Quality control analyst jobs in Manchester, NH - 266 jobs

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

Vicor is seeking a Wet Chemistry Lab Technician to join 3rd shift operations Sunday - Thursday. This individual will work in the wet chemistry process lab to support all plating fabrication operations. The candidate will work with the wet chemistry lab team for day to day production analysis as well as special projects. Job Description * Perform basic chemical analysis techniques. * Utilize chemical analysis equipment to include Auto-Titration, CVS, ICP, and UV-VIS. * Ability to input analysis results into TrueChem. * Maintain lab safety policies and procedures. Education / Qualifications * 1+ years of prior laboratory experience required. * Experience with Titration analysis, ICP or AA, UV-VIS. * Knowledge of operation and maintenance of lab equipment highly desired. * Knowledge of Microsoft Word, Excel, and PowerPoint required. * Must pay high attention to detail, possess self-motivating skills, and have the ability to self-inspect for quality and accuracy. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status. Vicor is an EO employer - M/F/Veteran/Disability Compensation Data Salary Range: $22 - $25/hour Please note: This range is based on our current market driven pay structures. Individual salaries are determined based upon a variety of factors including but not limited to, a candidates overall qualifications, such as skills, education, and experience as well as company internal equity.

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

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.

The QC Microbiologist conducts quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures. Duties will include analysis of pharmaceutical products through compendial methods and client specific test protocols. PRIMARY DUTIES AND RESPONSIBILITIES • Prepares and analyzes samples to determine microbiological quality through the following analyses: Microbial enumeration methods, absence of specified microorganisms, Sterility, endotoxin, and water quality analysis (bioburden, TOC, Conductivity). • Documents work in a clear and organized manner. • Revises procedures and ELNs under close supervision. • Follows all safety rules and regulations and conducts periodic safety audits. • Follows all cGMP rules and regulations. • Under close supervision confers with Microbiologists and other client personnel regarding research, procedures performed, related results and prepares reports. • Under close supervision will be trained to become proficient at assigned tasks in order to become subject matter experts. • Performs routine data generation and problem solving with a minimal rework. • Works under close supervision to ensure all work performed is executed in compliance with standard operating procedures, good manufacturing practices, and the regulations of the Food and Drug Administration. • Ensures all work performed strictly adheres to Company, client and Pharmacopeial methodologies. • Performs system maintenance and calibrations to ensure equipment is operating with specified requirements. • Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules. REQUIREMENTS & QUALIFICATIONS Qualifications include a BA or BS degree in Microbiology or related science discipline with 0-2 years of related experience is required. Knowledge of cGMP and related compliance regulations and guidances is preferred. SHIFT Monday - Thursday 2nd Shift MINIMUM SKILLS REQUIREMENTS • Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently. • A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and client personnel. • Must have excellent organizational, verbal communication and technical documentation skills. • Solid computer skills. • Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples. • Must be a team player with integrity and concern for the quality of Company products, services and staff member

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.

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

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

Support raw material qualifications, method transfers, and validation of assays such as UV-VIS Spectrometry, SDS Page, wet chemical analysis, utility testing (e.g. TOC, conductivity, and gas testing) and more complex assays including GC solvent analysis and various HPLC methodologies (e.g. peptide map and carbohydrate analysis). Review compendial methods (USP, EP, JP) for alignment with internal raw material test procedures and specifications. Perform routine/non-routine data analysis calculations. Document analytical data under cGMP and corporate guidelines. Participate and resolve laboratory investigations of unexpected analytical results. Write/review SOPs, test methods, material specifications, validation protocols and reports. Support cGMP laboratory initiatives following laboratory SOPs. Other duties may be assigned. Qualifications Bachelor's degree in chemistry, biochemistry, or related scientific discipline required. Master's degree preferred. 6 years experience with a Bachelors or 4 years with a Masters Additional Information Interested candidates may contact at Praveen.arora at artechinfo.com or ************

Shift: Monday through Friday, 8:00AM - 5:00PM Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives. Description: Lead formulation and process development for innovative drug products. Provide expert guidance on material and product evaluation using advanced technical knowledge. Design scalable formulations for small molecules and biologics in early-stage clinical trials. Optimize manufacturing processes and interpret analytical data to drive strategic decisions. Compensation: $105,000.00 - 120,000.00 per year Responsibilities: Analyze and interpret complex chemistry, biochemistry, and formulation data to identify trends and provide actionable insights to management and/or clients. Develop, validate, and transfer analytical methods; perform routine and advanced testing using instruments such as HPLC, GC, LC-MS, FTIR, and dd PCR. Design and develop robust, scalable formulations for small molecules and biologics in early-stage clinical trials; optimize manufacturing processes for drug products. Write and review GMP SOPs Conduct analytical testing following SOPs, regulatory guidelines, and GMP standards. Train and mentor team members on analytical methods, instrumentation, and best practices, as required Collaborate across teams to improve efficiency and deliver high-quality results. Promote a positive, customer-focused environment aligned with Pace 's mission. Requirements: Education: Bachelor's, Master's, or PhD degree in Chemistry, Biology, or a related field (advanced degree preferred). Experience: 5+ years in a laboratory setting with demonstrated expertise in analytical methods and formulation development. 3+ years of technical writing experience, including GMP SOP development. Skills: Strong organizational, leadership, and communication abilities. Ability to manage multiple projects simultaneously; self-motivated and results-driven. Proficiency with Office 365 and laboratory instrument software Independent in time management and project planning Mindset: Collaborative, detail-oriented, and committed to quality and compliance. Find Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work. Benefits When you join Pace , you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life. Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft. Equal Opportunity Employer Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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.

Shift: Monday through Friday, 8:00 AM - 4:30 PM Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives. SUMMARY Responsible for providing or overseeing the analysis, administration and oversight of comprehensive chemistry/biochemistry policies, programs and practices; may provide feedback and guidance to clients regarding the analysis of materials, products and/or devices utilizing complex to specialized professional and technical knowledge of chemistry/biochemistry/formulation development or related equipment, testing, and procedures. May design and develop robust and scalable formulations for small molecules and biologics for early-stage clinical trials. May develop and optimize manufacturing processes for drug products. May interpret analytical data to guide formulation and process development decisions. NOTE: This is an EVERGREEN posting where we are collecting candidates for a future role Compensation: $35.00 - 50.00 per hour ESSENTIAL FUNCTIONS Serves as a lead to staff to include providing work direction, guidance, and training. Overseeing or reviewing, completing, and processing comprehensive types of forms, documents, databases, and related materials and information. Provides complex to specialized analysis in support of various testing materials, products and/or devices utilizing various analytical instrumentation; follows Standard Operating Procedures and methods to perform testing. Provides complex to specialized review, analysis, interpretation, and documentation of testing results. Analyzes and reviews complex to specialized operations, results, feedback, and related chemistry/biochemistry/formulation information on an as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients. Provides training and guidance on analytical tests, methods, and instrumentation, as required. Provides complex to specialized analysis, interpretation and counsel to clients, staff, management, and functional leaders regarding chemistry/biochemistry policies, programs, and practices; involves broad operations and leading implementation and change. Analyzes and reviews complex to specialized operations, results, feedback, and related chemistry/biochemistry/formulation information on an ongoing to as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients. Assists with developing or participating in chemistry/biochemistry/formulation or cross functional project or program objectives, which includes proposed budgets, timelines, materials, personnel, and other project requirements, receives direction, and presents information to management and/or clients. Develop validate and transfer analytical methods. Provide routine and non-routine analysis using instruments such as HPLC, GC, LC-MS, and FTIR, DD-PCR, among others. Design and develop robust and scalable formulations for small molecules and biologics for early-stage clinical trials. May develop and optimize manufacturing processes for drug products. Ensure all activities adhere to SOP's, regulatory guidelines, GLP and GMP standards. Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team. Promotes and supports the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment. QUALIFICATIONS Education and Experience Bachelor's degree in chemistry/biochemistry, or a closely related field. Three to five (3-5) years of experience, including experience with specialized or technical programs or operations; OR an equivalent combination of education, training, and experience. Master's or PhD degree is strongly preferred. Required Knowledge and Skills Required Knowledge Complex to specialized principles, practices, and techniques of chemistry/biochemistry and formulation development. Broad understanding of the administration and oversight of chemistry/biochemistry programs, policies, and procedures. Complex to specialized methods to resolve chemistry/biochemistry problems, questions, and concerns. Broad understanding of applicable chemistry/biochemistry laws, codes, and regulations. Understanding of broad testing tools, equipment, and calibration. Computer applications and systems related to the work. Principles and practices to serving as an effective project team member. Methods to communicate with staff, coworkers, and customers to ensure safe, effective, and appropriate operations. Correct business English, including spelling, grammar, and punctuation. Required Skills Performing complex to specialized professional-level chemistry/biochemistry duties in a variety of assigned areas. Overseeing and administering broad and varied chemistry/biochemistry/formulation functions. Ability to operate and train others in analytical instruments and manufacturing equipment. Training others in policies and procedures related to the work. Serving as a team member and the development and management of projects. Operating in a both a team and individual contributor environment. Interpreting, applying, and explaining applicable laws, codes, and regulations. Preparing advanced to expert functionals reports, correspondence, and other written materials. Using initiative and independent judgment within established department guidelines. Using tact, discretion, and prudence in working with those contacted during the work. Performing effective oral presentations to large and small groups across functional peers and the department. Contributing effectively to the accomplishment of team or work unit goals, objectives and activities. Establishing and maintaining effective working relationships with various individuals contacted in the work. Find Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work. Benefits When you join Pace , you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life. Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft. Equal Opportunity Employer Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

The Senior Analyst will specifically support the gene therapy program pipeline including but not limited to technical transfer, method qualification, validation, verification, assay trending and routine GMP testing of AAV vector analytical methods (HPLC, LCMS, AUC, UV, CE-SDS, compendia methods and other methods as needed) for lot release and stability. The Senior Analyst, Quality Control Chemistry will support external laboratory testing and internal study protocol design, study report review and IND support as needed. This position will work with others in Quality Control, Analytical Development teams, Quality Assurance, Manufacturing and CROs to perform routine QC testing of in-process, DS, DP, and raw material samples. The individual will also work on data trending, invalid assays investigations, quality events (investigations, deviations, Change control, CAPAs). Responsibilities: Execute analytical test methods to support product release and stability of AAV products using different analytical techniques (e.g. HPLC, LCMS, AUC, UV, CE-SDS, compendia methods like Osmolality, pH, Sub visible particulates and Appearance) Review and approval of cGMP analytical data for release and stability testing from chemistry analytical test methods Supports and leads QC Chemistry laboratory operations (ex. Instrument qualification and maintenance. Housekeeping, qualify critical reagents, etc.). Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed. Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs), Method transfer/ validation protocol, Method transfer/ validation report for internal and external methods. Method Transfer / Validation of QC chemistry methods at internal and external laboratory. Model leadership behaviors and mentor/train junior staff The job responsibilities may change as needed to support activities relevant to the clinical phase. Requirements / Qualifications: BS/MS Analytical Chemistry, Biochemistry, Biophysics, or a related discipline with at least 5 years of experience working in a cGMP environment. Experience working in the cGMP QC lab of the pharmaceutical or biopharmaceutical industry is a must. Experience analyzing nucleic acids, virus capsids, antibodies, and/or other biologics materials using HPLC/UPLC, LCMS, AUC, UV- Vis, CE-SDS is strongly preferred. Experience working with external contract labs (CMOs, CROs) is a plus. Strong collaboration and team-working skills. Strong communication, interpersonal and organizational skills. Proven ability to work independently and effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines. Should be highly motivated, demonstrate good technical skills, have excellent organizational and communication skills, and be able to multitask in a fast-paced environment with changing priorities.

Wave Life Sciences (Wave) is a biotechnology company focused on delivering transformational therapies for patients with serious, genetically defined diseases. We differentiate ourselves through our proprietary chemistry platform that enables the production of stereopure oligonucleotides precisely targeting the underlying cause of rare diseases. At Wave, we welcome those who share a passion to change lives and embrace a culture that is thoughtful, dynamic, humble, and fearless. Together, we can contribute to our mission enabling every patient with a genetic disease to have access to life-changing treatments. Description: Wave Life Sciences seeks a highly motivated and energetic chemistry, biochemistry, or chemical engineering major to join its Analytical/QC team in Lexington, Massachusetts. The co-op role will be responsible for routine testing and method development activities in support of process development, GMP production and clinical development. The position offers the opportunity to directly learn analytical methods and techniques that are in widespread use throughout the pharmaceutical and biotech industry. In addition, the co-op student will gain exposure to important functions of the development and manufacturing of pharmaceuticals, including analytics and stability, manufacturing processes and quality systems. A successful candidate will have hands-on experience with basic wet chemistry, sampling and testing organic or inorganic compounds, as well as other laboratory techniques. Experience with some of the following are a plus: HPLC, Karl Fischer moisture analysis, UV-Vis spectroscopy, microbiology testing, FTIR spectroscopy, chemical synthesis or purification processes. The candidate should also be able to adapt to a fast pace dynamic environment where priorities can change rapidly. This position is based in Lexington, MA at Wave's growing GMP manufacturing facility. Responsibilities: Perform analytical testing of in-process, finished product (API), raw materials Analyzes research and production samples Documentation and organization of data sets and reporting of results to other departments Troubleshoots analyses and assists in performance of investigations Assists in procurement and tracking of reagents and materials Reviews data generated by other analysts Executes method qualifications and validations Minimum Qualifications: Working towards a Bachelor's degree in chemistry or a related discipline (i.e. biochemistry, chemical engineering) At least two years of an undergraduate education completed within a related discipline. Intern must have successfully completed chemistry courses. Must possess excellent oral and written skills, as well as superior organizational skills. Analytical chemistry laboratory skills Analytical chemistry knowledge Competencies: Effective Communication Independence Flexibility/Adaptability to Change Accountability Teamwork Decision making EEO Statement: Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences' employees to perform their job duties may result in discipline up to and including discharge. We value our relationships with professional recruitment firms. To protect the interests of all parties and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Wave Life Sciences, USA.

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.

The QC Microbiologist conducts quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures. Duties will include analysis of pharmaceutical products through compendial methods and client specific test protocols. PRIMARY DUTIES AND RESPONSIBILITIES Prepares and analyzes samples to determine microbiological quality through the following analyses: Microbial enumeration methods, absence of specified microorganisms, Sterility, endotoxin, and water quality analysis (bioburden, TOC, Conductivity). Documents work in a clear and organized manner. Revises procedures and ELNs under close supervision. Follows all safety rules and regulations and conducts periodic safety audits. Follows all cGMP rules and regulations. Under close supervision confers with Microbiologists and other client personnel regarding research, procedures performed, related results and prepares reports. Under close supervision will be trained to become proficient at assigned tasks in order to become subject matter experts. Performs routine data generation and problem solving with a minimal rework. Works under close supervision to ensure all work performed is executed in compliance with standard operating procedures, good manufacturing practices, and the regulations of the Food and Drug Administration. Ensures all work performed strictly adheres to Company, client and Pharmacopeial methodologies. Performs system maintenance and calibrations to ensure equipment is operating with specified requirements. Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules. SHIFT Monday - Thursday 3rd Shift REQUIREMENTS & QUALIFICATIONS Qualifications include a BA or BS degree in Microbiology or related science discipline with 0-2 years of related experience is required. Knowledge of cGMP and related compliance regulations and guidances is preferred. MINIMUM SKILLS REQUIREMENTS Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently. A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and client personnel. Must have excellent organizational, verbal communication and technical documentation skills. Solid computer skills. Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples. Must be a team player with integrity and concern for the quality of Company products, services and staff members.

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

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***********