For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.
Job Summary
The Biomanufacturing Associate II plays an integral role within CRL’s gene therapy manufacturing function by applying biological, bioprocess, manufacturing, mechanical, application, system, and technology principles, processes, procedures, inputs, and outputs, for designated production processes and handovers within a regulated environment to ensure the timely production and release of quality products, based on client specifications.
This role will apply solid knowledge and experience across a range of tasks, in resourceful and effective ways, requiring good judgment and initiative, when effectively executing manufacturing protocols.
Key Responsibilities and Duties:
• Apply and adhere to SOPs, cGMP, GLP, Quality, and Safety requirements. • Effectively execute a range of tasks, in line with SOPs, in one of the following areas:• Upstream Activities (e.g., solutions, media aliquot, and buffer preparation and autoclave materials for cell culture, staging of raw materials, seed train, bioreactor set up, fermentation monitoring and/or harvest). • Downstream Activities (e.g., cell lysis, chromatography purification, centrifugation, Tangential Flow Filtration (TFF), and final formulation steps). • Fill-Finish Activities (e.g., buffers and solutions filling, capping, labeling, gathering, and preparation of equipment and materials for final drug product). • Follow instructions when performing planned manufacturing activities, in alignment with the batch record. • Prepare, edit, and complete quality documents. Well-versed in applying GDP. • Ensure data integrity – accurately document and review work prior to submission.• Document, record, investigate, and report observed process variances/deviations, in real time. • Follow instructions when operating equipment. Prepare, clean, and maintain equipment/tools. • Troubleshoot routine issues, using root cause analysis.• Propose and implement approved improvements.• Create and implement safety practices, assist others, and report all incidents immediately. • Adhere to safe working practices and comply with site-based guidelines by applying: • Cleanroom and aseptic behaviors and procedures. • Proper Personal Protective Equipment (PPE) and gowning requirements.• Proper preparation, disinfection, sterilization, and sanitation methods/processes for equipment, etc. • The safe handling, transport, storage, and disposal of biological specimen, chemical, and hazardous materials.• An understanding of biosafety levels and applying specific controls.• Universal precautions with respect to OSHA guidelines. • Appropriate organization, sanitizing, and stocking of work area to avoid unsafe situations. • May assist others. • Ensure 100% on time completion of training plan. • Be punctual and flexible with work schedule, tasks, etc. to support business demands. • Perform other responsibilities as required.
Job Qualifications
• HS Diploma/equivalent with high grades in science and 3 years of related experience, A.S. with 2.5 years or a B.S. in biology/life sciences, bioengineering, or related discipline with 1.5 years of experience. Prior cell/gene therapy experience in a technical role covering a range of tasks within a cGMP and/or biotech manufacturing environment or other related industry, etc. Willing to become a qualified LEAN trainer. • Able to work in accordance with the Charles River Values. • Foster collaboration – is a team player, with a positive attitude, professional tone, and demeanor. • Is accountable and delivers high quality work on time. • Willing to continuously learn and improve.• Strong attention to detail, can recognize deviations, and has solid GDP skills.• Solid analytical, critical thinking, problem-solving and communication skills. • Solid knowledge/application of Word, Excel, Teams, databases, etc. Willing to learn PowerPoint. • Pass/maintain aseptic/gowning qualifications & media fill activities; work in a cleanroom at least 4 hours/day.
Compensation Data
The pay range for this position is $26.00 – $30.00 per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
About Biologics Testing SolutionsWith more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.
About Charles RiverCharles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.
At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
Equal Employment OpportunityCharles River Laboratories is an Equal Opportunity Employer – all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit www.criver.com.
帮助您找到属于您的时刻
当您向我们申请工作时，您会非常小心和努力。请放心，我们将同样努力寻找适合您的职位。我们的招聘流程如下：
职位搜索
了解 CRL、我们的文化以及我们为何开展我们的工作，同时寻找与您的兴趣和专业知识相匹配的职位。
申请
创建个人资料并申请您感兴趣的多个角色。
注意：根据职位的不同，您可能需要在申请中包含简历。评估和申请审查
如果需要，请完成评估，以确定该职位是否适合您，反之亦然。招聘人员将根据职位要求审查您的简历和资格，并确定后续步骤。
注意：在此过程中的任何时候，您都可以登录您的个人资料以查看您的申请状态。面试
通过与多元化的面试官会面来参与我们的包容性面试流程，他们将提供有关公司、文化和您的角色的信息，同时还会向您提出问题以评估您的技能、兴趣和专业知识。这也是您提问的好时机。 注意：Charles River 根据我们的 DNA（关注、领导力、责任心和团队合作）利用基于技术和行为的方法来提问。请熟悉 DNA 并准备好将您的经历与它们联系起来。
工作机会和入职
通过电话或电子邮件从 Charles River 招聘人员或招聘经理处接收有竞争力的录用通知书。录用通知书将包括您的头衔、工资、地点和其他相关信息。
注意： 接受后，您将与招聘人员一起确认入职日期，并在入职之前收到需要以电子方式完成的文件。对于美国的职位，一旦您接受，您将需要进行就业前药物筛查并通过犯罪背景调查。
求职
了解 CRL、我们的文化以及我们为何开展我们的工作，同时寻找与您的兴趣和专业知识相匹配的职位。
申请
创建个人资料并申请您感兴趣的多个角色。 注意: 根据职位的不同，您可能需要在申请中包含简历。
特色职位
Charles River每时每刻都在发生重要的事情。这意味着您可以探索令人兴奋的新职业机会。今天就申请吧！
寻找其他岗位？搜索所有职位。
每时每刻
在 Charles River，您将能够为令人难以置信的突破做出贡献，同时体验令人兴奋的成长和发展机会。
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生物制造技术员 I
支持新型细胞产品的生产、配方和储存（包括 cGMP、GDP 和无菌处理）。
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生物制造技术员 II
执行新型细胞产品的生产、配方和储存方面的专门活动（包括 cGMP、GDP 和无菌处理）。
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生物制造技术员 III
在与客户互动的同时，帮助推进新型细胞产品（包括 cGMP、GDP 和无菌处理）的生产、配方和储存。
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生物制造主管 / 专家
保持对专用设备的深入了解，以便作为所需设备的主题专家来解决问题。
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生物制造主管
监督生物制造人员，确保遵守 cGMP、CRL 质量体系和生物制造流程文件。
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生物制造经理
领导新型细胞产品的启动和 cGMP 生产中的生物制造活动。安排和管理员工，确保安全、合规的工作环境。
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关于Charles River
Charles River 是一家有着悠久历史的 CRO 公司。在这里，我们热衷于改善人们的生活质量。我们在全球设有 100 个分支机构，战略定位为协调全球资源并运用多学科视角来解决客户的独特挑战。我们的客户群包括全球制药公司、生物技术公司、政府机构、医院和世界各地的学术机构。
支持您的福祉
您的奉献和热情为世界各地的人们带来了拯救生命的改变。我们致力于为您提供福利，提高您的生活质量。
金融的
- 收益+激励
- 退休福利
- 假期+外出时间
- 认可
- 员工援助基金
职业
- 职业发展机会
- 职业发展
- 奖项
- 教育支持
关于Charles River
Charles River 是一家有着悠久历史的 CRO 公司。在这里，我们热衷于改善人们的生活质量。我们在全球设有 100 个分支机构，战略定位为协调全球资源并运用多学科视角来解决客户的独特挑战。我们的客户群包括全球制药公司、生物技术公司、政府机构、医院和世界各地的学术机构。