Manufacturing Associate jobs at Bausch + Lomb - 559 jobs

Note: Fully Onsite, Shift Work Schedule (includes weekends, and possibly nights) Once shift is determined shifts will be on a stable schedule. Must have: Manufacturing and PQA background Let's do this. Let's change the world. The Amgen North Carolina (ANC) Sr. Associate Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction-including development, clinical, and commercial operations. The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance Responsibilities: • Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations. • Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls. • Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA)s. • Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements. • Oversee and provide guidance during on-the-floor analytical testing. • Ensure that changes that could potentially impact product quality are assessed according to procedures. • Ensure that deviations from established procedures are investigated and documented per procedures. • Alert senior management of quality, compliance, supply and safety risks. • Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation. • Identification and implementation of continuous improvement opportunities within our processes and systems. • Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.

People selected for a Production Operator position may be placed in various roles within the production process of our Crown Health Care Laundry plant. There may be needs in either or both production areas - Soil or Clean. Assignments are determined based on hiring needs and production levels in each area. Below is a brief explanation for each of those areas of operation within the plant. Pay rates and scheduled work hours are based on area assigned. The primary purpose of the Production Operator is to rotate through various positions within the plant to facilitate the receiving, sorting, washing, drying, ironing and loading of linens to be delivered to various hospitals and medical facilities. You will learn to operate various production equipment as needed for your daily assignments. Equipment must be operated in such a manner as to meet and exceed our customer expectations daily in the safest possible manner. Employees are required to learn all equipment and rotate as needed. Typical learning curve for each position is no longer than 2-5 working days. Standards must be met for each position within two weeks of hire and sustained during employment. Employees will be placed in roles that meet production needs, and the skills and abilities of the employee. All Production Operation employees, whether working in Soil or Clean Production areas will be required to perform other duties as assigned. All employees will adhere to all quality standards and obey all safety standards. All Production Operation employees hired must be able to perform the essential functions of the job, with or without an accommodation. High School Education or GED preferred Excellent teamwork skills required. Employees must be willing to move between all jobs via rotation when needed. Soil Operations The primary purpose of this position is to safely sort returned, soiled linen into appropriate classifications in preparation for washing, washing and preparing the carts for the Clean Production side of the plant. Soil Operations: Duties & Essential Job Functions 1. Open customer returned soil bags (bags weigh approximately 45 lbs.), discard plastic bag, spread product out to allow for visibility on soil belt. Pre-sort classifications as required. Production standard are 45 bags or 2000 lbs. opened per hour for each operator. 2. Operators located on the work platform float between multiple positions moving up and down the belt sorting into the appropriate bins or slots. This is a team operation, where the group works together to ensure linens are sorted safely, quickly and accurately into appropriate bins on the line. 3. Move empty carts to appropriate area for cleaning and reuse. 4. Cart Cleaners are responsible for ensuring that the carts, that returned bagged soiled laundry are cleaned, sterilized, dried out and lined to be ready for clean linens to be built into each cart from the Clean lines, readying the carts for loading onto our trucks. Our Crown trucks leave loaded each day to deliver clean sterile linens to our customers. Clean Operations Clean Linen Operations: Duties & Essential Job Functions Employees will learn the following equipment/positions and be required to rotate as needed: Catcher: Will secure linen carts, will learn how to stack and build carts proficiently per our standards in a manner that's conducive to our customer standards. Remove linens from the Folder machine, count and stack them per stacking standards, and push the full baskets to the next staging area. Secure a linen cart. The incumbent will have to push, pull and put the cart into place. Remove items from the conveyor, normally catching items from up to six stations. If an item is caught or hung up in the machine, they must contact maintenance. Only maintenance or production managers can pull jams. The catcher may take empty carts over to the dryer area and bring another cart and bring it back to their work area. Adhere to quality standards in terms of quantity and quality of stacking. If the Catcher sees something in the item pile, such as a scrub or blanket that is not a Crown Health Care Laundry Services linen, the Catcher must pull it out and put it to the side. The Catcher may see things that are stained, and the feeder didn't see it. These must be removed and put to the side. Your supervisor or lead will tell you where to put these items. The Catcher will have to routinely make quality decisions such as the finishing of a linen that is ready to load in a cart. The Catcher may discover that an item is stuck or the machine is not functioning properly. They will decide when to call Maintenance. Hand Fold: The primary purpose of the Hand Folder is to take items as they come out of the washer or Presser and hand fold, stack and place on the appropriate cart or belt for transporting to the next stage of the process. 1. Remove product from the previous process. Identify through on your on-the-job training, how many items per stack. 2. Pull cart over to work area, adjusting the cart so that linen is at a comfortable waist level. 3. Fold items and place on the countertop. 4. For larger items, there may be group folding. Each folding partner grabs the lengthwise end of the item. The partners step back and make a lengthwise fold in the item. One person places it on the countertop, in stacks of five. 5. Fill up the cart in a like manner. 6. Take the cart over to the next work area. The Hand Folder will make many quality decisions, such as identifying if there is a hole or tear in the item, whether it is stained and needs to be rewashed. The Hand Folder will identify when product is not The Company product and remove it. The Hand Folder must decide how many items belong in a particular stack. Ironer: The primary purpose of the Ironer position is to run clean processed linen through the Ironer machine (Feeder, ironer, folder). 1. Bend down and lift flat sheets, blankets and/or pillowcases from the platform, loosen the linens to ensure safe handling prior to feeding them into the ironer. 2. Pull the flat sheets and feed linen into the spreader, via spreader clips or a spreader arm. 3. The first feed draws the linen into the spreader, and the second feed draws the linen into the ironer. 4. While feeding pillowcases, 2-4 people may be feeding at one time. The Ironer must decide when something goes in the re-wash basket per pre-established guidelines such as a hole, stain or anything that would make it not a good quality product. If an item is stuck in the machine, or if the machine is not functioning properly, decide when to call for maintenance. Always adhere to all safety requirements for the equipment and the position. Shipping Clerk: The primary purpose of the Shipping Clerk position is to fill finished carts of clean, processed linen throughout the facility, prepare them for shipment, and ensure that they are loaded onto the delivery trucks. The incumbent will build carts, accurately operate the scale to appropriately weigh the cart and record the information appropriately. Will require a Hep B shot. The Shipping Clerk is responsible for: Securing records of the orders Attaching a copy of the order form to the side of the cart Maintaining and tracking during the day which orders have been filled and which haven't been completed. Collecting finished carts: Repeatedly walking through the plant and proactively seeking out finished carts. Rolling the carts to the weighing area Weigh the carts: Pull the cart up onto the floor scale Record the weight into the software program Pull the weighed cart off the scale Push the next cart onto the scale and repeat the process Enter the proper information into the Shipping Software May load the delivery truck by pushing the weighed carts onto the back of the appropriate truck as required. May fill in for other positions as required, i.e., production operator/builder Basic computer knowledge and the willingness to learn new computer applications. Good recordkeeping skills required. Good analytical skills required. d24ad0b8-823f-4e68-a892-2986ccdf7392

Title:- Packaging Technician 2 Duration: Contract until Aug 2026 (Possible extension) This position is responsible for performing routine tasks, operating equipment, and troubleshooting in the area of automated Syringe Inspection and Syringe Packaging. This position supports execution of the production plan. Responsibilities • Operate and troubleshoot high-speed automated Inspection and Packaging equipment. Typical tasks include loading syringes onto automated inspection equipment, changing label reels, replenishing packaging items (e.g. inserts, labels, cartons, lidding rolls, base film rolls, shippers), operating syringe assembly machine, thermoformer, cartoner, case palletizer, serialization equipment, and wrapping pallets. • Participate in line changeovers and continuously strive to reduce line downtime and improve OEE%. • Ensure compliance with cGMPs and SOPs at all times. • Perform routine Quality and Safety inspection walk-throughs of the production areas. • Perform scheduled cleanings of equipment and packaging rooms. • Will serve as witness of routine unit operation tasks for batch record signing. Maintains all associated documentation for operations being performed. • May assist with formal CAPAs and NCRs as needed. • Adheres to the production schedule and provides overtime and weekend support when needed. • Performs routine assignments with supervision. Takes initiative to identify issues, troubleshoot, propose solutions, and keep management advised. • Other duties may be assigned as required. Skills Preferred Qualifications: • Prior mechanical experience and/or experience working as a Packaging Operator in Pharmaceutical or Medical device industries. • Engineering background • Experience working with automated Inspection and/or Packaging equipment. • Syringe/Vial Experience • Experience working in a manufacturing position in a GMP environment. • Production line experience in Pharma or Medical Device Terms of employment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job, majority of the work activities are performed while standing. • Ability to stand over intervals of several hours at a time • Ability to bend, squat, and reach • Ability to lift, push or pull various amounts of weight • Ability to pass the required visual acuity test (wearing corrective lenses if needed) Based on production demands and personnel availability, different start time scenarios or additional hours may be required so a flexible work schedule is required for the candidate. Core Work hours for the available shift is as follows: 2nd shift: Mon-Fri: 1:00PM - 9:30PM. Occasional Weekend Overtime is required. Education ________________________________________ HS Diploma or GED and 3-5 yrs experience AA degree in science, engineering or a related discipline and 1-3 year's experience BS degree in science, engineering, or a related discipline and 0-3 year's experience

The primary purpose of this position is to perform the assembly, label and package of Pip/Dil Accessory Kits within the production department. Responsible for performing inspection and documentation functions, transfer of material cages and raw material staging. Additionally, provides assistance with training, organizing, safety, 5S, housekeeping and maintenance functions in the production department. Primary Duties Perform low complexity manufacturing tasks, ensuring compliance with quality standards. Troubleshoot and resolve technical issues, collaborating with engineering teams to enhance manufacturing processes. coordinating with suppliers and internal teams. Monitor inventory levels and prepare logistics reports while ensuring compliance with safety and regulatory requirements. Maintain a clean and organized work environment to promote safety and operational efficiency Checks documentation to assure that the correct data forms are present and contain the correct identifying information - lot#, product name, date, etc. Documents all necessary information on the DHR forms following Good Documentation Practices. Assists with maintaining physical separation of lots by using separation and segregation practices and equipment such as yellow caution tape, red security ribbons or other physical barriers. Performs and records production counts of finished product and transports finished product to the designated area. Works in Instrument Manufacturing up to 25% of the time depending on Instrument demand vs. Pip/Dil demand." Performs and records production counts of finished product and transports finished product to designated area. Helps process product designated as not conforming according to NCMR instructions. Collaborate with team members to achieve production goals and maintain an efficient workflow. Perform all work in compliance with company quality procedures and standards. Performs other duties as assigned. Qualification and Experience This role requires High School Diploma, GED or equivalent. No experience necessary, however, light assembly experience is preferred. Knowledge Skills and Abilities Detail orientation to complete tasks without errors and produce high-quality work. Thriving in a fast-paced environment by managing tasks, multitasking, and adapting quickly to maintain productivity. Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently Communicates instructions clearly and effectively Ability to cooperate with others at all levels including leadership Effective verbal communication skills Consistently uphold and reflects the core ethical principles and values that bio Merieux promotes The pay for this role is $17.03/hr. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bio Merieux's bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate's experience and will be presented in writing at the time of the offer. In addition, bio Merieux offers a competitive Total Rewards package that may include: * A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options * Company-Provided Life and Accidental Death Insurance * Short and Long-Term Disability Insurance * Retirement Plan including a generous non-discretionary employer contribution and employer match. * Adoption Assistance * Wellness Programs * Employee Assistance Program * Commuter Benefits * Various voluntary benefit offerings * Discount programs * Parental leaves #biojobs Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bio Merieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bio Merieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site or contact us at [emailprotected]. BioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at , by email at [emailprotected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position Arrowhead is seeking a highly motivated Manufacturing Associate to join our growing Plant Operations team at our Verona Manufacturing site. This role will involve assisting in the large scale preparation of buffers utilized for purification steps of large scale oligonucleotides. The operator must comply with GLP/GMP protocols and be able to follow all association SOPs and work instructions when performing and documenting operations. Responsibilities Follow batch records, SOPs, and work instructions to detail Document all operations in batch records and logbooks Comply with GMP protocols Operate large scale oligonucleotide manufacturing equipment (i.e. buffer prep tanks, HMIs, oligonucleotide synthesizer, purification skid, tangential flow filtration system, lyophilizer, ChemGlass reactors, pH/conductivity meters, peristaltic pumps, etc.) Assist other chemists as needed within the Manufacturing group during synthesis and purification of oligonucleotides including: Reagent solution preparation Mobile phase preparation Column Packing Fraction collection Communicate with cross-functional groups such as Process Development, Analytical Development, Quality Control, Quality Assurance, etc. Maintain a clean work space Maintain safety by wearing required personal protective equipment Track and update raw material usage in D365 ERP software Requirements Bachelor of Science or appropriate, related work experience in a similar position Excellent oral and written communication skills Self-motivated team player with the ability to thrive in a fast paced, multi-disciplinary, matrixed environment Preferred Experience working in a GMP setting with controlled documentation Wisconsin pay range $63,000-$73,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. Position Summary Reporting to the Manufacturing Sr Manager, the Manufacturing Associate will perform manufacturing activities associated with LNP GMP manufacturing within a state-of-the-art manufacturing facility at 33 New York Ave in Framingham, MA. A successful candidate will be responsible for the manufacture of LNP therapies for clinical studies and as a commercial product. This role requires clear communication across multiple departments for the execution of daily activities. The ideal candidate will have experience successfully performing formulated LNP Manufacturing within a GMP environment. Responsibilities Perform clinical / commercial product manufacturing for LNP therapies according to cGMP standards and SOPs including Lipid and RNA Prep, T-Mix, and TFF operations Perform aseptic vial filling, visual inspection, cryopreservation, process reagent formulation, and material kitting. Transfer raw material inside cleanroom suite using sanitizing reagents or equipment. Participates in technology transfer from Process Development to the Manufacturing group. Assist in the life cycle development of Standard Operating Procedures (SOPs) for manufacturing in collaboration with PD / MSAT and Quality Systems groups. Ensures all materials and equipment are identified and available in time for manufacturing operations. Execute standard work per manufacturing schedule Participate in Quality investigations and resolutions. Ensure cGMP compliance through consistent execution. Other duties and projects as assigned to meet departmental requirements. Minimum Qualifications Certificate, associate's degree or higher in biological sciences or related fields and 2-5 years of relevant Manufacturing experience or related fields Available to work a flexible schedule as needed. Ability to don cleanroom garments and work within a classified environment (Grade B and C) Knowledge of GMP and industry standards T-Mix and TFF experience preferred Fluency in Windows and Microsoft Office applications Attentive to detail and accuracy Ability to effectively communicate and collaborate with internal stakeholders is essential Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view. Ability to execute and follow-through to completion Ability to lift 40 pounds Ability to stand for 6 hours in a clean room environment Self-driven, independently motivated, data driven and excellent problem-solving ability Competencies Collaborative - Openness, One Team Undaunted - Fearless, Can-do attitude Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems. Entrepreneurial Spirit - Proactive. Ownership mindset. Due to the nature of their work, our manufacturing and lab-based positions are located fully on-site. Manufacturing Associate: Base pay range of $35.00 per hour to $42.00 per hour + bonus, equity and benefits. The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. Position Summary Reporting to the Manufacturing Sr Manager, the Manufacturing Associate will perform manufacturing activities associated with LNP GMP manufacturing within a state-of-the-art manufacturing facility at 33 New York Ave in Framingham, MA. A successful candidate will be responsible for the manufacture of LNP therapies for clinical studies and as a commercial product. This role requires clear communication across multiple departments for the execution of daily activities. The ideal candidate will have experience successfully performing formulated LNP Manufacturing within a GMP environment. Responsibilities * Perform clinical / commercial product manufacturing for LNP therapies according to cGMP standards and SOPs including Lipid and RNA Prep, T-Mix, and TFF operations * Perform aseptic vial filling, visual inspection, cryopreservation, process reagent formulation, and material kitting. * Transfer raw material inside cleanroom suite using sanitizing reagents or equipment. * Participates in technology transfer from Process Development to the Manufacturing group. * Assist in the life cycle development of Standard Operating Procedures (SOPs) for manufacturing in collaboration with PD / MSAT and Quality Systems groups. * Ensures all materials and equipment are identified and available in time for manufacturing operations. * Execute standard work per manufacturing schedule * Participate in Quality investigations and resolutions. * Ensure cGMP compliance through consistent execution. * Other duties and projects as assigned to meet departmental requirements. Minimum Qualifications * Certificate, associate's degree or higher in biological sciences or related fields and 2-5 years of relevant Manufacturing experience or related fields * Available to work a flexible schedule as needed. * Ability to don cleanroom garments and work within a classified environment (Grade B and C) * Knowledge of GMP and industry standards * T-Mix and TFF experience preferred * Fluency in Windows and Microsoft Office applications * Attentive to detail and accuracy * Ability to effectively communicate and collaborate with internal stakeholders is essential * Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view. Ability to execute and follow-through to completion * Ability to lift 40 pounds * Ability to stand for 6 hours in a clean room environment * Self-driven, independently motivated, data driven and excellent problem-solving ability Competencies * Collaborative - Openness, One Team * Undaunted - Fearless, Can-do attitude * Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems. * Entrepreneurial Spirit - Proactive. Ownership mindset. Due to the nature of their work, our manufacturing and lab-based positions are located fully on-site. Manufacturing Associate: Base pay range of $35.00 per hour to $42.00 per hour + bonus, equity and benefits. The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************

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 Schedule: This position is for a Manufacturing Associate working a 2 days on, 2 days off, 3 days on shift rotation working the hours of 6:00 AM through 6:30 PM. Position Summary: Coordinate and perform cGMP manufacturing operations for manufacturing biopharmaceutical products. Ensure the effective use of material, equipment, and personnel while making products at high-quality levels. Responsibilities: Assist in the execution of procedures for microbial manufacturing, purification, or support area of manufacturing using SOP's and batch records Use equipment and techniques related to support for microbial fermentation and/or harvest and purification Responsible for completing paperwork for each task, cleaning procedures, aseptic processing techniques, Good Manufacturing Practices (GMP) and laboratory safety practices and procedures Responsibilities include hazardous and non-hazardous waste handling Requirements: Manufacturing Associate I: Bachelor's degree in a related scientific or engineering discipline and 0-2 years' experience in related cGMP manufacturing operations; or high school degree and 3-5 years' experience, or equivalent. 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 degree and 4-6 years' experience, or equivalent. Experience with fermenter, homogenizer, centrifuge, process tanks, chromatography systems, UF/DF, SCADA control systems, computer, and telephone. Salary Range: Manufacturing Associate I: $26.44 - $36.49 Manufacturing Associate II: $30.29 - $41.78 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit ********************* . KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

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.

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.

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. CONTRACT *Shift schedule is Sundays to Tuesdays alternating Saturdays. Hours is 6pm to 7 am. * Duties PROCESS KNOWLEDGE: Understanding of process theory and equipment operation. Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance. Support initiatives for process optimization. Identify and elevate processing issues and support solutions. Gain experience with automation systems (LIMS, MES, PI, etc.). TECHNICAL DOCUMENTATION: Provide feedback and/or suggested changes to operational procedures. Assist in the incorporation of new technologies, practices, and standards into procedures. Capable of writing and reviewing process documents. QUALITY AND COMPLIANCE: Understanding of cGMPs as related to Commercial Operations. Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.). BUSINESS: Ability to participate on projects and contribute to outcomes. Capability to learn and support new business systems (Track wise, ERP, etc.). Support trending of defined department metrics. WORK ENVIRONMENT/PHYSICAL DEMANDS * Consists of strenuous, repetitive work. The following list of physical movements may be used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands. * Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds. * May require work around loud equipment. • The use of personal protective equipment will be required. * Requires various shift based work and off hours. Skills * Strong communication skills-verbal and written * Ability to work in a team environment which includes good conflict resolution and collaboration * Displays good initiative to identify areas for improvement and implement solutions Education * Bachelor's degree in science related area or engineering * Associate's degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. In the U.S, the salary range for this position is $ 15 to $ 30 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors. The salary range for this position is: $15 to $30. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit:

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. CONTRACT ROLE-Sunday - Tuesday/Wednesday Shift from 6am - 7pm (Alternate every other Wednesday) Duties PROCESS KNOWLEDGE: Understanding of process theory and equipment operation. Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance. Support initiatives for process optimization. Identify and elevate processing issues and support solutions. Gain experience with automation systems (LIMS, MES, PI, etc.). TECHNICAL DOCUMENTATION: Provide feedback and/or suggested changes to operational procedures. Assist in the incorporation of new technologies, practices, and standards into procedures. Capable of writing and reviewing process documents. QUALITY AND COMPLIANCE: Understanding of cGMPs as related to Commercial Operations. Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.). BUSINESS: Ability to participate on projects and contribute to outcomes. Capability to learn and support new business systems (Track wise, ERP, etc.). Support trending of defined department metrics. WORK ENVIRONMENT/PHYSICAL DEMANDS * Consists of strenuous, repetitive work. The following list of physical movements may be used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands. * Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds. * May require work around loud equipment. • The use of personal protective equipment will be required. * Requires various shift based work and off hours. Skills * Strong communication skills-verbal and written * Ability to work in a team environment which includes good conflict resolution and collaboration * Displays good initiative to identify areas for improvement and implement solutions Education * Bachelor's degree in science related area or engineering * Associate's degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. In the U.S, the salary range for this position is $ 15 to $ 30 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors. The salary range for this position is: $15 to $30. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit:

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. This is a contract role: *Shift schedule rotating 12-hour night shift from 6PM to 7AM. Wednesday to Saturdays. Alternating Saturdays* Duties PROCESS KNOWLEDGE: Understanding of process theory and equipment operation. Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance. Support initiatives for process optimization. Identify and elevate processing issues and support solutions. Gain experience with automation systems (LIMS, MES, PI, etc.). TECHNICAL DOCUMENTATION: Provide feedback and/or suggested changes to operational procedures. Assist in the incorporation of new technologies, practices, and standards into procedures. Capable of writing and reviewing process documents. QUALITY AND COMPLIANCE: Understanding of cGMPs as related to Commercial Operations. Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.). BUSINESS: Ability to participate on projects and contribute to outcomes. Capability to learn and support new business systems (Track wise, ERP, etc.). Support trending of defined department metrics. WORK ENVIRONMENT/PHYSICAL DEMANDS * Consists of strenuous, repetitive work. The following list of physical movements may be used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands. * Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds. * May require work around loud equipment. • The use of personal protective equipment will be required. * Requires various shift-based work and off hours. Skills * Strong communication skills-verbal and written * Ability to work in a team environment which includes good conflict resolution and collaboration * Displays good initiative to identify areas for improvement and implement solutions Education * Bachelor's degree in science related area or engineering * Associate's degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. In the U.S, the salary range for this position is $ 15 to $ 30 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors. The salary range for this position is: $15 to $30. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit:

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Hours-Days: Sun-Tues/Wed 0600-1900 Duties PROCESS KNOWLEDGE: Understanding of process theory and equipment operation. Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance. Support initiatives for process optimization. Identify and elevate processing issues and support solutions. Gain experience with automation systems (LIMS, MES, PI, etc.). TECHNICAL DOCUMENTATION: Provide feedback and/or suggested changes to operational procedures. Assist in the incorporation of new technologies, practices, and standards into procedures. Capable of writing and reviewing process documents. QUALITY AND COMPLIANCE: Understanding of cGMPs as related to Commercial Operations. Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.). BUSINESS: Ability to participate on projects and contribute to outcomes. Capability to learn and support new business systems (Track wise, ERP, etc.). Support trending of defined department metrics. WORK ENVIRONMENT/PHYSICAL DEMANDS * Consists of strenuous, repetitive work. The following list of physical movements may be used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands. * Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds. * May require work around loud equipment. • The use of personal protective equipment will be required. * Requires various shift based work and off hours. Skills * Strong communication skills-verbal and written * Ability to work in a team environment which includes good conflict resolution and collaboration * Displays good initiative to identify areas for improvement and implement solutions Education * Bachelor's degree in science related area or engineering * Associate's degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. In the U.S, the salary range for this position is $ 15 to $ 30 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors. The salary range for this position is: $15 to $30. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit:

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases. These positions are for the 6pm to 7am shift from Wednesday to Saturday, with every other Saturday off. $28 hour Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. In the U.S, the salary range for this position is $ 15 to $ 30 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors. The salary range for this position is: $15 to $30. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit:

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases. These positions are for the 6pm to 7am shift from Wednesday to Saturday, with every other Saturday off. $28 hour Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. CONTRACT ***Shift schedule is Sundays to Tuesdays alternating Saturdays. Hours is 6pm to 7 am. *** Duties PROCESS KNOWLEDGE: Understanding of process theory and equipment operation. Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance. Support initiatives for process optimization. Identify and elevate processing issues and support solutions. Gain experience with automation systems (LIMS, MES, PI, etc.). TECHNICAL DOCUMENTATION: Provide feedback and/or suggested changes to operational procedures. Assist in the incorporation of new technologies, practices, and standards into procedures. Capable of writing and reviewing process documents. QUALITY AND COMPLIANCE: Understanding of cGMPs as related to Commercial Operations. Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.). BUSINESS: Ability to participate on projects and contribute to outcomes. Capability to learn and support new business systems (Track wise, ERP, etc.). Support trending of defined department metrics. WORK ENVIRONMENT/PHYSICAL DEMANDS • Consists of strenuous, repetitive work. The following list of physical movements may be used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands. • Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds. • May require work around loud equipment. • The use of personal protective equipment will be required. • Requires various shift based work and off hours. Skills • Strong communication skills-verbal and written • Ability to work in a team environment which includes good conflict resolution and collaboration • Displays good initiative to identify areas for improvement and implement solutions Education -Bachelor's degree in science related area or engineering -Associate's degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

The Manufacturing Associate I will perform Upstream or Downstream production activities for early and late-phase Cell Culture programs in a GMP environment. Responsibilities include executing tasks per SOPs, batch records, and GMP/GDP/GLP standards, ensuring compliance and accuracy. The role involves various unit operations such as media/buffer preparation, bioreactor operations, aseptic techniques, chromatography, ultrafiltration, and drug substance filling. Candidates must maintain process ownership, facility upkeep, and thorough documentation review to ensure compliance. The ideal candidate should have a basic understanding of cell culture, fermentation, or purification unit operations, with preference given to those experienced in single-use platform technology. Strong written and verbal communication skills are essential. The role requires an energetic, motivated, and dynamic individual who is highly organized and capable of maintaining efficiency and a positive demeanor in a fast-paced, multitasking environment The position will work on a rotating 2 - 2 -3 work schedule. This is a night shift position. The normal work hours are 7:00 pm - 7:00 am. Primary Responsibilities: Manufacture cell culture products according to manufacturing batch records while ensuring compliance with quality standards, company policies, and current regulations. Perform cleanroom operations, adhering to aseptic processing controls, including gowning and cleaning procedures. Document manufacturing procedures (e.g., SRs, EPRs, BRs) in compliance with Good Documentation Practices (GDP) at the time of execution. Ensure proper issuance and accountability of items used in manufacturing records (SR, EPR, BR). Demonstrate and apply knowledge of current Good Manufacturing Practices (cGMP) in daily tasks and responsibilities. Maintain and uphold 5S standards in the manufacturing environment. Operate and perform maintenance on equipment per applicable Standard Operating Procedures. Minimum Requirements: Manufacturing Associate I: Bachelor's degree in a related scientific or engineering discipline with 0-2 years of GMP manufacturing experience; OR high school diploma with 3-5 years of related GMP manufacturing experience. Energetic, motivated and dynamic individual. Must be organized and able to focus in a fast-paced, multi-tasked environment and maintain operational efficiency and positive demeanor. Language Ability: Fluent in English language both reading and writing. 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 employees of organization. Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Math Ability Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret graphs. Physical Demands Standing and sitting for long periods of time may be required at times. Lifting, pushing, and pulling may be required for stocking and movement of equipment. The use of ladder may be required when setting up bioreactors. Computer Skills Knowledge of and experience using MS Office, ERP, EDMS, production equipment software Equipment Use Knowledge of and experience using equipment - (Examples include Biosafety Cabinets, Incubators, Single Use Bioreactors, Chromatography Columns/Skids, Ultrafiltration Skids, Filling systems, Peristaltic Pumps and Other Single Use pumps, Automated Cell Counters, Blood Gas Analyzers, Metabolite Analyzers, Scales and Balances, pH and Osmolality meters, other lab, production, and office equipment.) Work Conditions: The job requires working within a cGMP manufacturing biotechnology facility which requires clean room operations. Clean room operations require donning clean room attire when entering clean room areas and maintaining good personal hygiene. Work Hours: 12 Hour Shift / 7PM-7AM / 2-2-3 The job requires working 12-hour shifts which may include working overnight. 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. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

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