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Manufacturing Operator jobs at Johnson & Johnson - 588 jobs

  • Global Government Affairs Strategy & Operations Lead

    Gilead Sciences, Inc. 4.5company rating

    Washington, DC jobs

    A leading biopharmaceutical company is seeking a dynamic executive to oversee government affairs operations, focusing on strategy development and budgeting. This role requires extensive experience in the biopharmaceutical industry, strong leadership skills, and the ability to influence stakeholders effectively. The position is instrumental in aligning government affairs with commercial strategies and will involve direct interaction with high-profile stakeholders. Competitive compensation package is offered based on qualifications and experience. #J-18808-Ljbffr
    $111k-141k yearly est. 5d ago
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  • Bio Manufacturing Operator

    Elanco 4.9company rating

    Elwood, KS jobs

    At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals' lives better makes life better - join our team today! $2,500 sign-on bonus eligible! Why Work at Elwood? The Elanco Elwood, Kansas facility was acquired from Kindred Biosciences in 2021 which offers a strong pipeline of innovative drugs for companion animals within the monoclonal antibody space. Working at a monoclonal antibody start-up facility in Elwood, Kansas presents an exciting opportunity to contribute to cutting-edge research: Monoclonal antibodies are an innovative type of biologic drug that can target specific molecules in the body to treat a variety of diseases, including cancer and autoimmune disorders. Working at a start-up facility that is developing these drugs is an opportunity to be on the forefront of medical research and contribute to developing treatments that can have a significant impact on pets' lives. Shift: This role has a 12-hour shift schedule - 5:00 AM to 5:00 PM, including every other weekend. Further details about the specific 12-hour shift schedule will be discussed during the interview process. Please note that weekend work will have a 4% premium and work outside of your shift hours will have 10% premium. Your Role: An operator is responsible for performing and documenting all tasks and activities associated with biologics manufacturing at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. Execute and monitor core mAb manufacturing processes (media/buffer prep, upstream/downstream processing, formulation, fill/finish, secondary packaging). Maintain cGMP compliance in a regulated environment (USDA/FDA/EMA). Follow SOPs and batch records precisely for equipment operation, processing, and daily tasks. Perform aseptic manipulations and maintain a sterile environment. Support equipment preparation, maintenance, and process improvements, while interfacing with QC for sampling and environmental monitoring. What You Need to Succeed (Minimum Qualifications): Education: High School Diploma or equivalent. Minimum 2 years' experience in a regulated, commercial GMP biomanufacturing environment (relevant experience may include media and buffer preparation, cell culture, fermentation, aseptic processing, chromatography, TFF, final formulation, and fill/finish). Proficient in basic computer skills (Windows/Microsoft Office) and communication (written & verbal). Demonstrates teamwork, initiative, a strong work ethic, and a positive attitude. Must be able to wear appropriate gowning and personal protective equipment (PPE) in production and manufacturing support areas. What will give you a competitive edge (preferred qualifications) Associate or Bachelor's degree in a biomanufacturing related discipline (eg. biology, chemistry, engineering, etc.). Experience in Downstream Processing. Understanding of USDA, FDA, and EU GMP regulatory standards for veterinary biologics. Good mechanical aptitude. Additional Information: Location: Elwood, KS (Onsite). Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. #LI_MNLC Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
    $40k-47k yearly est. Auto-Apply 21d ago
  • Manufacturing Operator, Granulation & Blending (2nd Shift)

    ANI Pharmaceuticals 4.4company rating

    East Windsor, NJ jobs

    About Us Welcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients' lives through the manufacturing and distribution of high-quality pharmaceutical products. With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike. We understand the importance of accessibility, and our products are available across a wide range of therapeutic areas, contributing to the well-being of communities globally. At ANI Pharmaceuticals, there are opportunities to contribute to our purpose every day. We value authenticity, knowledge, and hard work, we strive to celebrate our employees in a positive environment. Our culture empowers everyone to be successful and apply our full potential. About the Role The Manufacturing Operator will work alongside other members of the production team to operate and maintain production equipment in accordance with Standard Operating Procedures. The Manufacturing Operator will also document all aspects of production and maintenance (batch records, room usage, cleaning and operation details) in corresponding logbooks as dictated by ANI Standard Operating Procedures and FDA cGMP guidelines. The Manufacturing Operator should also have multiple years of experience with Granulation in a pharmaceutical production environment. Responsibilities Operation of production equipment Cleaning the production/ packaging rooms per Standard Operating Procedure Cleaning, maintaining and operating production machinery as per Standard Operating Procedure Following the instructions in the Batch Manufacturing Document while involved in production Documenting production operation in the Batch Manufacturing Document Documenting cleaning and operation details in the Equipment Log Book Documenting room usage in the Room Log Book with cleaning and usage details Complying to cGMP requirements of FDA in all steps of activities Skills 3-5 years of experience with Granulation and Pharmaceutical Formulation Solid working knowledge of FDA cGMP requirements Requirements: Must be 18 years or older High School Diploma or equivalent education Must have the ability to perform repetitive work and meet ANI Pharmaceuticals standards Must be able to read, comprehend and follow written and verbal instruction with accuracy Must have the ability to read, comprehend and follow written and verbal procedures Must have excellent accuracy/attention to detail Must have good basic communication and interpersonal skills Must be able to lift a minimum of 25 pounds. Other preferred qualifications include the ability to wear personal protective clothing/equipment and hearing protection where provided and must be able to work varying shifts The base salary (hourly) range for this position is $16.00 - $35.00; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge. ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and paid time off. Many of these benefits are subsidized or fully paid for by the company.
    $32k-40k yearly est. Auto-Apply 27d ago
  • Manufacturing Operator I

    Sun Pharmaceuticals, Inc. 4.6company rating

    Princeton, NJ jobs

    Sun Pharma is the worlds fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology. **Job Summary** Looking to start your career in pharmaceutical manufacturing? Join a team dedicated to producing high-quality drug products that make a difference in peoples lives. As a **Manufacturing Operator** , youll work hands-on with advanced equipment and processes in a regulated environment, ensuring every product meets strict safety and quality standards. This **1st shift position** offers a consistent weekday schedule and a great opportunity to grow within the industry. **Schedule:** 1st Shift | MondayFriday, 7:00 AM 3:30 PM **Key Responsibilities** Under close supervision, you will: + Operate equipment for one or more production processes, including Glatt fluid bed processing, granulation, blending, compression, coating, imprinting, banding, and encapsulation. + Perform machine changeovers, cleaning, and setup as needed. + Troubleshoot equipment and make adjustments to maintain production specifications. + Monitor and ensure adherence to quality standards throughout the manufacturing process. + Accurately complete all required manufacturing documentation. + Follow all Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP). + Use equipment safely and in compliance with OSHA regulations and equipment manuals. **Work Environment** Youll be working in a dynamic manufacturing setting that may include: + Exposure to noise, fumes, odors, gases, and dust. + Potential hazards such as moving mechanical parts, elevated workspaces, and chemicals. **Physical Requirements** + Regular use of hands, hearing, and speech. + Frequent standing, walking, sitting, bending, kneeling, crouching, crawling, pushing, and lifting. + Ability to lift and carry up to 50 pounds. + Must be able to wear required personal protective equipment (PPE), including respirators, safety glasses/goggles, and safety shoes. **Qualifications** + High School Diploma, GED, or equivalent required. + Forklift or equipment certification preferred. + Basic troubleshooting skills and understanding of cGMP and pharmaceutical regulations. + Familiarity with Occupational Health & Safety procedures. + Strong math and computer skills; experience with MS Office and SAP preferred. + Effective communication and interpersonal skills. + Basic English proficiency (CEFR A2 level). **Experience** This is an entry-level roleno prior experience required. Full training will be provided. _The presently-anticipated base compensation pay for this position is $21.84/hr. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan.Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time._ _The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors._ _The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s)._ _We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law._ **_Notice to Agency and Search Firm Representatives:_** _Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral._ We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
    $21.8 hourly 41d ago
  • Pharmaceutical Manufacturing Operator

    Capsugel Holdings Us 4.6company rating

    Bend, OR jobs

    Location: Bend, OR. This position requires on-site work and includes night shifts. Relocation compensation is available. Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of. Join our growing team in Bend, Oregon as a Pharmaceutical Manufacturing Operator. In this role, you'll help produce medicines that improve lives worldwide. We provide extensive training, so your willingness to learn and grow matters most. What you will get Starting pay of $24 per hour plus overtime and a 15% night shift premium Medical, dental, and vision insurance, plus 6% 401(k) employer match Generous Paid Time Off that increases with tenure Opportunities for technical and leadership growth-many operators advance within 18 months Access to Lonza's global benefits: ************************************** What you will do Operate and monitor equipment to mix, fill, and package medications safely Follow Standard Operating Procedures (SOPs) and maintain cleanroom standards Accurately measure ingredients and record production data Disassemble, clean, and reassemble equipment after each run Perform routine maintenance and safety checks Collaborate with team members to ensure smooth operations Support continuous improvement and quality initiatives What we are looking for High School diploma or GED Ability to work 12-hour shifts, including nights and weekends Strong attention to detail and communication skills Comfortable wearing Personal Protective Equipment (PPE) Ability to lift and move equipment safely Willingness to learn and work in a regulated environment Ability to pass background check, drug screen, and physical exam Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
    $24 hourly Auto-Apply 16d ago
  • Lead Mfg Operator PC - TEMP

    Noven Pharmaceuticals 4.6company rating

    Miami, FL jobs

    Directs and coordinates the packaging and or cartooning operation in accordance with Noven Pharmaceuticals Inc. SOPs and cGMP standards. The Lead Manufacturing Operator will set up, operate and change over packaging and or cartooning production equipment on the shift to which they are assigned. An LMO will assure that quality and documentation standards are maintained to ensure product compliance. Responsibilities Assure work center operates safely to produce products within established quality standards within the cGMP and SOP guidelines. Perform all set-ups and operate the machine in the prescribed area of responsibility. Assure the work center performs safely at a manufacturing rate consistent with established operating standards. Recognize and envelop quality assurance and maintenance into a comfortable routine operating team. Report to the shift supervisors all significant variances to quality and operating standards. Train employees within the work center for which he/she is responsible. Ensure documentation is completed and meet the prescribed standards. Ensure communication with oncoming shift LMO of any and all problems experienced during manufacturing. Assist maintenance technicians as directed by shift supervisor. Promote teamwork and a goal-oriented environment. Proficient operation/set up of packaging and cartoning machinery. Must meet medical requirements for personal protective equipment (PPE) used in manufacturing. Able to train/assist entry level LMOs. Able to assist senior LMO (Lead Machine Operator) in identifying minor mechanical problem with the equipment. Qualifications Competencies: Education / Experience: High school diploma with 1 year experience in a packaging operation or 3 years experience in a packaging environment in lieu of educational requirement Candidate must demonstrate mechanical aptitude, ability to speak, read and write in the English language, basic computer skills and demonstrate the ability to perform basic mathematical calculations. Judgment / Decision Making: Ability to ascertain that work complies with approved standards and meets the prescribed guidelines of Noven Pharmaceuticals Inc. Must demonstrate leadership qualities and work under moderate supervision. Employee must demonstrate the ability of adhering to stringent documentation requirements. Work Environment: Plant floor, pharmaceutical products. Physical Demands: The employee is occasionally required to climb, balance, stoop, kneel, and crouch. Must demonstrate the ability to lift and or move 50 pounds or greater.
    $21k-27k yearly est. Auto-Apply 60d+ ago
  • Mfg Operator BC - TEMP

    Noven Pharmaceuticals 4.6company rating

    Miami, FL jobs

    Responsible for overall activities related to manufacturing and packaging of potential and existing products. Operate and maintain small production equipment. Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities. Maintain records and cleanliness in compliance with cGMP, SOP, and Safety protocols. Responsibilities Process products in strict compliance with cGMP and SOPs. Operate and maintain production equipment. Participate in all production activities, including manufacturing, packaging, punching, and pouching of products. Clean equipment and manufacturing room in compliance with established policies and regulatory requirements. Set up equipment for operation, labeling, patch and pouch inspection, and special packaging clinical studies. Assist with shipping, receiving and warehousing. Perform related duties and special projects as assigned. Qualifications Competencies: Education / Experience: High school diploma or technical training. At least two years of professional experience with knowledge of manufacturing process is required as related to the pharmaceutical industry. In lieu of that, at least 1-3 years of working experience in another industry with demonstrated ability to learn new processes and procedures quickly. Good communication skills. Highly organized operator is essential with strong attention to detail as well. Judgment / Decision Making: Duties performed are of a routine order within established practices. Some minor decisions and judgment within established precedent is required Work Environment: Production environment with exposure to airborne particles, moving parts, and odors. Carelessness could result in minor injury. Physical Demands: Majority of time spent standing, stooping and bending. Regularly required to lift and carry objects weighing up to fifty pounds. Visual acuity and manual dexterity required to operate machinery as necessary.
    $21k-27k yearly est. Auto-Apply 15d ago
  • Mfg Operator PC - TEMP

    Noven Pharmaceuticals 4.6company rating

    Miami, FL jobs

    Responsible for overall activities related to manufacturing and packaging of potential and existing products. Operate and maintain small production equipment. Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities. Maintain records and cleanliness in compliance with cGMP, SOP, and Safety protocols. Responsibilities Process products in strict compliance with cGMP and SOPs. Operate and maintain production equipment. Participate in all production activities, including manufacturing, packaging, punching, and pouching of products. Clean equipment and manufacturing room in compliance with established policies and regulatory requirements. Set up equipment for operation, labeling, patch and pouch inspection, and special packaging clinical studies. Assist with shipping, receiving and warehousing. Perform related duties and special projects as assigned. Qualifications Competencies: Education / Experience: High school diploma or technical training. At least two years of professional experience with knowledge of manufacturing process is required as related to the pharmaceutical industry. In lieu of that, at least 1-3 years of working experience in another industry with demonstrated ability to learn new processes and procedures quickly. Good communication skills. Highly organized operator is essential with strong attention to detail as well. Judgment / Decision Making: Duties performed are of a routine order within established practices. Some minor decisions and judgment within established precedent is required Work Environment: Production environment with exposure to airborne particles, moving parts, and odors. Carelessness could result in minor injury. Physical Demands: Majority of time spent standing, stooping and bending. Regularly required to lift and carry objects weighing up to fifty pounds. Visual acuity and manual dexterity required to operate machinery as necessary.
    $21k-27k yearly est. Auto-Apply 60d+ ago
  • Mfg Operator BC - TEMP

    Noven Pharmaceuticals 4.6company rating

    Miami, FL jobs

    Overview The Mfg Operator BC performs all the general duties and operations to manufacture the product. An operator will operate machines and handle components using prescribed standard operating procedures and cGMP guidelines to manufacture and ensure the product meets the quality requirements. The operator will complete the necessary documentation and records to maintain quality control. Responsibilities Operate punching, pouching and cartooning machines Operate blending, coating, and slitting machines. Blend various ingredients for the coating process Perform set-ups and operate the equipment in the prescribed area of responsibility Assure work center operates safely to produce products within established quality standards within the cGMP and SOP guidelines Check and weigh components to ensure compliance Clean production room and equipment Perform duties as trained and assigned Maintain a clean organized work area Ability to follow oral and written instructions Ability to work in a fast paced manufacturing environment Must meet medical requirements for personal protective equipment (PPE) used in manufacturing Ability to work with Controlled Substances and all required procedures Completes assigned training curriculums within assigned time frames before performing any activity associated with the training topic Ensure documentation is completed and meet the prescribed standards Qualifications Education / Experience: High school diploma. Candidate must demonstrate mechanical aptitude, ability to speak, read and write in the English language and demonstrate the ability to perform basic mathematical calculations. Judgment / Decision Making: Ability to ascertain that work complies with approved standards and meets the prescribed guidelines of Noven Pharmaceuticals Inc. Must be able to operate production equipment with minimal supervision from the LMO. Employee must demonstrate the ability of adhering to stringent documentation requirements. Work Environment: Plant floor, pharmaceutical products. Physical Demands: The employee is occasionally required to climb, balance, stoop, kneel, and crouch. Must demonstrate the ability to lift and or move 50 pounds or greater.
    $21k-27k yearly est. Auto-Apply 7d ago
  • Manufacturing Operator II/III (2nd shift)

    Novo Nordisk 4.9company rating

    Durham, NC jobs

    About the Department For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. 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 Emerging Technologies -Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies. 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 manufacturing equipment to achieve production goals. Relationships Reports to Shift Manager. Essential Functions * Setup, operate, monitor & control equipment, systems & processes * Clean & sanitize manufacturing, filling & packaging rooms & equipment per SOPs * Execute production schedule to achieve production goals * Handle labeling & components correctly; transferring, counting, FIFO, returns, etc * Participate actively in & support event response * Read & follow SOPs, job instructions & other documents to ensure compliance * Identify, report & resolve quality issues * Assist during equipment maintenance, including restoration of lost function, predictive & preventative maintenance * Record/review production data in BPR & associated forms * Follow all safety & environmental requirements in the performance of duties * Other duties 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 Diploma or Equivalent required * Associate's Degree or Bioworks Certification preferred * Minimum of one (1) year of experience in manufacturing environment required * Minimum of one (1) year of experience in pharmaceutical solid dose manufacturing or other FDA regulated industry preferred * Ability to read, write & understand complicated product documentation & standard operating procedures with attention to detail required * Computer literacy including use of Microsoft Office suite programs required * Basic mechanical skills preferred We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger - a legacy of impact that reaches far beyond today. 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.
    $36k-43k yearly est. 6d ago
  • Manufacturing Operator I - 2nd shift

    Novo Nordisk 4.9company rating

    Durham, NC jobs

    About the Department For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. 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 Emerging Technologies -Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies. 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 manufacturing equipment to achieve production goals. (2nd shift Packaging - Monday through Thursday 4pm - 2:30am) includes 10% shift differential Relationships Reports to Shift Manager. Essential Functions + Setup, operate, monitor & control equipment, systems & processes + Clean & sanitize manufacturing, filling & packaging rooms & equipment per SOPs + Execute production schedule to achieve production goals + Handle labeling & components correctly; transferring, counting, FIFO, returns, etc + Participate actively in & support event response + Read & follow SOPs, job instructions & other documents to ensure compliance + Identify, report & resolve quality issues + Assist during equipment maintenance, including restoration of lost function, predictive & preventative maintenance + Record/review production data in BPR & associated forms + Follow all safety & environmental requirements in the performance of duties + Other duties 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 Diploma or Equivalent required + Associate's Degree or Bioworks Certification preferred + Minimum of one (1) year of experience in pharmaceutical solid dose manufacturing or other FDA regulated industry preferred + Ability to read, write & understand complicated product documentation & standard operating procedures with attention to detail required + Computer literacy including use of Microsoft Office suite programs required + Basic mechanical skills preferred We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger - a legacy of impact that reaches far beyond today. 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.
    $36k-43k yearly est. 5d ago
  • Machine Operator - 3rd Shift

    PL Developments Careers 4.6company rating

    Piedmont, SC jobs

    PL Developments, also known as PLD, is a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods Work schedule: Sunday - Thursday 10:00pm - 6:30am The Machine Operator is responsible for managing batch record documentation, operating and maintaining pouch filling machinery, and ensuring accurate preparation of ingredients. This role requires a meticulous approach to handling equipment, being detail-oriented, following precise procedures, and maintaining high standards of cleanliness and organization. JOB QUALIFICATIONS: High school diploma required. Associates degree in science, math, or mechanical engineering preferred. A minimum of 3 years complex machine operation experience required Must be able to communicate in English Excellent communication, mathematical and writing skills Attention to detail and ability to focus Ability to proactively view machine operation and determine problems/defects in advance of occurance Must be able to read and follow written directions Forklift certification needed (certification provider by PLDevelopments). Ability to work overtime as needed Willinginess to work on weekends Flexibility to accommodate various shifts, including first and second Ability to follow compound formulations Ability to handle multiple tasks with minimal supervision POSITION RESPONSIBILITIES: Record and complete batch record documents Set up pouch filling machine, operate PLC/HMI interface and changeover/clean intricate pieces of the assembly Determine batch characteristics, type and weight of ingredients to be used Select, pre-weigh ingredients to specification and to reconcile ingredient usage for each batch Wash and sanitize mixing tanks and other equipment as necessary PHYSCIAL REQUIREMENTS: Walking, standing, stooping and bending for long periods of time Must be able to pick up 50 lbs Must be able to work both in climate controlled and outdoor environments Comfortable with exposure to confined areas and chemicals BENEFITS: PLD is a proud employer offering many corporate benefits, including: ⠁ Medical and Dental Benefits ⠁ Vision ⠁ 401K with employer match ⠁ Group Life Insurance ⠁ Flex Spending Accounts ⠁ Paid Time Off and Paid Holidays ⠁ Tuition Assistance ⠁ Corporate Discount Program ⠁ Opportunities to Flourish Within the Company PL Developments is 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, disability, or veteran status. #HP1
    $26k-35k yearly est. 60d+ ago
  • Manufacturing Operator, Granulation & Blending (2nd Shift)

    ANI Pharmaceuticals 4.4company rating

    Trenton, NJ jobs

    About Us Welcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients' lives through the manufacturing and distribution of high-quality pharmaceutical products. With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike. We understand the importance of accessibility, and our products are available across a wide range of therapeutic areas, contributing to the well-being of communities globally. At ANI Pharmaceuticals, there are opportunities to contribute to our purpose every day. We value authenticity, knowledge, and hard work, we strive to celebrate our employees in a positive environment. Our culture empowers everyone to be successful and apply our full potential. About the Role The Manufacturing Operator will work alongside other members of the production team to operate and maintain production equipment in accordance with Standard Operating Procedures. The Manufacturing Operator will also document all aspects of production and maintenance (batch records, room usage, cleaning and operation details) in corresponding logbooks as dictated by ANI Standard Operating Procedures and FDA cGMP guidelines. The Manufacturing Operator should also have multiple years of experience with Granulation in a pharmaceutical production environment. Responsibilities * Operation of production equipment * Cleaning the production/ packaging rooms per Standard Operating Procedure * Cleaning, maintaining and operating production machinery as per Standard Operating Procedure * Following the instructions in the Batch Manufacturing Document while involved in production * Documenting production operation in the Batch Manufacturing Document * Documenting cleaning and operation details in the Equipment Log Book * Documenting room usage in the Room Log Book with cleaning and usage details * Complying to cGMP requirements of FDA in all steps of activities Skills * 3-5 years of experience with Granulation and Pharmaceutical Formulation * Solid working knowledge of FDA cGMP requirements Requirements: * Must be 18 years or older * High School Diploma or equivalent education * Must have the ability to perform repetitive work and meet ANI Pharmaceuticals standards * Must be able to read, comprehend and follow written and verbal instruction with accuracy * Must have the ability to read, comprehend and follow written and verbal procedures * Must have excellent accuracy/attention to detail * Must have good basic communication and interpersonal skills * Must be able to lift a minimum of 25 pounds. * Other preferred qualifications include the ability to wear personal protective clothing/equipment and hearing protection where provided and must be able to work varying shifts The base salary (hourly) range for this position is $16.00 - $35.00; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge. ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and paid time off. Many of these benefits are subsidized or fully paid for by the company.
    $32k-40k yearly est. Auto-Apply 27d ago
  • Manufacturing Operator I

    Cambrex 4.4company rating

    Longmont, CO jobs

    Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients. Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview The Manufacturing Operator will properly operate solid dose manufacturing equipment to perform production of drug products. Personnel in this position will operate manufacturing processing equipment by following standard operations procedures and batch records in accordance with FDA cGMPs. The main focus for personnel in this position will be responsible to operate, set-up and break down production equipment, clean production areas and maintain consumable supplies. Responsibilities Properly operates, sets-up and breaks-down production equipment. Maintains cGMP suites readiness for manufacturing activities including consumable allocation, cleaning of work area and tools and equipment disinfection. Performs minor mechanical maintenance of equipment. Maintains consumable supply inventory. Washes small utensils and glassware for department. Properly performs drug product manufacturing, packaging and labeling activities under direct supervision. Follows written procedures. Distributes clinical supplies. Clearly and accurately documents activities for production records and manufacturing equipment (production notebooks, cleaning logs, maintenance logs, etc) Perform basic math calculations. Assists with batch records for cGMP manufacturing under direct supervision. Other duties as assigned. Qualifications/Skills Mechanical aptitude is preferred Moderate knowledge of manufacturing equipment for cGMP environment Ability to wear Personal Protective Equipment (PPE). Understands and follows safety procedures and works in a manner to avoid injury to self and co-workers. Willingness to work with highly toxic and controlled substances. Ability to conduct routine in-process testing and visual inspections and identify out-of-specification conditions. Ability to work in a regulated environment (FDA/DEO/OSHA) and strictly follow procedures. Effectively communicates both verbally and in writing. Ability to read and comprehend detailed written instructions. Ability to clearly and concisely document al work activities in a timely manner utilizing existing forms and records. Writes legibly. Perform basic math functions to include product accountability and material adjustment calculations and rounding. Basic computer skills. Ability to move materials throughout facility using appropriate methods and equipment. Operate machinery and read process control instruments to ensure proper operation. Identify operations problems when they occur. Ability to clean rooms, equipment and tools for use in a cGMP environment. Perform basic troubleshooting applications. Provide basic training to other operators after learning a skill set. Minimal interaction. On an as needed basis. Exhibited leadership skill in individual area of expertise. Must have the ability to work overtime when required. Must adhere to attendance policy of Avista. Expected to arrive for shift on time and contact management immediately if unable to attend work for any period of time. May directly interact with auditors during a scheduled inspection. Ability to work effectively within a team environment. Education, Experience & Licensing Requirements High school diploma or equivalent with 0-5 years of experience in a regulated environment. The hiring range in Colorado for this position is $27/hr. -$33/hr. ; however, base pay offered may vary depending on job-related knowledge, education, skills and experience of the applicant, internal equity and alignment with market data. This hiring range encompasses several levels. This information is provided per the Colorado Equal Pay Act. This position includes a competitive benefits package. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. Supervision Received: Works under limited supervision. Physical Demands, Work Environment, and Travel Physical Demands 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop. The employee must be able to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds. Specific vision abilities required. Environment and Protective Equipment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet. Travel: Little to no expected travel time. Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law. #LI-SK1High school diploma or equivalent with 0-5 years of experience in a regulated environment. The hiring range in Colorado for this position is $27/hr. -$33/hr. ; however, base pay offered may vary depending on job-related knowledge, education, skills and experience of the applicant, internal equity and alignment with market data. This hiring range encompasses several levels. This information is provided per the Colorado Equal Pay Act. This position includes a competitive benefits package. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. Properly operates, sets-up and breaks-down production equipment. Maintains cGMP suites readiness for manufacturing activities including consumable allocation, cleaning of work area and tools and equipment disinfection. Performs minor mechanical maintenance of equipment. Maintains consumable supply inventory. Washes small utensils and glassware for department. Properly performs drug product manufacturing, packaging and labeling activities under direct supervision. Follows written procedures. Distributes clinical supplies. Clearly and accurately documents activities for production records and manufacturing equipment (production notebooks, cleaning logs, maintenance logs, etc) Perform basic math calculations. Assists with batch records for cGMP manufacturing under direct supervision. Other duties as assigned.
    $27-33 hourly Auto-Apply 20d ago
  • Supervisor Manufacturing

    Frontage Laboratories, Inc. 3.9company rating

    Exton, PA jobs

    Manufacturing Manager Title: Manager, Manufacturing Operations Reports to : Vice President, PD & Manufacturing Full-time Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position/Job Summary: The Manager Manufacturing Operations position is responsible for all aspects of Clinical Trial Material manufacturing for the company. Accountabilities include manufacturing staff supervision, facility and equipment qualification, technology transfer, scheduling, and management of manufacturing projects. Manufacturing projects span multiple disciplines including, but not limited to material sourcing, process development, analytical testing, and business development. Develop and implement technically sound batch records, SOPs, specifications, protocols, and reports as required, while adhering to CGMP and GDP. Manage manufacturing activities and interaction/compliance with clients and appropriate regulatory authorities as needed. Roles & Responsibilities: Manage the manufacturing and supply of clinical trial materials (CTM), for Oral Solid Doses and Sterile drug product for clinical studies from development till post-marketing. Manage a team of manufacturing technologists, operators, and warehouse coordinators. Interface with product development team for transfer of knowledge and processes for CTM Batch Manufacturing Collaborate with other teams including but not limited to product development, procurement, supply chain, analytical testing, quality assurance and business development to ensure proper project execution. Develop and implement technically sound clinical Manufacturing batch records, SOPs, protocols, and specifications as required. Manage review quality control records, Change Controls, CAPAs and other GMP related documents and support on-time closure of deviations and CAPAs. Partner with CMC project management for alignment on and prioritization within manufacturing timelines to deliver CTM. Write, review and approve SOP's, qualification protocols, and other GMP documentation. Develop and maintain strategic partnerships with technical and operational colleagues to optimally collaborate with other departments and clients. Implements site initiatives in production operation as advised by site management. Ensures manufacturing, testing and CTM labeling/shipping/packaging is done according to guidelines and specifications. Execution and overseeing of facility and equipment qualification/validation which includes authoring specification, protocols, and writing reports. Responsible for compliance monitoring of area operations. Participates in regulatory and customer audits/inspections. Collaborates with functional departments to resolve issues. Process and analyze manufacturing results, data and provide status updates to the management. Establish and maintain positive relationships with project stakeholders. Education, Experience & Skills Required: Bachelor's Degree in Pharmaceuticals, Engineering or Sciences 8+ years in the pharmaceutical industry. Strong experience in tech transfer, process development, facility & equipment validation/qualification, and pharmaceutical manufacturing. 5+ years of people management experience. Experience with cGMP guidelines and regulations. Strong knowledge of FDA, EMEA & ISO regulations. Strong oral and written communication and interpersonal skills. Ability to work well in a team environment, eager, adaptable. Ability to perform frequent physical tasks with strength and mobility. Experience in microbiology and sterile manufacturing is a plus. Salary and Benefits : Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
    $60k-85k yearly est. Auto-Apply 18d ago
  • Manufacturing Associate Level 3 (B Shift Days)

    Capsugel Holdings Us 4.6company rating

    Portsmouth, NH jobs

    Manufacturing Associate III The shift schedule is from 7am-7pm, on a rotational schedule every other week: Week 1: Sun, Wed, Thurs Week 2: Mon, Tues, Fri, Sat Shift differentials are included for weekends worked The Manufacturing Associate III is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. Level III associates are expected to be fully proficient in executing process recipes, following written procedures (SOPs), monitoring equipment and processes, independently performing laboratory tasks, including pH, conductivity testing, product sampling, and conducting routine sanitization tasks to maintain facility and equipment and train other operators on these tasks. They are expected to demonstrate a significant knowledge of cGMP compliance and an in-depth understanding of process flow and be able to make decisions based on that experience. Level III Operators are able to troubleshoot routine and non-routine equipment events, initiate deviations, review batch records and logbooks. What you will get: An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. Medical, dental and vision insurance. Our full list of global benefits can be found here: *************************************** What you will do: Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), troubleshooting issues and review documentation as appropriate. Demonstrate proficiency and understanding of suite-specific production activities and laboratory tasks such as bioreactor inoculation, chromatography column operation, product sampling, etc. and the scientific theory behind the operations. May train other associates on these tasks and theory. Administrative tasks - attending shift exchange, meetings, sending/receiving emails, participating in projects, technical writing (deviations, document change forms, etc.). Attain qualification for all assigned tasks and maintain individual training plan Perform material movements, transfer raw materials, chemicals into, out of, across the production areas. Maintain facility and equipment through routine cleaning and sanitization, support 6S programs. Perform other duties as assigned. What we are looking for: High School Diploma or equivalent. Bachelor's Degree preferred 2+ years GMP manufacturing experience preferred. Ability to wear appropriate PPE required Able to follow written procedures Proven logic and decision-making abilities, critical thinking skills Strong written and verbal communication skills required Able to navigate deadlines and a quickly changing environment About Lonza: At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board. Ready to shape the future of life sciences? Apply now.
    $74k-103k yearly est. Auto-Apply 13d ago
  • External Manufacturing Supervisor

    Bacardi-Martini 4.7company rating

    Jacksonville, FL jobs

    ABOUT YOU With a primary responsibility of leading contract manufacturing for Bacardi Jacksonville, the External Manufacturing Supervisor will provide strategic support to the business that ensures company goals and objectives are accomplished, in the most cost-efficient manner. Additionally, you they will manage communications between senior leaders and primos and actively liaise with internal and external executives on various projects and tasks related to contract manufacturing. RESPONSIBILITIES - WITH OUR CONSUMER AT THE HEART, YOUR KEY RESPONSIBILITIES WILL BE TO: External Manufacturing Oversight: · Develop and manage all external manufacturing processes, labor, information, and expenditures · Build and maintain a network of external manufacturing sites that support short- and long-term strategies · Ensure superb customer service and value beyond price Compliance & Standards: · Ensure all external manufacturing sites adhere to Bacardi standards (Quality, GMP, SLA) · Liaise with QEHS for compliance, quality, and corporate responsibilities · Ensure proper cost reporting and adherence to Bacardi financial standards Strategic Projects & Collaboration: · Support global and regional projects with emphasis on external manufacturing · Collaborate with procurement during negotiations and contract preparation · Liaise with Regional Tax and Customs & Excise teams to ensure compliance Process Improvement: · Develop and track KPIs for external manufacturers in support of Bacardi Operating System (BOS) · Drive continuous improvement and lean manufacturing initiatives · Co-lead intra-company and external best practices SKILLS - THE SKILLS AND EXPERIENCE NEEDED TO CREATE YOUR LEGACY: · Minimum 5 years of experience in bottling/packaging (FMCG, food & beverage, pharmaceutical, etc.) · Bachelor's degree in Business or Engineering required; Master's degree preferred · Experience in developing and overseeing budgets · Strong written and verbal communication skills · Excellent time management and ability to coordinate multiple projects · Proficiency in Microsoft Office and aptitude for learning new systems · Ability to maintain confidentiality and operate with integrity PERSONAL QUALITIES: · Leadership: Demonstrates the ability to lead cross-functional teams and external partners with confidence and clarity. · Strategic Thinking: Understands the broader business context and aligns manufacturing strategies with company goals. · Adaptability: Thrives in a fast-paced, dynamic environment and adjusts quickly to changing priorities. · Stakeholder Management: Builds strong relationships with internal and external stakeholders, fostering collaboration and trust. · Problem Solving: Approaches challenges with a proactive mindset and delivers effective, data-driven solutions. · Integrity: Maintains confidentiality and acts with professionalism and ethical responsibility. LEADERSHIP AGILITY At Bacardi we care deeply about finding brilliant talent who can bring the following personal attributes to help elevate our 3Fs: Fearless, Family, Founder culture to the next level. Belonging: You have a strong capacity to create a culture of ‘Belonging', where people feel appreciated for who they are, what they do, and who they can become Self-Awareness: You have high levels of self-awareness, are reflective and know yourself well, understanding both your own strengths and weaknesses and your impact on others People Agility: You bring a deep ability to understand and relate to people and navigate through tough situations to harness and multiply collective performance Results Agility: You demonstrate consistent delivery of results in first-time situations by inspiring teams, exhibiting a presence that builds confidence in yourself and others. Mental Agility: You can think critically to penetrate complex problems and expand the possibilities by making fresh connections. You think strategically whilst being execution focused and bring creativity to the challenges you're presented with Change Agility: You have a deep natural curiosity, desire to experiment and ability to effectively deal with the heat of change. You have a growth and learning mindset: ready to test, stumble, learn and apply from experience Disclaimer: Bacardi seeks talent from all backgrounds to bring diversity of thought, agility and capability to our organization across the globe. We promote a working environment where all employees are treated and rewarded fairly. We do not tolerate any form of discrimination that adversely affects individuals or groups on the basis of national origin, race, color, religion, sex, gender, sexual orientation, marital status, disability, age, and any other legally protected aspect of a person's identity. U.S. applicants have rights under Federal Employment Laws. Perks of Working for us At Bacardi, we are committed to providing our Primos (employees) with a comprehensive Total Rewards package of compensation, benefits, incentives, allowances, well-being, and much more to meet the needs of themselves and their families. It goes beyond just Cash! The total rewards program is based on pay for performance, whereby the incentive programs are linked to company and individual performance. Compensation, Paid Time Off & Retirement: Competitive Pay Package Competitive Holiday/Paid Time Off, plus additional days offered ( i.e., volunteer day, allowing you to give back to the community) Retirement/Pension Plan Health & Wellbeing Medical, Critical Illness, and Life Insurance Calm Meditation App subscription (free) Employee Assistance Programs Best-in-class, family-friendly, and inclusive leave policies Additional Benefits The benefits /perks may vary depending on the nature of your employment with Bacardi, your work location, and are subject to change. Some benefits may be subject to an employee contribution. Some benefits may be fully or partially subsidized. Incentive plans are linked to the nature of your employment and can vary based on region, market, function or brand.
    $49k-67k yearly est. Auto-Apply 7d ago
  • GMP Manufacturing Supervisor (Nights) - Cell Therapy

    Capsugel Holdings Us 4.6company rating

    Portsmouth, NH jobs

    Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their idea, big and small, genuinely improve the world, and that's the kind of work we want to be a part of. The Manufacturing Technical Supervisor will provide a safe, controlled work environment in all areas of responsibility. He or she must be aware of the site safety objectives and make sure they are communicated and understood by all staff. The Manufacturing Technical Manager will act as the Subject Matter Expert in the assigned area (i.e. Cell Growth, Drug Product Filling, etc.) during manufacturing operations until the manufacturing staff is fully proficient. The Manufacturing Technical Supervisor will provide in suite oversight of the manufacturing process during critical operations (i.e. harvest, vial filling, visual inspection, etc.) Work with Internal and Joint Project Teams to bring on and maintain customers' processes in production facility. Responsible for all tech transfers from a manufacturing standpoint. The Manufacturing Technical Manager must attend the lessons learned events for the Cell Therapy (CT) area and own actions for manufacturing. Own and manage planned deviations and change controls related to start-up of Cell Therapy. Provide/Arrange effective trainings for manufacturing staff related to any new equipment or systems to be used in Cell Therapy. Collaborate with Manufacturing Supervisor(s) to incorporate process and operational improvements into new customer processes in manufacturing. Collaborate with Senior Manufacturing Manager to determine equipment and materials the suite will need to purchase in order to run the process. May be required to provide input to Head of Emerging Technology and/or Senior Manager for budgetary/financial planning. May act as fill in for Senior Manufacturing Manager in their absence. Key Responsibilities Support the definition and execution of Operational Readiness Activity for all Emerging Technology projects at Lonza Portsmouth (LPO) to include. Set up of manufacturing procedures & collaboration with Quality Assurance (QA) to develop & execute quality systems aligned with existing operations & finished dose requirements. Support building & establishing the manufacturing team. Delivery of clinical & commercial material as required. Support the development and execution of appropriate Safety, Training, Gowning, Material, Visual Inspection, Cleaning, and Scheduling. Support the definition and execution of all activity in compliance with environmental health and safety (EHS) requirements. Provide oversight and support to the definition and execution of Technical Transfer activities for Cell Therapy Projects at LPO to include operational input into material requirements, process execution & methods transfer, operational input into defining & executing manufacturing activity related to Technical Transfer - water runs, training runs, particle runs, engineering runs etc. Enable timely delivery of milestones for the Technical Transfer. Coordination with Portsmouth Mammalian Operations and customer technical team. Timely and accurate financial reporting of project progress & revenue status Progression of proposals and change orders. Appropriate interaction with key external (customer) and internal stakeholders. Perform other duties as assigned. Key Requirements Related working knowledge with degree, significant work experience without degree required BS Preferred, additional experience in lieu of degree considered Direct interaction with regulatory agencies Core involvement in Technical Transfer and project activity Leadership of organizational change, staff hiring and training Continuous Improvement activities Generation and optimization of electronic batch documentation Experience of biological manufacturing operations - Fermentation, Purification, Drug Product Filling and Freezing processes. Experience operating automated Drug Product Filling machines using Isolator technology Experience of Autologous / cross training environments requiring innovative resourcing solutions preferred Experience of automated and manual visual inspection systems preferred. Solid staff management experience and proven ability to manage budgets. Ability to work inter-departmentally and potentially with customers. Excellent leadership skills a must. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
    $74k-106k yearly est. Auto-Apply 21d ago
  • GMP Manufacturing Supervisor (Nights)

    Capsugel Holdings Us 4.6company rating

    Portsmouth, NH jobs

    Posted Job Advert The actual location of this job is in Portsmouth, NH. Relocation assistance is available for eligible candidates and their families, if needed. Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of. Join a global team of over 18,000 people making a meaningful difference from day one. As a GMP Manufacturing Supervisor at our Portsmouth site you will coordinate and support production activities for Cell and Gene processes. Find out more about what a life at Lonza in Portsmouth, NH could look like for you by watching this short video. What you'll get: An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. Medical, dental and vision insurance. The full list of our global benefits can be also found on *************************************** What you'll do: Coordinate and support the execution of Cell and Gene production activities, ensuring compliance with ET and site quality systems. Lead and develop the manufacturing team to meet business needs and career goals. Support the timely and complete delivery of clinical and commercial materials. Coordinate various strategies, including EHS, Training, Gowning, Material, Visual Inspection, APS, Cleaning, Scheduling, Financial Management and EM. Maintain manufacturing areas to the highest cleanliness and 6S standards. Support technology transfer activities and ensure timely goal achievement. Establish methods and procedures for attaining specific goals. What we're looking for: BS degree preferred significant experience may be considered in lieu of degree. Minimum 5 years related experience with a degree or 8 years without. Proven experience in biological GMP manufacturing operations. Strong leadership and team development skills. Ability to coordinate complex projects and ensure timely delivery. Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
    $74k-106k yearly est. Auto-Apply 51d ago
  • Supervisor, Radiopharmaceutical Manufacturing (3rd Shift)

    Northstar Medical Radioisotopes 4.4company rating

    Beloit, WI jobs

    Join the best radiopharmaceutical company in the world! If you're looking to make an impact while building a meaningful career in a specialized, fast-growing field, NorthStar Medical Radioisotopes is the place to do it. NorthStar Medical Radioisotopes is a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer. At the forefront of NorthStar's technological innovation is scientific excellence, using first-in-kind electron accelerator technology and integrated campus capabilities to drive progress in radiopharmaceutical manufacturing. Our work is driven by a meaningful mission-advancing life-saving radiopharmaceutical development and ensuring a reliable supply of critical medical isotopes for patients in need. As a rapidly growing organization operating on the cutting edge of science, we offer exceptional career growth and professional development opportunities, supported by world-class facilities and a competitive benefits package. Position The Supervisor, Radiopharmaceutical Manufacturing will be responsible for leading daily production activities, ensuring compliance with all regulatory standards, safety standards, and company policies. This role is responsible for delivering all types of batches, including but not limited to clinical and commercial client batches per schedule and contract obligations. This position will lead and mentor a team, efficiently allocate resources, and continuously seek to enhance production processes to optimize operational efficiency. This position plays a key role in maintaining the integrity and safety of the manufacturing environment which is essential for the successful delivery of clinical and commercial radiopharmaceutical products. Responsibilities Manage the day-to-day activities and personnel to ensure efficient manufacturing of products to meet the master production schedule ensuring compliance with regulatory requirements, while maintaining high safety standards. Provide leadership, training, and support to the team. Responsible for the performance of team members and ensuring training requirements are achieved. Monitor and enforce strict quality assurance procedures and key operational metrics to meet the specifications of each product. Address and resolve any issues related to equipment, processes, or personnel in a timely and effective manner with proper communication and/or escalation as needed. Effectively communicate with essential manufacturing support groups to ensure clarity on product specifications, address any escalations promptly, and coordinate delivery schedules. Regularly update management on production status and any critical issues. Responsible to ensure complete and accurate records are maintained for Radiopharmaceutical Manufacturing (Batch Production Record) according to customer and/or Product Development orders. Assist leader in maintaining the department's budget, focusing on the efficient allocation and utilization of resources by monitoring monthly production expenditures. Collaborate with the manufacturing support teams to allocate resources effectively, supporting the technology transfer and process scale-ups in radiopharmaceutical manufacturing to meet business needs and product development goals. Early Development After 3 months, you will: Demonstrate a strong understanding of foundational cGMP requirements and just‑in‑time radiopharmaceutical manufacturing principles, with the ability to guide team members in applying them consistently. Obtain qualification as a Radiation Worker, including training in ALARA principles and isotope‑specific safety protocols, enabling you to model best practices and reinforce a strong safety culture. Build effective working relationships with cross‑functional partners-including Quality, Science, and Engineering-to support operational coordination and ensure timely, compliant delivery of radiopharmaceutical products. Gain expertise with NorthStar's advanced manufacturing systems and processes, preparing you to oversee daily operations and support the development of technical staff. After 6 months, you will: Contribute to Operational Excellence by managing team performance against key KPIs and implementing process improvements that enhance production efficiency, safety, and product quality. Achieve Qualified Operator status and obtain qualifications as a licensed Authorized User, with the capability to oversee and support the team in executing full batch manufacturing of novel isotopes while ensuring adherence to defined regulatory standards and procedures. Develop and lead a high performing organization, positioning yourself as a key leader who drives team capability, fosters continuous improvement, and supports the growth of cutting‑edge manufacturing operations. Fully integrate into NorthStar's mission to transform oncology care, actively supporting a high‑performing team that enables global access to innovative radiopharmaceutical therapies. Qualifications Associate's Degree (AS) in a STEM discipline and minimum four (4) years of cGMP experience; or equivalent combination of education and experience. Minimum one (1) year of experience leading others required. Please note the company cannot provide immigration-related sponsorship (including H-1B status, O-1 status, Optional Practical Training support, etc.) for this position. Each successful applicant will be required to complete the Form I-9, Employment Eligibility Verification, demonstrating both identity and employment authorization, on or before the first day of employment. Under federal law, only truthful information may be provided on the Form I-9. Shift Information Third shift hours are Monday - Thursday 9pm - 7:30am (shift ends Friday morning). During this position's training period (approximately 60 days), the ability to work alternate shifts is required. Primary shift placement will occur upon completion of the training program. Additionally, this position supports production in a 24-hour manufacturing facility. Working occasional overtime, weekends, and holidays is required. Benefits Medical, dental, and vision insurance Healthcare Flex Spending Account (FSA) and Dependent Care FSA Company-paid short-term and long-term disability Company-paid life insurance & AD&D coverage Pet insurance 401(k) match Paid holidays and paid time off (PTO) Paid parental leave Bonus plan Equity Incentive Program Working Conditions This role may involve working in a controlled cleanroom environment, general office setting, or specific manufacturing areas. Conditions may include: Exposure to varying temperatures, both indoors (heated/air-conditioned spaces) and outdoors Noise levels range from quiet to loud, depending on the work area Specific vision abilities, including near vision, visual acuity, and color discrimination Personal Protective Equipment (PPE) is required and may include: Respirators, gloves, safety glasses, and full protective clothing Compliance with cleanroom gowning protocols (e.g., removal of all jewelry, including piercings) Prohibition of cosmetics, fragrances (perfume, aftershave), and nail products, including polish, artificial nails, or extensions As a radiopharmaceutical manufacturing site, radiation may be present in the laboratory and production areas. Employees in this role may be required to: Follow strict radiation safety procedures Participate in dosimetry monitoring and bioassay testing as part of the company protocol Inform leadership of any health conditions that may affect product integrity, by cleanroom standards Location NorthStar Medical Radioisotopes is proud to call Beloit, Wisconsin home. Our headquarters and primary manufacturing facility are located in this vibrant, growing community that combines the charm of a small city with the advantages of a central Midwest location. Beloit features a lively, revitalized downtown filled with local restaurants, shops, and cultural events, and is just a short drive from major metropolitan areas including Madison, Milwaukee, Chicago, and Rockford. Situated in the heart of the South Central Wisconsin and Northern Illinois region, Beloit offers a rare blend of urban amenities and scenic natural surroundings. Whether you're drawn to outdoor recreation, educational institutions, the arts, or historic landmarks, the area provides rich and diverse experiences for all interests. A variety of nearby communities, ranging from rural towns to suburban neighborhoods, offer flexible housing options and access to multiple school districts, making Beloit an excellent choice for individuals and families considering relocation. NorthStar Medical Radioisotopes is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
    $58k-77k yearly est. Auto-Apply 2d ago

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