Post job

Manufacturing Operator jobs at Integra LifeSciences

- 499 jobs
  • Blood Manufacturing Specialist - 3rd Shift (Sun-Thur 11pm-730am)

    Versiti 4.3company rating

    Columbus, OH jobs

    Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive. Position Summary Under the direction of the department leadership, prepares quality biological blood components within the prescribed time following regulatory and operational standards as specified in the Standard Operating Procedures and departmental procedures. WHEN YOU WILL WORK: 3rd Shift: Sunday-Thursday, 11:00pm-7:30am On-call availbility as needed Full Time, Non-Exempt role Training schedule may differ from traditional schedule. COMPENSATION: $18.04/hr.+ based on experience - paid training provided Benefits eligible including medical/dental/vision insurance options, 7% 401(k) match, EAP, employee wellness program, generous PTO, and more. Shift differentials for evenings/weekends Evenings (after 6:00pm) - $1.50/hr. Weekends - $2.00/hr. Total Rewards Package Benefits Versiti provides a comprehensive benefits package based on your job classification. Full-time regular employes are eligible for Medical, Dental, and Vision Plans, Paid Time Off (PTO) and Holidays, Short- and Long-term disability, life insurance, 7% match dollar for dollar 401(k), voluntary programs, discount programs, others. Responsibilities Manufactures Red Blood Cells (RBCs), Fresh Frozen Plasma and Recovered Plasma Manufactures Neonatal RBCs. Sterile docks Pedipaks to Platelet Apheresis, Neonatal RBCs Performs leukoreduction of Whole Bloods and RBCs Manufactures Cryoprecipitate, Pooled Cryoprecipitate and Cryo Reduced Plasma Labels products to meet regulatory and inventory requirements Manufactures additional specialty products as needed by customer base Follows procedures pertaining to the proper storage of RBCs, platelet products and frozen products Performs and documents equipment function checks and QC as required Maintains a level of productivity that allows department to achieve production goals Works weekend, holiday rotations and on-call, as needed Other duties, as assigned Performs other duties as assigned Complies with all policies and standards Qualifications Education High School Diploma required equivalent required Experience Less than 1 year 1-6 months related experience and/or training or equivalent combination of education and experience required Knowledge, Skills and Abilities Ability to read, interpret, and write documents such as operating forms, operating and maintenance instructions, and other department manuals required Above average attention to detail and problem-solving skills required Ability to apply judgment to written or oral instructions required Aptitude for computers and data entry skills required Ability to manage interruptions in a fast-paced environment required Customer service and communication skills required Able to organize work to provide productive work flow needed in component manufacturing required Flexibility to work independently and with a team required Organized, able to prioritize and handle multiple tasks at one time required Be able and available to work a flexible working schedule as required based on volume and timing of blood collections required Ability to work independently with limited written or oral instruction required Understands military time required Tools and Technology General office equipment (computer, printer, fax, copy machine) required Microsoft Suite (Word, Excel, PowerPoint, Outlook) required Software systems (Blood Establishment Computer Systems, Title21) required Lab specific equipment, including, but not limited to: • Sealers • Centrifuge • Water bath • Scales required Not ready to apply? Connect with us for general consideration.
    $18 hourly Auto-Apply 39d ago
  • Manufacturing Operator / Production Assembler

    Getinge Group 4.5company rating

    Wayne, NJ jobs

    With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview Responsible for assembling products and recording required information to meet production requirements and quality standards. Contribute to operation of production cell, and assure compliance with GMP, ISO, ESD and all other regulatory requirements. Job Responsibilities and Essential Duties * Ability to follow assembly drawings, parts lists and process papers * Ability to work independently, or as part of a group and display a high quality of skill in both mechanical and electronic assembly with a minimum of supervision. * Ability to inspect work and materials * Ability to use basic test and measurement equipment * Full understanding of document control procedures * Ability to train other Manufacturing Operators * Demonstrated ability to follow and implement GMP, ESD and all other applicable regulatory requirements * Material control responsibility * Determine if components and/or assemblies meet specification and reject if necessary. * Escalate issues to Manager as necessary Minimum Requirements * High School diploma preferred * 1-3 years previous experience in a manufacturing environment * Ability to work the 7AM - 3:30PM shift * Electromechanical assembly experience strongly preferred * Must have basic computer skills, SAP experience a plus * Must be able to work in a team environment Required Knowledge, Skills and Abilities * Ability to follow assembly drawings, parts lists and process papers * Ability to work independently, or as part of a group and display a high quality of skill in both mechanical and electronic assembly with a minimum of supervision. * Ability to inspect work and materials * Ability to use basic test and measurement equipment * Full understanding of document control procedures * Ability to train other Manufacturing Operators * Demonstrated ability to follow and implement GMP, ESD and all other applicable regulatory requirements * Material control responsibility * Determine if components and/or assemblies meet specification and reject if necessary. * Escalate issues to Manager as necessary Pay Range: $20.60/hour - $25.00/hour #LI-BS1 About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: * Health, Dental, and Vision insurance benefits * 401k plan with company match * Paid Time Off * Wellness initiative & Health Assistance Resources * Life Insurance * Short and Long Term Disability Benefits * Health and Dependent Care Flexible Spending Accounts * Commuter Benefits * Parental and Caregiver Leave * Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
    $20.6-25 hourly 34d 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 $35.00 per hour to $42.00 per hour + bonus, equity and benefits. The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************
    $35-42 hourly 53d 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 $35.00 per hour to $42.00 per hour + bonus, equity and benefits. The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: ***********************************************
    $35-42 hourly Auto-Apply 52d ago
  • (CW) Manufacturing Associate (TEMPORARY)

    Biomarin Pharmaceutical Inc. 4.6company rating

    Novato, CA jobs

    Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Duties PROCESS KNOWLEDGE: Understanding of process theory and equipment operation. Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance. Support initiatives for process optimization. Identify and elevate processing issues and support solutions. Gain experience with automation systems (LIMS, MES, PI, etc.). TECHNICAL DOCUMENTATION: Provide feedback and/or suggested changes to operational procedures. Assist in the incorporation of new technologies, practices, and standards into procedures. Capable of writing and reviewing process documents. QUALITY AND COMPLIANCE: Understanding of cGMPs as related to Commercial Operations. Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.). BUSINESS: Ability to participate on projects and contribute to outcomes. Capability to learn and support new business systems (Track wise, ERP, etc.). Support trending of defined department metrics. Manufacturing Associate: WORK ENVIRONMENT/PHYSICAL DEMANDS * Consists of strenuous, repetitive work. The following list of physical movements may be used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands. * Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds. * May require work around loud equipment. * The use of personal protective equipment will be required. * Requires various shift-based work and off hours. Skills * Strong communication skills-verbal and written * Ability to work in a team environment which includes good conflict resolution and collaboration * Displays good initiative to identify areas for improvement and implement solutions Education * Bachelor's degree in science related area or engineering is nice to have. * Associate's degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry is nice to have. 06:00 AM to 07:00 PM Sunday to Wednesday (Every other Wednesday off) Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. In the U.S, the salary range for this position is $ 15 to $ 30 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors. The salary range for this position is: $15 to $30. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit:
    $15-30 hourly 60d+ ago
  • (CW) Manufacturing Associate (TEMPORARY)

    Biomarin Pharmaceutical Inc. 4.6company rating

    Novato, CA jobs

    Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Hours-Days: Sun-Tues/Wed 0600-1900 Duties PROCESS KNOWLEDGE: Understanding of process theory and equipment operation. Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance. Support initiatives for process optimization. Identify and elevate processing issues and support solutions. Gain experience with automation systems (LIMS, MES, PI, etc.). TECHNICAL DOCUMENTATION: Provide feedback and/or suggested changes to operational procedures. Assist in the incorporation of new technologies, practices, and standards into procedures. Capable of writing and reviewing process documents. QUALITY AND COMPLIANCE: Understanding of cGMPs as related to Commercial Operations. Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.). BUSINESS: Ability to participate on projects and contribute to outcomes. Capability to learn and support new business systems (Track wise, ERP, etc.). Support trending of defined department metrics. WORK ENVIRONMENT/PHYSICAL DEMANDS * Consists of strenuous, repetitive work. The following list of physical movements may be used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands. * Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds. * May require work around loud equipment. • The use of personal protective equipment will be required. * Requires various shift based work and off hours. Skills * Strong communication skills-verbal and written * Ability to work in a team environment which includes good conflict resolution and collaboration * Displays good initiative to identify areas for improvement and implement solutions Education * Bachelor's degree in science related area or engineering * Associate's degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. In the U.S, the salary range for this position is $ 15 to $ 30 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors. The salary range for this position is: $15 to $30. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit:
    $15-30 hourly 53d ago
  • (CW) Manufacturing Associate (TEMPORARY)

    Biomarin Pharmaceutical Inc. 4.6company rating

    Novato, CA jobs

    Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Worldwide Research and Development From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases. Manufacturing Associate PROCESS KNOWLEDGE: Understanding of process theory and equipment operation. Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance. Support initiatives for process optimization. Identify and elevate processing issues and support solutions. Gain experience with automation systems (LIMS, MES, PI, etc.). TECHNICAL DOCUMENTATION: Provide feedback and/or suggested changes to operational procedures. Assist in the incorporation of new technologies, practices, and standards into procedures. Capable of writing and reviewing process documents. QUALITY AND COMPLIANCE: Understanding of cGMPs as related to Commercial Operations. Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.). BUSINESS: Ability to participate on projects and contribute to outcomes. Capability to learn and support new business systems (Track wise, ERP, etc.). Support trending of defined department metrics. WORK ENVIRONMENT/PHYSICAL DEMANDS * Consists of strenuous, repetitive work. The following list of physical movements may be used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands. * Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds. * May require work around loud equipment. * The use of personal protective equipment will be required. * Requires various shift based work and off hours. Skills * Strong communication skills-verbal and written * Ability to work in a team environment which includes good conflict resolution and collaboration * Displays good initiative to identify areas for improvement and implement solutions Education * Bachelor's degree in science related area or engineering is nice to have. * Associate's degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry is nice to have. Hours 6:00 PM to 7:00 AM Alternating Sat/Sun - Tues Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. In the U.S, the salary range for this position is $ 15 to $ 30 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors. The salary range for this position is: $15 to $30. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit:
    $15-30 hourly 60d+ ago
  • (CW) Manufacturing Associate

    Biomarin Pharmaceutical 4.6company rating

    Novato, CA jobs

    Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Temporary Manufacturing Associate position is for a 6pm to 7am shift from Wednesday to Saturday, with every other Saturday off. Responsibilities: Operating large-scale bioprocess equipment for Cell Culture, Purification, or Buffer and Media processing; performing all aspects of processing with a broad understanding of science, compliance, and technical aspects; displaying competency with process equipment and automated control systems; performing cleaning and sterilization of parts and equipment used in the manufacturing process; and having knowledge of biotech manufacturing processes and equipment, including cell culture, depth and tangential flow filtration, column chromatography, protein purification and formulation, and/or buffer and media operations. The candidate should have the ability to understand, apply, and evaluate basic chemistry, biology, and scientific principles as appropriate for the position. Proficiency with compliance, adherence to standard operating procedures, batch records, good documentation practices, and data capturing is also essential. Desired skills: 1-2 years of experience in a GMP and Manufacturing field. The equipment involved includes chromatography skids, TFF skids, buffer tanks, lab washers, and autoclaves. Education: Bachelor's degree in a science-related area or engineering, or an associate's degree in a science-related area or a biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry. (While a BA/BS is preferred, it is not required; a biotech certificate is acceptable). Work Environment: Involves strenuous, repetitive work. This includes daily physical movements such as bending, reaching, climbing stairs and ladders, kneeling, and making numerous equipment connections using hands. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
    $36k-43k yearly est. Auto-Apply 49d ago
  • Production Operators - Amityville

    Natural Organics 3.9company rating

    Amityville, NY jobs

    Natural Organics Inc. is a privately held company in Melville, NY proudly doing business for over 50 years. NaturesPlus is the flagship brand of Natural Organics, a family-driven dietary supplement manufacturer that has been trusted by generations of loyal consumers. Our unique fusion of nature and science has led to the development of formulations including multivitamins, shake powders and specialty products tailored to the needs of men, women and children...all designed to enable our customers to live their best lives. We are currently seeking entry level workers for our Amityville NY facility to assist in the manufacture and packaging of nutraceuticals such as vitamins and energy supplements. We offer Full-time, Day Shift positions in various departments including but not limited to Product-Compression, Product-Encapsulation, and Product-Coating. Some lifting up to 50 lbs. Candidate must be a highly motivated self-starter with checkable references. Benefits: Competitive salary, Medical, Dental, Life Insurance, Aflac, Short- and Long-Term Disability, 401(k) with company match, Generous paid time off days and holidays, Opportunities for professional development and growth, Discounted vitamins and supplements.
    $32k-38k yearly est. 60d+ ago
  • Production Operators - Amityville

    Natural Organics Inc. 3.9company rating

    Amityville, NY jobs

    Job Description Natural Organics Inc. is a privately held company in Melville, NY proudly doing business for over 50 years. NaturesPlus is the flagship brand of Natural Organics, a family-driven dietary supplement manufacturer that has been trusted by generations of loyal consumers. Our unique fusion of nature and science has led to the development of formulations including multivitamins, shake powders and specialty products tailored to the needs of men, women and children...all designed to enable our customers to live their best lives. We are currently seeking entry level workers for our Amityville NY facility to assist in the manufacture and packaging of nutraceuticals such as vitamins and energy supplements. We offer Full-time, Day Shift positions in various departments including but not limited to Product-Compression, Product-Encapsulation, and Product-Coating. Some lifting up to 50 lbs. Candidate must be a highly motivated self-starter with checkable references. Benefits: Competitive salary, Medical, Dental, Life Insurance, Aflac, Short- and Long-Term Disability, 401(k) with company match, Generous paid time off days and holidays, Opportunities for professional development and growth, Discounted vitamins and supplements. Job Posted by ApplicantPro
    $32k-38k yearly est. 14d 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
  • Supervisor, Manufacturing Upstream

    Avid Bioservices 4.2company rating

    Tustin, CA jobs

    Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Supervisor, Manufacturing Upstream is responsible for the supervision of Upstream manufacturing staff and operations as well as regularly performing hands on operational activities. This includes ensuring that production is maintained in full cGMP compliance through on the floor observation, direction, and participation. * Schedule, plan and coordinate production activities. * Perform cell culture and bioreactor operations from thaw through TFF on the production floor, as required. * Responding to process alarms by arriving on-site during non-business hours * cGMP documentation. * Revise initiate and review Batch Production Records (BPRs), Standard Operating Procedures (SOPs), forms and Batch History Records (BHRs). * Identify, escalate, and write deviation reports (IRs/DRs/CAPAs). Follow through on corrective and preventative actions to ensure cGMP compliance. * Manage the development of SOPs to ensure all manufacturing operations comply with internal and external regulatory agencies. * Coordinate manufacturing, validation, and maintenance activities with supporting departments. * Oversee the setup of new manufacturing processes and critical equipment. * Identify the technical, procedural and equipment issues that hinder production and compliance. * Communicate with team members, supervisor and members of other departments, as appropriate, to assure prompt resolution of problems. * Assist in the transfer of technology from Process Development to GMP Manufacturing. * Assist with technical and compliance investigations, inspections and audits. * Report all unsafe activities to department manager, EHS and/or Human Resources. * Participate in proactive team efforts to achieve departmental and company goals. * Manage direct reports and escalate issues to manager as needed. * Perform other duties as assigned. Minimum Qualifications: * Bachelor's degree in biology, biotechnology, chemical engineering or related field plus 3 - 5 years' cGMP upstream experience or equivalent combination of experience and education. * A minimum of 3 years of supervisory experience specifically in upstream processing is required. The ideal candidate will be a self-driven leader with a proven track record of building strong and efficient floor operations. Position Type/Expected Hours of Work: This role is a full-time position with a Sunday through Wednesday schedule, working 10 hours each day (4 days x 10 hours), with operating hours from 7:00am to 6:00pm. During the initial training period, working days and hours will be Monday through Friday from 7:00am to 4:00pm. Compensation: We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $ $75,000 - $95,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment. Who you are: * You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way. * Your written and verbal skills are out of this world, and you communicate with clarity and confidence. * You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything. * You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers. Physical Demands & Work Environment: In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
    $75k-95k yearly Auto-Apply 40d ago
  • Supervisor, Manufacturing Downstream (Flex)

    Avid Bioservices 4.2company rating

    Tustin, CA jobs

    Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Supervisor, Manufacturing Downstream is responsible for the supervision of Downstream manufacturing staff and operations as well as regularly performing hands-on operational activities. This includes ensuring that production is maintained in full cGMP compliance through on the floor observation, direction, and participation. * Schedule, plan and coordinate production activities. * Perform purification operations (column chromatography, nano-filtration, tangential flow filtration, aseptic bulk fills, etc.) on the production floor, as required. * cGMP documentation. * Revise initiate and review Batch Production Records (BPRs), Standard Operating Procedures (SOPs), forms and Batch History Records (BHRs). * Identify, escalate, and write deviation reports (IRs/DRs/CAPAs). Follow through on corrective and preventative actions to ensure cGMP compliance. * Manage the development of SOPs to ensure all manufacturing operations comply with internal and external regulatory agencies. * Coordinate manufacturing, validation, and maintenance activities with supporting departments. * Oversee the setup of new manufacturing processes and critical equipment. * Identify the technical, procedural and equipment issues that hinder production and compliance. * Communicate with team members, supervisor and members of other departments, as appropriate, to assure prompt resolution of problems. * Assist in the transfer of technology from Process Development to GMP Manufacturing. * Assist with technical and compliance investigations, inspections and audits. * Report all unsafe activities to department manager, EHS and/or Human Resources. * Participate in proactive team efforts to achieve departmental and company goals. * Manage direct reports and escalate issues to manager as needed. * Perform other duties as assigned Minimum Qualifications: * Bachelor's degree in biology, Biotechnology, Chemical Engineering or related field plus 3 - 5 years' cGMP purification experience or equivalent combination of experience and education. * A minimum of 3 years of supervisory experience specifically in downstream processing is required. The ideal candidate will be a self-driven leader with a proven track record of building strong and efficient floor operations. Preferred Qualifications: * Bachelor's degree in life sciences or related field. Position Type/Expected Hours of Work: This role is a full-time position with a Sunday through Wednesday or a Wednesday through Saturday schedule, working 10 hours each day (4 days x 10 hours), with operating hours from 5:00pm to 4:00am. During the initial training period, working days and hours will be Monday through Friday 7:00am to 4:00pm. Compensation: We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $75,000 - $95,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment. Who you are: * You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way. * Your written and verbal skills are out of this world, and you communicate with clarity and confidence. * You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything. * You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers. Physical Demands & Work Environment: In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
    $75k-95k yearly Auto-Apply 40d ago
  • Supervisor, Manufacturing Downstream

    Avid Bioservices 4.2company rating

    Tustin, CA jobs

    Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Supervisor, Manufacturing Downstream is responsible for the supervision of Downstream manufacturing staff and operations as well as regularly performing hands-on operational activities. This includes ensuring that production is maintained in full cGMP compliance through on the floor observation, direction, and participation. * Schedule, plan and coordinate production activities. * Perform purification operations (column chromatography, nano-filtration, tangential flow filtration, aseptic bulk fills, etc.) on the production floor, as required. * cGMP documentation. * Revise initiate and review Batch Production Records (BPRs), Standard Operating Procedures (SOPs), forms and Batch History Records (BHRs). * Identify, escalate, and write deviation reports (IRs/DRs/CAPAs). Follow through on corrective and preventative actions to ensure cGMP compliance. * Manage the development of SOPs to ensure all manufacturing operations comply with internal and external regulatory agencies. * Coordinate manufacturing, validation, and maintenance activities with supporting departments. * Oversee the setup of new manufacturing processes and critical equipment. * Identify the technical, procedural and equipment issues that hinder production and compliance. * Communicate with team members, supervisor and members of other departments, as appropriate, to assure prompt resolution of problems. * Assist in the transfer of technology from Process Development to GMP Manufacturing. * Assist with technical and compliance investigations, inspections and audits. * Report all unsafe activities to department manager, EHS and/or Human Resources. * Participate in proactive team efforts to achieve departmental and company goals. * Manage direct reports and escalate issues to manager as needed. * Perform other duties as assigned Minimum Qualifications: * Bachelor's degree in biology, Biotechnology, Chemical Engineering or related field plus 3 - 5 years' cGMP purification experience or equivalent combination of experience and education. * A minimum of 3 years of supervisory experience specifically in downstream processing is required. The ideal candidate will be a self-driven leader with a proven track record of building strong and efficient floor operations. Preferred Qualifications: * Bachelor's degree in life sciences or related field. Position Type/Expected Hours of Work: This role is a full-time position with a Monday through Friday schedule, working 8 hours each day (5 x 8 hours), with operating hours from 8:00am to 5:00pm. The employee must also, if instructed, have the ability to work overtime, weekends and/or holidays when necessary. Compensation: We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $75,000 - $95,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment. Who you are: * You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way. * Your written and verbal skills are out of this world, and you communicate with clarity and confidence. * You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything. * You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers. Physical Demands & Work Environment: In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
    $75k-95k yearly Auto-Apply 40d ago
  • Supervisor, Manufacturing Downstream (Flex)

    Avid Bioservices 4.2company rating

    Tustin, CA jobs

    Description Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Supervisor, Manufacturing Downstream is responsible for the supervision of Downstream manufacturing staff and operations as well as regularly performing hands-on operational activities. This includes ensuring that production is maintained in full cGMP compliance through on the floor observation, direction, and participation. Schedule, plan and coordinate production activities. Perform purification operations (column chromatography, nano-filtration, tangential flow filtration, aseptic bulk fills, etc.) on the production floor, as required. cGMP documentation. Revise initiate and review Batch Production Records (BPRs), Standard Operating Procedures (SOPs), forms and Batch History Records (BHRs). Identify, escalate, and write deviation reports (IRs/DRs/CAPAs). Follow through on corrective and preventative actions to ensure cGMP compliance. Manage the development of SOPs to ensure all manufacturing operations comply with internal and external regulatory agencies. Coordinate manufacturing, validation, and maintenance activities with supporting departments. Oversee the setup of new manufacturing processes and critical equipment. Identify the technical, procedural and equipment issues that hinder production and compliance. Communicate with team members, supervisor and members of other departments, as appropriate, to assure prompt resolution of problems. Assist in the transfer of technology from Process Development to GMP Manufacturing. Assist with technical and compliance investigations, inspections and audits. Report all unsafe activities to department manager, EHS and/or Human Resources. Participate in proactive team efforts to achieve departmental and company goals. Manage direct reports and escalate issues to manager as needed. Perform other duties as assigned Minimum Qualifications: Bachelor's degree in biology, Biotechnology, Chemical Engineering or related field plus 3 - 5 years' cGMP purification experience or equivalent combination of experience and education. A minimum of 3 years of supervisory experience specifically in downstream processing is required. The ideal candidate will be a self-driven leader with a proven track record of building strong and efficient floor operations. Preferred Qualifications: Bachelor's degree in life sciences or related field. Position Type/Expected Hours of Work:This role is a full-time position with a Sunday through Wednesday or a Wednesday through Saturday schedule, working 10 hours each day (4 days x 10 hours), with operating hours from 5:00pm to 4:00am. During the initial training period, working days and hours will be Monday through Friday 7:00am to 4:00pm. Compensation: We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $75,000 - $95,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment. Who you are: You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way. Your written and verbal skills are out of this world, and you communicate with clarity and confidence. You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything. You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers. Physical Demands & Work Environment: In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
    $75k-95k yearly Auto-Apply 39d ago
  • Supervisor, Manufacturing Downstream

    Avid Bioservices 4.2company rating

    Tustin, CA jobs

    Description Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Supervisor, Manufacturing Downstream is responsible for the supervision of Downstream manufacturing staff and operations as well as regularly performing hands-on operational activities. This includes ensuring that production is maintained in full cGMP compliance through on the floor observation, direction, and participation. Schedule, plan and coordinate production activities. Perform purification operations (column chromatography, nano-filtration, tangential flow filtration, aseptic bulk fills, etc.) on the production floor, as required. cGMP documentation. Revise initiate and review Batch Production Records (BPRs), Standard Operating Procedures (SOPs), forms and Batch History Records (BHRs). Identify, escalate, and write deviation reports (IRs/DRs/CAPAs). Follow through on corrective and preventative actions to ensure cGMP compliance. Manage the development of SOPs to ensure all manufacturing operations comply with internal and external regulatory agencies. Coordinate manufacturing, validation, and maintenance activities with supporting departments. Oversee the setup of new manufacturing processes and critical equipment. Identify the technical, procedural and equipment issues that hinder production and compliance. Communicate with team members, supervisor and members of other departments, as appropriate, to assure prompt resolution of problems. Assist in the transfer of technology from Process Development to GMP Manufacturing. Assist with technical and compliance investigations, inspections and audits. Report all unsafe activities to department manager, EHS and/or Human Resources. Participate in proactive team efforts to achieve departmental and company goals. Manage direct reports and escalate issues to manager as needed. Perform other duties as assigned Minimum Qualifications: Bachelor's degree in biology, Biotechnology, Chemical Engineering or related field plus 3 - 5 years' cGMP purification experience or equivalent combination of experience and education. A minimum of 3 years of supervisory experience specifically in downstream processing is required. The ideal candidate will be a self-driven leader with a proven track record of building strong and efficient floor operations. Preferred Qualifications: Bachelor's degree in life sciences or related field. Position Type/Expected Hours of Work:This role is a full-time position with a Monday through Friday schedule, working 8 hours each day (5 x 8 hours), with operating hours from 8:00am to 5:00pm. The employee must also, if instructed, have the ability to work overtime, weekends and/or holidays when necessary.Compensation: We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $75,000 - $95,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment. Who you are: You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way. Your written and verbal skills are out of this world, and you communicate with clarity and confidence. You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything. You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers. Physical Demands & Work Environment: In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
    $75k-95k yearly Auto-Apply 39d ago
  • Supervisor, Manufacturing Upstream

    Avid Bioservices 4.2company rating

    Tustin, CA jobs

    Description Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Supervisor, Manufacturing Upstream is responsible for the supervision of Upstream manufacturing staff and operations as well as regularly performing hands on operational activities. This includes ensuring that production is maintained in full cGMP compliance through on the floor observation, direction, and participation. Schedule, plan and coordinate production activities. Perform cell culture and bioreactor operations from thaw through TFF on the production floor, as required. Responding to process alarms by arriving on-site during non-business hours cGMP documentation. Revise initiate and review Batch Production Records (BPRs), Standard Operating Procedures (SOPs), forms and Batch History Records (BHRs). Identify, escalate, and write deviation reports (IRs/DRs/CAPAs). Follow through on corrective and preventative actions to ensure cGMP compliance. Manage the development of SOPs to ensure all manufacturing operations comply with internal and external regulatory agencies. Coordinate manufacturing, validation, and maintenance activities with supporting departments. Oversee the setup of new manufacturing processes and critical equipment. Identify the technical, procedural and equipment issues that hinder production and compliance. Communicate with team members, supervisor and members of other departments, as appropriate, to assure prompt resolution of problems. Assist in the transfer of technology from Process Development to GMP Manufacturing. Assist with technical and compliance investigations, inspections and audits. Report all unsafe activities to department manager, EHS and/or Human Resources. Participate in proactive team efforts to achieve departmental and company goals. Manage direct reports and escalate issues to manager as needed. Perform other duties as assigned. Minimum Qualifications: Bachelor's degree in biology, biotechnology, chemical engineering or related field plus 3 - 5 years' cGMP upstream experience or equivalent combination of experience and education. A minimum of 3 years of supervisory experience specifically in upstream processing is required. The ideal candidate will be a self-driven leader with a proven track record of building strong and efficient floor operations. Position Type/Expected Hours of Work: This role is a full-time position with a Sunday through Wednesday schedule, working 10 hours each day (4 days x 10 hours), with operating hours from 7:00am to 6:00pm. During the initial training period, working days and hours will be Monday through Friday from 7:00am to 4:00pm.Compensation: We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $ $75,000 - $95,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment. Who you are: You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way. Your written and verbal skills are out of this world, and you communicate with clarity and confidence. You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything. You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers. Physical Demands & Work Environment: In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
    $75k-95k yearly Auto-Apply 39d ago
  • Supervisor, Manufacturing

    Bioventus 4.2company rating

    Memphis, TN jobs

    Are you ready to work for a more active world? At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives. The Supervisor, Manufacturing is responsible for leading daily production operations for a manufacturing line. This role oversees production associates, ensures safe and compliant manufacturing practices, maintains throughput, quality, and service levels, and drives continuous improvement within a regulated medical device environment. The supervisor manages staffing, workflow, standard work adherence, performance, and communication across the shift to meet SQDC targets and support business growth. Key Responsibilities: * Lead day-to-day production activity for the Surgical manufacturing line, ensuring safe, efficient, and compliant operations. * Assign labor, balance workloads, and manage resource allocation to meet production schedules and takt time requirements. * Execute shift huddles, communication updates, and performance reviews (hour-by-hour boards, tier meetings, etc.). * Monitor production metrics (throughput, FPY, scrap, downtime, labor efficiency) and take immediate action to address issues. * Ensure adherence to manufacturing instructions, device history records, SOPs, and regulatory requirements (FDA QSR, ISO 13485). * Support and document deviations, nonconformances, and quality holds; partner with Quality Engineering to resolve issues. * Maintain traceability, proper documentation, and batch/lot control throughout production. * Provide direction, coaching, performance feedback, and development to production team members. * Manage staffing, timekeeping, training, and cross-training to ensure adequate skill coverage. * Lead onboarding for new associates and ensure proficiency in standard work and quality expectations. * Support performance management, attendance guidance, and corrective action when necessary. * Partner with Supply Chain to ensure material availability, component accuracy, and inventory integrity. * Escalate equipment issues promptly and work with Maintenance/Engineering to restore operation. * Enforce safety standards, ergonomic practices, and proper use of PPE. * Participate in Production Readiness for NPI/Sustaining Engineering changes. * Holds oneself and others accountable to conduct business in a manner compliant with Bioventus' Code of Compliance and Ethics, policies and procedures and internal controls applicable to their role. * Other duties as assigned. Education and Experience (Knowledge, Skills & Abilities) * Bachelors degree (preferred) or a high school diploma with relevant experience * 3-5 years experience in a regulated manufacturing environment (medical device, pharmaceutical, biotech, or equivalent) required. * Prior experience in a leadership or supervisory role required. * Strong understanding of Good Manufacturing Practices (GMP), FDA QSR, and ISO 13485 requirements. * Demonstrated ability to lead a team, manage production flow, and communicate effectively. * Proven ability to manage priorities, problem-solve, and drive performance in a fast-paced environment. * Experience within medical device assembly or surgical product manufacturing, preferred. * Knowledge of Lean, Six Sigma, standard work, and continuous improvement tools, preferred. * Experience with ERP systems (SAP preferred) Place in the Organization Reports to: Director, Manufacturing Direct Reports: Yes Are you the top talent we are looking for? Apply now! Hit the "Apply" button to send us your resume and cover letter. Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. We believe we are bettered by all forms of diversity and take pride in working with top talent from every walk of life. In the spirit of inclusivity, qualified applicants will be considered without regard to age, ethnicity, disability, gender, veteran status, gender expression, gender identity, nationality, race, religion or sexual orientation. All individuals, regardless of personal characteristics, are encouraged to apply.
    $52k-68k yearly est. Auto-Apply 8d ago
  • Manufacturing Formulation Supervisor 3rd shift

    Berkshire Sterile Manufacturing LLC 3.7company rating

    Lee, MA jobs

    The Formulation Supervisor is a working supervisor role responsible for all aspects of formulation activities to ensure achievement of the production and quality goals set by management as well as providing support and direction to formulation personnel. Duties and Responsibilities Oversee and participate in daily formulation activities and ensure all scheduled tasks/events are completed Responsible for lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention or errors that could lead to product and or financial loss Maintain weekly/daily schedule Use production schedule and activities, communicate necessary to do tasks to associates and/or leads Communicate and maintain the thaw / equilibration schedules for chemicals and/or equipment Maintain an adequate supply of formulation supplies so as not to impact the production schedule, follow replenishing process as needed Review Master Production Batch records in timely manner and provides suggestions/corrections to PE member Review SOPs accurately for communicating and initiate the documentation change process (DCR/MOC) for needed documentation changes within established timeframes Complete executed Batch Records accurately and complete manufacturing review within established timeframes prior to submission to QA for review Initiate process deviations as they occur within the department, participate in investigations, and contribute to identifying corrective and preventative actions Identify safety risks and alerts management to take corrective action Provide timely communication to management and clients of issues, challenges as well as opportunities for process improvements Other duties as assigned Regulatory Responsibilities Ensure all work is conducted following a high standard of GMP compliance and written SOP and batch records Comply with all area SOPs and ensure logbooks are completed and adhere to cGMP requirements Supervisory Responsibilities Assign and direct work, provide direction, resources and resolve problems Participate in recruiting Provide feedback on performance to Formulation Manager Train team members and ensures proper training is completed prior to assigning tasks Experience Familiar with cGMP regulations and principles and how to apply them to the manufacturing of pharmaceutical/biotech products Two (2) to three (3) years' work experience in formulation within a GMP environment preferably in fill finish pharmaceutical operations or proven ability of same Leadership experience as a team lead of supervisor type role preferred Education Bachelor's degree preferred An equivalent combination of education and experience may be considered Knowledge, Skills & Abilities Possess working knowledge of formulation/compounding processes and equipment cGMP and cGLP practices Experience with Microsoft Office and general computer proficiency Attention to detail Able to follow rules and regulations Mechanical aptitude Resilient, can quickly move forward despite challenges, thrives on challenges to improve skills and abilities Honesty, integrity, respect and courtesy with leadership and peers Ability to build collaborative relationships Supervisory skills Conflict resolution Able to perform complex work instructions and trouble shoot complex problems Physical Requirements Able to meet gowning requirements Visual acuity Fine and gross motor skills to manipulate tools and equipment Able to remain stationary for continuous prolonged periods of time Able to lift 30lbs repeatedly Able to wear PPE Able to be medically qualified to participate in respirator program Able to use standard office equipment with or without reasonable accommodation
    $71k-103k yearly est. Auto-Apply 47d ago
  • Manufacturing Formulation Supervisor 3rd shift

    Berkshire Sterile Manufacturing LLC 3.7company rating

    Lee, MA jobs

    The Formulation Supervisor is a working supervisor role responsible for all aspects of formulation activities to ensure achievement of the production and quality goals set by management as well as providing support and direction to formulation personnel. Duties and Responsibilities Oversee and participate in daily formulation activities and ensure all scheduled tasks/events are completed Responsible for lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention or errors that could lead to product and or financial loss Maintain weekly/daily schedule Use production schedule and activities, communicate necessary to do tasks to associates and/or leads Communicate and maintain the thaw / equilibration schedules for chemicals and/or equipment Maintain an adequate supply of formulation supplies so as not to impact the production schedule, follow replenishing process as needed Review Master Production Batch records in timely manner and provides suggestions/corrections to PE member Review SOPs accurately for communicating and initiate the documentation change process (DCR/MOC) for needed documentation changes within established timeframes Complete executed Batch Records accurately and complete manufacturing review within established timeframes prior to submission to QA for review Initiate process deviations as they occur within the department, participate in investigations, and contribute to identifying corrective and preventative actions Identify safety risks and alerts management to take corrective action Provide timely communication to management and clients of issues, challenges as well as opportunities for process improvements Other duties as assigned Regulatory Responsibilities Ensure all work is conducted following a high standard of GMP compliance and written SOP and batch records Comply with all area SOPs and ensure logbooks are completed and adhere to cGMP requirements Supervisory Responsibilities Assign and direct work, provide direction, resources and resolve problems Participate in recruiting Provide feedback on performance to Formulation Manager Train team members and ensures proper training is completed prior to assigning tasks Experience Familiar with cGMP regulations and principles and how to apply them to the manufacturing of pharmaceutical/biotech products Two (2) to three (3) years' work experience in formulation within a GMP environment preferably in fill finish pharmaceutical operations or proven ability of same Leadership experience as a team lead of supervisor type role preferred Education Bachelor's degree preferred An equivalent combination of education and experience may be considered Knowledge, Skills & Abilities Possess working knowledge of formulation/compounding processes and equipment cGMP and cGLP practices Experience with Microsoft Office and general computer proficiency Attention to detail Able to follow rules and regulations Mechanical aptitude Resilient, can quickly move forward despite challenges, thrives on challenges to improve skills and abilities Honesty, integrity, respect and courtesy with leadership and peers Ability to build collaborative relationships Supervisory skills Conflict resolution Able to perform complex work instructions and trouble shoot complex problems Physical Requirements Able to meet gowning requirements Visual acuity Fine and gross motor skills to manipulate tools and equipment Able to remain stationary for continuous prolonged periods of time Able to lift 30lbs repeatedly Able to wear PPE Able to be medically qualified to participate in respirator program Able to use standard office equipment with or without reasonable accommodation
    $71k-103k yearly est. Auto-Apply 49d ago

Learn more about Integra LifeSciences jobs