QC Investigations Specialist
Quality control analyst job in Boston, MA
Title: QC Investigations Specialist
Employment Type: Contract
Status: Accepting Candidates
About the role
This role supports real-time manufacturing operations by leading investigations, resolving on-floor issues, and ensuring high-quality documentation. You'll partner closely with manufacturing, QC, materials, and facilities teams to maintain operational continuity and compliance.
Key Responsibilities
• Triage manufacturing issues and lead analytical investigations and root cause analysis.
• Write clear, compliant quality documentation including deviations and CAPAs.
• Coordinate with SMEs to determine immediate actions, containment, and impact assessments.
• Interpret data to support structured problem-solving and continuous improvement.
• Provide technical operations support across manufacturing and QC functions.
Qualifications
• 6+ years pharmaceutical or biotech manufacturing experience.
• 4+ years analytical investigation and QC-focused experience.
• Strong background in RCA, deviation management, and GxP documentation.
• Ability to interpret analytical data and think scientifically under time-sensitive conditions.
• Experience partnering cross-functionally with manufacturing, QC, materials, and facilities teams.
Compensation (MA Pay Transparency):
• Estimated hourly range: $50-$55/hr (W-2).
• Final rate within this range will be based on skills, experience, and interview results.
Scientist/Senior Scientist, Analytical Development and Quality Control
Quality control analyst job in Woburn, MA
Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess' patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.
The Role
We are seeking a talented, collaborative, and highly motivated individual with expertise analytical methods highly focused on HPLC and QC operations to join our core team of scientists and engineers. The Senior Scientist will execute Quality Control testing, and associated operations and contribute to analytical testing to ensure compliance with cGMP requirements. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market.
Key Responsibilities
Lead the design, development, optimization, and execution of HPLC-based analytical methods (e.g., RP-HPLC, SEC, IEX) to support in-process, release, and stability testing.
Develop, qualify, validate, and characterize GMP-compliant purity, SEC, and content methods for intermediates and drug products, with a strong emphasis on chromatographic workflows.
Author and execute cGMP method qualification and validation protocols, prepare reports, and perform/oversee routine QC testing.
Serve as Subject Matter Expert for chromatography methods during investigations of deviations, OOS/OOT events, assay failures, and other non-conformance issues.
Provide technical leadership in HPLC troubleshooting, instrument maintenance coordination, data integrity practices, and chromatographic data review.
Independently author method SOPs, analytical protocols, technical reports, and contribute to regulatory submissions.
Maintain rigorous laboratory documentation and complete, audit-ready analytical records.
Collaborate effectively with QC, Manufacturing, Process Development, and Regulatory teams to enable program success across phases.
Thrive in a fast-paced, cross-functional environment with excellent communication and organizational skills.
Qualifications
Ph.D. in Analytical Chemistry, Biochemistry, or related field with a minimum of 4 years (10 years for Senior Scientist) in the biotech/pharmaceutical industry; or M.S. with commensurate experience.
Demonstrated in-depth expertise in HPLC, including method development, troubleshooting, system suitability design, chromatographic theory, and data interpretation.
Hands-on experience with multiple chromatographic techniques (RP-HPLC, SEC, IEX, affinity, gradient optimization, detector setup/maintenance).
Proven success developing and validating GMP analytical methods and supporting GMP operations.
Experience with complementary analytical techniques such as UV-Vis, LC-MS, CE, ELISA, or other functional assays is beneficial.
Experience working in a QC or cGMP laboratory environment with strong understanding of data integrity requirements (ALCOA+).
Strong organizational skills, precision in documentation, and ability to manage multiple analytical workflows simultaneously.
Excellent oral and written communication skills.
Commitment to collaborative work within interdisciplinary project teams.
At Vaxess, we're bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to ******************.
Senior Analyst I, Quality Control Chemistry
Quality control analyst job in Woburn, MA
A recognized pharma company is hiring a Senior Analyst I, Quality Control Chemistry on a one-year contract basis near Boston, MA.
is for candidates who are able to work on a W2 basis.**
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
Perform other duties, as needed
Qualifications:
5+ years of experience working in cGMP environment
Bachelor's and/or Master's Degree in Analytical Chemistry, Biochemistry, Biophysics, or a related discipline
Experience working in the cGMP QC lab of the Pharmaceutical or Biopharmaceutical industry
Experience working with external contract labs (CMOs, CROs)
Desired Skills:
Experience analyzing Nucleic Acids, Virus Capsids, Antibodies, and/or other Biologics materials using HPLC/UPLC, LCMS, AUC, UV- Vis, CE-SDS
Quality Control Technician
Quality control analyst job in Rochester, MA
Location: Rochester MA (100% On-site), 1st shift only 6:30A-3:30P M-F, salary range $72K-$82K, full-time role:
health insurance with an HRA, dental, vision, LTD, and a 401(k) retirement plan with an employer match. 3 weeks PTO, 1 week sick. Generous relocation package offered. Qualified candidates are encouraged to apply.
Large precast concrete supplier in Massachusetts and New Hampshire, providing high-quality products for over 70 years. Their extensive product range includes septic tanks, manholes, drainage structures, bulkheads, curbing, residential steps, and retaining wall systems, all crafted to precise specifications. They cater to engineers, contractors, and homeowners, emphasizing superior performance and exceptional customer service.
The Quality Control Technician (“QC Technician”) will work within the production plant and is ultimately responsible for product testing. The QC Tech will assist in the execution of quality control processes, procedures and protocol associated with the production of pre and post concrete pours.
Responsibility
Responsible for ACI concrete field tests
Responsible for quality control inspections in manufacturing plant
Inspect forms before pouring (Pre-Pour).
Inspect product after removed from forms (Post-Pour)
Notifies Production Supervisor if deficiencies are found.
Perform and/or schedule repairs on products as needed.
Housekeeping - maintain a clean work area. Including cleanliness within breakroom, restroom, and general facility areas.
Expected to maintain knowledge of precast plant techniques and procedures.
May assist with precast production operation as needed.
Characteristics
Always committed to safety. Maintain a safe work area. Follow safe work practices as outlined in the Safety Program.
Always committed to quality. Follow and implement quality control measures.
Excellent attendance.
Reliable means of transportation to and from work.
Ability to learn, organize and prioritize work and handle multiple tasks.
Outstanding attitude, honesty, and ethic at all times.
Expected to use sound judgment, diplomacy, and discretion.
Work independently or cooperatively with others.
Self-drive in carrying out the functions of the job.
Requirements:
ACI Concrete Field-Testing Grade 1 Certified (preferred)
NPCA PQS Training
Must be at least 18 years of age per federal guidelines.
Good communication skills, both verbal and written to all levels of staff
Ability to remain focused in busy environment.
Computers and tablets skills in order to perform tasks.
Ability to read blueprints and sketches.
2nd shift Quality Control Operator Level II
Quality control analyst job in Millbury, MA
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
QC Scientist - Method Validation & QC Operations
Quality control analyst job in Boston, MA
About Aura:
Aura Biosciences is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors that aim to preserve organ function. Our lead candidate, bel-sar (AU-011), is currently in late-stage development for primary choroidal melanoma and in early-stage development in other ocular oncology indications and bladder cancer. Aura Biosciences is headquartered in Boston, MA. Our mission is to grow as an innovative global oncology company that positively transforms the lives of patients.
For more information, visit aurabiosciences.com. Follow us on X (formerly Twitter) @AuraBiosciences and visit us on LinkedIn.
Position Summary:
Aura Biosciences is seeking a highly motivated and detail-oriented QC Scientist to support method validation and routine QC operations for our innovative oncology therapeutics. This role is critical to ensuring the integrity and compliance of analytical methods used in the testing of drug substance and drug product across clinical stages.
Key Responsibilities:
Lead and execute method qualification and validation activities in alignment with ICH guidelines and GMP standards.
Support and oversight of routine QC testing of plasmid, drug substance (DS) and drug product (DP), including release and stability studies.
Collaborate with CMOs and CROs to ensure timely and compliant execution of analytical activities.
Author and review technical documentation including validation plans, protocols, reports, SOPs, and CoAs.
Manage validation timelines and proactively provide solutions to method challenges.
Participate and lead investigations (OOT/OOS), CAPAs, and continuous improvement initiatives.
Review and trend analytical data routinely for specification evaluation.
Ensure compliance with internal quality systems and regulatory expectations.
Contribute to cross-functional CMC discussions and provide technical input on overall analytical strategy.
Key Skills
Analytical Method Validation - Strong understanding of ICH Q2(R2), GMP principles including compendial methods and data integrity.
Instrumentation Expertise - Proficiency in HPLC, UV-Vis, Empower, Bioassays, qPCR other analytical platforms and compendial methods.
Collaboration - Effective communication with internal teams and prior experience managing external partners (CMOs/CROs) is preferred.
Technical Writing - Skilled in drafting and reviewing protocols, reports, and SOPs.
Problem Solving - Experience with OOS/OOT investigations and root cause analysis.
Project Management - Ability to manage timelines and deliverables across multiple stakeholders.
Regulatory Knowledge - Familiarity with FDA and EMA expectations for QC and validation.
Attention to Detail - High level of accuracy in data review and documentation.
Statistical analysis using JMP, Minitab or equivalent.
Minimal travel is required to CMOs.
Role is a hybrid role (minimum 3 days onsite).
Minimum BS in Sciences with at least +5 years' experience or MS and 2+ years
Salary & Benefit Information:
Salary Range: $105,000/yr - $135,000/yr
(Placement within the listed range depends on many factors including, but not limited to: geographic location, degree, years of experience, and internal company equity)
Health insurance with FULL premium coverage
401K with company match
Employee Stock Purchase Program (ESPP)
Competitive paid time off (PTO)
Company-paid short & long-term disability insurance and life insurance
QC Microbiology Scientist
Quality control analyst job in Andover, MA
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
QC Scientist I Raw Materials
Quality control analyst job in Westborough, MA
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at *****************
Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.
Astellas is announcing a QC Scientist I Raw Materials opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.
Purpose:
The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead. This role will mentor junior analysts and develop and facilitate training initiatives within the labs.
Essential Job Responsibilities:
Develop/author/revise technical reports and laboratory procedures (SOPs, methods)
Execute and troubleshoot raw material testing in support of production activities
Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures
Design and perform testing in support of method transfer/validation/qualification/verification
Review/authorize data and perform analysis and interpretation of test results and trends
Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations
Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration
Support and mentor junior team members
Collaborate with other network sites to share best practices
Other duties as required
Quantitative Dimensions:
The QC Scientist I Raw Materials will be accountable for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality.
Organizational Context:
The QC Scientist I Raw Materials will typically report to the Senior Manager, Quality Control Raw Materials. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization
Sr. Scientist/Scientist II-III, QC Critical Reagents
Quality control analyst job in Lexington, MA
The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.
WORKING AT GENEZEN
Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.
JOB SUMMARY
The Sr. Scientist/Scientist II-II, Critical Reagents is responsible for overseeing all reference standards and other critical reagents in line with internal SOPs and ICH guidelines. This individual will work collaboratively with QC Operations, Analytical Development, and Quality Assurance in support of clinical pipeline and commercial products. This position requires strong leadership skills, statistical and technical knowledge, and a commitment to quality and compliance. The position will be hired at the Scientist II, Scientist III or Sr. Scientist level based upon the experience of the successful candidate.
ESSENTIAL JOB FUNCTIONS
Oversee the Critical Reagents and Materials function.
Oversee the day-to-day operations of the GC QC Technical Services group.
Provided operational oversight for critical reagent and materials management across the quality organization.
Develop and maintain robust systems for the qualification, monitoring, tracking and storage of critical reagents and materials.
Collaborate with cross-functional groups to ensure the continued supply of qualified reagents and materials.
Act as the primary point of contact for the monitoring, tracking, and storage of critical reagents and materials.
Manage inventory, strategic planning, and lifecycle management of reference standards and critical materials.
Represent Quality Control on project teams and in meetings as required.
Authors and reviews standard operating procedures, protocols, and reports as required.
Manages the implementation/maintenance/continuous improvement of Quality Systems as required.
SPECIAL JOB REQUIREMENTS
Adaptability required as work schedule may change based on business needs
Criminal background check required
Other duties as assigned
KNOWLEDGE, SKILLS AND EXPERIENCE
EDUCATION / CERTIFICATIONS / LICENSES
Essential/Desired
BS or MS in Life Sciences or Engineering
Essential
ON-THE-JOB EXPERIENCE
8+ years of pharma/biotech industry experience
Essential
Well versed in cGMP/ICH/FDA/EU regulations and guidelines
Essential
Large molecule, gene or cell therapy experience is required.
Essential
Expertise in reference standards programs, including ICH regulations and quality control methods.
Essential
Strong background in biostatistics for evaluation comparability and qualification of new reference standards and control reagents.
Desired
Experience in Quality Control within the biological pharmaceutical industry.
Desired
Proficiency in writing SOPs, qualifications protocols, and reports.
Essential
Familiarity with statistical software (JMP).
Essential
SKILLS / ABILITIES
Excellent analytical and problem-solving skills
Essential
Must possess excellent communication and organizational skills
Essential
Cross functional collaboration ability to work well with diverse groups
Essential
Ability to manage multiple activities with challenging timelines
Essential
Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint)
Essential
Effective oral and written communication skills
Essential
Confident, independent, self-starter, proactive, and results-oriented with high performance and compliance standards
Essential
Exhibits highest integrity and committed to ethics and compliance standards
Essential
Open and transparent in sharing data and information
Essential
PHYSICAL DEMANDS
While performing the duties of this job, the employee is required to meet the following physical demands:
Work Environment
Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
Occasionally exposed to extremely loud noise levels
Movement
Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms
Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl
Lifting
Frequently lift and/or move up to 25 pounds
Occasionally lift and/or move up to 50 pounds
Vision
Frequently utilize close vision and the ability to adjust focus
Communication
Frequently required to communicate by talking, hearing, using telephone and e-mail
Pay Range:
The annual salary range for this position is $100,000-$145,000.
GENEZEN'S CURES VALUE-BASED COMPETENCIES
Committed to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
Urgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.
Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.
Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.
GENEZEN'S BENEFITS
Paid vacation days, amount based on tenure
Paid sick time
10 observed holidays + 2 floating holiday + 1 volunteer day
401(k) plan with company match up to 6% of salary, vested immediately
Share Appreciation Rights
Choice of several healthcare plans
FSA and HSA programs
Dental & vision care
Employer-paid basic term life/personal accident insurance
Voluntary disability, universal life/personal accident insurance
Accidental Death & Dismemberment (AD&D) Insurance
ADDITIONAL DETAILS
Nothing in the job description for this role restricts management's right to assign or reassign duties and responsibilities to this job at any time.
This position requires a criminal background check.
Genezen is an Equal Opportunity Employer.
Genezen participates in EVerify.
Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.
Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.
Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum--to name just a few reasons why this area is a great place to live.
Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.
Auto-ApplyQC Scientist
Quality control analyst job in Devens, MA
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: ************ |
Sr Scientist, Quality Control Analytical Development (6-month Contract)
Quality control analyst job in Milford, MA
Advancing medicine to save lives. Together.
Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases.
Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions - together with our clients.
Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability.
As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives.
Duties and Responsibilities
Laboratory role to support the qualification and validation of analytical methods for biologic drugs and process related impurities
Primary focus on the execution of experiments to support the validation of molecular biology assays including but not limited to ELISAs for residual HCP, residual protein a, and relative potency assays as well as qPCR
Work collaboratively within a group of scientists to perform analytical method development qualification or validation under cGMP in collaboration with the Quality Control unit
Apply expertise in molecular biology, cell biology and/or immunochemistry to analytical development team across the lifecycle of the procedures
Participate in the technology transfer of analytical methods into QC and analytical method qualification Method transfer, method validation, method development
Review & revise SOPs and/or author reports, protocols & other documentation as appropriate
Collaborate with other labs to prepare methods for transfer to the QC GMP labs
Provide training and work direction for group members as required
Qualifications
Bachelor's Degree in chemistry or a biological science with minimum of
8+ years of related experience (or master's degree with 5+ years of experience) in a cGMP environment
Experience utilizing Spectramax M5 or M2 plate readers and the associated Softmax GMP software required
Strong understanding of molecular biology assays in support of the product quality testing for Biologics drug substances/drug products
Experience with analytical characterization of biologics is expected
Strong organizational, time management skills, and prioritize work schedule to meet deadlines
Must be able to communicate effectively with managers, peers, and clients
Must demonstrate effectiveness in ability to train others as needed
Strong knowledge and expertise of quality requirements pertinent to pharmaceutical AD labs
Strong working knowledge of laboratory safety including standard precautions associated with
hazardous & biohazardous material handling
Experience with drug substance, drug products, intermediates, as well as experience with monoclonal antibodies is desired
Experience in other biophysical characterization methods CE (capillary electrophoresis), chromatography, SEC/RP/IEX-U(H) PLC, SDS-CGE, iCIEF, CIEX, Peptide mapping is a plus
Computer skills to include full competence with Microsoft Word, Power Point & Excel
Working Conditions
Laboratory environment working with chemical reagents and analytical equipment
Normal office working conditions: computer, phone, files, fax, copier
Personal Protective Equipment must be worn as required
Minimum travel required
Physical Requirements
Frequent lifting up to 10 lbs.; frequent standing/walking
Manual and visual dexterity required to perform laboratory and computer tasks for prolonged periods
PPE as required
____________________________________________________________________________
Base Pay Range
$52/hr - $67/hr
Auto-ApplySenior Scientist - Quality Control
Quality control analyst job in Boston, MA
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: *****************************************************
Auto-ApplyQC Microbiology Scientist (In person interview)
Quality control analyst job in Andover, MA
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
Senior Analyst I, Quality Control Chemistry
Quality control analyst job in Woburn, MA
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.
QC Chemist
Quality control analyst job in Framingham, MA
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
***********
Sr. QC Analyst, Microbiology
Quality control analyst job in Hopkinton, MA
WHO WE ARE
RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people's lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.
THE ROSLINCT WAY
Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people's development, growth, and the ability to impact patients.
ACCELERATING YOUR FUTURE
· Author, review, approval, and final authorization of microbiology methods (test results and records, test methods, equipment records) and ensuring adherence to regulatory agency requirements, Client standards, policies, SOPs for cell therapy products and experience with EU Annex requirements.
· Execute procedures for microbiology methods in support of method lifecycle activities including method transfer, qualification, validation, compendial verification, and performance monitoring.
· Support microbiology equipment installation and qualification, ensuring 21 CFR Part 11 compliance.
· Participate as microbiology method subject matter expert (SME) in investigations, OOS, deviation, change controls, and CAPAs to support cGMP operations.
· Provide support to QC Operations as method SME: develop training approach, training documents and provide training for new methods.
· Perform non-routine/routine QC testing for in process samples, product testing, stability testing, or raw material testing as needed.
· Work collaboratively with cross functional departments including but not limited to QC Technical Services, Quality Assurance, and Program Management.
· Ability to prepare technical data and present to senior leadership.
WHAT YOU WILL BRING
· Bachelor's degree in Biology (Microbiology)
· 4+ years of microbiology laboratory experience with rapid microbiological methods is a plus (rapid sterility, endotoxin, gram stain).
· Experience in a cGMP QC laboratory environment performing environmental monitoring, contamination control and investigation writing.
· Excellent/Effective written and verbal communications skills.
· Prepare technical data and present to senior leadership.
· Escalate issues professionally and on a timely basis.
OUR COMMITMENT
All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.
RoslinCT is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.
Auto-ApplySr. QC Analyst, Microbiology
Quality control analyst job in Hopkinton, MA
WHO WE ARE
RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people's lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.
THE ROSLINCT WAY
Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people's development, growth, and the ability to impact patients.
ACCELERATING YOUR FUTURE
· Author, review, approval, and final authorization of microbiology methods (test results and records, test methods, equipment records) and ensuring adherence to regulatory agency requirements, Client standards, policies, SOPs for cell therapy products and experience with EU Annex requirements.
· Execute procedures for microbiology methods in support of method lifecycle activities including method transfer, qualification, validation, compendial verification, and performance monitoring.
· Support microbiology equipment installation and qualification, ensuring 21 CFR Part 11 compliance.
· Participate as microbiology method subject matter expert (SME) in investigations, OOS, deviation, change controls, and CAPAs to support cGMP operations.
· Provide support to QC Operations as method SME: develop training approach, training documents and provide training for new methods.
· Perform non-routine/routine QC testing for in process samples, product testing, stability testing, or raw material testing as needed.
· Work collaboratively with cross functional departments including but not limited to QC Technical Services, Quality Assurance, and Program Management.
· Ability to prepare technical data and present to senior leadership.
WHAT YOU WILL BRING
· Bachelor's degree in Biology (Microbiology)
· 4+ years of microbiology laboratory experience with rapid microbiological methods is a plus (rapid sterility, endotoxin, gram stain).
· Experience in a cGMP QC laboratory environment performing environmental monitoring, contamination control and investigation writing.
· Excellent/Effective written and verbal communications skills.
· Prepare technical data and present to senior leadership.
· Escalate issues professionally and on a timely basis.
OUR COMMITMENT
All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.
RoslinCT is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.
Auto-ApplyFormulation Technician
Quality control analyst job in Woburn, MA
Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess' patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.
Vaxess is a multi-disciplinary organization, integrating mechanical, industrial, biomedical, and chemical engineering with chemistry, biology, and human factors to address important unmet medical needs. We are seeking a skilled, collaborative, and highly motivated formulation technician with expertise in chemical, biotech, medical device or pharmaceutical manufacturing to join our growing team. The Formulation Technician will play a pivotal, hands-on role in meeting overall production goals by ensuring execution of formulation activities, while closely collaborating with cross-functional teams.
Responsibilities
Performs cGMP formulation operations according to documented procedures or batch records
Operates formulation equipment such as fluid dispensers, mixers, pumps, and filtration systems
Completes production batch records, logbooks, test records, and other documentation following Good Documentation Practices in a timely manner
Performs in-process assays such as pH, density, filter integrity, and API concentration measurement
Contributes to root cause analyses (RCA) and process development investigations
Reviews and verifies documentation for completeness and compliance with regulatory standards
Supports formulation related process development efforts as needed
Adheres to all safety guidelines, including PPE usage, chemical handling, and emergency procedures.
Performs other assigned duties related to manufacturing, facilities, and quality control as needed
Qualifications
2 + years' relevant experience working in regulated environments in chemical, biotech, medical device or biopharmaceutical industries; experience working in a clean room is preferred
High school diploma minimal, associate's degree or trade certifications preferred
Strong laboratory techniques including pipetting, weighing, mixing solutions, aliquoting, and documentation
Ability to work in a laboratory and clean room environment
Good written and verbal communication skills, attention to detail, and a demonstrated ability to work independently as well as effectively within a team
Entrepreneurial spirit and drive to positively impact global human health
Vaxess is building a team of exceptional people to rapidly advance product development. We work closely as a team and thrive in a dynamic, exciting, and engaging work environment. If you're interested in joining the Vaxess team, please submit your CV/resume to ******************.
QC Scientist I Raw Materials
Quality control analyst job in Westborough, MA
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at *****************
Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.
Astellas is announcing a QC Scientist I Raw Materials opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.
Purpose:
The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead. This role will mentor junior analysts and develop and facilitate training initiatives within the labs.
Essential Job Responsibilities:
* Develop/author/revise technical reports and laboratory procedures (SOPs, methods)
* Execute and troubleshoot raw material testing in support of production activities
* Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures
* Design and perform testing in support of method transfer/validation/qualification/verification
* Review/authorize data and perform analysis and interpretation of test results and trends
* Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations
* Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration
* Support and mentor junior team members
* Collaborate with other network sites to share best practices
* Other duties as required
Quantitative Dimensions:
The QC Scientist I Raw Materials will be accountable for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality.
Organizational Context:
The QC Scientist I Raw Materials will typically report to the Senior Manager, Quality Control Raw Materials. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization
Senior Scientist - QC Stability Data Review
Quality control analyst job in Boston, MA
Shift: Full-Time; Monday - Friday; 8am-5pm EST
ONSITE/HYBRID:
This is a fully onsite role based at our customer's site in
(Boston, MA).
We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner.
Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
Key responsibilities:
Perform technical and quality reviews of internal and external documents, including raw data, stability protocols/reports, CoAs/stability data reports, risk assessments, sampling plans, shelf-life reports and etc.
Enter and trend stability data in SLIM system and generate stability timepoint summary reports.
Establish/extend DS and DP shelf lives and generate shelf-life reports based on stability data.
Plan, manage and communicate stability pulls and ensure stability testing occurs within specified testing windows.
Education and Experience:
Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
Sr. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years')
OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years')
OR PhD
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
Proven Experience with stability studies, stability protocols/reports, CoAs/stability data reports, risk assessments, sampling plans, shelf-life reports, including raw data and external documents.
Stability data in SLIM system and generate stability timepoint summary reports.
DS and DP shelf lives and generate shelf-life reports based on stability data.
Plan, manage and communicate stability pulls and ensure stability testing occurs within specified testing windows.
Attention to detail and ability to multitask, review tons of data.
Working Environment:
Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary and/or standing for typical working hours.
Able to lift and move objects up to 25 pounds
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with
proficiency.
May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Compensation and Benefits
The salary range estimated for this position based in Massachusetts is $90,000.00-$110,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: *****************************************************
Auto-Apply