDLING / EXPOSURE Position may involve handling of or exposure to metallic powders and other powder materials, polymeric resins, cleaning solutions, inert gases, and acids. Skills, Abilities, Competencies Required: Position requires the ability to intermittently lift and carry up to 50 pounds PPE including eye protection, hearing protection, and gowning required depending on task performed May require extended periods of standing, extensive work with the operator's hands and tools, as well as occasional squatting, kneeling, and working with a ladder Working conditions include standard conditions of a machine shop. Machine shop conditions may include noise, dust, and temperature extremes. Work environment may also include a controlled environment requiring the technician don PPE such as gown, hair net, shoe covers and nitrile gloves. restor3d is an equal opportunity employer

Kincell Bio engineers cells into therapies . With manufacturing facilities located in Research Triangle Park, NC and Gainesville, FL, Kincell Bio is a contract development and manufacturing organization (CDMO) with the mission to streamline CMC development, apply expertise in analytical and process development and GMP manufacturing, testing and release from early clinical to pivotal studies and product launch. Kincell Bio is focused on supporting innovative companies developing immune cell therapies, including autologous and allogeneic CAR-T, TCR, TILs, Tregs and CAR-NK technologies. We offer challenging career opportunities, competitive benefits, and an environment that recognizes and rewards performance. For more information, please visit our website at ******************* Kincell is seeking a highly motivated Manufacturing Specialist who will be a key contributor to a dynamic and collaborative Manufacturing team. As a Manufacturing Specialist, you will have the responsibility to assure initiatives related to production readiness and compliance are optimized and executed appropriately in the areas of cGMP production. This position will directly support manufacturing for all production-related activities. You will work with cross-functional teams to identify and implement meaningful corrective actions arising from deviations and audit observations. In addition, you will be operating automatic and manual cell therapy equipment with a variety of complexity in CAR-T, CAR-M, or CAR-NK processes in accordance with standard operating procedures and policies as needed. You will perform quality control analyses as required to complete in-process batches and identify variations. You will be trained in handling hazardous materials and emergency procedures since you will be handling leukapheresis cellular materials. As part of manufacturing operations, you will be a team member who is relied on to have a good understanding of procedures, techniques, tools materials, and equipment to help support cGMP activities at the RTP, NC site. Your work and decision-making will be team-based and will focus on the prioritization of workflows centered on the process and available resources. You will follow standard operating procedures to complete tasks which may vary in scope, complexity, and timing. Patients need colleagues like you who take pride in their work and look for successful outcomes. You will help ensure patients have the therapies they need when they need them. You will be operating cell therapy process equipment of varying complexity with different processes in accordance with standard operating procedures. Essential Duties and Responsibilities Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document. In depth knowledge of aseptic processing/cell culture/cell therapy manufacturing in a cGMP setting. Provides direct on the floor support for manufacturing, including participating in daily GMP manufacturing activities. Author and reviews SOPs, Master Batch Records and related GMP documents. Manage deviations, change controls, and CAPAs to ensure compliance with internal procedures and regulatory requirements. Provide support for all related start-up and continuous improvement activities related to operational readiness and operational excellence, including procedure creation, revision, equipment qualification and validation. Work collaboratively with cross functional teams, partners, and vendors to gather background knowledge needed to complete assignments. Provides manufacturing and operational guidance and recommendations in a professional and collaborative manner to internal and external stakeholders. Maintaining personal responsibility with Personal Protective Equipment (PPE) Proficient in Microsoft Word, Excel, PowerPoint, and other standard applications used in technical field. Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully. Required: B.S degree in Natural Sciences (i.e, Biology, Chemistry, etc.) or Engineering (Chemical, Biomedical, etc.) and 5-7+ years of manufacturing experience Must be able to work onsite daily and be willing to have a flexible schedule to support a multi-shift operation that covers nights and weekends as needed. Ability to work independently and stay on task in a fast-paced environment without direct supervision. Working knowledge of validation and related concepts. Must have experience in drafting and reviewing technical documents with high technical writing skill. Provides consistently prompt, efficient, dependable, and highly skilled services. Understands, selects, and uses appropriate risk management and root cause analysis tools. Takes initiative in making improvement suggestions to promote operational goals. Applies Quality concepts and company policies to resolve issues of moderate complexity in an effective manner. Reflects solid understanding of strategies and goals and can take part in major parts of projects or provide expert service. Recommends improvements to on-going processes and projects. Facilitates designing processes with Quality built in from the beginning. Identifies, and uses good judgement to handle out-of-compliance situations. Good listening and communication skills. Positive approach and highly collaborative persona. Must be able to lift bags and/or containers of media of up to 40+lbs. Manage personal time and professional development. Maintain accountability for your own outcomes and prioritized workflows. Preferred: M.S degree in Natural Sciences (i.e, Biology, Chemistry, etc.) or Engineering (Chemical, Biomedical, etc.) and 3-5+ years of manufacturing experience Have knowledge of cell and gene therapy processing, the metric system, and scales. Excellent project management skills to ensure projects and goals are met in a timely manner. Travel Requirements N/A Location This is an office-based position located at the RTP, NC site. #LI-Onsite Kincell Bio provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable, federal, state, and local laws. Kincell Bio complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. NOTE TO EMPLOYMENT AGENCIES: Kincell Bio values our relationships with our Recruitment Partners. We will only accept resumes from those partners who have been contracted by a member of our Human Resources team to collaborate with us. We are not responsible for any fees related to resumes that are unsolicited or are received without contract.

Job DescriptionDescription: About Kymera: Kymera International is a leading global developer and manufacturer of specialty materials, including metal powders, pastes, and granules, as well as high-performance surface technologies. Serving diverse industries such as aerospace, defense, automotive, and electronics, Kymera International is enabling innovation while adhering to the highest standards of sustainability and operational excellence. We are committed to ethical business practices and the continuous improvement of our compliance programs, ensuring we meet all regulatory obligations globally. Position Overview: The Production Operator has a key role within the Production Department, responsible for operating and monitoring automatic processing equipment to ensure efficient and safe manufacturing processes. This position requires attention to detail, adherence to safety protocols, and the ability to work collaboratively within a team to meet production goals. The operator will also maintain accurate records, perform quality checks, and adjust equipment to ensure optimal performance. Job Duties: · Operate automatic processing equipment such as shot furnaces (copper melting furnace), shot dryers, thin layer furnaces (continuous belt furnaces), grinding mills, and blenders. · Utilize automated control boards to monitor and adjust variable criteria such as temperature, load, and atmosphere pressure. · Monitor control boards, read and interpret instruments, and make necessary adjustments to maintain prescribed specifications. · Record weights, perform simple calculations, and collect samples. · Work in Antimony and Cuban departments as needed. · Perform additional duties and responsibilities as assigned. Competency: · Ability to read and interpret Material Safety Data Sheets, Job Safety Analyses, and Standard Operating Procedures. · Comprehensive understanding of processes and control board monitoring points. · Capability to act independently to prevent or minimize risks to product, self, or equipment. Education and/or Experience: · High school diploma or general education degree (GED). · One to three months of related experience and/or training, or an equivalent combination of education and experience. · Basic computer skills required. Other Skills and Abilities: · Must be able to work rotating shifts. · Ability to operate forklift equipment. Physical Demands: · The employee must occasionally lift and/or move up to 70 pounds. EEO Statement: Kymera International is an equal opportunity employer committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, disability, age, or veteran status. Requirements:

Summary: We are seeking a dependable and adaptable Consumables Manufacturing Technician to join our team. This role is hands-on and dynamic, involving the assembly and testing of Life Science consumables such as reagent kits, microfluidic chips, and tubing sets. You'll work across multiple production areas and be expected to learn new processes and technologies as part of a collaborative and fast-paced environment. This position requires full-time commitment, punctuality, and a strong work ethic. We're looking for someone who takes pride in doing things right the first time, is eager to learn, and can be trusted to stay focused and productive throughout the day. Responsibilities Essential Duties and Responsibilities: * Assemble and test Life Science consumables with precision and consistency. * Perform work on reagent manufacturing, microfluidic chip production, and tubing set assembly production lines. * Follow detailed work instructions and standard operating procedures. * Maintain accurate and complete production records and notes. * Conduct visual inspections and quality assurance sampling. * Support New Product Introduction (NPI) efforts and assist with process transfers and production line commissioning. * Participate in continuous improvement initiatives to enhance production efficiency. * Perform routine laboratory maintenance and cleaning activities. Qualifications Education and/or Work Experience Requirements: * Associate degree in Chemistry preferred. * At least 1 year of experience in a production or manufacturing environment. * Strong wet-lab chemistry skills including gravimetric and volumetric solution preparations (preferred and prioritized) * Ability to follow detailed instructions and maintain high attention to detail. * Experience using hand tools for delicate assembly of miniaturized components. * Familiarity with chemical dispensing and microscopic inspection. * Cleanroom experience and knowledge of scaling from prototype to volume manufacturing is a plus. * Prior experience with microfluidic device manufacturing is highly regarded. * Reliable, punctual, and committed to working full 8-hour shifts. * Comfortable learning new tasks and adapting to evolving production needs. * Basic computer skills for electronic documentation and recordkeeping. * Clear and professional communication skills. What Repligen Offers Repligen offers you a competitive remuneration package, including a yearly bonus, non-contributory pension, generous PTO, partial compensation on your personal health insurance and flexible working hours. But most importantly Repligen offers you a stimulating, collaborative environment with steep learning curves and the opportunity to contribute to the healthcare of patients worldwide. All of this with an international team in Waltham, MA. Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated hourly rate/salary range for this role, based in the United States of America is $21.25/Hr. -$28.75/Hr. Compensation decisions are dependent on several factors including, but not limited to an individual's qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.

Requirements Reliable means of transportation is required for all positions Must be able to pass a drug screen Background check is required Self-motivated worker Good basic math and written communication skills Safety conscious Willingness to take on responsibility Able to work in a team Good attendance - punctual Able to lift up to 50 lbs. Able to read, follow instruction, and record information Work experience in an industrial environment Proven knowledge of general plant safety What Knowledge and Skills We Prefer: High School Diploma or equivalent is preferred Manufacturing or closely related experience Forklift experience preferred The Working Conditions: Mechanical noise Dusty and dirty work environment due to materials and raw materials Varying temperatures from warm to cold. The Physical Requirements: Ability to lift push, pull, and carry 25 pounds frequently. Ability to lift, push, pull, and carry 50 pounds occasionally. Standing for extended periods of time. Walking, stooping, bending, crouching, twisting, climbing, and kneeling. As a team member at CORMETECH you'll enjoy: Benefits are provided on the first day of hire. These benefits include medical, dental, and vision. CORMETECH also provides several company paid benefits, such as basic life insurance, short-term disability, and long-term disability. We offer a generous PTO package, a company match on our 401(k), and a quarterly bonus plan. Location: Cormetech is located in Charlotte, North Carolina, Durham North Carolina, Kings Mountain North Carolina, and Cleveland Tennessee. This position will be based out of our Durham, North Carolina location. This position will be in-person. We look forward to receiving your application and seeing if we are a good fit for each other! Equal Opportunity Cormetech, Inc.is an Equal Opportunity Employer. The success of Cormetech depends upon attracting, retaining, developing, and promoting the most qualified people regardless of race, color, sex, age, religion, national origin, sexual orientation, gender identity, disability, or veteran's status. The above declarations are not intended to be an all-inclusive list of the duties and responsibilities of the job described, nor are they intended to be such a listing of the skills and abilities required to do the job. Rather, they are intended only to describe the general nature of the job. Screener Questions: Operation Associate DUR How many years of chemical mixing experience do you have? How many years of Forklift experience do you have? How many years of Manufacturing experience do you have? What is the highest level of education you have completed? Must be able to pass drug screen. (required) Yes Correct No Must be able to pass a background check. (required) Yes Correct No What shift(s) are you willing to work? (not all shifts may be available) Select all that apply. 1st 2nd 3rd