QC Bioanalytical Scientist
Quality control analyst job in Milford, MA
Title: QC Bioanalytical Scientist
Employment Type: Contract (6 months)
Status: Accepting Candidates
About the role
This role supports QC Bioanalytical activities focused on analytical method qualification, validation, and assay execution for biologic drug substances and process-related impurities. The scientist will work closely with QC and development teams to advance analytical methods into GMP testing environments.
Key Responsibilities
• Perform analytical method qualification and validation for biologics and process impurities.
• Execute ELISA, qPCR, potency, and other immunochemical assays to support method lifecycle activities.
• Support method development, transfer, and technology transfer into QC laboratories.
• Prepare, review, and revise technical protocols, reports, and SOPs.
• Collaborate with cross-functional teams to ensure assay readiness and compliance.
• Provide training and technical guidance to QC staff as needed.
Qualifications
• Bachelor's degree with 8+ years, or Master's with 5+ years in Chemistry, Biology, or related field.
• Hands-on experience with ELISA, qPCR, immunochemistry assays, and biologics analytical characterization.
• Strong understanding of GMP, analytical method lifecycle, and QC environments.
• Experience with SoftMax and plate-based analytical systems preferred.
• Background working with biologics, monoclonal antibodies, and drug substances/products.
• Strong technical documentation and communication skills.
Compensation (MA Pay Transparency):
• Estimated hourly range: $55-$65/hr (W-2).
• Final rate within this range will be based on skills, experience, and interview results.
Associate Synthetic Chemist
Quality control analyst job in Boston, MA
We are seeking an enthusiastic Associate Synthetic Chemist to support the discovery of small molecules for next-generation 3D printing resins. You will work hands-on in the lab, executing syntheses of novel molecules, characterizing products, and exploring photochemical and photophysical structure-property relationships. This role is ideal for highly motivated early-career chemists who love synthesis and are excited to accelerate innovation through fast, iterative chemistry. You will be closely mentored by experienced synthetic chemists and will collaborate with analytical scientists and engineers developing our printing systems.
Responsibilities
Design, execute, and troubleshoot small molecule synthetic routes, with a focus on divergent or modular approaches to rapidly generate lead candidates.
Purify products using chromatography and crystallization techniques.
Characterize compounds via UPLC, NMR, UV/Vis and IR spectroscopy, and mass spectrometry.
Work with cross-functional teammates to explore photochemical and photophysical structure-property relationships that drive 3D printing performance.
Maintain excellent electronic lab notebook documentation.
Contribute to management of chemical databases (e.g., commercial, proprietary, and virtual compound libraries).
Minimum Qualifications
Bachelor's degree in Chemistry or a closely related field with equivalent advanced chemistry coursework.
≥2 years of intensive organic synthesis laboratory experience (academic research and/or industrial roles).
Experience with synthetic planning with chemical databases (e.g., SciFinder, Reaxys).
Excellent command of synthetic and physical organic chemistry fundamentals.
Experience with air-sensitive techniques (e.g., Schlenk line), purification (chromatography/crystallization), and data interpretation (NMR / LC-MS).
Evidence of strong documentation and organizational skills, attention to detail, and the ability to manage multiple workflows efficiently.
Evidence of strong collaboration and teamwork talents/skills.
Ability to thrive in a fast-paced, collaborative R&D environment.
Preferred Qualifications
Command of the basics of photochemistry.
Experience with heterocyclic and/or extended aromatic systems, especially those relevant to organic (opto)electronics.
Benefits
We offer competitive compensation packages in our VC-backed startup.
Benefits include a full suite of offerings covering medical, dental, vision and 401k plan.
Beautiful setting looking out over a river and seaport; outdoor seating and picnic areas.
Highly collaborative work environment.
Additional Information
Travel: Occasional travel may be required from time to time
Location: Boston, Massachusetts
We value diversity in our company and are an Equal Opportunity Employer.
Electrochemist -- GOEDC5653014
Quality control analyst job in Marlborough, MA
Prepare chemical solutions and maintain plating baths for electroplating operations.
Operate and maintain electroplating equipment including tanks, rectifiers, and agitation systems.
Calibrate and maintain laboratory instruments such as pH meters, spectrophotometers, and conductivity meters.
Perform routine and specialized tests to monitor plating thickness, adhesion, and surface finish properties.
Analyze chemical concentrations and adjust bath compositions to maintain optimal plating conditions.
Document experimental procedures, results, and observations in lab notebooks and digital systems.
Clearly and concisely communicate research to team lead and other team members.
Collaborate with R&D teams to assist in research and development of new plating processes and surface treatments
Collaborate with sales teams to troubleshoot customer plating issues.
Ensure compliance with safety protocols, environmental regulations, and waste disposal procedures.
Preferred:
Experience with production-scale electroplating.
Associate, Bachelor, or Master's degree in Chemistry, Chemical Engineering, Materials Science, or related field.
1+ years of experience in a chemical laboratory setting, with a focus on electroplating or surface finishing is a plus
Strong understanding of electrochemical principles and electroplating chemistry (e.g., nickel, copper, silver, tin) is a plus
Experience with a diverse range of analytical equipment, including UV-Vis, AA, SEM, XRF, XRD, wet chemical techniques, and surface analysis methods.
Knowledge of ASTM and ISO standards and quality control procedures.
Experience with corrosion science or surface science.
Experience with Lean Six Sigma or certification.
Qualifications:
Strong bias for action and willing to go the extra mile
Well-organized, detail-oriented, and results-driven team player.
Methodical, proficient in data analysis, and excellent problem-solving skills.
Ability to work both independently and as part of a multidisciplinary team.
Familiarity with lab safety standards and chemical handling procedures
Quality Control (QC) Equipment Technician
Quality control analyst job in Norwood, MA
Contract Length: 6 month with potential extension
About the Role
We are seeking a highly motivated and independent QC Equipment Technician to be the operational and compliance expert for all laboratory equipment within our state-of-the-art biopharmaceutical Quality Control (QC) facilities. This specialized role is critical for ensuring the continuous qualification, calibration, and maintenance of high-precision analytical instrumentation, directly supporting the compliance and integrity of our clinical and commercial testing programs.
Key Responsibilities
The QC Equipment Technician manages the full lifecycle of laboratory assets and supports the robust quality system that governs their use:
Equipment Lifecycle & Maintenance
Coordinate and schedule calibration, maintenance, and Installation, Operational, Performance Qualification (IOPQ) activities with Facilities, Metrology, and QC end-users to minimize equipment downtime and address Out of Tolerance (OOT) events immediately.
Monitor, coordinate, and communicate equipment lifecycle timelines-from acquisition and induction to qualification, implementation, and decommissioning-utilizing project management tools.
Submit asset induction, work, and administrative requests to ensure equipment failures are addressed immediately and data in the Computerized Maintenance Management System (CMMS) is accurate and in the proper state.
Serve as the primary QC point person for all equipment inquiries, acting as the liaison between the laboratory team and appropriate external vendors.
Ensure all vendor representatives strictly follow site safety and cGMP procedures when working on equipment.
Perform minor, non-invasive repairs on high-precision systems like UHPLC (e.g., changing capillaries, flow cells, needles/seats) and execute basic troubleshooting to diagnose complex failures.
Quality & Compliance Documentation
Support the authoring, review, and maintenance of high-stakes quality system records, including Deviations, Change Controls, and CAPAs (Corrective and Preventive Actions) as required.
Author, revise, and maintain Equipment/Instrument Standard Operating Procedures (SOPs).
Review preventative maintenance reports, calibration certifications, CMMS records, and perform system inventory audits to ensure compliance.
Ensure all equipment documentation meets stringent cGMP, GDP (Good Documentation Practices), and data integrity requirements (ALCOA+) throughout its operational life.
Ensure all tasks are performed in compliance with safety and cGMP requirements.
Inventory & Logistics
Order supplies and maintain inventory for equipment consumables and accessories.
Assist with locating and collecting assets due for service and returning them to the laboratory promptly once service is complete.
Basic Qualifications
Education: Bachelor's degree (BS) in a relevant scientific discipline (e.g., Chemistry, Biology, Engineering, or related field).
Experience:
Minimum of 5 years of experience in a regulated laboratory setting with a BS degree.
OR
Minimum of 3+ years of experience in a GMP Quality Control (QC) laboratory setting.
Knowledge: Demonstrated aptitude and ability to learn quickly to develop a strong understanding of GxP principles (cGMP, GLP).
Skills: Proven expertise in laboratory equipment IOPQ, calibration, maintenance, and troubleshooting. Familiarity with electronic Quality Management Systems (eQMS) and CMMS software.
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 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, Analytical Chemistry & Quality Control
Quality control analyst job in Coventry, RI
Job Description
Senior Scientist, Analytical Chemistry & Quality Control
Salary: $100,000-$130,000
FLSA Status: Exempt
We are on the search for a Senior Scientist to join our team at Pharmaron's manufacturing site in Coventry, RI. In this position, the Senior Scientist, Analytical will support process chemistry and manufacturing activities through analytical method development, optimization, validation, and transfer in compliance with all applicable guidelines.
Primary Responsibilities:
Develop, optimize and validate analytical methods that are GMP friendly based on quality-by-design and document formal protocols and reports.
Participate in method transfer activities, including writing protocols and reports.
Perform stability testing and data trending, as required.
Review and Approval of Scientific Reports and SOPs.
Manage analytical projects, coordinate analytical activities and ensure the project timelines are met.
Implementing new analytical techniques and strategies to expand departmental capabilities.
Solving multiple complex scientific problems.
Ensuring adherence to GMP.
Presenting and communicating clearly and effectively with clients.
Experience and Education:
PhD in Chemistry with 2 years of experience or MSc/BS in Chemistry or related field with 6 years of experience with the following instrumentation: HPLC, GC, NMR, FTIR, UV.
Excellent communication skills, both verbal and written.
Effective in managing multiple competing activities and delivering to timelines.
Ability to work in a cross-functional environment.
Working knowledge of cGLP/cGMP and applicable FDA, EMA, and ICH guidance preferred.
High level of awareness of innovative technologies and ability to adapt to in-house needs.
Why Pharmaron?
Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process. With over 21,000 employees and operations in the U.S., U.K., and China, Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.
Collaborative Culture:
You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. Our core cultural values are "Employees Number One" and "Clients Centered," setting Pharmaron apart from other organizations.
Benefits:
As part of our commitment to your well-being, we offer a comprehensive benefits package, including:
Medical, Dental & Vision Insurance with significant employer contributions.
Employer-funded Health Reimbursement Account.
Healthcare & Dependent Care Flexible Spending Accounts.
100% Employer-paid Employee Life and AD&D Insurance.
Short- and Long-Term Disability Insurance.
401(k) plan with generous employer match.
Access to an Employee Assistance Program.
Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!
As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.
#ED-L1
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 - 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 $100,000.00-$120,000.00.
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-ApplyQuality Control Chemist
Quality control analyst job in Groton, CT
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
•
Working with some supervision, applies established knowledge of laboratory techniques such as HPLC, dissolution, UV/VIS spectrophotometry, moisture by KF, and others to perform product stability testing.
• Candidate will be responsible for understanding and performing routine analytical testing for stability samples, evaluating and documenting results in a timely manner. Understands and follows all SOPs and written test procedures.
• Performs testing within established standard test times and maintains quality and productivity at acceptable levels as communicated by the supervisor. Candidate will execute troubleshooting of instrumentation and will be expected to maintain laboratory equipment in good working condition.
• Candidate will perform laboratory investigation steps with appropriate approvals and with some guidance from supervisor. Keeps supervisor fully informed of all results and project status on a daily basis and reports critical information in a timely manner.
Qualifications
•
Qualifications: Essential Skills- 1-3 years of experience in a related laboratory, HPLC, Dissolution, UV/VIS spectrometry, moisture by KF. Strong understanding of GMP concepts and requirements is desired.
• Empower (CDAS) experience is desirable
Additional Information
For more information, please contact,
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-ApplyQC 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.
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
QC Scientist / Snr QC Scientist , Quality Control & Analytical
Quality control analyst job in Coventry, RI
Job Description
Position: QC Scientist/Sr. Scientist (3rd shift, working hours: 11 pm- 7am), Quality Control & Analytical
FLSA Status: Exempt
We are on the search for a 3rd shift QC Scientist to join our QC team at Pharmaron's manufacturing site in Coventry, RI. In this position, the Scientist will support manufacturing and process chemistry activities through analytical method verification, optimization and sample testing in compliance with all applicable guidelines.
Primary Responsibilities:
Sample raw materials and conduct QC testing of raw materials, intermediates, API, IPC and cleaning verification samples following established procedures.
Document and report results of all experiments in a timely-manner consistent with department practices and governing procedures, as applicable.
Participate in method transfer or validation activities, including executing the protocols and preparing the reports.
Review experimental data, notebooks, and instrument qualification protocols / reports.
Write, revise, develop, and evaluate SOPs.
Maintain good laboratory practices and GMP in compliance with safety and environmental requirements.
Ability to work successfully in both a team/matrix environment as well as independently.
Report lab event or deviation and participate in the investigation.
Ensure high quality in QC and analytical work and accurately document all necessary and relevant information in a clear concise manner as per cGMPs.
Provide training to other team members on instrument and testing method.
Participate, support and facilitate site audits as directed and required.
Perform other related assignments and duties as required and assigned.
Experience and Education:
BS in Chemistry with 3+ years of experience or MSc in Chemistry with 1+ year of experience.
Have experience of using the following instrumentation: HPLC, GC, FTIR and KF.
Ability to perform routine QC work independently or with less guidance.
Excellent communication skills, both verbal and written.
Effective in managing multiple competing activities and delivering to timelines.
Ability to work in a cross-functional environment.
Working knowledge of cGLP/cGMP and applicable FDA, EMA, and ICH guidance preferred.
Why Pharmaron?
Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process. With over 21,000 employees and operations in the U.S., U.K., and China, Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.
Collaborative Culture:
You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. Our core cultural values are "Employees Number One" and "Clients Centered," setting Pharmaron apart from other organizations.
Benefits:
As part of our commitment to your well-being, we offer a comprehensive benefits package, including:
Medical, Dental & Vision Insurance with significant employer contributions.
Employer-funded Health Reimbursement Account.
Healthcare & Dependent Care Flexible Spending Accounts.
100% Employer-paid Employee Life and AD&D Insurance.
Short- and Long-Term Disability Insurance.
401(k) plan with generous employer match.
Access to an Employee Assistance Program.
Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!
As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.
#IL-14
Senior 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 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-ApplySenior Scientist, Quality Control Analytical Development
Quality control analyst job in Milford, MA
Title: Senior Scientist / Scientist, Quality Control Analytical Development
Employment Type: Contract (6 months)
Status: Accepting Candidates
About the role
This position supports QC Analytical Development through analytical method qualification, validation, and assay execution for biologic drug substances. The role partners closely with development and QC teams to advance methods into GMP testing environments.
Key Responsibilities
• Perform analytical method qualification and validation for biologics and process-related impurities.
• Execute ELISA, qPCR, and potency assays supporting method lifecycle activities.
• Support method development, transfer, and technology transfer into QC laboratories.
• Prepare, review, and revise technical protocols, reports, and SOPs.
• Collaborate cross-functionally with QC and development teams to ensure method readiness.
• Provide training and technical guidance to team members when needed.
Qualifications
• Bachelor's degree with 8+ years, or Master's with 5+ years in Chemistry, Biology, or related field.
• Hands-on experience with ELISA, qPCR, immunochemistry, and biologics analytical characterization.
• Strong understanding of cGMP, pharmaceutical analytical development, and method lifecycle.
• Experience with SoftMax and plate-based analytical systems.
• Background with biologics, monoclonal antibodies, drug substances/products preferred.
• Excellent documentation, communication, and organizational skills.
Compensation (MA Pay Transparency):
• Estimated hourly range (Senior Scientist): $55-$65/hr (W-2).
• Final rate within this range will be based on skills, experience, and interview results.
QC Scientist / Snr QC Scientist , Quality Control & Analytical
Quality control analyst job in Coventry, RI
Position: QC Scientist/Sr. Scientist (3rd shift, working hours: 11 pm- 7am), Quality Control & Analytical
FLSA Status: Exempt
We are on the search for a 3rd shift QC Scientist to join our QC team at Pharmaron's manufacturing site in Coventry, RI. In this position, the Scientist will support manufacturing and process chemistry activities through analytical method verification, optimization and sample testing in compliance with all applicable guidelines.
Primary Responsibilities:
Sample raw materials and conduct QC testing of raw materials, intermediates, API, IPC and cleaning verification samples following established procedures.
Document and report results of all experiments in a timely-manner consistent with department practices and governing procedures, as applicable.
Participate in method transfer or validation activities, including executing the protocols and preparing the reports.
Review experimental data, notebooks, and instrument qualification protocols / reports.
Write, revise, develop, and evaluate SOPs.
Maintain good laboratory practices and GMP in compliance with safety and environmental requirements.
Ability to work successfully in both a team/matrix environment as well as independently.
Report lab event or deviation and participate in the investigation.
Ensure high quality in QC and analytical work and accurately document all necessary and relevant information in a clear concise manner as per cGMPs.
Provide training to other team members on instrument and testing method.
Participate, support and facilitate site audits as directed and required.
Perform other related assignments and duties as required and assigned.
Experience and Education:
BS in Chemistry with 3+ years of experience or MSc in Chemistry with 1+ year of experience.
Have experience of using the following instrumentation: HPLC, GC, FTIR and KF.
Ability to perform routine QC work independently or with less guidance.
Excellent communication skills, both verbal and written.
Effective in managing multiple competing activities and delivering to timelines.
Ability to work in a cross-functional environment.
Working knowledge of cGLP/cGMP and applicable FDA, EMA, and ICH guidance preferred.
Why Pharmaron?
Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process. With over 21,000 employees and operations in the U.S., U.K., and China, Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.
Collaborative Culture:
You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. Our core cultural values are "Employees Number One" and "Clients Centered," setting Pharmaron apart from other organizations.
Benefits:
As part of our commitment to your well-being, we offer a comprehensive benefits package, including:
Medical, Dental & Vision Insurance with significant employer contributions.
Employer-funded Health Reimbursement Account.
Healthcare & Dependent Care Flexible Spending Accounts.
100% Employer-paid Employee Life and AD&D Insurance.
Short- and Long-Term Disability Insurance.
401(k) plan with generous employer match.
Access to an Employee Assistance Program.
Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!
As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.
#IL-14