Quality control analyst jobs in Lawrence, MA - 298 jobs

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess' patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world. The Role We are seeking a talented, collaborative, and highly motivated individual with expertise analytical methods highly focused on HPLC and QC operations to join our core team of scientists and engineers. The Senior Scientist will execute Quality Control testing, and associated operations and contribute to analytical testing to ensure compliance with cGMP requirements. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market. Key Responsibilities Lead the design, development, optimization, and execution of HPLC-based analytical methods (e.g., RP-HPLC, SEC, IEX) to support in-process, release, and stability testing. Develop, qualify, validate, and characterize GMP-compliant purity, SEC, and content methods for intermediates and drug products, with a strong emphasis on chromatographic workflows. Author and execute cGMP method qualification and validation protocols, prepare reports, and perform/oversee routine QC testing. Serve as Subject Matter Expert for chromatography methods during investigations of deviations, OOS/OOT events, assay failures, and other non-conformance issues. Provide technical leadership in HPLC troubleshooting, instrument maintenance coordination, data integrity practices, and chromatographic data review. Independently author method SOPs, analytical protocols, technical reports, and contribute to regulatory submissions. Maintain rigorous laboratory documentation and complete, audit-ready analytical records. Collaborate effectively with QC, Manufacturing, Process Development, and Regulatory teams to enable program success across phases. Thrive in a fast-paced, cross-functional environment with excellent communication and organizational skills. Qualifications Ph.D. in Analytical Chemistry, Biochemistry, or related field with a minimum of 4 years (10 years for Senior Scientist) in the biotech/pharmaceutical industry; or M.S. with commensurate experience. Demonstrated in-depth expertise in HPLC, including method development, troubleshooting, system suitability design, chromatographic theory, and data interpretation. Hands-on experience with multiple chromatographic techniques (RP-HPLC, SEC, IEX, affinity, gradient optimization, detector setup/maintenance). Proven success developing and validating GMP analytical methods and supporting GMP operations. Experience with complementary analytical techniques such as UV-Vis, LC-MS, CE, ELISA, or other functional assays is beneficial. Experience working in a QC or cGMP laboratory environment with strong understanding of data integrity requirements (ALCOA+). Strong organizational skills, precision in documentation, and ability to manage multiple analytical workflows simultaneously. Excellent oral and written communication skills. Commitment to collaborative work within interdisciplinary project teams. At Vaxess, we're bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to ******************.

Title: QC Equipment Technician Employment Type: Contract Duration: 6+ months Status: Accepting Candidates About the role Support a regulated laboratory or manufacturing team by ensuring equipment operates reliably, efficiently, and in compliance with quality standards. Key Responsibilities Investigate and resolve issues related to equipment failures, system deficiencies, deviations, and troubleshooting activities Author and support quality system records, including deviations, change controls, and CAPAs, as required Monitor and coordinate equipment lifecycle activities, including acquisition, qualification/validation, implementation, and decommissioning Track and communicate equipment timelines using project management tools Ensure equipment documentation complies with cGMP, GDP, and data integrity requirements Qualifications BS degree with a minimum of 3 years of relevant experience, or 3+ years of experience in a GMP laboratory setting Demonstrated ability to quickly learn and apply GxP principles Strong attention to detail and documentation practices Experience supporting regulated laboratory or manufacturing equipment preferred Compensation (MA Pay Transparency) Estimated hourly range: $30-$35/hour (W-2) Final rate within this range will be based on skills, experience, and interview outcomes

A leading biotechnology company in Boston is seeking an Associate Director, GMP Operational Quality to ensure compliance and quality oversight for commercial drug manufacturing. The role includes managing relationships with vendors, mentoring team members, and leading quality improvement initiatives. Candidates should possess strong knowledge of cGMPs, a scientific degree, and extensive experience in quality assurance and project management. This position offers a hybrid work model and competitive compensation package. #J-18808-Ljbffr

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.

Job Description About Us Stellar Industries is a rapidly growing industry leader in manufacturing metalized ceramics. We are a major supplier of innovative, high-quality parts to the Aerospace, Photonics, Telecommunications, and Commercial industries. The company was acquired by TRUMPF Photonics in 2019 and has significant growth goals. About the Role The Quality Control Inspector Level II maintains quality standards by inspecting incoming materials from outside suppliers, in-process production, and finished products in accordance with the quality standards and operating procedures set forth by the Head of Quality Control/Quality Assurance. What You Get to Do Works independently with minimal supervision. Maintain an organized and clean work area. Uses Hand tools, including but not limited to tweezers, calipers, and micrometers. Confirms specifications by conducting visual and measurement tests. Works with a variety of blueprints and technical drawings; must be able to interpret changing requirements as products and builds vary. Completes a General Inspection Report by documenting inspection findings regarding product dimensions, quantity of parts accepted/rejected, and basis of rejection. Uses Vision Systems and documents results into the computer. Follow all safety protocols. Cross-train as requested in other areas of the company. About You Minimum of 3 years of quality control experience. Must be able to work in a sitting position for up to 10 hours. Must be able to wear a lab coat, spittle mask, and gloves while working. The position requires working with measuring devices and microscopes. Individuals must have previous experience working in a similar environment. Must be able to work independently and demonstrate extremely high levels of precision and accuracy. line, High-Temperature BTU Furnaces, as well as various facility-related items, including air handlers, air compressors, air filtration units, etc. What We Offer Competitive pay A generous benefits package that includes medical, dental, 401K plan, and PTO Employer-paid vision plan, Employer paid Basic Life and AD&D Insurance, and Employer Paid Disability Insurance Tuition Reimbursement 4-Day workweek, Monday-Thursday 12 pm-10:30 pm Monday-Thursday 12:00 pm - 10:30 pm

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

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

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera's mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team. What You'll Do: The Senior Scientist, Analytical Development and Quality Control will support analytical development and quality control activities performed by our external partners for cGMP manufacturing, quality release, and stability. The Senior Scientist will work directly with technical counterparts at vendor sites to implement the required product controls and ensure the integrity of data generated by our external partners. This role will also provide critical support for regulatory filings and ensure compliance with global regulatory standards. Required location: Waltham, MA (hub-based, onsite 3-4 days per week) Responsibilities: Participate in the assessment and selection of Contract Development and Manufacturing Organizations (CDMOs) Oversee analytical activities conducted by these CDMOs to ensure external partners fulfill technical needs and quality standards Perform detailed review and provide data integrity oversight of data generated at CDMOs Ensure appropriate methods are developed and implemented for drug substance and drug product based on identified critical quality attributes Provide oversight of phase-appropriate method validation activities in alignment with current regulatory requirements Oversee stability programs to support product retest, shelf-life, and expiration dating Contribute to the preparation of data summaries and reports, and data review of regulatory submissions (INDs, NDAs, IMPDs) Ensure analytical methods and data meet regulatory requirements, generate data to justify specification limits, and assess trends in stability data Ensure all analytical activities comply with GMP, ICH guidelines, and other relevant regulations Participate in internal and external investigations of quality events (e.g., deviations, CAPAs, OOS, etc.) Work closely with Manufacturing and Quality Assurance teams to generate cGMP compliant data during product development and manufacturing Provide technical guidance and support to internal teams and external partners Oversee the preparation and review of technical documents, including protocols, reports, and SOPs Ensure data integrity and traceability in all analytical documentation Required Qualifications: PhD with a minimum of 6 years, MS with a minimum of 10 years, or BS with a minimum of 12 years of experience in analytical development and quality control within the pharmaceutical or biotech industry Proven experience with peptides and small molecules in both injectable and solid oral dosage forms Experience managing outsourced activities with CDMOs Strong expertise in analytical techniques such as HPLC, UPLC, MS, GC, and spectroscopic methods Knowledge of regulatory requirements (FDA, EMA) and ICH guidelines related to analytical development Proven effective communication and interpersonal skills Ability to work effectively in a fast-paced, collaborative environment Preferred Qualifications: Experience with combination drug/device presentations is preferred Experience with establishing peptide drug substance analytical control strategy for various peptide synthesis modalities (linear SPPS, hybrid approaches, LPPS, and/or recombinant) is preferred Education: PhD or MS degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or related field, or a BS degree with a commensurate amount of directly applicable industry experience Salary Range $115,000 - $140,000 USD For Full Time Roles: This range represents the company's good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants-because your well-being and future matter to us. EQUAL EMPLOYMENT OPPORTUNITY INFORMATION: Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances. E-Verify: Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires. #LI-Hybrid

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: ************ |

Piper Health & Sciences is seeking a full-time iPSC Production Scientist to a join growing organization's Bio/Engineering Production team onsite at their Massachusetts location. The ideal candidate will have a strong biology background and hands-on experience in iPSC stem cell culture, differentiation, and QC within a pharmaceutical or biotech environment. Responsibilities of the iPSC Production Scientist Include: * Full-time onsite schedule: Monday-Friday, 9:00 AM - 5:00 PM * Lead and support iPSC production and related lab activities * Perform hands-on stem cell culture and differentiation * Execute QC-related tasks in accordance with SOPs * Maintain accurate lab documentation and records * Support Bio/Engineering Production workflows * Follow all safety, GMP, and GLP standards Qualifications of the iPSC Production Scientist Include: * Biology degree strongly preferred (Biomedical Engineering degrees are NOT a fit) * Proven hands-on experience with: * iPSC cell culture * Stem cell differentiation * Quality Control (QC) processes * Pharmaceutical or biotech industry experience preferred Compensation of the iPSC Production Scientist Includes: * Salary Range: $83,200.00 - $114,000.00 per year (=$40.00 - $55.00 per hour) based on experience and certifications. * Comprehensive Benefits: CIGNA Medical, Dental, Vision; 401k through ADP and sick leave as required by law. * Ability to work with a well renowned and growing organization that has a robust pipeline and quality culture. This job opens for applications on 1/9/2025. Applications for this job will be accepted for at least 30 days from the posting date. #LI-AW1 #LI-ONSITE keywords: Scientist, iPSC Production, stem cell culture, induced pluripotent stem cells, cell differentiation, quality control, QC, laboratory scientist, cell biology, biotechnology, pharmaceutical production, bioengineering, GMP, GLP, SOP compliance, tissue engineering, regenerative medicine, bioprocessing, cell therapy, stem cell research, lab operations, onsite scientist, Medford MA jobs, contract scientist, PhD biology, master's biology, postdoctoral research, biotech scientist, pharma scientist, cell culture specialist, stem cell specialist, iPSC scientist, QC scientist, bio production scientist, laboratory techniques, cell-based assays, biotech careers, pharma careers, stem cell manufacturing, cell culture workflows, life sciences jobs, biopharma jobs, laboratory compliance, scientific documentation, biotech industry experience, pharmaceutical industry experience, cell line development, research scientist, production scientist, laboratory QC, stem cell differentiation protocols, cell culture maintenance, full-time onsite scientist, bioengineering production team, regenerative biology, tissue culture, cell therapy manufacturing, biotechnology research, pharmaceutical QC, biomanufacturing, cell biology techniques, stem cell QC testing, scientific method, laboratory safety standards, GMP compliance, GLP compliance, biotech contract role, scientist contract position, iPSC culturing, stem cell production, biotech Medford MA, pharma Medford MA, scientific careers, laboratory scientist jobs, cell therapy scientist, bioprocess scientist, QC laboratory scientist, stem cell lab work, biotech production workflows, pharmaceutical production workflows, life sciences contract jobs, biotech contract scientist, pharma contract scientist.

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. This position will have the primary responsibility for daily formulation activities to ensure schedule activities are completed, formulation materials and equipment are maintained, as well as the responsibility for performing corrective and preventative actions. As a secondary function, provide troubleshooting expertise for manufacturing of products both internally and externally of the company. Schedule: Sunday - Wednesday 6:00AM - 4:30PM Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned. Has ownership for the daily formulation activities to ensure scheduled all scheduled tasks/events are completed Is responsible for critical steps in the formulation process including but not limited to, 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 finical loss Initiate the production of batch documentation used for engineering and cGMP production. Prepare and update Master Production Batch records and SOPs accurately for communicating and initiate the documentation change process for needed documentation changes Complete executed Batch Records accurately and completely prior to submission to supervision for review Comply with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements Author process deviations when these occur within the department, participate in investigations, and contribute to identifying corrective and preventative actions Cross train to increase technical skills across the department Accountable for timely communication to management and clients of issues, challenges as well as opportunities for process improvements. As a member of the manufacturing team, you will perform other manufacturing tasks for example filling, capping etc., as needed. Work with enabling groups to improve/implement processes. Other duties as assigned. Strong interpersonal skills Strong working knowledge of MS Office suite is preferable Attention to detail and positive attitude are key attributes Able to follow rules and regulations perfectly Works directly with aseptic and non-aseptic personnel. Works closely with Quality Assurance, MTS, Validation etc. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required: High School education or AS degree or BS degree in Chemical Engineering/ Bio Chemistry or other industry related discipline is preferred Experience and knowledge of formulation/compounding tools and equipment Minimum 1-2 year's work experience in a GMP environment preferably in fill finish pharmaceutical operations Demonstrated ability to prioritize multiple projects and activities Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. #LI-KC1 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.

Sr. Scientist - FSP - Quality Control Shift: Full-Time; Monday - Friday; 8am-5pm EST ONSITE: This is a fully onsite role based at our customer's site in (Boston, MA). We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner. Our Laboratories Functional Service Partnership (FSP) team plays a direct role in advancing drug development by creating sustained groups of talent within our customers' organizations to provide long-term support. Through this collaborative approach, our professionals bring their commitment to excellence, industry knowledge, and operational strength directly into customer environments, helping to enhance capabilities and advance the delivery of life-changing therapies. Key responsibilities: Perform in-process, release, and stability testing and/or review independently following established methodology, procedures and SOPs Maintain accurate testing records and adhere to cGMP/GDP expectations May participate in executing method validations and/or method transfers Assist in troubleshooting of analytical methods with the assistance of manager when necessary May participates in author and review of data, SOPs, analytical methods, protocols and reports May participate in compliance related teams working towards the goal of continuous improvement. Report OOT/OOS results and other deviations to area management. Perform other laboratory duties as assigned. Education and Experience: Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar Sr. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years') OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years') OR PhD In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: Understands cGMP concepts and general practices Knowledge and experience in chromatography, dissolution, and Karl Fisher Knowledge of various complex laboratory equipment including HPLC, GC, KF, dissolution, TOC, UV, IR, pH meter, and balance Strong attention to detail Demonstrate good communication skills both oral and written. A minimum of a Bachelor Degree in science or related discipline is required. Typically requires 4 years of experience in GMP pharmaceutical/biopharmaceutical industry Working Environment: Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary and/or standing for typical working hours. Able to lift and move objects up to 25 pounds Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Compensation and Benefits The salary range estimated for this position based in Massachusetts is $95,000.00-$110,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: *****************************************************

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 ***********

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.

Title: QC Specialist - Chemistry Employment Type: Contract Status: Accepting Candidates About the role This role supports Quality Control Chemistry operations by leading QC Sample Management activities across multiple lab functions. You will ensure compliant, on-time sample processing while partnering with digital and quality teams in a fast-paced cGMP environment. Shift: Wednesday-Saturday, 6:00 AM-4:00 PM. Key Responsibilities • Lead QC Sample Management operations supporting Chemistry, Microbiology, Bioassay, and Raw Materials • Oversee daily schedules to ensure compliant sample processing and documentation • Author and maintain SOPs, deviations, CAPAs, and change controls • Act as primary support for audit readiness and regulatory inspections • Partner with Digital teams to optimize LIMS (LabVantage) and data workflows • Manage CTU systems, investigations, and compliance issue resolution Qualifications • BA/BS with 3-5 years or MS with 1-3 years of cGMP Quality Control experience • Strong hands-on experience with QC Sample Management • Proficiency with LIMS and Veeva Quality Systems • Working knowledge of FDA, EU, and ICH regulations • Experience with gowning, aseptic technique, and lab safety practices • Proven people management and cross-functional leadership skills Compensation (MA Pay Transparency): • Estimated hourly range: $40-$45/hr (W-2) • Final rate within this range will be based on skills, experience, and interview results.

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

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 PRINCIPAL OBJECTIVE OF THE POSITION: 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: ************ |

Shift: Full-Time; Monday - Friday; 8am-5pm EST ONSITE/HYBRID: This is a fully onsite role based at our customer's site in (Boston, MA). We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner. Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits. Key responsibilities: Perform technical and quality reviews of internal and external documents, including raw data, stability protocols/reports, CoAs/stability data reports, risk assessments, sampling plans, shelf-life reports and etc. Enter and trend stability data in SLIM system and generate stability timepoint summary reports. Establish/extend DS and DP shelf lives and generate shelf-life reports based on stability data. Plan, manage and communicate stability pulls and ensure stability testing occurs within specified testing windows. Education and Experience: Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar Sr. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years') OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years') OR PhD In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: Proven Experience with stability studies, stability protocols/reports, CoAs/stability data reports, risk assessments, sampling plans, shelf-life reports, including raw data and external documents. Stability data in SLIM system and generate stability timepoint summary reports. DS and DP shelf lives and generate shelf-life reports based on stability data. Plan, manage and communicate stability pulls and ensure stability testing occurs within specified testing windows. Attention to detail and ability to multitask, review tons of data. Working Environment: Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary and/or standing for typical working hours. Able to lift and move objects up to 25 pounds Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Compensation and Benefits The salary range estimated for this position based in Massachusetts is $90,000.00-$110,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: *****************************************************

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***********