Post job

Manufacturing Associate jobs at Vericel Corp

- 95 jobs
  • Associate I, Cell Therapy Manufacturing

    Vericel Corporation 4.2company rating

    Manufacturing associate job at Vericel Corp

    At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care). Position Summary: The Associate I, Cell Therapy Manufacturing is responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements. Schedule: This role will be required to work on-site Sun-Wed or Wed-Sat. Position Scope: Perform manufacturing procedures inside a manufacturing clean room in accordance with established SOPs, cGMPs, and safety regulations. Qualified to perform aseptic manipulations of cell culture operations. Document all operations in Electronic Batch Records and log sheets according to cGMPs and established SOPs. Maintain manufacturing-controlled areas in an inspection ready state. Perform clean room equipment sanitization. Record equipment and facility metrology data to ensure the equipment operates within specifications. Report out of specification readings to production management. Able to work independently upon completion of training. Be receptive to feedback and guidance from manager and other more experienced staff. Ability to organize, plan and manage time to effectively complete daily tasks. The ability to cooperate with others in a team environment will be critical to success. Practice safe work habits and adhere to Vericel's safety procedures and guidelines. Able to make cell-culture decisions based on cell observations and guidelines in written procedures. Assist in reviewing and revising production documents (SOP's and electronic records). Fully trained in at least one unit operation in both product lines. Ability to identify and report deviations and contribute to deviation investigations. In addition to being fully qualified in MACI or Epicel, cross train and qualify in at least one core competency e.g. 3T3, Media Prep, GP, TrackWise, Veeva. Achieve Qualified Trainer status. Other duties as assigned. Qualifications: Bachelor's degree (Life Sciences or related field) with 0 - 2 years of experience working in a cGMP environment in the biotechnology/pharmaceutical industry or Biotechnology certificate with 1 - 2+ years of experience working in a cGMP environment in the biotechnology/pharmaceutical industry or HS diploma/GED with 4 - 6+ years of cGMP experience. Excellent communication skills, written and verbal. Experience with Microsoft Office suite. Experience in small scale tissue culture processing (preferred). Experience working within a regulated environment that is frequently audited by internal and external Agencies, such as the FDA and ISO (preferred). Ability to sit for long periods of time while performing cell culture operations. Ability to lift, carry, push and pull up to 50 lbs. Ability to work 1 weekend day and rotating holiday coverage. Ability to gown and gain entry to manufacturing areas. Why Vericel? Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care. Career Growth: Be a part of a growing organization with opportunities to expand your impact. Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives. The hourly wage range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $23.08 to $27.40 per hour. The actual salary offered will be determined based on factors such as the candidate's qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above. In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited. EEO Statement All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer. Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.
    $23.1-27.4 hourly Auto-Apply 60d+ ago
  • Associate I, Cell Therapy Manufacturing

    Vericel Corporation 4.2company rating

    Manufacturing associate job at Vericel Corp

    At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care). Position Summary: The Associate I, Cell Therapy Manufacturing is responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements. Schedule: This role will be required to work on-site Sun-Wed or Wed-Sat. Position Scope: Perform manufacturing procedures inside a manufacturing clean room in accordance with established SOPs, cGMPs, and safety regulations. Qualified to perform aseptic manipulations of cell culture operations. Document all operations in Electronic Batch Records and log sheets according to cGMPs and established SOPs. Maintain manufacturing-controlled areas in an inspection ready state. Perform clean room equipment sanitization. Record equipment and facility metrology data to ensure the equipment operates within specifications. Report out of specification readings to production management. Able to work independently upon completion of training. Be receptive to feedback and guidance from manager and other more experienced staff. Ability to organize, plan and manage time to effectively complete daily tasks. The ability to cooperate with others in a team environment will be critical to success. Practice safe work habits and adhere to Vericel's safety procedures and guidelines. Able to make cell-culture decisions based on cell observations and guidelines in written procedures. Assist in reviewing and revising production documents (SOP's and electronic records). Fully trained in at least one unit operation in both product lines. Ability to identify and report deviations and contribute to deviation investigations. In addition to being fully qualified in MACI or Epicel, cross train and qualify in at least one core competency e.g. 3T3, Media Prep, GP, TrackWise, Veeva. Achieve Qualified Trainer status. Other duties as assigned. Qualifications: Bachelor's degree (Life Sciences or related field) with 0 - 2 years of experience working in a cGMP environment in the biotechnology/pharmaceutical industry or Biotechnology certificate with 1 - 2+ years of experience working in a cGMP environment in the biotechnology/pharmaceutical industry or HS diploma/GED with 4 - 6+ years of cGMP experience. Excellent communication skills, written and verbal. Experience with Microsoft Office suite. Experience in small scale tissue culture processing (preferred). Experience working within a regulated environment that is frequently audited by internal and external Agencies, such as the FDA and ISO (preferred). Ability to sit for long periods of time while performing cell culture operations. Ability to lift, carry, push and pull up to 50 lbs. Ability to work 1 weekend day and rotating holiday coverage. Ability to gown and gain entry to manufacturing areas. Why Vericel? Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care. Career Growth: Be a part of a growing organization with opportunities to expand your impact. Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives. The hourly wage range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $23.08 to $27.40 per hour. The actual salary offered will be determined based on factors such as the candidate's qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above. In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited. EEO Statement All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer. Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.
    $23.1-27.4 hourly Auto-Apply 60d+ ago
  • Manufacturing Associate - Warsaw - 2nd Shift

    Tecomet, Inc. 4.7company rating

    Warsaw, IN jobs

    Manufacturing Associate The Manufacturing Associate will provide assistance throughout the plant as needed by performing simple machine operation and other miscellaneous production and shipping tasks as assigned, while assisting in achieving Tecomet's Principles of Safety, Quality, Customer Satisfaction and Innovation. Principle Responsibilities Operate machines and/or perform simple production tasks in the manufacture of Tecomet products. Operate machines that have already been set up. Prepare and load parts as instructed. Perform assembly. Perform simple inspections during production to detect quality problems. Ensure material and required documentation is complete and correct, and that certifications are present. Verify certifications with customer print specifications and router procedures. Additional functions and requirements may be assigned by supervisors and/or management as deemed appropriate. Qualification Requirements Credentials/Experience: High school diploma or general education degree (GED). Knowledge, Skills, and Abilities: Manufacturing operations. Measuring devices. Finish work efficiently and volunteer to help in other areas. Help others keep additional machines running. Learn additional machine operations or production tasks to become available for additional responsibilities while maintaining quality and productivity at or above required performance levels. Consistently produce at superior levels of quality and productivity. Use communication with co-workers to improve unit production. Be flexible in accepting new tasks and new ways of doing things. Adjust work hours to fit production needs Accurately use calipers, micrometers, and other precision measurement devices after training period. Read, write clearly, and follow written procedures. Efficiently operate a computer. Other Requirements Work Environment 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. Physical Requirements The employee could frequently be required to walk; use hand to finger, handle, or feel; reach with hands and arms and talk or hear. The employee could be required to sit; climb or balance and stoop, kneel, crouch, or crawl. The employee could occasionally lift and or move up to 50 pounds. Specific vision abilities required by the job could include close vision, distance vision, peripheral vision and ability to adjust focus. Travel Requirements No Americans with Disabilities Act (ADA): Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
    $28k-39k yearly est. Auto-Apply 60d+ ago
  • Manufacturing Associate - Weekend Shift

    Tecomet, Inc. 4.7company rating

    Claypool, IN jobs

    Manufacturing Associate The Manufacturing Associate will provide assistance throughout the plant as needed by performing simple machine operation and other miscellaneous production and shipping tasks as assigned, while assisting in achieving Tecomet's Principles of Safety, Quality, Customer Satisfaction and Innovation. Principle Responsibilities Operate machines and/or perform simple production tasks in the manufacture of Tecomet products. Operate machines that have already been set up. Prepare and load parts as instructed. Perform assembly. Perform simple inspections during production to detect quality problems. Ensure material and required documentation is complete and correct, and that certifications are present. Verify certifications with customer print specifications and router procedures. Additional functions and requirements may be assigned by supervisors and/or management as deemed appropriate. Qualification Requirements Credentials/Experience: High school diploma or general education degree (GED). Knowledge, Skills, and Abilities: Manufacturing operations. Measuring devices. Finish work efficiently and volunteer to help in other areas. Help others keep additional machines running. Learn additional machine operations or production tasks to become available for additional responsibilities while maintaining quality and productivity at or above required performance levels. Consistently produce at superior levels of quality and productivity. Use communication with co-workers to improve unit production. Be flexible in accepting new tasks and new ways of doing things. Adjust work hours to fit production needs Accurately use calipers, micrometers, and other precision measurement devices after training period. Read, write clearly, and follow written procedures. Efficiently operate a computer. Other Requirements Work Environment 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. Physical Requirements The employee could frequently be required to walk; use hand to finger, handle, or feel; reach with hands and arms and talk or hear. The employee could be required to sit; climb or balance and stoop, kneel, crouch, or crawl. The employee could occasionally lift and or move up to 50 pounds. Specific vision abilities required by the job could include close vision, distance vision, peripheral vision and ability to adjust focus. Travel Requirements No Americans with Disabilities Act (ADA): Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Equal Opportunity / Affirmative Action Employer / Protected Veterans / Disabilities/Drug Free Workplace Tecomet, Inc is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, gender identity, religion, sexual orientation, national origin, disability, genetic information, pregnancy, protected veteran status, or any other protected characteristic as outlined by federal, state, or local laws.
    $28k-39k yearly est. Auto-Apply 60d+ ago
  • Manufacturing Associate, LNP

    Crispr Therapeutics AG 4.6company rating

    Framingham, MA jobs

    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 $40.00 per hour to $44.00 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: ***********************************************
    $40-44 hourly 38d ago
  • Manufacturing Associate, LNP

    Crispr Therapeutics 4.6company rating

    Framingham, MA jobs

    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 $40.00 per hour to $44.00 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: ***********************************************
    $40-44 hourly Auto-Apply 39d ago
  • Manufacturing Associate II

    Immatics 4.3company rating

    Houston, TX jobs

    J oin Immatics and shape the future of cancer immunotherapy ; one patient at a time! Immatics is committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of PRAME, a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCR bispecifics. Why Join Us? Innovative Environment: Help to pioneer advancements in cancer immunotherapy. Collaborative Culture: Be part of a diverse team dedicated to your professional growth. Global Impact: Contribute to therapies that make a lasting impact on patients globally. We are seeking a Manufacturing Associate II to support our CMC-GMP Manufacturing team. The Manufacturing Associate will be responsible for performing complex, highly specialized and time sensitive technical cell manipulation and testing procedures on irreplaceable cellular products during clinical manufacturing. FLSA Classification: Hourly, Non-Exempt Schedule: 8:00 AM - 5:00 PM; Monday to Friday; On-site This is a critical position and may require working overtime, after-hours, weekends, or holidays to ensure business continuity. Reports to: Manufacturing Manager Location: Manufacturing personnel alternate between the current office and manufacturing locations. Weatherford - 13203 Murphy Rd. Stafford, TX 77477 UTHealth Science Center-1941 East Rd, BBSB 6102 Houston, TX 77054 What You'll Do: As a Manufacturing Associate, you will play a key role in supporting our Manufacturing operations: Fulfill the operator and verifier roles in performing cell growth and manipulation procedures such as cell enrichment, cell culture, cellular product cryopreservation, cell product thaw/wash. Accurately perform procedures in compliance with FDA's Good Laboratory Practices, Good Manufacturing Practices, Good Tissue practices, as well as standards set by other accreditation agencies including but not limited to FACT, CAP, and CLIA. Adhere to ALCOAC++ and cGDocP requirements while accurately performing procedures and maintaining documentation in compliance with SOPs. Document deviations and events, notify supervisor and quality management personnel in a timely manner and assist in investigation of root cause and any required corrective actions. Responsible for aseptic handling of reagents and products to ensure the integrity and sterility of cellular products until final infusion to the patient. Must adhere to special cleaning and gowning requirements for the facility requiring specialized gowning such as masks, sterile jumpsuits, hair and shoe covers. Ability to work productively and to participate in a highly creative and fast-paced environment Secondary Functions: Independently perform calculations to determine cell viability, dilutions, and cell concentrations. Completes all appropriate logs and trackers. Maintains GMP cleanliness: autoclaving, bleaching liquid waste, removing waste, general cleanliness and organization of the office and facility. Maintains knowledge regarding donor evaluation, screening and testing, labeling and product acceptability and release criteria. Conducts activities to support study plans, and IQ/OQ/PQs. Provide input or feedback regarding change controls, WI, SOPs, study plans, reports, deviations, OOS/OOE, and CAPA's as directed. Performs routine equipment maintenance and troubleshooting. Prepares and presents manufacturing summaries, as needed. Required Experience and Education: Biomanufacturing Technology Associate of Applied Science Degree, Biomanufacturing Technology Level 2 Certificate, or equivalent. or Associate Degree in Biology, Biochemistry, Biotechnology, Biomanufacturing or other related field. Two (2) to Four (4) years of cell therapy manufacturing experience. Preferred Experience and Education: Bachelor's Degree in Biology, Biochemistry, Biotechnology or other related field. Four (4) years of cell therapy manufacturing experience. Competencies Independent Working- routine tasks with limited supervision; non-standard tasks with close supervision. Communication- clear and efficient verbal and written communication; common courtesy; interaction mainly limited to own team (peers and supervisor) Problem Solving- ability to identify, deeply analyze and communicate problems; basic ability to develop suitable solutions. Critical Thinking- basic reflection on standard processes; identification of basic need and room for improvement within own or narrow scope. Initiative- high degree of initiative and intrinsic motivation to exceed basic expectations of own tasks and responsibilities. Organizational & Prioritization Skills- basic organization skills required to structure own daily tasks according to predefined work packages, schedule and standard lab processes; prioritization in close interaction with supervisor. Coachability- receive pre-defined trainings essential for area of responsibility; high responsiveness to constructive criticism and basic ability to autonomously reflect on required improvements; timely implementation of suggested improvements. Leadership Skills, Training & Supervision- basic leadership skills required for on-the-job trainings and guidance/support of (new) team members (e.g. providing and receiving feedback, empathy, honesty, reliability); train, instruct and coordinate E level; train D & C level during onboarding Work Environment: Typical office environment with moderate noise levels (~20% of work hours). Uses phone, computer, office equipment and supplies on a regular basis. cGMP clean room spaces and facilities (~80% of work hours). Grade A/B/C/D GMP environment with associated facility noise levels. Uses cleanroom phone, computer, variety of equipment and reagent/supplies. General unclassified laboratory spaces, as needed. Common laboratory equipment and noise levels While performing the duties of this job, the employee routinely handles blood components and is occasionally exposed to temperatures between -196°C and 40°C, liquid nitrogen, liquid nitrogen vapor, dry ice, and carbon dioxide. Travel required: Travel may be required between the office building and manufacturing facility on a daily basis Physical demands: Carrying- to transport an object - usually by holding it in the hands or arms but may occur on the shoulder. Climbing- moving up or down step stools or ladders while maintaining balance Communicating Verbally - expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly, or quickly. Feeling- the ability to detect different materials or temperatures with fingers and hands. Gowning- sitting or standing to don or remove sterile PPE. Hearing - the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds. Typing - entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others. Lifting - raising or lowering an object (up to 25 lbs.) from one level to another (includes upward pulling). Near Visual Acuity - clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers). Undergo and pass a color blindness evaluation and assessment of vision abilities required for this position. Pushing - Exerting force upon an object so that the object moves away from the object. Must be able to push carts and gas tanks on rolling wheels (approximately 50 lbs.). Pulling - Exerting force upon an object so that the object moves toward the force. Must be able to pull carts and gas tanks on rolling wheels (approximately 50 lbs.) Reaching- Extending both hands and/or arms perpendicular to the floor and in front of your body towards an object for extended periods of time. Sitting - remaining in a sitting position for at least 50% of the time. Standing/Walking - remain on one's feet in an upright position at a workstation. Stooping - occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscle Work authorization/security clearance requirements: Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment Affirmative Action/EEO statement: Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. What do we offer? At Immatics, we believe in investing in our team's health, safety and well-being. Here's what you can expect if you join Immatics Comprehensive Benefits: Competitive rates for Health, Dental, and Vision Insurance 4 weeks of Paid Time off, granted up front each year and prorated for first and last year of employment. Sick Time Off - 56 hours 12 Paid Holidays 100% Employer-Paid Life Insurance up to at 1x annual salary 100% Employer Paid Short- and Long-Term Disability Coverage 401(k) with Immediate Eligibility & company match… You are eligible for 401(k) plan participation as of your first paycheck. The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment. Partially paid Parental Leave for eligible employees. (3 weeks) Additional voluntary employee paid coverages including Accident, Hospital Indemnity, and Critical Illness Employee Paid Identity Theft Protection and Pet Insurance. Professional Growth: Opportunities to work with leading experts in the field of T-cell immunotherapy. Company provided learning and development opportunities Fast paced, high demand collaborative and dynamic environment.
    $26k-34k yearly est. Auto-Apply 42d ago
  • Manufacturing Associate II - Second Shift

    Immatics 4.3company rating

    Houston, TX jobs

    J oin Immatics and shape the future of cancer immunotherapy ; one patient at a time! Immatics is at the forefront of immunotherapy innovation, working to harness the power of T cells to transform cancer treatment. Immatics is an exceptional clinical-stage biopharmaceutical company active in the discovery and development of T cells redirecting cancer immunotherapies. We use these powerful T cells to develop groundbreaking immunotherapies that target cancer cells. We are dedicated to transforming cancer treatment and improving patient outcomes through cutting-edge research and advanced TCR technology. Why Join Us? Innovative Environment: Help to pioneer advancements in cancer immunotherapy. Collaborative Culture: Be part of a diverse team dedicated to your professional growth. Global Impact: Contribute to therapies that make a lasting impact on patients globally. We are seeking a Manufacturing Associate II to support our CMC-GMP team. The Manufacturing Associate II will be responsible for performing complex, highly specialized and time sensitive technical cell manipulations and testing procedures on irreplaceable cellular products during clinical manufacturing. FLSA Classification: Hourly, Non-Exempt Schedule: 1230 - 2100; Monday to Friday; On-site Reports to: Associate Manufacturing Manager Location: 13203 Murphy Road Suite 100 Stafford, TX 77477 What You'll Do: As a Manufacturing Associate II, you will play a key role in supporting our manufacturing operations: Knowledge of current cGMP. Fulfill the operator and verifier roles in performing cell growth and manipulation procedures such as cell enrichment, cell culture, cellular product cryopreservation, cell product thaw/wash. Accurately perform procedures in compliance with FDA's Good Laboratory Practices, Good Manufacturing Practices, Good Tissue practices, as well as standards set by other accreditation agencies including but not limited to FACT, CAP, and CLIA. Adhere to ALCOAC++ and cGDocP requirements while accurately performing procedures and maintaining documentation in compliance with SOPs. Document deviations and events, notify supervisor and quality management personnel in timely manner, and assist in investigation of root cause and any required corrective actions. Responsible for aseptic handling of reagents and products to ensure the integrity and sterility of cellular products until final infusion to the patient. Must adhere to special cleaning and gowning requirements for the facility requiring specialized gowning such as masks, sterile jumpsuits, hair and shoe covers. Ability to work productively and to participate in a highly creative and fast-paced environment. Secondary Functions: Independently perform calculations to determine cell viability, dilutions, and cell concentrations. Completes all appropriate logs and trackers. Maintains GMP cleanliness: autoclaving, bleaching liquid waste, removing waste, general cleanliness and organization of the office and facility. Maintains knowledge regarding donor evaluation, screening and testing, labeling and product acceptability and release criteria. Conducts activities to support study plans, and IQ/OQ/PQs. Provide input or feedback regarding change controls, WI, SOPs, study plans, reports, deviations, OOS/OOE, and CAPA's as directed. Performs routine equipment maintenance and troubleshooting. Prepares and presents manufacturing summaries, as needed Required Experience and Education: Bachelor's degree in biology, Biochemistry, Biotechnology or another related field. Two (2) to Four (4) years of cell therapy manufacturing experience. Preferred Experience and Education: Bachelor's degree in biology, Biochemistry, Biotechnology or another related field. Four (4) years of cell therapy manufacturing experience. Competencies: Independent Working- routine tasks with limited supervision; non-standard tasks with close supervision. Communication- clear and efficient verbal and written communication; common courtesy; interaction mainly limited to own team (peers and supervisor) Problem Solving- ability to identify, deeply analyze and communicate problems; basic ability to develop suitable solutions. Critical Thinking- basic reflection on standard processes; identification of basic need and room for improvement within own or narrow scope. Initiative- high degree of initiative and intrinsic motivation to exceed basic expectations of own tasks and responsibilities. Organizational & Prioritization Skills- basic organization skills required to structure own daily tasks according to predefined work packages, schedule and standard lab processes; prioritization in close interaction with supervisor. Coachability- receive pre-defined training essential for area of responsibility; high responsiveness to constructive criticism and basic ability to autonomously reflect on required improvements; timely implementation of suggested improvements. Leadership Skills, Training & Supervision- basic leadership skills required for on-the-job trainings and guidance/support of (new) team members (e.g. providing and receiving feedback, empathy, honesty, reliability); train, instruct and coordinate E level; train D & C level during onboarding. Work Environment: Typical office environment with moderate noise levels (~20% of work hours). Uses phone, computer, office equipment and supplies on a regular basis. cGMP clean room spaces and facilities (~80% of work hours). Grade A/B/C/D GMP environment with associated facility noise levels. Uses cleanroom phone, computer, variety of equipment and reagent/supplies. General unclassified laboratory spaces, as needed. Common laboratory equipment and noise levels. While performing the duties of this job, the employee routinely handles blood components and is occasionally exposed to temperatures between -196°C and 40°C, liquid nitrogen, liquid nitrogen vapor, dry ice, and carbon dioxide. Travel required: Travel may be required between the office building and manufacturing facility on a daily basis. Physical demands: Communicating Verbally - expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly. Hearing - the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds. Keyboarding - entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others. Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object - usually by holding it in the hands or arms but may occur on the shoulder. Near Visual Acuity - clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers). Pushing - Exerting force upon an object so that the object moves away from the object. Pulling - Exerting force upon an object so that the object moves toward the force. Sitting - remaining in a sitting position for at least 50% of the time. Standing/Walking - remain on one's feet in an upright position at a workstation. Stooping - occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles. Work authorization/security clearance requirements: Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment. Affirmative Action/EEO statement: Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medical conditions, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. What do we offer? At Immatics, we believe in investing in our team's health, safety and well-being. Here's what you can expect if you join Immatics Comprehensive Benefits: Competitive rates for Health, Dental, and Vision Insurance 4 weeks of Paid Time off, granted up front each year and prorated for first and last year of employment. Sick Time Off - 56 hours 12 Paid Holidays 100% Employer-Paid Life Insurance up to at 1x annual salary, up to 100K ( club together) 100% Employer Paid Short- and Long-Term Disability Coverage 401(k) with Immediate Eligibility & company match… You are eligible for 401(k) plan participation as of your first paycheck. The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment. Partially paid Parental Leave for eligible employees. (3 weeks) Additional voluntary employee paid coverages including Accident, Hospital Indemnity, and Critical Illness Employee Paid Identity Theft Protection and Pet Insurance. Professional Growth: Opportunities to work with leading experts in the field of T-cell immunotherapy. Company provided learning and development opportunities Fast paced, high demand collaborative and dynamic environment.
    $26k-34k yearly est. Auto-Apply 24d ago
  • Cannabis Production/Manufacturing Associate

    Onecall HR 4.3company rating

    Orange, MA jobs

    Job Description Temple Hill Collective, Inc. (THCI) is hiring a Production Associate for our cannabis product manufacturing facility in Orange, MA. THCI is a cannabis product manufacturer based in Orange, MA. We operate an independent cannabis manufacturing facility that produces cannabis products for sale at licensed cannabis dispensaries throughout the state of MA. At THCI, the Production Associates role is to perform all the tasks and actions necessary to produce a variety of cannabis products to our exacting standards. The Production Associates job duties include, but are not limited to, the following tasks: Completing all manufacturing and packaging tasks as assigned by the production manager and in accordance with the appropriate standard operating procedures set forth by THCI. Adhering to all company policies as well as all local, state, and Cannabis Control Commission regulations at all times. Maintaining quality control measures to ensure the highest quality of product. Upholding all standards and procedures pertaining to facility cleanliness, such as cleaning of supplies, workspaces, and equipment. Assist with any other tasks or responsibilities as assigned by the Director of Production and/or direct supervisor. General Requirements: 1-3 years of cannabis production (vape production) experience strongly preferred. Excellent computer proficiency including Google Workspace. Must possess a strong work ethic and be reliable and dependable. Excellent verbal and written communication skills, including the ability to effectively communicate calmly and professionally. Must be able to work under pressure and meet deadlines while maintaining a positive attitude and providing exemplary focus and attention to detail. Ability to work effectively as part of the team or independently to carry out assignments to completion within parameters of the instructions given. Required Skills: Demonstrate normal capabilities with computer systems, software, and hardware common to general business operations and record-keeping procedures Experience in product manufacturing and/or commercial kitchen operations is highly preferred. Physical Requirements: Must be able to perform repetitive techniques accurately and consistently. Must be able to stand for long periods of time, along with frequent bending. Manual dexterity sufficient to reach/handle items, work with fingers. Ability to lift to 50 pounds and push up to 100 pounds with assistance. Additional Qualifications: Ability to pass a Massachusetts mandated background check (Federal Criminal Background Check) Cannabis manufacturing/production experience preferred, but we will consider other qualifications in lieu of cannabis industry experience Must have reliable transportation Ability to comply with daily use of provided PPE, such as masks, hair nets, beard covers, respirators, boot covers, scrubs, and non-slip shoes, as necessary. May be required to complete testing during the interview process.
    $28k-44k yearly est. 28d ago
  • Manufacturing Associate 2nd & 3rd shift

    Berkshire Sterile Manufacturing LLC 3.7company rating

    Lee, MA jobs

    Perform all production operations in the areas assigned within the facility. Perform production support operations in areas assigned and support start-up, changeovers and tech transfer activities. Duties and Responsibilities Operate glass washers and autoclave Prepare buffers, medias and other solutions, following written procedures and batch records Operate process equipment such as tanks, clean in place skids (CIP/SIP), agitators, filtration devices, autoclaves, glass washers, integrity testing and other small equipment Perform process steps in coordination with other associates asking for help as needed so as not to perform steps without proper training/qualification Adhere to scheduling changes and responds appropriately Communicate with supervisor on issues regarding work orders or shifts in process parameters Give input and make suggestions to improve process Follow all GMP's and EHS procedures Attend and completes all mandatory training Ensure training plan is accurate and up-to-date Complete all necessary documentation per the required GMP practices Participate in presenting the manufacturing areas in a state of audit readiness Perform production operations following written SOP's/BR's in accordance with GMPs Other duties as assigned Regulatory Responsibilities Conduct business in a responsible manner that complies with all state, FDA, OSHA and HIPAA regulations, or otherwise as applicable Supervisory Responsibilities N/A Experience Experience in a GMP environment and in an approved laboratory under minimal supervision preferred Education Associates Degree or High School Diploma with zero (0) to two (2) or more years of directly related experience. Degree in other discipline (or lack of degree) may be considered if sufficient technical depth has been achieved from professional experience Knowledge, Skills & Abilities Understanding of the basic FDA cGMP regulations Verbal and written skills Basic software application skills (Word, Power Point) Able to follow detailed processing instruction Accurately document all necessary documentation Satisfactory audio-visual acuity Ability to read and write English Familiarization with technical issues in the area Ability to work shift that covers a 24/7 operation Ability to work shifts and off hours, as applicable Physical Requirements Ability to sit or stand for prolonged periods of time Ability to lift and carry materials weighing as much as 50lbs
    $33k-49k yearly est. Auto-Apply 60d+ ago
  • Manufacturing Associate 2nd & 3rd shift

    Berkshire Sterile Manufacturing LLC 3.7company rating

    Lee, MA jobs

    Perform all production operations in the areas assigned within the facility. Perform production support operations in areas assigned and support start-up, changeovers and tech transfer activities. Duties and Responsibilities Operate glass washers and autoclave Prepare buffers, medias and other solutions, following written procedures and batch records Operate process equipment such as tanks, clean in place skids (CIP/SIP), agitators, filtration devices, autoclaves, glass washers, integrity testing and other small equipment Perform process steps in coordination with other associates asking for help as needed so as not to perform steps without proper training/qualification Adhere to scheduling changes and responds appropriately Communicate with supervisor on issues regarding work orders or shifts in process parameters Give input and make suggestions to improve process Follow all GMP's and EHS procedures Attend and completes all mandatory training Ensure training plan is accurate and up-to-date Complete all necessary documentation per the required GMP practices Participate in presenting the manufacturing areas in a state of audit readiness Perform production operations following written SOP's/BR's in accordance with GMPs Other duties as assigned Regulatory Responsibilities Conduct business in a responsible manner that complies with all state, FDA, OSHA and HIPAA regulations, or otherwise as applicable Supervisory Responsibilities N/A Experience Experience in a GMP environment and in an approved laboratory under minimal supervision preferred Education Associates Degree or High School Diploma with zero (0) to two (2) or more years of directly related experience. Degree in other discipline (or lack of degree) may be considered if sufficient technical depth has been achieved from professional experience Knowledge, Skills & Abilities Understanding of the basic FDA cGMP regulations Verbal and written skills Basic software application skills (Word, Power Point) Able to follow detailed processing instruction Accurately document all necessary documentation Satisfactory audio-visual acuity Ability to read and write English Familiarization with technical issues in the area Ability to work shift that covers a 24/7 operation Ability to work shifts and off hours, as applicable Physical Requirements Ability to sit or stand for prolonged periods of time Ability to lift and carry materials weighing as much as 50lbs
    $33k-49k yearly est. Auto-Apply 60d+ ago
  • Manufacturing Associate 2nd & 3rd shift

    Berkshire Sterile Manufacturing LLC 3.7company rating

    Lee, MA jobs

    Job Description Perform all production operations in the areas assigned within the facility. Perform production support operations in areas assigned and support start-up, changeovers and tech transfer activities. Duties and Responsibilities Operate glass washers and autoclave Prepare buffers, medias and other solutions, following written procedures and batch records Operate process equipment such as tanks, clean in place skids (CIP/SIP), agitators, filtration devices, autoclaves, glass washers, integrity testing and other small equipment Perform process steps in coordination with other associates asking for help as needed so as not to perform steps without proper training/qualification Adhere to scheduling changes and responds appropriately Communicate with supervisor on issues regarding work orders or shifts in process parameters Give input and make suggestions to improve process Follow all GMP's and EHS procedures Attend and completes all mandatory training Ensure training plan is accurate and up-to-date Complete all necessary documentation per the required GMP practices Participate in presenting the manufacturing areas in a state of audit readiness Perform production operations following written SOP's/BR's in accordance with GMPs Other duties as assigned Regulatory Responsibilities Conduct business in a responsible manner that complies with all state, FDA, OSHA and HIPAA regulations, or otherwise as applicable Supervisory Responsibilities N/A Experience Experience in a GMP environment and in an approved laboratory under minimal supervision preferred Education Associates Degree or High School Diploma with zero (0) to two (2) or more years of directly related experience. Degree in other discipline (or lack of degree) may be considered if sufficient technical depth has been achieved from professional experience Knowledge, Skills & Abilities Understanding of the basic FDA cGMP regulations Verbal and written skills Basic software application skills (Word, Power Point) Able to follow detailed processing instruction Accurately document all necessary documentation Satisfactory audio-visual acuity Ability to read and write English Familiarization with technical issues in the area Ability to work shift that covers a 24/7 operation Ability to work shifts and off hours, as applicable Physical Requirements Ability to sit or stand for prolonged periods of time Ability to lift and carry materials weighing as much as 50lbs
    $33k-49k yearly est. 29d ago
  • Manufacturing Technician III

    Nitto Denko 4.2company rating

    Milford, MA jobs

    About this opportunity : As a Manufacturing Technician III, you'll be responsible for the implementation of assigned production operations working within defined production schedules in a cGMP environment. Key Responsibilities: May specialize in either purification or synthesis processes. As required, may cross train on basic or non-technical operations associated with other functions within the company. Maintain a clean and organized work environment in accordance with defined procedures. Assist Process Support Group in the execution of special projects and data collection. Demonstrate proficiency on the execution of key manufacturing processes which may include all or portions of the following: synthesis, cleavage and deprotection, chromatography, ultrafiltration , or freeze-drying Qualify lower levels on key manufacturing processes. May act as a lead for any given campaign. Review of basic cGMP documentation including solution and raw material reconciliation. Develop, review and revise SOPs and PIs to assure documentation reflects current operations. Qualify on basic investigational documentation including OOT, SHE, and CAPA's. Revise generic documentation to keep up with industry standards and customer expectations. Required Skills/Abilities: Minimum education requires high school diploma or equivalent with college level chemistry or equivalent work experience. A biotechnology certificate or college degree is preferred. Must have knowledge of basic laboratory instrumentation such as use of pH meter, UV instrumentation, and solution delivery systems (process skids). Must have knowledge of relevant manufacturing processes which may include chemical synthesis, chromatography, ultrafiltration, freeze-drying, and aseptic technique. Experience in cGMP manufacturing environment. The annualized salary range for this position is $74,200.00 - $90,700.00.
    $74.2k-90.7k yearly 14h ago
  • Manufacturing Technician II (2nd Shift)

    Nitto Denko 4.2company rating

    Milford, MA jobs

    About this opportunity : As a Manufacturing Technician II, you'll be responsible for the implementation of assigned production operations working within defined production schedules in a cGMP environment.This is a 2nd shift position and comes with a 15% shift differential. Key Responsibilities: Maintain a clean and organized work environment. Responsible for following GMP and safety cultures, procedures, and regulations. Identify and submit safety hazards and incidents. Complete GMP documentation in a compliant manner. May review less complex documentation like logbooks. May revise procedures under direct supervision. May participate in investigations. May execute CAPA tasks. Identify and implement small continuous improvement projects. Responsible for assigned production activity and ensuring training is compliant prior to performing operations. Problem solving: basic understanding of process and documentation. Ability to identify abnormal results and report to higher position. Proficient in the assigned area of the process. Required Skills/Abilities: Minimum education requirements: high school diploma or equivalent with college level Chemistry degree or equivalent work experience. A biotechnology certificate or college degree is preferred. Must have knowledge of basic laboratory instrumentation such as use of pH meter, UV instrumentation, and solution delivery systems (process skids). Two plus years of experience in cGMP manufacturing environment. Performance/other experience can be considered pending manager discretion. The annualized salary range for this roles is $61,700.00 - $75,600.00.
    $61.7k-75.6k yearly 11d ago
  • Associate I, Cell Therapy Manufacturing

    Vericel Corporation 4.2company rating

    Manufacturing associate job at Vericel Corp

    Job Description At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care). Position Summary: The Associate I, Cell Therapy Manufacturing is responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements. Schedule: This role will be required to work on-site Sun-Wed or Wed-Sat. Position Scope: Perform manufacturing procedures inside a manufacturing clean room in accordance with established SOPs, cGMPs, and safety regulations. Qualified to perform aseptic manipulations of cell culture operations. Document all operations in Electronic Batch Records and log sheets according to cGMPs and established SOPs. Maintain manufacturing-controlled areas in an inspection ready state. Perform clean room equipment sanitization. Record equipment and facility metrology data to ensure the equipment operates within specifications. Report out of specification readings to production management. Able to work independently upon completion of training. Be receptive to feedback and guidance from manager and other more experienced staff. Ability to organize, plan and manage time to effectively complete daily tasks. The ability to cooperate with others in a team environment will be critical to success. Practice safe work habits and adhere to Vericel's safety procedures and guidelines. Able to make cell-culture decisions based on cell observations and guidelines in written procedures. Assist in reviewing and revising production documents (SOP's and electronic records). Fully trained in at least one unit operation in both product lines. Ability to identify and report deviations and contribute to deviation investigations. In addition to being fully qualified in MACI or Epicel, cross train and qualify in at least one core competency e.g. 3T3, Media Prep, GP, TrackWise, Veeva. Achieve Qualified Trainer status. Other duties as assigned. Qualifications: Bachelor's degree (Life Sciences or related field) with 0 - 2 years of experience working in a cGMP environment in the biotechnology/pharmaceutical industry or Biotechnology certificate with 1 - 2+ years of experience working in a cGMP environment in the biotechnology/pharmaceutical industry or HS diploma/GED with 4 - 6+ years of cGMP experience. Excellent communication skills, written and verbal. Experience with Microsoft Office suite. Experience in small scale tissue culture processing (preferred). Experience working within a regulated environment that is frequently audited by internal and external Agencies, such as the FDA and ISO (preferred). Ability to sit for long periods of time while performing cell culture operations. Ability to lift, carry, push and pull up to 50 lbs. Ability to work 1 weekend day and rotating holiday coverage. Ability to gown and gain entry to manufacturing areas. Why Vericel? Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care. Career Growth: Be a part of a growing organization with opportunities to expand your impact. Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives. The hourly wage range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $23.08 to $27.40 per hour. The actual salary offered will be determined based on factors such as the candidate's qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above. In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited. EEO Statement All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer. Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.
    $23.1-27.4 hourly 16d ago
  • Manufacturing Lead Associate (Tech Ops)

    Lyell Immunopharma 4.3company rating

    Bothell, WA jobs

    Using living cells to treat - and sometimes even cure - cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. And for patients with hematologic malignancies, there is a need for next-generation cell therapies that can deliver increased response rates and longer duration of response. We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell's product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to advance next-generation CAR T-cell therapies, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency. POSITION SUMMARY: The individual in this role will be responsible for supporting the operations in our cGMP clinical manufacturing site producing plasmids, viral vectors, and autologous cell therapies. This role is primarily responsible for performing daily manufacturing operations. The role will also be responsible for supporting additional manufacturing responsibilities. KEY ROLE AND RESPONSIBILITIES: Execute the Day-to-Day Manufacturing Processing • Provide routine on-the-floor support and execute operations. • Execute manufacturing operations safely, as scheduled, and right the first time for delivery of treatment to patients. • Assist the supervisor leading daily operations and resolving floor issues. • Assist the supervisor to ensure all operational duties are completed each day/shift. • Assist in development and implementation of GMP SOPs related to Manufacturing Operations. • Maintain production facilities at a high standard of cleanliness and organization. • Perform equipment maintenance and calibrations as required. • Maintain appropriate level of training for assigned responsibilities. • Identify and report risks in the manufacturing areas that could negatively impact the quality of patient therapies. • Ensure timely review and closure of electronic batch records, exceptions, deviations. • Assist with CAPA and change controls as needed. Collaborate Effectively ● Be a team player, offer assistance, and respond well to requests for help from team members. ● Use strong communication and build relationships. ● Demonstrate technical acumen, operational understanding, and GMP compliance. ● Support operational excellence initiatives. ● Promote a culture of safety and GMP compliance. ● Identify opportunities for continuous improvement. ● Lead team huddles. PREFERRED EDUCATION & EXPERIENCE: ● BSc degree in a relevant field (eg biochemistry, chemical engineering, bioengineering, or related scientific field) ● Minimum 8 years' experience in GMP biopharmaceutical operations preferably with experience in cell therapy, mammalian cell culture, and/or microbial fermentation. ● Experience with quality management systems (e.g. Deviations, CAPAs, Change Management). ● Experience with electronic systems such as MES and ERP. ● Familiar with regulations for GMP manufacturing of drug substance, drug products, cellular and gene therapies, and viral vectors for clinical phase therapies. ● Proven track record in cGMP manufacturing operations, including producing therapies safely and right the first time. ● Fast learner, adaptable, and excellent cross-collaboration and inter-personal skills. ● The desire and ability to work in a fast-paced, start-up environment. PHYSICAL REQUIREMENTS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing their duties, the employee must be able to do the following: ● Confirm visual information in the environment such as batch record and SOP steps were completed properly, parameters on equipment and computer screens, status of materials and equipment, and perform visual inspection of materials and product. A vision test may be required. Use of corrective lenses is acceptable. ● Stand and step over a gowning bench (12-24”) and aseptically don head-to-toe non-sterile and sterile gowns. SHIFT WORK, WEEKEND WORK AND HOLIDAY COVERAGE: Due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely as possible, shift work, weekend work, and holiday work will be required. We are looking for passionate team members to join our team that are willing to learn, grow, and evolve with us. Part of this evolution will be to work together to continually assess and modify our shift structure to best support delivering these critical products to our patients. Lyell offers its employees a range of compensation and benefits. To assist you with your decision to apply for this role, the following decision to apply for this role, the following information and links to our site highlight our competitive market position and support to our employees and their dependents. The salary range for this position is $108,000 to $120,000, annually, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell's compensation practices and an applicant's qualifications and experience. Employees are also eligible to participate in Lyell's Equity Incentive Plan. Our Employee Benefits program is extensive and includes subsidized medical, dental and vision plans from your first day of employment, FSA, Company provided Life and AD&D Insurance as well as STD and LTD Insurance, ESPP, a 401(k) Plan with Company match, mass transit commuter benefits, cell phone reimbursement and a range of supplemental benefits that you may choose to elect. Our paid time-off benefits currently include 18 days' vacation, 9 day's sick leave, 8 observed holidays as well as a floating holiday. We also have a summer and a winter office shutdown. At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees. Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws. We've learned from experience that some of the best people don't always match our requirements perfectly - if you're interested and think you could fit, please don't hesitate to apply.
    $108k-120k yearly Auto-Apply 60d+ ago
  • Manufacturing Technician, 2nd Shift

    Conformis Inc. 4.3company rating

    Wilmington, MA jobs

    The Manufacturing Technician position is responsible for the manufacture, inspection, and final product packaging and sterilization of Conformis implants and components. 2 nd Shift - Mon - Fri, 3:00pm - 11:30pm Essential Duties and Responsibilities: Develop and maintain strong internal working relationships across Conformis. Understand the objectives, responsibilities, and mission of the Production department and work towards those goals. Prioritize and plan work activities; adapt for changing conditions. Execute daily maintenance and start-up activities. Perform machine set-ups. Perform inspection of components and assembly as required. Perform cleaning, pouching/sealing, labeling, and sterilization operations. Strict adherence to Good Documentation Practices when executing all assignments. Perform timely and accurate transactions of workflow in ERP system. Participate in inventory cycle counts, variance investigation, and reconciliation. Assist in performing required process capability studies, equipment installation qualifications, and process validation. Assist in the investigation and implementation of corrective actions on product and process failures. Comply with all company policies and procedures including safety regulations, personal protective equipment requirements, Standard Operating Procedures, Work Instructions, and Good Manufacturing Procedures. Interface with vendors to seek solutions for equipment repairs and refurbishment. Responsible for upkeep of manufacturing areas and provide a clean and safe work environment. Review all manufacturing documentation, assembly, inspection, test, and packaging procedures, and provide feedback. Other duties as assigned. Qualifications: High School diploma or equivalent; Technical education preferred. 2+ years' work experience in a medical device and/or regulated environment. Familiarity with Oracle (or equivalent) ERP systems and Microsoft Office Applications. Familiar with ISO Standards and Good Manufacturing Practices. Excellent verbal and written communication. Demonstrated English reading and writing skills. Ability to understand and follow comprehensive work instructions and guidance documents. Shipping/receiving/stockroom experience a plus. Skills, Abilities, Competencies Required: Excellent written and verbal communication skills. Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. Strong organizational, analytical, and time-management skills. Able to self-motivate and work both independently and as part of a team. Manual dexterity to handle tools, inspection gauges, and equipment of different sizes. Demonstrated organizational skills. Ability to work in a fast-paced environment and multitask. Comfortable with change. Flexible to work overtime, extended hours, and weekends as business demands. Ability to work as part of a team as well as independently. Working conditions: Ability to lift, pull, and push up to 40 lbs. Ability to stand for prolonged periods of time. Ability to work in a Class 10,000 or ISO class VII clean room environment for prolonged periods of time. Capable of working in material blending area with necessary personal safety equipment (eye protection, dust masks). Busy work environment with frequent interruptions. Must be aware of hazards within the company; adhere to quality and safety standards established by FDA and other regulatory agencies. Able to work in changing environments (reduced lighting, increased noise, temperature variances, unpleasant odors, dust, etc.). Conformis is an Equal Opportunity Employer
    $34k-50k yearly est. Auto-Apply 60d+ ago
  • Manufacturing Technician, 2nd Shift

    Conformis Inc. 4.3company rating

    Wilmington, MA jobs

    The Manufacturing Technician position is responsible for the manufacture, inspection, and final product packaging and sterilization of restor3d implants and components. 2 nd Shift - Mon - Fri, 3:00pm - 11:30pm Essential Duties and Responsibilities: Develop and maintain strong internal working relationships across restor3d. Understand the objectives, responsibilities, and mission of the Production department and work towards those goals. Prioritize and plan work activities; adapt for changing conditions. Execute daily maintenance and start-up activities. Perform machine set-ups. Perform inspection of components and assembly as required. Perform cleaning, pouching/sealing, labeling, and sterilization operations. Strict adherence to Good Documentation Practices when executing all assignments. Perform timely and accurate transactions of workflow in ERP system. Participate in inventory cycle counts, variance investigation, and reconciliation. Assist in performing required process capability studies, equipment installation qualifications, and process validation. Assist in the investigation and implementation of corrective actions on product and process failures. Comply with all company policies and procedures including safety regulations, personal protective equipment requirements, Standard Operating Procedures, Work Instructions, and Good Manufacturing Procedures. Interface with vendors to seek solutions for equipment repairs and refurbishment. Responsible for upkeep of manufacturing areas and provide a clean and safe work environment. Review all manufacturing documentation, assembly, inspection, test, and packaging procedures, and provide feedback. Other duties as assigned. Qualifications: High School diploma or equivalent; Technical education preferred. 2+ years' work experience in a medical device and/or regulated environment. Familiarity with Oracle (or equivalent) ERP systems and Microsoft Office Applications. Familiar with ISO Standards and Good Manufacturing Practices. Excellent verbal and written communication. Demonstrated English reading and writing skills. Ability to understand and follow comprehensive work instructions and guidance documents. Shipping/receiving/stockroom experience a plus. Skills, Abilities, Competencies Required: Excellent written and verbal communication skills. Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. Strong organizational, analytical, and time-management skills. Able to self-motivate and work both independently and as part of a team. Manual dexterity to handle tools, inspection gauges, and equipment of different sizes. Demonstrated organizational skills. Ability to work in a fast-paced environment and multitask. Comfortable with change. Flexible to work overtime, extended hours, and weekends as business demands. Ability to work as part of a team as well as independently. Working conditions: Ability to lift, pull, and push up to 40 lbs. Ability to stand for prolonged periods of time. Ability to work in a Class 10,000 or ISO class VII clean room environment for prolonged periods of time. Capable of working in material blending area with necessary personal safety equipment (eye protection, dust masks). Busy work environment with frequent interruptions. Must be aware of hazards within the company; adhere to quality and safety standards established by FDA and other regulatory agencies. Able to work in changing environments (reduced lighting, increased noise, temperature variances, unpleasant odors, dust, etc.). restor3d is an Equal Opportunity Employer
    $34k-50k yearly est. Auto-Apply 60d+ ago
  • Manufacturing Technician II (Aseptic)

    Anika Therapeutics 4.3company rating

    Bedford, MA jobs

    Salary Range:$55,000.00 To $65,000.00 Annually The Aseptic Manufacturing Technician II has primary responsible for the activities and procedures required for the manufacture and filling of Aseptic products. The position follows established procedures in the execution of daily activities and receives instructions on new assignments. Specific Tactical Responsibilities: * Operates production equipment according to Standard Operating Procedures (SOPs), Batch Records, Manufacturing Directions (MD), and Manufacturing Operating Procedure (OPM) * Executes all procedures associated with aseptic fills (transfer, set-up, sanitization, autoclaving, process simulation, etc.,) * Performs scheduled cleanings and sterilization of equipment * Supports change over activities * Troubleshoots and resolves process related issues * Records data into Batch Records, log books and OPM's * Reviews Logbook and Forms * Documents all work activities according to Good Documentation Practices * Reports procedural deviations and nonconformance to management * Maintains current training on all assigned procedures to include read & understood, skills development and classroom training activities as required Job Complexity: The position works on assignments that are routine in nature where cGMP experience is required to perform work activities. The Aseptic Manufacturing Technician II normally follows procedures on routine work, requires instruction and training on new assignments. Supervisory Responsibilities: None Required Qualifications: * High school diploma, GED or equivalent experience * 2-4 years related experience in a cGMP manufacturing environment * Ability to work flexible hours to complete work activities * Must possess written and verbal communication skills * Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas; ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes * Ability to lift, pull or push equipment requiring up to 25-50 lbs; ability to stand for 6 hours in a production suite * Ability to climb ladders and work platforms * Ability to work around chemicals (alcohols, acids & bases) * Ability to work flexible hours to complete work activities Desired Experience, Knowledge, and Skills: * Manufacturing experience in a medical device industry * Experience working in a clean room or using aseptic technique * Experience using commercial scale automated equipment * Ability to perform computerized transactions and maintain spreadsheets are a plus The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life. The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law. submit your resume We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.
    $55k-65k yearly 60d+ ago
  • Manufacturing Technician I (Crosslink)

    Anika Therapeutics 4.3company rating

    Bedford, MA jobs

    The Crosslink Manufacturing Technician has primary responsible for the activities and procedures required for the cross linked hyaluronic acid product production. The position works under close supervision and follows established procedures in the execution of daily activities. Specific Tactical Responsibilities: Operates production equipment according to Standard Operating Procedures (SOPs), Batch Records, Manufacturing Directions (MD), and Manufacturing Operating Procedure (OPM) Executes all procedures associated with cross linked hyaluronic acid product production Performs scheduled cleanings and sterilization of equipment Adheres strictly to written work instructions to perform solvent recovery, clean out of place, clean in place of complex equipment and components Assists with troubleshooting and resolution of process related issues Records data into Batch Records, log books and OPM's Documents all work activities according to Good Documentation Practices Reports procedural deviations and nonconformance to management Maintains current training on all assigned procedures to include read & understood, skills development and classroom training activities as required Job Complexity: The position works on assignments that are routine in nature where cGMP experience is required to perform work activities. The Crosslink Manufacturing Technician I normally receives detailed instruction on routine work and training on new assignments. Supervisory Responsibilities: None Required Qualifications: High school diploma, GED or equivalent experience 0 - 1 years related experience in a manufacturing environment Ability to work flexible hours to complete work activities Must possess good written and verbal communication skills Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas; ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes Ability to lift, pull or push equipment requiring up to 25-50 lbs; ability to stand for 6 hours in a production suite Ability to climb ladders and work platforms Ability to work around chemicals (alcohols, acids & bases) Ability to work flexible hours to complete work activities Desired Experience, Knowledge, and Skills: Manufacturing experience in a medical device industry Experience working in a clean room or using aseptic technique Experience using commercial scale automated equipment Ability to perform computerized transactions and maintain spreadsheets are a plus
    $33k-48k yearly est. Auto-Apply 60d+ ago

Learn more about Vericel Corp jobs