Quality control analyst jobs in Lynn, MA

Location: Rochester MA (100% On-site), 1st shift only 6:30A-3:30P M-F, salary range $72K-$82K, full-time role: health insurance with an HRA, dental, vision, LTD, and a 401(k) retirement plan with an employer match. 3 weeks PTO, 1 week sick. Generous relocation package offered. Qualified candidates are encouraged to apply. Large precast concrete supplier in Massachusetts and New Hampshire, providing high-quality products for over 70 years. Their extensive product range includes septic tanks, manholes, drainage structures, bulkheads, curbing, residential steps, and retaining wall systems, all crafted to precise specifications. They cater to engineers, contractors, and homeowners, emphasizing superior performance and exceptional customer service. The Quality Control Technician (“QC Technician”) will work within the production plant and is ultimately responsible for product testing. The QC Tech will assist in the execution of quality control processes, procedures and protocol associated with the production of pre and post concrete pours. Responsibility Responsible for ACI concrete field tests Responsible for quality control inspections in manufacturing plant Inspect forms before pouring (Pre-Pour). Inspect product after removed from forms (Post-Pour) Notifies Production Supervisor if deficiencies are found. Perform and/or schedule repairs on products as needed. Housekeeping - maintain a clean work area. Including cleanliness within breakroom, restroom, and general facility areas. Expected to maintain knowledge of precast plant techniques and procedures. May assist with precast production operation as needed. Characteristics Always committed to safety. Maintain a safe work area. Follow safe work practices as outlined in the Safety Program. Always committed to quality. Follow and implement quality control measures. Excellent attendance. Reliable means of transportation to and from work. Ability to learn, organize and prioritize work and handle multiple tasks. Outstanding attitude, honesty, and ethic at all times. Expected to use sound judgment, diplomacy, and discretion. Work independently or cooperatively with others. Self-drive in carrying out the functions of the job. Requirements: ACI Concrete Field-Testing Grade 1 Certified (preferred) NPCA PQS Training Must be at least 18 years of age per federal guidelines. Good communication skills, both verbal and written to all levels of staff Ability to remain focused in busy environment. Computers and tablets skills in order to perform tasks. Ability to read blueprints and sketches.

Company Information: Tedor is a privately held pharmaceutical company a CDMO that develops drug product for both innovator and established companies. We are customer-focused oral solid dose CDMO with a strong track record of meeting aggressive development and commercialization timelines Over the past 20 years we have helped customers received many product approvals.We attribute this success to our company-wide focus on quality, customer service, and meeting timelines. Everything we do, and how we do it, is focused on helping our clients to achieve their product objectives. Position Summary: The role of the Quality Control Chemist is a vital role that is essential to manage and execute the quality testing that is required for drug substance on the commercial market. Quality Control Chemist will also be responsible for method validation and release & stability testing for clinical trial and commercial drug products; therefore, verifying all products and/or substances meet acceptable quality standards and that they are in accordance with the company's policies & procedures, FDA policies & procedures, and any applicable cGMP requirements. Additionally, ensuring compliance, accuracy, and timeliness of specified testing processes, environmental monitoring, data review, data analysis, and data trending of all raw materials, finished formulations, stability samples, client-based & company-based projects, method development, equipment calibrations/qualification and/or transfers, and cleaning study qualifications are all essential responsibilities. Quality Control Chemists are expected to collaborate with QC Analysts and Development Chemists while performing the QC Chemist position. This is a full-time, non-exempt position that includes a competitive salary, and strong benefits. The Quality Control Chemist will report Directly to the Quality Control Manager or Director. Position Description: Responsibilities Head the collaboration between QC and Developmental Chemists personnel but also cross department collaboration regarding drug product development, commercial operations, commercial manufacturing, Quality Assurance, and Analytical Development. Evaluation of QC laboratory operational execution and resources needed to preform tests. Generate, review and revise QC GMP documentation (SOPs, protocols, technical reports, specifications, etc.) as needed. Revise and manage technical transfer of methods from internal labs for raw material analysis, in-process testing, as well as API and Drug Product testing under supervision of the Director. Review and report all QC data and generate Certificates of Analysis. Monitor and trend QC data generated by internal and contract testing labs. Initiate ICH stability study protocols, execute and generate of interim reports. Manage, write, and review Out of Specification/Atypical results/Out of Trend investigations, deviations, and CAPAs. Investigate and troubleshoot method issues. Review relevant sections of regulatory filings. Monitor calibration schedule. Contact vendors. Schedule visits for PM/Calib and repairs. Assist vendors on site. Coordinate stability operation activities and ensure quality products and systems. Determine stability sample requirements, develop stability protocols and oversee execution of stability protocols. Monitor stability chambers and chart recorders on a daily basis to confirm environmental conditions for acceptance with established specifications. Prepare stability data graphs to estimate expiration dates and verify product shelf life. Evaluate stability trends and prepare reports. Equipment Qualification, including data integrity program. Position Type & Expected Hours of Work This is a full-time, non-exempt position requiring a minimum of 40 hours of work per week, Monday through Thursday and some in person Friday's.. Some responsibilities may require work outside of normal office hours. Work Environment Level 2: Office Environment and Laboratory Environment The work environment characteristics described here are representative of those a teammate encounters while performing the essential functions of this role and within the daily operations of a professional office environment. Reasonable accommodations may be made to enable employees with disabilities to perform essential functions. This job operates in a professional office environment, as well as the laboratory environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, as well as standard laboratory equipment and instrumentation. An employee in this role will be exposed to standard hazards founds within a laboratory environment such as chemicals; bloodborne pathogens; fumes; select agents; confined spaces. Proper laboratory attire and safety gear such as protective eyewear; laboratory coat; appropriate gloves must be observed. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. This role requires standard physical demands within a standard office and laboratory environment where sustained periods of standing, sitting, or walking will be part of an employee's daily routine, whether they are at their desk or in the laboratory. While performing the duties of this role, an employee is regularly required to talk or hear; use hands or fingers to handle or feel; reach with arms; bend or stoop; climb stairs; crawl or crouch; kneel; push or pull; type on a keyboard; use a computer mouse. Lastly, an employee must be able to lift ten (10) pounds. Travel Limited travel is expected for this position. Required Education & Experience B.S. in Chemistry or Pharmaceutical Science, or other related discipline such as life sciences, drug product development. Five to Seven (3 - 5) years of work/laboratory experience in the pharmaceutical industry, Quality Control (QC). 3 + years of experience in a regulated manufacturing or QC laboratory environment of analytical methods for pharmaceutical products Experience in QC testing of pharmaceutical and/or biologic products in a GMP environment. Solid understanding of GMP compliance, Quality Control CMC requirements for ANDAs, and other regulatory filings Excellent interpersonal, verbal, and written communication skills Demonstrated collaborative skills and prior leadership roles or positions Comfortable in a fast-paced, small company environment, ability to adjust workload based upon changing priorities Technical knowledge Strong Microsoft Word, Excel, and Office skills Experience in contracting testing laboratories Preferred Experience & Experience BS in relevant life science, scientific, or engineering discipline Three to Five (3 - 5) years of work/laboratory experience in the pharmaceutical industry, Quality Control (QC). Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. All duties, responsibilities, and activities may be subject to change at any time with or without notice. EEO Statement: Tedor Pharma, Inc. is proud to be an Equal Employment Opportunity and Affirmative Action employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminated based upon race, religion, color, marital status, national origin, gender, sexual orientation, gender identity, gender expression, age, status as a protected veteran, ancestry, medical condition, pregnancy, genetic information, status as an individual with any mental and/or physical disabilities, or any other status protected under federal, state, or local law.

We are seeking an enthusiastic Associate Synthetic Chemist to support the discovery of small molecules for next-generation 3D printing resins. You will work hands-on in the lab, executing syntheses of novel molecules, characterizing products, and exploring photochemical and photophysical structure-property relationships. This role is ideal for highly motivated early-career chemists who love synthesis and are excited to accelerate innovation through fast, iterative chemistry. You will be closely mentored by experienced synthetic chemists and will collaborate with analytical scientists and engineers developing our printing systems. Responsibilities Design, execute, and troubleshoot small molecule synthetic routes, with a focus on divergent or modular approaches to rapidly generate lead candidates. Purify products using chromatography and crystallization techniques. Characterize compounds via UPLC, NMR, UV/Vis and IR spectroscopy, and mass spectrometry. Work with cross-functional teammates to explore photochemical and photophysical structure-property relationships that drive 3D printing performance. Maintain excellent electronic lab notebook documentation. Contribute to management of chemical databases (e.g., commercial, proprietary, and virtual compound libraries). Minimum Qualifications Bachelor's degree in Chemistry or a closely related field with equivalent advanced chemistry coursework. ≥2 years of intensive organic synthesis laboratory experience (academic research and/or industrial roles). Experience with synthetic planning with chemical databases (e.g., SciFinder, Reaxys). Excellent command of synthetic and physical organic chemistry fundamentals. Experience with air-sensitive techniques (e.g., Schlenk line), purification (chromatography/crystallization), and data interpretation (NMR / LC-MS). Evidence of strong documentation and organizational skills, attention to detail, and the ability to manage multiple workflows efficiently. Evidence of strong collaboration and teamwork talents/skills. Ability to thrive in a fast-paced, collaborative R&D environment. Preferred Qualifications Command of the basics of photochemistry. Experience with heterocyclic and/or extended aromatic systems, especially those relevant to organic (opto)electronics. Benefits We offer competitive compensation packages in our VC-backed startup. Benefits include a full suite of offerings covering medical, dental, vision and 401k plan. Beautiful setting looking out over a river and seaport; outdoor seating and picnic areas. Highly collaborative work environment. Additional Information Travel: Occasional travel may be required from time to time Location: Boston, Massachusetts We value diversity in our company and are an Equal Opportunity Employer.

Prepare chemical solutions and maintain plating baths for electroplating operations. Operate and maintain electroplating equipment including tanks, rectifiers, and agitation systems. Calibrate and maintain laboratory instruments such as pH meters, spectrophotometers, and conductivity meters. Perform routine and specialized tests to monitor plating thickness, adhesion, and surface finish properties. Analyze chemical concentrations and adjust bath compositions to maintain optimal plating conditions. Document experimental procedures, results, and observations in lab notebooks and digital systems. Clearly and concisely communicate research to team lead and other team members. Collaborate with R&D teams to assist in research and development of new plating processes and surface treatments Collaborate with sales teams to troubleshoot customer plating issues. Ensure compliance with safety protocols, environmental regulations, and waste disposal procedures. Preferred: Experience with production-scale electroplating. Associate, Bachelor, or Master's degree in Chemistry, Chemical Engineering, Materials Science, or related field. 1+ years of experience in a chemical laboratory setting, with a focus on electroplating or surface finishing is a plus Strong understanding of electrochemical principles and electroplating chemistry (e.g., nickel, copper, silver, tin) is a plus Experience with a diverse range of analytical equipment, including UV-Vis, AA, SEM, XRF, XRD, wet chemical techniques, and surface analysis methods. Knowledge of ASTM and ISO standards and quality control procedures. Experience with corrosion science or surface science. Experience with Lean Six Sigma or certification. Qualifications: Strong bias for action and willing to go the extra mile Well-organized, detail-oriented, and results-driven team player. Methodical, proficient in data analysis, and excellent problem-solving skills. Ability to work both independently and as part of a multidisciplinary team. Familiarity with lab safety standards and chemical handling procedures

Job Overview:Fall 2026 Co-Op - MES and Quality - Burlington, MA As a Fall 2026 Co-Op - MES and Quality Co-Op in Burlington, MA at Keurig Dr Pepper (KDP), you will be a part of the beverage revolution. You will be working in a fast-paced, highly technical manufacturing environment that produces some of KDP's most popular beverages. Each co-op will lead high-impact projects and will be provided with opportunities to grow professionally. Come learn what it takes to succeed at an industry-leading company and help contribute to our ongoing success. You will be able to directly participate in the implementation of new technology that improves our manufacturing process. Shift/Schedule: The KDP 2026 Fall Co-op Program will run from July 13 - Decemeber 11, 2026Full-time; 40 hours per week Monday-Friday 8:00am until 5:00pm In-Person As a Co-op you will: Gain knowledge in executing operational plans and projects, including data analytics and developing visualizations for DMS (Daily Management Systems) and QMS(Quality Management Systems). Participate in AGILE project management and lead the development, verification, and testing of Data Analytics dashboards and visualization tools. Influence software capabilities to achieve six sigma quality performance and enhance Quality Management System. Assist with TPM (Total Productive Maintenance) implementation and Lean activities, including participation in Continuous Improvement or Kaizen events. Test and verify new technology systems implemented for the Quality management and Manufacturing process. Elements of the KDP Co-op Program include: Engaging and partnering on innovative projects to gain experience in a challenging, cross functional team environment Participate in meet & greets and lunch & learns with KDP executives and other organization leaders Receive professional development training such as networking, professional skills development and presenting Be paired with a mentor to enhance your knowledge of other parts of the business and build your network Complete a project from start to finish and present it and your takeaways to your team, department vice president and other KDP stakeholders Total Rewards:$31/hour Paid bi-weekly $5,000 Sign-on Bonus, paid within first 30 days of employment Requirements:Must be an undergraduate currently enrolled in a full-time academic program from an accredited college or university, majoring in Information Technology, Computer Science, Analytics, Engineering or another related field Available to work 40 hours per week (M-F, 8am-5pm) Excellent organizational skills and attention to detail with a demonstrated ability to manage multiple projects, prioritize requests, and meet deadlines Strong communication skills including excellent listening, written, and verbal abilities Ability to work cross-functionally, be independently driven, and a self-starter Strong skills in Microsoft Excel and PowerPoint Please note: This position is limited to persons with permanent right to work in the United States. We incorporate HireVue, an automated interview tool, into our campus recruitment process. Please visit this link to learn more about HireVue and how to prepare. *We recommend checking with your campus career center for additional preparation resources such as InterviewStream, Big Interview and more Company Overview:Keurig Dr Pepper (NASDAQ: KDP) is a leading beverage company in North America, with a portfolio of more than 125 owned, licensed and partners brands and powerful distribution capabilities to provide a beverage for every need, anytime, anywhere. We operate with a differentiated business model and world-class brand portfolio, powered by a talented and engaged team that is anchored in our values. We work with big, exciting beverage brands and the #1 single-serve coffee brewing system in North America at KDP, and we have fun doing it! Together, we have built a leading beverage company in North America offering hot and cold beverages together at scale. Whatever your area of expertise, at KDP you can be a part of a team that's proud of its brands, partnerships, innovation, and growth. Will you join us? We strive to be an employer of choice, providing a culture and opportunities that empower our team of ~29,000 employees to grow and develop. We offer robust benefits to support your health and wellness as well as your personal and financial well-being. We also provide employee programs designed to enhance your professional growth and development, while ensuring you feel valued, inspired and appreciated at work. Keurig Dr Pepper is an equal opportunity employer and recruits qualified applicants and advances in employment its employees without regard to race, color, religion, gender, sexual orientation, gender identity, gender expression, age, disability or association with a person with a disability, medical condition, genetic information, ethnic or national origin, marital status, veteran status, or any other status protected by law. A. I. Disclosure: KDP uses artificial intelligence to assist with initial resume screening and candidate matching. This technology helps us efficiently identify candidates whose qualifications align with our open roles. If you prefer not to have your application processed using artificial intelligence, you may opt out by emailing your resume and qualifications directly to kdpjobs@kdrp. com.

About Aura: Aura Biosciences is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors that aim to preserve organ function. Our lead candidate, bel-sar (AU-011), is currently in late-stage development for primary choroidal melanoma and in early-stage development in other ocular oncology indications and bladder cancer. Aura Biosciences is headquartered in Boston, MA. Our mission is to grow as an innovative global oncology company that positively transforms the lives of patients. For more information, visit aurabiosciences.com. Follow us on X (formerly Twitter) @AuraBiosciences and visit us on LinkedIn. Position Summary: Aura Biosciences is seeking a highly motivated and detail-oriented QC Scientist to support method validation and routine QC operations for our innovative oncology therapeutics. This role is critical to ensuring the integrity and compliance of analytical methods used in the testing of drug substance and drug product across clinical stages. Key Responsibilities: Lead and execute method qualification and validation activities in alignment with ICH guidelines and GMP standards. Support and oversight of routine QC testing of plasmid, drug substance (DS) and drug product (DP), including release and stability studies. Collaborate with CMOs and CROs to ensure timely and compliant execution of analytical activities. Author and review technical documentation including validation plans, protocols, reports, SOPs, and CoAs. Manage validation timelines and proactively provide solutions to method challenges. Participate and lead investigations (OOT/OOS), CAPAs, and continuous improvement initiatives. Review and trend analytical data routinely for specification evaluation. Ensure compliance with internal quality systems and regulatory expectations. Contribute to cross-functional CMC discussions and provide technical input on overall analytical strategy. Key Skills Analytical Method Validation - Strong understanding of ICH Q2(R2), GMP principles including compendial methods and data integrity. Instrumentation Expertise - Proficiency in HPLC, UV-Vis, Empower, Bioassays, qPCR other analytical platforms and compendial methods. Collaboration - Effective communication with internal teams and prior experience managing external partners (CMOs/CROs) is preferred. Technical Writing - Skilled in drafting and reviewing protocols, reports, and SOPs. Problem Solving - Experience with OOS/OOT investigations and root cause analysis. Project Management - Ability to manage timelines and deliverables across multiple stakeholders. Regulatory Knowledge - Familiarity with FDA and EMA expectations for QC and validation. Attention to Detail - High level of accuracy in data review and documentation. Statistical analysis using JMP, Minitab or equivalent. Minimal travel is required to CMOs. Role is a hybrid role (minimum 3 days onsite). Minimum BS in Sciences with at least +5 years' experience or MS and 2+ years Salary & Benefit Information: Salary Range: $105,000/yr - $135,000/yr (Placement within the listed range depends on many factors including, but not limited to: geographic location, degree, years of experience, and internal company equity) Health insurance with FULL premium coverage 401K with company match Employee Stock Purchase Program (ESPP) Competitive paid time off (PTO) Company-paid short & long-term disability insurance and life insurance

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Qualifications QC Microbiologist 5-8 years in biopharmaceutical setting , BS in Microbiology . QC Microbiologist requires: Proficiency in aseptic technique Endotoxin testing using Kinetic Methods Bioburden testing using membrane filtration methods Familiarity with general lab equipment Knowledge of cGMP requirements Must be able to perform lab bench testing QC Microbiologist duties: Performs traditional microbiology testing (Bioburden, endotoxin) in support of commercial product release testing Performs laboratory support functions such as review of data, maintenance of equipment and support of investigations May act as delegate /representative for QCM area on cross functional teams for investigations and continuous improvement projects Receives some supervision on routine work and instructions on new assignments. Organizes daily activities to ensure timely completion of assignments. Receives direction from scheduling. Reports on missed tasks Communicates straightforward This position will interact with peers of same or higher level QCM management and may interact with QA Additional Information $60HR 12 months

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products. AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a QC Scientist I Raw Materials opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA. Purpose: The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead. This role will mentor junior analysts and develop and facilitate training initiatives within the labs. Essential Job Responsibilities: Develop/author/revise technical reports and laboratory procedures (SOPs, methods) Execute and troubleshoot raw material testing in support of production activities Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures Design and perform testing in support of method transfer/validation/qualification/verification Review/authorize data and perform analysis and interpretation of test results and trends Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration Support and mentor junior team members Collaborate with other network sites to share best practices Other duties as required Quantitative Dimensions: The QC Scientist I Raw Materials will be accountable for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. Organizational Context: The QC Scientist I Raw Materials will typically report to the Senior Manager, Quality Control Raw Materials. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. WORKING AT GENEZEN Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team. JOB SUMMARY The Sr. Scientist/Scientist II-II, Critical Reagents is responsible for overseeing all reference standards and other critical reagents in line with internal SOPs and ICH guidelines. This individual will work collaboratively with QC Operations, Analytical Development, and Quality Assurance in support of clinical pipeline and commercial products. This position requires strong leadership skills, statistical and technical knowledge, and a commitment to quality and compliance. The position will be hired at the Scientist II, Scientist III or Sr. Scientist level based upon the experience of the successful candidate. ESSENTIAL JOB FUNCTIONS Oversee the Critical Reagents and Materials function. Oversee the day-to-day operations of the GC QC Technical Services group. Provided operational oversight for critical reagent and materials management across the quality organization. Develop and maintain robust systems for the qualification, monitoring, tracking and storage of critical reagents and materials. Collaborate with cross-functional groups to ensure the continued supply of qualified reagents and materials. Act as the primary point of contact for the monitoring, tracking, and storage of critical reagents and materials. Manage inventory, strategic planning, and lifecycle management of reference standards and critical materials. Represent Quality Control on project teams and in meetings as required. Authors and reviews standard operating procedures, protocols, and reports as required. Manages the implementation/maintenance/continuous improvement of Quality Systems as required. SPECIAL JOB REQUIREMENTS Adaptability required as work schedule may change based on business needs Criminal background check required Other duties as assigned KNOWLEDGE, SKILLS AND EXPERIENCE EDUCATION / CERTIFICATIONS / LICENSES Essential/Desired BS or MS in Life Sciences or Engineering Essential ON-THE-JOB EXPERIENCE 8+ years of pharma/biotech industry experience Essential Well versed in cGMP/ICH/FDA/EU regulations and guidelines Essential Large molecule, gene or cell therapy experience is required. Essential Expertise in reference standards programs, including ICH regulations and quality control methods. Essential Strong background in biostatistics for evaluation comparability and qualification of new reference standards and control reagents. Desired Experience in Quality Control within the biological pharmaceutical industry. Desired Proficiency in writing SOPs, qualifications protocols, and reports. Essential Familiarity with statistical software (JMP). Essential SKILLS / ABILITIES Excellent analytical and problem-solving skills Essential Must possess excellent communication and organizational skills Essential Cross functional collaboration ability to work well with diverse groups Essential Ability to manage multiple activities with challenging timelines Essential Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint) Essential Effective oral and written communication skills Essential Confident, independent, self-starter, proactive, and results-oriented with high performance and compliance standards Essential Exhibits highest integrity and committed to ethics and compliance standards Essential Open and transparent in sharing data and information Essential PHYSICAL DEMANDS While performing the duties of this job, the employee is required to meet the following physical demands: Work Environment Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock Occasionally exposed to extremely loud noise levels Movement Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl Lifting Frequently lift and/or move up to 25 pounds Occasionally lift and/or move up to 50 pounds Vision Frequently utilize close vision and the ability to adjust focus Communication Frequently required to communicate by talking, hearing, using telephone and e-mail Pay Range: The annual salary range for this position is $100,000-$145,000. GENEZEN'S CURES VALUE-BASED COMPETENCIES Committed to Science We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare. Urgency in action for the patients We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs. Resilience & Grit in operations We are committed to overcoming challenges, learning from failures, and persistently striving for success. Execute with Excellence & Integrity We are dedicated to delivering quality results and upholding ethical principals. Solutions driven for our partners We are committed to being a proactive, collaborative, creative and open-minded partner. GENEZEN'S BENEFITS Paid vacation days, amount based on tenure Paid sick time 10 observed holidays + 2 floating holiday + 1 volunteer day 401(k) plan with company match up to 6% of salary, vested immediately Share Appreciation Rights Choice of several healthcare plans FSA and HSA programs Dental & vision care Employer-paid basic term life/personal accident insurance Voluntary disability, universal life/personal accident insurance Accidental Death & Dismemberment (AD&D) Insurance ADDITIONAL DETAILS Nothing in the job description for this role restricts management's right to assign or reassign duties and responsibilities to this job at any time. This position requires a criminal background check. Genezen is an Equal Opportunity Employer. Genezen participates in EVerify. Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas. Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts. Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum--to name just a few reasons why this area is a great place to live. Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.

Mindlance is a national recruiting company which partners with many of the leading employers in the Life Sciences, IT, and Financial Services sectors, feel free to check us out at ************************* Job Description To provide technical, scientific and project support for the Quality Control- Technical Support team in establishing and monitoring testing procedures, investigations, technical transfer of methods, training of staff, and analysis of data and trends. PRIMARY RESPONSIBILITIES: 1. Provides technical support for method transfers, including protocol / report authoring and reviewing, data analysis. 2. Leads projects related to Quality Control programs as assigned. 3. Trains staff, monitors and oversees testing of Analytical Chemistry methods. In depth understanding of at least one discipline (cell based Bioassay, Immunoassay, Electrophoresis, Separation technology [chromatography]. 4. Provides technical and operational expertise for training and developing staff, assisting in troubleshooting and performing investigations for out of specification results. 5. Writes technical reports, reviews and revises standard operating procedures as needed. 6. Assists in troubleshooting laboratory equipment and procedures, taking required corrective action. Qualifications PREREQUISITES / QUALIFICATIONS: • Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, a related discipline, or its equivalent is preferred • Minimum of 4 years of experience as a senior analyst in Biologics QC lab or experience in a related biopharmaceutical GLP or GMP laboratory. • Strong technical experience with analytical methodologies. Perform troubleshooting of instrumentation and methods. Have ability to recognize instrumentation and method issues and provide recommendation on instrument and method improvements for the network. • Previous experience with method transfer desired. • Experience with LIMS and Smart lab computer applications a plus. • Proficient in common computer software applications. • Strong general laboratory and organizational skills, effective communication skills, both oral and written. • Strong attention to detail. Additional Information Regards _________________________________________________________________________________________________________ Ankit Gupta | Team Recruitment | Mindlance, Inc. | Office: ************ |

Advancing medicine to save lives. Together. Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases. Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions - together with our clients. Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability. As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives. Duties and Responsibilities Laboratory role to support the qualification and validation of analytical methods for biologic drugs and process related impurities Primary focus on the execution of experiments to support the validation of molecular biology assays including but not limited to ELISAs for residual HCP, residual protein a, and relative potency assays as well as qPCR Work collaboratively within a group of scientists to perform analytical method development qualification or validation under cGMP in collaboration with the Quality Control unit Apply expertise in molecular biology, cell biology and/or immunochemistry to analytical development team across the lifecycle of the procedures Participate in the technology transfer of analytical methods into QC and analytical method qualification Method transfer, method validation, method development Review & revise SOPs and/or author reports, protocols & other documentation as appropriate Collaborate with other labs to prepare methods for transfer to the QC GMP labs Provide training and work direction for group members as required Qualifications Bachelor's Degree in chemistry or a biological science with minimum of 8+ years of related experience (or master's degree with 5+ years of experience) in a cGMP environment Experience utilizing Spectramax M5 or M2 plate readers and the associated Softmax GMP software required Strong understanding of molecular biology assays in support of the product quality testing for Biologics drug substances/drug products Experience with analytical characterization of biologics is expected Strong organizational, time management skills, and prioritize work schedule to meet deadlines Must be able to communicate effectively with managers, peers, and clients Must demonstrate effectiveness in ability to train others as needed Strong knowledge and expertise of quality requirements pertinent to pharmaceutical AD labs Strong working knowledge of laboratory safety including standard precautions associated with hazardous & biohazardous material handling Experience with drug substance, drug products, intermediates, as well as experience with monoclonal antibodies is desired Experience in other biophysical characterization methods CE (capillary electrophoresis), chromatography, SEC/RP/IEX-U(H) PLC, SDS-CGE, iCIEF, CIEX, Peptide mapping is a plus Computer skills to include full competence with Microsoft Word, Power Point & Excel Working Conditions Laboratory environment working with chemical reagents and analytical equipment Normal office working conditions: computer, phone, files, fax, copier Personal Protective Equipment must be worn as required Minimum travel required Physical Requirements Frequent lifting up to 10 lbs.; frequent standing/walking Manual and visual dexterity required to perform laboratory and computer tasks for prolonged periods PPE as required ____________________________________________________________________________ Base Pay Range $52/hr - $67/hr

360 IT Professionals is a Software Development Company based in Fremont, California that offers complete technology services in Mobile development, Web development, Cloud computing and IT staffing. Merging Information Technology skills in all its services and operations, the company caters to its globally positioned clients by providing dynamic feasible IT solutions. 360 IT Professionals work along with its clients to deliver high-performance results, based exclusively on the one of a kind requirement. Our services are vast and we produce software and web products. We specialize in Mobile development, i.e. iPhone and Android apps. We use Objective C and Swift programming languages to create native applications for iPhone, whereas we use Android Code to develop native applications for Android devices. To create applications that work on cross-platforms, we use a number of frameworks such as Titanium, PhoneGap and JQuery mobile. Furthermore, we build web products and offer services such as web designing, layouts, responsive designing, graphic designing, web application development using frameworks based on model view controller architecture and content management system. Our services also extend to the domain of Cloud Computing, where we provide Salesforce CRM to effectively manage one's business and ease out all the operations by giving an easy platform. Apart from this, we also provide IT Staffing services that can help your organization to a great extent as you can hire highly skilled personnel's through us. We make sure that we deliver performance driven products that are optimally developed as per your organization's needs. Take a shot at us for your IT requirements and experience a radical change. Job Description • This role will report to the Manager of QC Microbiology for support of product testing area. The candidate will support release testing for commercial, clinical and PV products. The candidate will support a variety of GMP activities in the QCM laboratory area. Analyst will be assigned testing roles via QCM standard work process • Performs traditional microbiology testing (Bio burden, endotoxin) in support of commercial product release testing • Performs laboratory support functions such as review of data, maintenance of equipment and support of investigations • May act as delegate /representative for QCM area on cross functional teams for investigations and continuous improvement projects • Receives some supervision on routine work and instructions on new assignments. • Organizes daily activities to ensure timely completion of assignments. Receives direction from scheduling. Reports on missed tasks • Communicates straightforward • This position will interact with peers of same or higher level QCM management and may interact with QA Qualifications • BS in Microbiology preferred • 5-8 years in biopharmaceutical setting preferred. • Proficiency in aseptic technique • Endotoxin testing using Kinetic Methods • Bio burden testing using membrane filtration methods • Familiarity with general lab equipment • Knowledge of cGMP requirements • Must be able to perform lab bench testing Additional Information Thanks and Regards, Karan Sharma 510-254-3300 ext. 150

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Analytical Development Scientist II to take a leading role in method development, validation, and transfer activities that support the full product lifecycle-from clinical to commercial programs-as well as R&D initiatives. As a member of the team, you'll apply your deep technical expertise to lead projects, mentor junior staff, and collaborate cross-functionally. Your work will directly impact the quality, reliability, and efficiency of our pharmaceutical development and manufacturing operations. What You'll Do Lead method development & validation: Develop, validate, and transfer analytical methods using HPLC/UPLC, CE, ELISA, FTIR, KF, UV/VIS, and more in compliance with ICH and GMP guidelines. Execute complex testing: Conduct analytical testing to support process development, method transfers, and validation activities. Ensure compliance: Document laboratory work in accordance with GDP requirements; author and review protocols, reports, technical summaries, and SOPs. Problem-solve & innovate: Troubleshoot method and instrumentation issues, propose solutions, and bring in new technologies to improve efficiency, robustness, and compliance. Drive efficiency: Independently manage multiple projects, ensuring timelines, quality, and cross-team collaboration. Support quality systems: Participate in cleaning validations, method qualifications, and audit readiness as needed. What We're Looking For Education/Experience: Bachelor's degree in a scientific discipline with 5+ years of relevant experience, OR Master's degree with 5+ years in a cGMP laboratory environment. Technical expertise: Extensive hands-on experience with analytical techniques (HPLC/UPLC, GC, CE, ELISA, FTIR, UV/VIS, Karl Fisher, SDS-PAGE, particle size analysis, pH, osmometry). Regulatory knowledge: Strong working knowledge of cGMP, ICH, USP, and global compendial guidance. Skills: Excellent problem-solving, technical writing, and project management abilities; proficiency in MS Office and lab-based data systems. Attributes: Detail-oriented, resilient, collaborative, and adaptable in a fast-paced environment. Preferred: Experience in a contract development/manufacturing organization (CDMO). #LI-LL1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

At Eurofins Professional Scientific Services (PSS), we believe the work we do matters-and so do our employees. We offer a unique opportunity to grow within the biopharmaceutical industry, supported by a collaborative team, professional development resources, and a competitive benefits package. Eurofins Scientific is a global leader in analytical testing across food, environment, pharmaceutical, and cosmetic industries. Our mission is to make life and our environment safer, healthier, and more sustainable. Job Description We are seeking a skilled HPLC Method Development Chemist to join our Cambridge-based team. This role focuses on developing, optimizing, and qualifying analytical methods for synthetic molecules, with a strong emphasis on HPLC and related chromatographic techniques . Key Responsibilities Develop and optimize HPLC methods for synthetic molecule analysis Support process and formulation development through analytical testing Interpret and communicate analytical data to cross-functional teams Troubleshoot instrumentation and method-related issues Author technical reports and documentation in compliance with cGMP/GLP standards Independently design and execute experiments Collaborate with team members to meet project goals Maintain accurate records and adhere to safety and regulatory guidelines Qualifications Bachelor's degree in chemistry, biology, pharmacy, engineering, or related field with 4+ years of relevant experience OR Master's degree with 2+ years of relevant experience Hands-on experience with HPLC and other analytical techniques (e.g., GC, Dissolution, Karl Fischer, spectroscopy) Strong problem-solving and organizational skills Effective communication and teamwork abilities Authorization to work in the U.S. without restriction or sponsorship Additional Information What to Expect in the Hiring Process: 10-15 Minute Phone Interview with Region Recruiter 45-60 Minute Virtual Interview with Manager and/or Group Leader 45-60 Minute In-Person Meeting to Meet the Team and Discuss the Role Additional Details: This is a full-time, onsite position based on a first-shift schedule (Monday through Friday, 8:00am to 5:00pm), with overtime required as needed. Candidates located within a commutable distance to Cambridge, Massachusetts, are strongly encouraged to apply. Excellent full-time benefits include: Comprehensive medical coverage, dental, and vision options Life and disability insurance 401(k) with company match Paid vacation and holidays Hourly rate is between $39-$44, depending on education and experience Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

At Eurofins Professional Scientific Services (PSS), we believe the work we do matters-and so do our employees. We offer a unique opportunity to grow within the biopharmaceutical industry, supported by a collaborative team, professional development resources, and a competitive benefits package. Eurofins Scientific is a global leader in analytical testing across food, environment, pharmaceutical, and cosmetic industries. Our mission is to make life and our environment safer, healthier, and more sustainable. Job Description We are seeking a skilled HPLC Method Development Chemist to join our Cambridge-based team. This role focuses on developing, optimizing, and qualifying analytical methods for synthetic molecules, with a strong emphasis on HPLC and related chromatographic techniques. Key Responsibilities Develop and optimize HPLC methods for synthetic molecule analysis Support process and formulation development through analytical testing Interpret and communicate analytical data to cross-functional teams Troubleshoot instrumentation and method-related issues Author technical reports and documentation in compliance with cGMP/GLP standards Independently design and execute experiments Collaborate with team members to meet project goals Maintain accurate records and adhere to safety and regulatory guidelines Qualifications Bachelor's degree in chemistry, biology, pharmacy, engineering, or related field with 4+ years of relevant experience OR Master's degree with 2+ years of relevant experience Hands-on experience with HPLC and other analytical techniques (e.g., GC, Dissolution, Karl Fischer, spectroscopy) Strong problem-solving and organizational skills Effective communication and teamwork abilities Authorization to work in the U.S. without restriction or sponsorship Additional Information What to Expect in the Hiring Process: 10-15 Minute Phone Interview with Region Recruiter 45-60 Minute Virtual Interview with Manager and/or Group Leader 45-60 Minute In-Person Meeting to Meet the Team and Discuss the Role Additional Details: This is a full-time, onsite position based on a first-shift schedule (Monday through Friday, 8:00am to 5:00pm), with overtime required as needed. Candidates located within a commutable distance to Cambridge, Massachusetts, are strongly encouraged to apply. Excellent full-time benefits include: Comprehensive medical coverage, dental, and vision options Life and disability insurance 401(k) with company match Paid vacation and holidays Hourly rate is between $39-$44, depending on education and experience Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description JobDescription: Skills: Must be detail-orientedand able to work with a high volume of documents in a fast-paced environment.Be highly organized and process-oriented. PreferredQualifications: Additional Information Best Regards, Sneha Shrivastava ***********

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of. Check out this video about what a career at our Portsmouth NH facility could look like for you: Your Career with Lonza in Portsmouth, NH (youtube.com) Job Summary The Quality Control (QC) Analyst will act as a team member of the Quality Control department to support production of in-process and final product drug lots for customers. They will also participate in quality testing for ongoing customer stability studies and provide on-time, high quality results to meet Lonza's manufacturing demands. A QC Analyst applies job skills and company policies and procedures to complete a variety of tasks. They will work on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required and works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. 8 Hour Day Shifts: Monday through Friday Key Responsibilities Running test samples for in-process, lot release and stability studies. Reviewing assays. Writing quality records (Deviations, CAPA, Change Control) and test methods. Performs other duties as assigned. Key Requirements Bachelor's or Associate's Degree preferably in Microbiology, Biochemistry, or related science discipline. Use of Microsoft Suites (Word, Excel, PowerPoint). Use of Laboratory computer systems. Experience using GMP Quality Systems such as: TrackWise, LIMS preferred. Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

WHO WE ARE RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people's lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science. THE ROSLINCT WAY Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people's development, growth, and the ability to impact patients. ACCELERATING YOUR FUTURE · Author, review, approval, and final authorization of microbiology methods (test results and records, test methods, equipment records) and ensuring adherence to regulatory agency requirements, Client standards, policies, SOPs for cell therapy products and experience with EU Annex requirements. · Execute procedures for microbiology methods in support of method lifecycle activities including method transfer, qualification, validation, compendial verification, and performance monitoring. · Support microbiology equipment installation and qualification, ensuring 21 CFR Part 11 compliance. · Participate as microbiology method subject matter expert (SME) in investigations, OOS, deviation, change controls, and CAPAs to support cGMP operations. · Provide support to QC Operations as method SME: develop training approach, training documents and provide training for new methods. · Perform non-routine/routine QC testing for in process samples, product testing, stability testing, or raw material testing as needed. · Work collaboratively with cross functional departments including but not limited to QC Technical Services, Quality Assurance, and Program Management. · Ability to prepare technical data and present to senior leadership. WHAT YOU WILL BRING · Bachelor's degree in Biology (Microbiology) · 4+ years of microbiology laboratory experience with rapid microbiological methods is a plus (rapid sterility, endotoxin, gram stain). · Experience in a cGMP QC laboratory environment performing environmental monitoring, contamination control and investigation writing. · Excellent/Effective written and verbal communications skills. · Prepare technical data and present to senior leadership. · Escalate issues professionally and on a timely basis. OUR COMMITMENT All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. RoslinCT is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products. AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a QC Scientist I Raw Materials opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA. Purpose: The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead. This role will mentor junior analysts and develop and facilitate training initiatives within the labs. Essential Job Responsibilities: * Develop/author/revise technical reports and laboratory procedures (SOPs, methods) * Execute and troubleshoot raw material testing in support of production activities * Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures * Design and perform testing in support of method transfer/validation/qualification/verification * Review/authorize data and perform analysis and interpretation of test results and trends * Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations * Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration * Support and mentor junior team members * Collaborate with other network sites to share best practices * Other duties as required Quantitative Dimensions: The QC Scientist I Raw Materials will be accountable for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. Organizational Context: The QC Scientist I Raw Materials will typically report to the Senior Manager, Quality Control Raw Materials. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization