Quality control analyst jobs in Lynn, MA - 354 jobs

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.

Sr. QC Analyst, Flow Cytometry & Molecular Team, will be executing analytical method transfers to Quality Control, optimize and troubleshoot assays for improvement. He/she will be responsible for authoring protocols, authoring Standard Operating Procedures (SOPs) and Test Methods. He/she will be executing various quality control methods, analyzing data, and reporting data. He/she will assist in the implementation of new assay methodologies and the associated instrumentation. Identifies and supports initiation and completion of deviations, corrective and preventative actions, and laboratory investigations in compliance with all applicable quality systems and current cGMPs. This position is highly visible in the organization and requires the ability to interface with multiple groups, and the ability to assess method suitability, interpret results, perform tasks independently, and troubleshoot. HOW YOU WILL MAKE AN IMPACT Perform routine and non-routine quality control testing on in-process samples and finished products. Operate and maintain laboratory equipment and instruments, ensuring proper calibration and adherence to cGMP Compliance. Provide support for method feasibility/transfers/qualification/validation and stability testing. Support analytical equipment installation and qualification Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner. Review all data in accordance with applicable procedures and cGMP requirements. Author, review, and/or approve Protocols, SOPs, Test Methods, and other procedures required to operate a QC laboratory. Participate in internal and external audits, inspections, investigations, change controls and CAPAs Contribute to continuous improvement initiatives, identifying opportunities for efficiency gains and process optimization within the quality control function. Anticipate and troubleshoot problems. Communicate effectively with management regarding task completion, roadblocks, and needs. Become a qualified trainer on assigned assays and deliver training to analysts, documenting training per procedural and cGMP requirements. Provide support to QC Analytical Subject Matter Expert in Flow Cytometry. Work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects. Communicate effectively with cross-functional peers, and department management. WHAT YOU WILL BRING Bachelor's Degree in scientific discipline. 4+ years of relevant experience in cGMP Quality Control Laboratory. Hands-on experience with various analytical techniques such as flow cytometry, qPCR, dPCR, ELISAs,cell-based assays, and scientific knowledge in the characterization and transfer of analytical methods. Experience with rapid microbiological methods is a plus (e.g. mycoplasma) Knowledge of cGMP/ICH/FDA regulations. Ability to independently prioritize/manage activities. Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and attention to detail. Proficient in MS Office applications and information technologies that support documentation and data management systems. Strong troubleshooting, problem-solving skills, oral and written skills. Ability to multi-task and interact with multiple groups in a team-oriented environment.

Quality Inspector III - Weekdays About Us Founded in 2015 to develop the world's first industrially scalable laser metal additive manufacturing solution, our client is reshaping how the world manufactures critical products. They build and operate advanced digital infrastructure that enables innovation, accelerates growth, and supports sustainability across aerospace, defense, medical, and other essential industries. Through vertically integrated capabilities, including scalable additive manufacturing and precision machining, they deliver true end-to-end production at scale by combining cutting-edge technology with a foundation of proven industrial craftsmanship. Their team brings deep expertise in manufacturing, materials science, software, automation, and operations, united by a shared commitment to quality, curiosity, and accountability. They foster an inclusive culture where people take ownership, solve meaningful problems, and continuously learn, because diverse perspectives lead to better outcomes. Job Purpose As a Quality Inspector III at our client, you will work in a diversified role within the Quality Inspection team dedicated to ensuring every product delivered meets the highest standards of precision, safety, and reliability. By applying expertise in inspection methods, quality systems, and problem-solving, this role safeguards customer trust, drives continuous improvement, and supports innovation in metal additive manufacturing. This position operates on the weekday shift: Monday-Friday, 6:00 AM to 2:30 PM. Key Responsibilities Perform First Article Inspections (FAI) and routine part inspections using calipers, micrometers, and other gauges. Verify that materials, equipment, processes, and products comply with quality specifications. Develop and validate inspection and test methods; assist in creating SOPs and inspection protocols. Monitor, analyze, and report on product quality metrics. Support compliance with customer, internal, and industry requirements (AS9100, ISO 9001, ISO 13485) through audits and gap analysis. Assist in developing and implementing process controls, corrective actions, and continuous improvement initiatives. Ensure workflows, processes, and products comply with safety regulations. Investigate and troubleshoot product or production issues. Inspect manufactured parts, issue non-conformance reports, and facilitate MRB hardware disposition and corrective action tasks. Work independently and manage daily priorities with minimal supervision. Communicate and collaborate with operations personnel to ensure production needs are met. Initiate and communicate identified nonconformances. Qualifications 5+ years of experience performing part inspections with strong drawing interpretation skills. Extensive knowledge of GD&T principles. Experience with First Article Inspections (FAI), Test Method Validation (TMV), and developing inspection methods. Proficiency in AQL sampling techniques. Skilled in performing dimensional and visual inspections. Experience with root cause analysis, data analysis, and troubleshooting. Experience in medical device, aerospace, or defense manufacturing required. Hands-on experience with advanced inspection equipment and software, including CMMs, PCMMs, vision systems, profilometers, and blue-light scanners (e.g., Zeiss, Faro, Keyence). Ability to troubleshoot issues encountered with inspection equipment. Self-motivated, hands-on team player with excellent communication skills; adaptable to fast-paced environments and excited by new challenges in metal additive manufacturing.

Adecco Staffing is partnering with a reputable manufacturing facility in Peterborough, NH to hire Quality Control Inspectors for all shifts! This is a temp-to-hire or direct-hire opportunity, depending on your level of Inspection experience. The position offers competitive pay rates and the opportunity to join a growing company. Pay Rate: $17-$26 per hour, depending on experience and shift Schedules Available: 1st Shift Monday through Friday 7:00am-3:30pm, OT available 2nd Shift Monday through Friday 3:15pm-11:45pm, OT available 3rd Shift Sunday through Thursday 11:30pm-7:00am (paid for 8), OT available Job Summary: Responsible for ensuring the quality of processes and product within an assigned functional area. Essential Duties and Responsibilities: The following represent general inspection functions which may or may not be required depending upon the functional area in which you are assigned. Inspectors may be reassigned to a different sub function at any time based on the business need, and training will be provided. Perform dimensional inspection using mechanical and visual inspection equipment, such as an optical comparator, contour reader, dial indicators, inspection hand tools, surface plates, height gauges, air gauges, specialized bearing measurement equipment, and gauge blocks. Measure bearing assemblies and/or component features such as roundness, concentricity, perpendicularity, flatness, sphericity, surface finish, surface noise and vibration levels using specialized equipment. Complete basic control charts, run charts, prepare charts, and histograms. Read and understand drawings, specifications, procedures, standards and instructions. Write inspection rejection reports in accordance with company procedures, and maintain detailed inspection records using appropriate forms. Make recommendations regarding quality and manufacturing improvements as needed. Perform visual inspection of bearing assemblies, and/or bearing components, using microscope and the unaided eye. Communicate with Manufacturing & Quality personnel and other disciplines as required in a timely and professional manner. Why Apply? Competitive pay rates with the potential for overtime. Temp-to-hire or direct-hire opportunity based on your level of experience. Work in a high-level manufacturing facility with advanced equipment and processes. Training and growth opportunities available. If you are interested in this exciting opportunity and feel you have the skills to succeed, please apply today with an updated resume or call 603-###-####! We look forward to hearing from you. Pay Details: $17.00 to $26.00 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Equal Opportunity Employer/Veterans/Disabled Military connected talent encouraged to apply To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for Employers San Francisco Fair Chance Ordinance Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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

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 QC Senior/Principal Scientist for Analytical Method Validation is key role within our Quality Control Technical Services (QCTS) department within our CDMO facility. The individual in this role will work collaboratively with new and current clients, analytical development team, quality control, manufacturing and quality assurance. Lead transfer and validate next generation analytical procedures for the testing of viral vectors, cell banks and gene therapy products in support of Genezen's services and commercial products in compliance with company policies and procedures and regulatory guidelines. ESSENTIAL JOB FUNCTIONS Ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities. Works independently and is responsible for optimization, qualification, transfer and validation of analytical methods associated with cGMP production. SME for cell-based and analytical method protocols and reports related to QC Method transfer, qualification, feasibility and validation. Perform statistical analyses of data generated during method validation studies, qualification and critical material qualification. Responsible for monitoring analytical method performance, including assessment of analytical method system suitability requirements. Present to cross-functional teams and effectively communicate critical analytical issues and solutions. Coordinate with Critical Material Sr. Scientist to design and qualify critical materials required for cell based methods to support phase appropriate readiness Support cGMP operations, including generation of documentation in support of change controls and corrective actions/preventative actions, deviations, out-of-specification (OOS) results, and other investigations or assay troubleshooting. Subject matter expertise in product quality attribute methods relevant to gene therapeutic product (e.g. cell function characterization assays, HPLC, dd PCR / qPCR, ELISA, Potency Assay, plate-based assays, CE-SDS, SDS-PAGE and western blot) and/or viral vector manufacturing. Familiar with FDA and EMA guidance documents relevant to gene therapy. Working knowledge of quality systems requirements. Demonstrated leadership skills and the ability to collaborate with and effectively influence others. Interface with clients and Genezen cross-functional teams to define technical requirements and provide routine project updates. Assure that laboratory procedures are current and facilitate updates as required Provide coaching to QCTS scientists and develop and contribute to their technical development Lead training of new analytical methods and support QC analysts on execution, data analysis and technical review of data generated in GMP lab. Complete documentation in accordance with current Good Manufacturing Practices (cGMP). Identify, lead, and/or support continuous improvements to current processes/procedures accordingly for increased compliance and efficiency Support onboarding and qualification of new instruments in cGMP laboratory environment. 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 Ph.D or MS in Molecular Biology/Biochemistry or other related Life Sciences ON-THE-JOB EXPERIENCE Minimum 8 years of analytical laboratory experience in GLP/cGMP environment ideally associated with analytical method validation and transfer. Prior experience with analytical method validations, analytical data trending/statistical analysis Understanding of QC instrument qualification is preferred. Thorough understanding of industry testing requirements/standards Preferred experience with performing cell based bioassays using mammalian cell-lines (such as HELA, HEK-293, Huh-7 etc.) along with QC instrument qualification is essential. Thorough understanding of industry testing requirements/standards related to gene/cell therapy products. Familiar with ICH, FDA and EMA guidance documents relevant to gene/cell therapy. Working knowledge of quality systems requirements SKILLS / ABILITIES Computer/software literacy (MS Word, Excel, JMP, Minitab, and LIMS etc.) Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential Ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities Proven demonstration of technical writing skills such as protocol, reports, procedures etc. Effective project management and presentation skills Good/effective communication and organizational skills with the ability to work well with others and independently Ability to work collaboratively with cross functional departments Pay Range: The annual salary range for this position is $120,000-$160,000. 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 Regularly sit for long periods of time 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 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.

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

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

Piper Health & Sciences is seeking a full-time iPSC Production Scientist to join a 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 is 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 (equivalent to $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 1/12/2026. 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.

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: *****************************************************

At QIAGEN, we are driven by a simple but powerful vision: making improvements in life possible. We're dedicated to revolutionizing science and healthcare for the better. From our entrepreneurial roots to our current global presence, we've grown into a force for positive change. With thousands of employees across six continents, collaboration is our greatest strength. We're always striving to identify talented individuals to join our exceptional teams. We have played a pivotal role in shaping modern science and healthcare, and we're just getting started. If you're someone who thrives on new challenges, values diversity and wants to make a tangible difference in people's lives, then QIAGEN is the place for you. At QIAGEN, every day is an opportunity to make a real-life impact. Join us, grow with us, and together, let's shape the future of biological discovery. The Finished Goods Formulation Technician II formulates buffers, diluents, and PCR master mixes for the Finished Goods team. This position is charged with adhering to the Quality System to execute consistent processes that result in repeatable product for on time delivery. Responsibilities include: Job performance will involve a variety of activities including but not limited to: * Perform applicable processes as detailed in work instructions, including but not limited to: o Chemical material handling o Care and use of formulation equipment (i.e., balances, overhead mixes, stir plates, etc.) o Measurement of materials by mass and volume o Annealing oligos o Thawing and handling of enzymes, oligos, and light sensitive products o Line clearance and PPE usage * Perform SAP transactions for order confirmations. * Record production activities on all applicable forms in accordance with Good Documentation Practices. * Assist in maintaining inventory system to keep materials related to Formulation orders organized, stocked, and ensure inventory levels are accurate within SAP. * Contribute to and support department/corporate goals * Work with Supervisor to ensure personal growth through individual goal setting and participate in a dialog around performance reviews. * Complete all required quality documentation training as issued through Master Control. * Contribute to quality documentation development/improvements within and across departments, as needed. * Ensure compliance to applicable ISO Quality and EHS regulations and standards. * Contribute to a strong team mindset with a focus on creative problem solving. * Assist in training additional team members, if applicable. * Assist the Finished Goods Dilutions and/or Fill/Pack teams, as needed. Your profile: * Bachelor's of Science degree and 1 or more years related industry experience or the equivalent combination of education and experience * Understanding of ISO Quality and Lean Manufacturing concepts Personal Requirements * Attention to detail * Strong communication skills What we offer * Bonus/Commission * Local benefits * Referral Program * Volunteer Day * Internal Academy (QIALearn) * Employee Assistance Program * Hybrid work (conditional to your role) Our people are the heartbeat of everything we do. Passion drives us as we push boundaries to innovate and evolve. We inspire with our leadership and make an impact with our actions. We cultivate a collaborative, supportive environment where each individual and team can flourish. We champion accountability and encourage entrepreneurial thinking. QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.

At QIAGEN, we are driven by a simple but powerful vision: making improvements in life possible. We're dedicated to revolutionizing science and healthcare for the better. From our entrepreneurial roots to our current global presence, we've grown into a force for positive change. With thousands of employees across six continents, collaboration is our greatest strength. We're always striving to identify talented individuals to join our exceptional teams. We have played a pivotal role in shaping modern science and healthcare, and we're just getting started. If you're someone who thrives on new challenges, values diversity and wants to make a tangible difference in people's lives, then QIAGEN is the place for you. At QIAGEN, every day is an opportunity to make a real-life impact. Join us, grow with us, and together, let's shape the future of biological discovery. The Finished Goods Formulation Technician II formulates buffers, diluents, and PCR master mixes for the Finished Goods team. This position is charged with adhering to the Quality System to execute consistent processes that result in repeatable product for on time delivery. Responsibilities include: Job performance will involve a variety of activities including but not limited to: · Perform applicable processes as detailed in work instructions, including but not limited to: o Chemical material handling o Care and use of formulation equipment (i.e., balances, overhead mixes, stir plates, etc.) o Measurement of materials by mass and volume o Annealing oligos o Thawing and handling of enzymes, oligos, and light sensitive products o Line clearance and PPE usage · Perform SAP transactions for order confirmations. · Record production activities on all applicable forms in accordance with Good Documentation Practices. · Assist in maintaining inventory system to keep materials related to Formulation orders organized, stocked, and ensure inventory levels are accurate within SAP. · Contribute to and support department/corporate goals · Work with Supervisor to ensure personal growth through individual goal setting and participate in a dialog around performance reviews. · Complete all required quality documentation training as issued through Master Control. · Contribute to quality documentation development/improvements within and across departments, as needed. · Ensure compliance to applicable ISO Quality and EHS regulations and standards. · Contribute to a strong team mindset with a focus on creative problem solving. · Assist in training additional team members, if applicable. · Assist the Finished Goods Dilutions and/or Fill/Pack teams, as needed. Your profile: · Bachelor's of Science degree and 1 or more years related industry experience or the equivalent combination of education and experience · Understanding of ISO Quality and Lean Manufacturing concepts Personal Requirements · Attention to detail · Strong communication skills What we offer Bonus/Commission Local benefits Referral Program Volunteer Day Internal Academy (QIALearn) Employee Assistance Program Hybrid work (conditional to your role) Our people are the heartbeat of everything we do. Passion drives us as we push boundaries to innovate and evolve. We inspire with our leadership and make an impact with our actions. We cultivate a collaborative, supportive environment where each individual and team can flourish. We champion accountability and encourage entrepreneurial thinking. QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.

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.

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 ***********

Responsibilities 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, and SOPs for cell therapy products. 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 subject matter expert (SME) in investigations, 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. 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 Escalate issues professionally and on a timely basis.

Adecco Staffing is working with a company in Lowell, MA to find a qualified Inventory Control Specialist! This is a temp to hire opportunity. Shift: 7:00AM - 7:00PM, Monday-Friday Pay: $20-$26/hour DOE The Quality Assurance Specialist is part of the QA/QC department, and is responsible for ensuring that all products and processes meet the company's high-quality standards and regulatory requirements. This role involves conducting kettle sample testing for consistency along with other tests as assigned by the QA Manager to uphold our commitment to excellence, consistency and customer satisfaction. Responsibilities: Product Testing and Inspection: Perform regular routine quantitative and qualitative testing (consistency, pH, particulate distribution, etc.) on all kettle products to ensure they meet established quality standards prior to packaging. Enforce Quality Standards: Assist in creating and establishing quality standards for soups and sauces based on sensory evaluation, texture, flavor, and appearance. Support Functions: Provide support to QA team members to advance our collective goal and professionalism. Documentation and Record Keeping: Maintain accurate records of testing performed and corrective actions taken for non-conformance. Collaboration: Work with QA, R&D, Director of Commercialization to discuss quality findings and develop solutions to enhance product consistency. Continuous Improvement: Identify areas for improvement in production processes and participate in the implementation of quality enhancement initiatives. Issue Resolution and Corrective Actions: Identify non-conformities or out-of-compliance situations and communicate them to production teams and supervisors. Participate in root cause analysis and implement corrective and preventive actions. Environment includes exposure to temperature changes, allergens, machinery noise, and production equipment. Requirements: High school diploma or equivalent; degree in Food Science, Culinary Arts, or related field preferred. Previous experience in quality control or assurance in the food industry, particularly with soups and sauces, is desirable. Effective communication and teamwork abilities. Knowledge: Familiarity with food safety regulations and quality certification standards (e.g., HACCP, SQF) is a plus. If you are interested & qualified, please apply with your updated resume! Pay Details: $20.00 to $26.00 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Equal Opportunity Employer/Veterans/Disabled Military connected talent encouraged to apply To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for Employers San Francisco Fair Chance Ordinance Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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 QC Senior/Principal Scientist for Analytical Method Validation is key role within our Quality Control Technical Services (QCTS) department within our CDMO facility. The individual in this role will work collaboratively with new and current clients, analytical development team, quality control, manufacturing and quality assurance. Lead transfer and validate next generation analytical procedures for the testing of viral vectors, cell banks and gene therapy products in support of Genezen's services and commercial products in compliance with company policies and procedures and regulatory guidelines. ESSENTIAL JOB FUNCTIONS Ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities. Works independently and is responsible for optimization, qualification, transfer and validation of analytical methods associated with cGMP production. SME for cell-based and analytical method protocols and reports related to QC Method transfer, qualification, feasibility and validation. Perform statistical analyses of data generated during method validation studies, qualification and critical material qualification. Responsible for monitoring analytical method performance, including assessment of analytical method system suitability requirements. Present to cross-functional teams and effectively communicate critical analytical issues and solutions. Coordinate with Critical Material Sr. Scientist to design and qualify critical materials required for cell based methods to support phase appropriate readiness Support cGMP operations, including generation of documentation in support of change controls and corrective actions/preventative actions, deviations, out-of-specification (OOS) results, and other investigations or assay troubleshooting. Subject matter expertise in product quality attribute methods relevant to gene therapeutic product (e.g. cell function characterization assays, HPLC, dd PCR / qPCR, ELISA, Potency Assay, plate-based assays, CE-SDS, SDS-PAGE and western blot) and/or viral vector manufacturing. Familiar with FDA and EMA guidance documents relevant to gene therapy. Working knowledge of quality systems requirements. Demonstrated leadership skills and the ability to collaborate with and effectively influence others. Interface with clients and Genezen cross-functional teams to define technical requirements and provide routine project updates. Assure that laboratory procedures are current and facilitate updates as required Provide coaching to QCTS scientists and develop and contribute to their technical development Lead training of new analytical methods and support QC analysts on execution, data analysis and technical review of data generated in GMP lab. Complete documentation in accordance with current Good Manufacturing Practices (cGMP). Identify, lead, and/or support continuous improvements to current processes/procedures accordingly for increased compliance and efficiency Support onboarding and qualification of new instruments in cGMP laboratory environment. 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 Ph.D or MS in Molecular Biology/Biochemistry or other related Life Sciences ON-THE-JOB EXPERIENCE Minimum 8 years of analytical laboratory experience in GLP/cGMP environment ideally associated with analytical method validation and transfer. Prior experience with analytical method validations, analytical data trending/statistical analysis Understanding of QC instrument qualification is preferred. Thorough understanding of industry testing requirements/standards Preferred experience with performing cell based bioassays using mammalian cell-lines (such as HELA, HEK-293, Huh-7 etc.) along with QC instrument qualification is essential. Thorough understanding of industry testing requirements/standards related to gene/cell therapy products. Familiar with ICH, FDA and EMA guidance documents relevant to gene/cell therapy. Working knowledge of quality systems requirements SKILLS / ABILITIES Computer/software literacy (MS Word, Excel, JMP, Minitab, and LIMS etc.) Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential Ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities Proven demonstration of technical writing skills such as protocol, reports, procedures etc. Effective project management and presentation skills Good/effective communication and organizational skills with the ability to work well with others and independently Ability to work collaboratively with cross functional departments Pay Range: The annual salary range for this position is $120,000-$160,000. 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 Regularly sit for long periods of time 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 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.

FSP - Sr. Scientist - Quality Compliance / Change 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: Be the Analytical Development (AD) point of contact for change controls. Responsibilities include but not limited to: participate in change control review, evaluate impact to AD and collaborate with SMEs for joint assessment, initiate, track and close change control record Support internal audit programs to ensure compliance and pre-approval inspection readiness Assist in the revision of governance SOPs for AD, including but not limited to Method Validation and Method Transfer, Establishing Specification Review analytical data. Perform data verification to ensure accuracy and completeness of information presented in analytical documents and regulatory filings (IND/BLA) Propose and implement ways to ensure and improve timely closure of change control, investigation, CAPA, ELN and completion of trainings Support other analytical development activities as needed 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: Relevant Analytical Development, Quality Control or Quality Assurance experience is required Attention to detail and follow up with collaborators to ensure timely completion of assignment Ability to communicate to a wide variety of audiences, exchanges complex and sensitive information and gain alignment around a proposed action Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency Excellent technical writing skills are essential Knowledge of relevant ICH and regulatory guidelines and good understanding of GMP concept Hands-on experience and In-depth knowledge of change control, deviations, CAPA and investigation Experience in biologics, gene and cell therapy is desirable 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: *****************************************************