Quality control analyst jobs in Lakewood, NJ - 112 jobs

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Title: Scientist I Duration: 6 Months (Possibility of Extension) Location: Ewing NJ 08628 Shift - Can be flexible, can start as early as 7:30 AM (end at 4 PM), up to 9 AM (end at 5:30 PM) Job Description The Analytical Scientist will be involved in the design, planning, organization and evaluation of drug product and combination drug/device product development. They will perform analytical testing on formulation and manufacturing intermediate dosage forms as well as inhalation devices (aerosol performance testing) as part of a project team within Analytical Chemistry. The position requires use and application of analytical chemistry principles, theories, and concepts. Work is directly supervised. The Analytical Scientist will follow established procedures and methodologies and contributes to completion of routine scientific/technical tasks and has limited discretion to vary from established procedures. Ability to work both closely with other team members from various disciplines as well as the ability to work independently when needed. The Analytical Scientist will assist with the development of new procedures and methodologies (based on prior established techniques at this site) to develop solutions to solve scientific/technical problems of limited scope. Qualifications Mandatory and/or minimum requirements: Prior experience with aerosol performance testing of inhalation dosage forms is required - (1 year or more of experience is required) Prior experience with aerosol performance testing in a pharmaceutical environment (R&D preferred but QC setting acceptable) Ability to work in a team-based / collaborative environment Excellent documentation skills Desirable attributes/qualifications: Prior experience with Waters Alliance HPLCs and Empower Prior experience creating technical documents including standard operating procedures and reports Prior experience with MS Word, Excel, and PowerPoint for presenting data Attention to detail in execution and documentation Required levels experience and/or education: BS/MS in Chemistry or a related field, 3-7 yrs of experience (1-3 years could be considered depending upon relevance of experience to our needs) Additional Information Feel free to forward my email to your friends/colleagues who might be available. We do offer referral bonus Thank you for your time and consideration. I look forward to hearing from you! Kind Regards Ruchi Kumari Clinical Recruiter Integrated Resources, Inc. IT Life Sciences Allied Healthcare CRO Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I (DIRECT BOARD) # 732-844-8716 (F) 732-549-5549 LinkedIn: https://www.linkedin.com/in/ruchi-kumari Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)

The primary role of the Senior QC Bioassay Scientist is to provide analytical support for GMP manufacturing, process development, and stability studies. The Senior QC Bioassay scientist will develop, qualify, and execute immunoassays, cell-based potency assays, and other analytical test methods for raw materials, highly potent APIs, antibody-drug conjugates (ADCs), and other pharmaceutical products in a GMP setting. The incumbent works cross-functionally with internal departments and external resources on QC related issues. The Senior QC Bioassay Scientist supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. Manage and lead a group of junior scientists. Perform all work in a safe and compliant manner in accordance with EHS best practices and cGMP guidelines. Work with management and vendors to acquire, install, and qualify new equipment. Maintain, clean, calibrate, troubleshoot, and repair analytical instruments and equipment. Develop and execute ELISA, cell-based, other types of immunoassays, and plate based analytical methods for small molecules, proteins, and antibody drug conjugates. Support lab management by tracking and replenishing critical reagents and consumable inventory. Analysis of raw materials, in-process samples, finished products, and stability samples by various analytical instruments in a GMP compliant lab. Prepare standard operating procedures (SOPs), analytical test methods, protocols, reports, etc. as needed. Conduct OOS, risk assessment, and root cause investigations and/or assist management with these investigations. Write deviations, change controls, and CAPAs, and/or assist management with these documents. Document work in laboratory notebooks and logbooks according to organizational GDP policies. Write, review, and execute analytical protocols & reports for method transfers, qualifications, and validations in GMP setting. Manage work outsourced to third-party analytical and metrology service providers. Perform detailed peer review of analytical data to ensure accuracy. Perform other tasks and assignments as needed and specified by management. Qualifications Required Knowledge, Skills and Abilities: Strong background in analytical sciences. Experience in leading people and projects Hands-on experience with various analytical techniques, including ELISA, PCR, SPR, BLI, flow cytometry, microscopy, Western blot, cell culture, etc. Proficiency with Microsoft Office Excellent verbal and written communication skills as well as interpersonal skills. Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members. Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfill the business need. Education and Experience Requirements: BS, MS, or PhD degree in chemistry, biology, biochemistry, or related discipline. BS with at least 10 years of relevant experience, MS or higher degree with at least 5 years of relevant experience, or equivalent combination of work experience, education, and training At least 5 years of experience in a GMP manufacturing or CRO setting. Physical Demands: Typically requires standing and walking for entire shift. Occasionally requires lifting of up to 20 pounds. Frequently requires the use of a step stool. Requires manual dexterity and visual abilities. Working Conditions: Office/ Laboratory position. Certificates and Licenses required: N/A Compensation: $100,000 to 120,000 per annum NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.

The Quality Control Chemist-II is responsible for performing a variety of complex analytical testing, ensuring the quality of dietary supplements and OTC products through testing, documentation, and compliance with regulatory standards. This position also involves reviewing and maintaining SOPs, Testing Procedures, calibrations, and other controlled documents to support quality assurance activities. Additionally, the Chemist-II will assist with troubleshooting and minor repairs of laboratory equipment and support stability testing and documentation. This mid-level position will require more independent work, the ability to mentor QC chemist-I and Lab Tech personnel, and involvement in process improvements and corrective actions. ESSENTIAL FUNCTIONS ( Essential functions, as defined under the Americans with Disabilities Act, may include the following tasks, knowledge, skills and other characteristics. This list of tasks is illustrative ONLY and is not a comprehensive listing of all functions and tasks performed by positions in this class. It does not imply that all positions within the class perform all of the duties listed, nor does it necessarily list all possible duties that may be assigned.) Coordinates with other QC Supervisors and laboratory management so that the shared resources such as laboratory instruments, reagents, etc. are available for assigned staff to perform their job duties effectively and efficiently. Performs the pharmaceutical OTC & Dietary supplement analysis to support OTC & Dietary Supplement manufacturing which includes assay, impurity, dissolution testing, content uniformity, and physical testing. Conduct Analysis in compliance with cGMP requirements, compendia standards, and internal procedures. Maintain accurate record of analysis and perform documentation to company standards Perform laboratory analysis right first time, contemporaneous documentation, analyze and document the results. Notify manager immediately of nonconforming data or unexpected occurrences. Reviews and analyzes the stability samples and associated analytical data, prepares or assists in preparing Stability Summary Reports for Annual Product Review Reports. Reviews/Checks of analytical data by following test methods/SOPs. Performs operational qualification on analytical instruments, analytical method verification/validations, validation protocols and reports for analytical methods. Conducts laboratory investigation (OOS/OOT) under the supervision of laboratory management. Organize work schedule to complete assigned tasks efficiently and on schedule. Work under direction provided by supervisor and other duties as assigned Assist in Training and monitoring of the new hires (trainees) in learning or performing basic skills and assists in evaluating the need of any potential equipment for laboratory. Ensures the laboratory is kept in a safe working environment and in compliance with OSHA and other laboratory safety standards. Maintains knowledge of the latest guidelines of regulatory requirements of International Conference of Harmonization, USP, USFDA and OSHA. Complies with all regulatory/ in-house requirements may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP, cGLP, documentation. Assists in compilation of regulatory documents. Managing the Pharmacopeia changes and up gradation and implementing the same after upgrading the change repeated documents through proper channels of change control and training to all concerned. EXPERIENCE AND QUALIFICATIONS T o perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the experience and education required : EDUCATION & EXPERIENCE o Bachelors degree in Chemistry or related science field with eight (8) to ten (10) years lab experience in a pharmaceutical chemical or related industrial experience; preferably solid dosage forms manufacturing. Method Development experience is preferred. o Masters degree or higher with six (6) to eight (8) years of progressive lab experience in a pharmaceutical chemical or related industry; preferably generic pharmaceuticals. Method Development experience is preferred. o Demonstrated skills and experience in leading a group of QC Chemists. COMPUTER SKILLS o Basic knowledge of computers using MS Office, MS Outlook and business software systems commonly used in the pharmaceutical industry required. MATHEMATICAL SKILLS o Requires a strong knowledge of algebra, calculus and statistics and how they are applied. o Math skills commensurate with scientific background are required. KNOWLEDGE, SKILLS AND ABILITIES To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and abilities required : INDUSTRY KNOWLEDGE: Knowledge and experience of applicable FDA regulatory standards and requirements for the solid oral dosage manufacturing required. Knowledge of analysis of pharmaceutical dosage forms and raw materials utilizing HPLC, GC, ICP-MS, UV, TLC, dissolution testing, spectroscopic and wet chemistry techniques is a plus. COMMUNICATION SKILLS: Advance level of written and verbal communication skills with the ability to read, technical procedures or governmental regulations. Ability to write reports, and required documentations. REASONING ABILITY: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form. Must possess initiative and trouble shooting ability.

Job Title: Quality Control ChemistJob Description We are seeking a dedicated Quality Control Chemist to join our team. The ideal candidate will conduct quality control testing of raw materials and finished products using various analytical techniques. This role requires a strong understanding of chromatography, spectroscopy, and other analytical methods to ensure regulatory compliance and product quality. Responsibilities * Conduct quality control testing on raw materials and finished products using analytical techniques such as HPLC, UPLC, GC, UV-Vis, FT-IR, and dissolution apparatus. * Interpret and report analytical results, maintaining accurate laboratory records, and ensuring compliance with regulatory requirements. * Collaborate with the quality assurance team to ensure products meet in-house and regulatory quality specifications. * Operate, maintain, and calibrate analytical instruments, ensuring they are functioning properly. * Adhere to health and safety guidelines, ensuring a safe working environment in the laboratory. * Ensure compliance with international regulations such as FDA and EMA. * Work collaboratively with R&D and production teams to support product development and release. * Provide technical support and training to junior team members or other departments. Essential Skills * 3-7 years of routine testing experience using HPLC and dissolution techniques. * Proficiency in working with solid oral dosage forms, raw materials, and finished products. * Experience with analytical instruments such as GC, FTIR, KF, and UV-VIS. * Strong understanding of Pharma GMP practices. * Competence in laboratory applications including wet chemistry, titration, and chromatography. * Basic computer skills in MS Word, Excel, and Outlook. Additional Skills & Qualifications * Bachelor's degree in Chemistry, Analytical Chemistry, Biochemistry, Biology, or a related field. * Proven hands-on experience in a pharmaceutical analytical laboratory. * Ability to document and record analytical experiments and results as per cGMP guidelines. * Strong problem-solving skills and attention to detail. * Knowledge of regulatory guidelines such as GMP and GLP. Work Environment The role is based in a laboratory setting, involving exposure to chemicals, reagents, and specialized equipment. The position may require standing for extended periods and the ability to lift moderate weight, approximately 25 pounds. A team of 10 professionals works collaboratively in this environment. Overtime may be required to meet project deadlines. Job Type & Location This is a Contract to Hire position based out of East Windsor, NJ. Pay and Benefits The pay range for this position is $35.00 - $35.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in East Windsor,NJ. Application Deadline This position is anticipated to close on Jan 26, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Job Title - QC Sr.Scientist-I, Project WuXi Biologics is a is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. WuXi Biologics' achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD culture of Passion, Reward, Opportunity, Unity, and Determination. WuXi Biologics offers exciting job opportunities and careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies Job Summary Supports Quality Control clients related integrated, standalone or related QC department projects and ad hoc work. Work closely and collaborate with external departments such as PM and CMC leaders with QC internal testing functions to ensure smooth orderly management of QC methods and timelines. Responsible for overall QC projects deliverables and meeting clients' expectations regarding projects' completions and IND filings. Responsible as the function lead or functional sponsor to managing specific QC projects' communications and deliverables to clients. Demonstrates strong oral and written communication skills and actively contributes to project training, reports/COAs/COTs generation and documentation. Responsibilities: * Supports in overseeing the Quality Control clients related integrated, standalone or related QC department projects. * Lead multiple matrix teams involving Analytical development, QC testing teams to establish and accomplish method transfer and Qualification Strategy. * Attends regular internal or external QC projects clients' meetings to understand each clients' specific requirements and needs. * Able to work and collaborate closely with external departments such as PM and CMC leaders and communicate certain needs to QC internal testing functions to ensure smooth orderly management of QC methods and timelines. * Provides key input and recommendation of clients' data review or investigation process. Serves as lead for client discussions regarding project quality or investigations/deviations. * Strong Technical and Scientific knowledge of protein-based assays, including HPLC, CE electrophoresis, ELISA, PCR and/or potency methods. * Ensure compliance to training, testing, documentation and general lab management requirements for Industry Standards and/or Regulations * Participate in preparation of project-related audits when needed. * Effective multi-tasking skills and time management required. * Ability to evaluate technical data and record data accurately and legibly. * Able to conduct or support clients' site visits routinely or ad hoc basis. * Supervises staff and manages staff's deliverables to meet expectations * Ability to work effectively as part of a team and exhibit effective interpersonal skills. * Support any required QC documentations such SOP, protocols, final reports, investigations, and deviations when needed. * Conducts critical review of results and reports data when needed. * Supports in proposal drafting, providing pricing support. Qualifications: * Bachelor or advanced Graduate degree in Biology, Cell Biology, or equivalent field. * A least 5+ years of relevant experience or equivalent for Bachelors', 3+ years for Master's in the Quality Control or related field or equivalent experience. * Candidate must possess extensive knowledge and experience in analytical and QC operations of pharmaceutical industry, understand current regulations and industry trends of biologics product development, characterization and manufacturing testing requirement including cGMP, ICH, EMA, FDA, and other global compendia regulations and guidance. * Solid track record of working experience in quality control operation to support clinical and commercial scale manufacturing product testing and regulatory IND/BLA filing. * He or She should have demonstrated ability of problem solving and decision making. * Ability to rapidly pivot between strategic and tactical thinking/planning and manage multiple priorities to achieve department and site objectives. * Project management experience is preferred. The salary range for this position is 72,800-116,500 The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender

**General Description:** Perform QC Chemistry laboratory activities with a primary focus on capillary electrophoresis techniques to support GMP manufacturing, testing, and release of material, intermediates and finished biological products (monoclonal antibodies) under FDA/EU regulations, applicable International Regulations, and BeOne Medicines' processes and procedures. **Essential Functions of the Job:** + Perform routine and non-routine testing using capillary electrophoresis techniques (e.g., CE-SDS, CZE, ic IEF) in the QC Chemistry laboratory to ensure timely and compliant generation and reporting of in-process, release, and stability test results in support of manufacturing operations. + Review, interpret, and report analytical data in accordance with GMP regulations and internal procedures. + Lead troubleshooting efforts for analytical methods and instrumentation related to CE. + Conduct laboratory investigations, including OOS, Out of Trend, deviations, and invalid assays. + Implement corrective actions and preventive actions (CAPAs). + Participate in transfer and method validation activities, including protocol preparation, protocol execution, and report preparation. + Support routine operations, including but not limited to instrument qualification and maintenance, SOP generation and revision, test record keeping, etc. + Maintain equipment in a qualified and calibrated state, coordinating with metrology or vendors as needed. + Manage inventory of reagents and supplies for the laboratory. + Participate in internal and external GMP audits, as needed. + Train other junior level analysts and new hires on CE instrumentation, GMP practices, and data analysis. + Serving as subject matter expert in one or more areas of required testing. + Interacts with all levels of BeOne employees. + Undertake other duties as required. **Education/Experience Required:** + Bachelor's or above in Chemistry, Biochemistry, or Biotechnology related scientific discipline. + Minimum of 4+ years of working experience in an FDA-regulated biotechnology, pharmaceutical company are required. + Working knowledge and experience with chemistry analytical methods such as HPLC, GC, TOC, Capillary Electrophoresis (CGE-Reduced, CGE-Non-Reduced, and Capillary Zone Electrophoresis), etc. + Familiar with Waters Empower Chromatography Data System. + Familiar with instrument and equipment validation. Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level. Working knowledge with USP/EP and cGMP/EU GMP regulations. + Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level. + Credible and confident communicator (written and verbal) at all levels. + Strong analytical and problem-solving ability. + Hands-on approach, with a 'can do' attitude. + Ability to prioritize, demonstrating good time management skills. + Excellent attention to detail, with the ability to work accurately in a busy and demanding environment. + Self-motivated, with the ability to work proactively using own initiative. + Committed to learning and development. **Computer Skills:** + Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint). **Travel:** + Must be willing to travel approximately 10%. + Ability to work on a computer for extended periods of time. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

About Atrium: What you do matters. As a people-centric organization, we foster an environment of collaboration, high performance, and innovation where your talents are valued and your achievements are celebrated. Join us and become part of an inclusive team. Client Overview: Our client is a leading pharmaceutical contract development and manufacturing organization (CDMO), specializing in oral solid dosage and ingestible powder products. They partner with pharmaceutical companies to support drug development and manufacturing needs with a strong focus on quality, compliance, and innovation. They are now looking for a Quality Control Chemist - Pharmaceutical. Salary/Hourly Rate: $34/hr - $36/hr Position Overview: Our client is seeking a skilled Quality Control Chemist - Pharmaceutical to join their onsite team. The Quality Control Chemist will play a critical role in quality control testing, data interpretation, and regulatory compliance within a fast-paced pharmaceutical CDMO environment. This position is ideal for candidates with hands-on experience in analytical instrumentation and a strong understanding of GMP standards. Responsibilities of the Quality Control Chemist - Pharmaceutical: * Perform QC testing of raw materials and finished products, including tablets, capsules, and other dosage forms, using analytical techniques such as HPLC, UPLC, GC, UV-Vis, FT-IR, dissolution apparatus, and particle size analysis. * Independently interpret and report analytical results while maintaining detailed and accurate laboratory records. * Ensure compliance with regulatory standards, including FDA and EMA guidelines. * Operate, calibrate, and maintain analytical instruments and laboratory equipment. * Collaborate with cross-functional teams, including R&D and production, to support product development and release. * Provide technical support and training to junior staff as needed. Required Experience/Skills for the Quality Control Chemist - Pharmaceutical: * 3-7 years of hands-on experience in a pharmaceutical analytical laboratory. * Proficiency with analytical instruments such as HPLC/UPLC, GC, UV-Vis, FT-IR, and dissolution apparatus. * Strong documentation skills aligned with cGMP guidelines. * Ability to troubleshoot analytical techniques and instrumentation. * Excellent attention to detail and strong problem-solving capabilities. Preferred Experience/Skills for the Quality Control Chemist - Pharmaceutical: * Experience working in a CDMO environment. * Familiarity with ingestible powder and oral solid dosage product testing. * Knowledge of international regulatory standards and quality systems. Education Requirements: * Bachelor's degree in Chemistry, Analytical Chemistry, Biochemistry, Biology, or a related scientific field. Benefits: * Atrium Care Package available, upon eligibility (including healthcare plans, discount programs, and paid time off).

Gelest, Inc., part of the Mitsubishi Chemical Group, is hiring a Development Chemist to join our team in Morrisville, PA. This role offers the opportunity to contribute to our mission of delivering innovative specialty chemical solutions to customers worldwide. The Development Chemist will play a key role in designing, developing, and optimizing chemical processes for specialty chemical products. This hands-on role involves synthetic organic chemistry, process development from lab to pilot scale, and data acquisition and analysis to ensure safe, reliable, and cost-effective manufacturing. The Development Chemist will collaborate closely with Product Development, Engineering, Production, and Quality teams to translate laboratory discoveries into scalable processes that meet business and regulatory requirements. **PRINCIPAL ACCOUNTABILITIES:** + Design and perform laboratory experiments involving synthetic organic reactions, route evaluation, optimization, and troubleshooting. + Generate and analyze process data to identify improvement opportunities. + Scale laboratory processes to pilot and full production, ensuring robust transfer of technology and clear documentation. + Utilize analytical techniques (GC, NMR, FTIR, MS) to characterize materials, monitor reactions, and assess process performance. + Document experiments, observations, and recommended improvements in lab notebooks and technical reports. + Support process hazard assessments, safety reviews, and compliance with environmental, health, and safety regulations. + Maintain awareness of industry developments, new technologies, and specialty chemical manufacturing best practices. + Perform other duties as assigned. **KNOWLEDGE/ EXPERIENCE/SKILLS:** To perform the job successfully, an individual should demonstrate the following competencies: + Bachelor's degree in Chemistry, Chemical Engineering, or a related field. Master's degree preferred. + 1-3+ years of experience in specialty chemical synthesis, chemical process development, or scale-up preferred. + Hands-on experience with laboratory techniques and equipment preferred. + Background in synthetic organic chemistry, including multi-step synthesis and reaction mechanism understanding is preferred. + Experience with process development, including reaction kinetics, heat, and mass transfer, mixing, and scale-up considerations is preferred. + Hands-on experience with analytical instrumentation (GC, NMR, FTIR, MS) is preferred. + Excellent written and verbal communication, including technical reporting. + Commitment to maintaining a safe and compliant work environment. + Must be able to wear required PPE (safety shoes, glasses, gloves, hard hat; respirators as needed). + Must be able to climb ladders and stairs to collect samples and observe processes. + Must be able to lift up to 50 pounds and operate a forklift. + **Must be able to work 2nd shift:** Four (4) 10-hour shifts, Monday-Thursday, 12:30 PM - 11:00 PM **Supplemental Company Information:** Gelest, located in Morrisville, PA-conveniently accessible from Interstate 95, Route 1, and the PA/NJ Turnpikes-offers a rewarding career with competitive pay and a comprehensive benefits package, including: + Generous paid time off + Medical, Dental, Vision, and optional supplemental plans for employees and their families + 401(k) with a competitive company match + Company-paid Life Insurance, AD&D, Short-Term Disability, and Long-Term Disability + Eligibility for an annual performance bonus + Company-provided uniforms, work boots, and PPE The salary range for this position is $27.00 (entry level) - $35.00 per hour. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations may influence base pay offered. This salary will be subject to a geographic adjustment (according to a specific city and state), if an authorization is granted to work outside of the location listed in this posting.

Tris Pharma, Inc. (******************* is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology. Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success. Our Quality Control Department is growing and we have an opening for QC Analytical Senior Chemists I. This is a 1st shift position working Monday-Friday in our Monmouth Junction, NJ laboratories. The Senior Quality Control (QC) Analytical Chemist performs analytical testing of raw materials, packaging components, in-process (IP), finished product (FP), stability samples (ST), analytical method transfers and method verifications following analytical methods, United States Pharmacopeia (USP)/National Formulary Chapters, protocols, Standard Operating Procedures (SOPs) under current Good Manufacturing Practices (cGMPs) and company policies. The incumbent is also responsible for training/ mentoring junior chemists, performing laboratory investigations and root cause determinations, initiating and drafting investigations, SOPs and revising analytical methods etc. Collaborating closely with, and under the direct supervision of Team Leads, and QC Managers, she/he develops and demonstrates advanced analytical knowledge and expertise while carrying out laboratory work to support QC activities and performs special projects, as assigned ESSENTIAL FUNCTIONS Carries out responsibilities in accordance with company policies, SOPs and state, federal and local laws Performs testing of raw materials, in-process (IP), finished products (FP) and/or stability sample (ST) samples including dissolution, assay, content/blend uniformity, particle size distribution and other tests according to the analytical methods, USP procedures in a regulated laboratory environment. Performs analytical method transfers and method verifications Analyzes and interprets test results Operates general analytical instruments during raw material, IP and FP testing such as High Pressure Liquid Chromatography (HPLC), Ultra Violet visible spectroscopy (UV/Vis), automatic titration, Infra-Red Spectroscopy (IR), Atomic Absorption (AA), Thin Layer Chromatography (TLC) and dissolution apparatus (Distek) Assists with the identification and troubleshooting of problems with instrumentation and analytical preparations Complies with all company policies and procedures, including safety rules and regulations Adheres to GMPs and current Good Documentation Practices (GDPs) Hands-on experience with analytical instrumentation (i.e., UV, IR, HPLC, GC and/or dissolution instruments) in a pharmaceutical or biotechnology setting Strong hands-on experience performing and interpreting Related Compounds analysis (Impurity analysis) Demonstrated ability to apply good laboratory techniques while maintaining efficiencies required in a QC lab Requirements Minimum education and years of relevant work experience: Senior Chemist I - Bachelors degree in Chemistry or related science field and minimum 4 years lab experience in a cGMP related industry in positions of increasing technical responsibility. Special knowledge or skills needed and/or licenses or certificates required: In-depth, hands on experience with analytical instrumentation (i.e., UV, IR, HPLC, GC and/or dissolution instruments) in a pharmaceutical or biotechnology setting In-depth, hands on experience performing and interpreting analytical results and performing laboratory investigations In-depth, hands on experience with analytical method verifications and method transfers Demonstrated ability to apply good laboratory techniques while maintaining the efficiencies required in QC lab Proficiency with Microsoft Office Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines Planning, organization and time management skills including the ability to support and prioritize multiple projects Fluent in English (verbal and written) Ability and/or experience training and mentoring lower level chemists Ability and willingness to work additional hours as required by business needs Excellent ability to identify and distinguish colors Special knowledge or skills needed and/or licenses or certificates preferred: Experience working with Food and Drug Administration (FDA), current Good Laboratory Practices (cGLPs), cGMPs, and SOPs regulatory rules, regulations and guidelines Proficiency with Empower software Experience with wet chemistry and chemistry related to sampling methods, quality control systems, analysis and documentation practices and procedures Travel requirements: 0% Physical requirements: Laboratory based position Ability to lift up to 30 lbs Ability to use Personal Protective Equipment (PPE) Ability to stand for extended periods of time QC Analytical Senior Chemist I Anticipated Salary range: $85-100k Base salary offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity. Additional benefits: In addition to base salary, all full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups. Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-onsite

Penn Life Sciences is seeking a detail-oriented QC Chemist I to join our team in Langhorne, PA. The QC Chemist I performs routine analytical testing in support of sterile drug product manufacturing, batch release, and stability programs within a cGMP-regulated environment. This role is responsible for generating accurate, compliant laboratory data while executing approved analytical methods and maintaining strict adherence to data integrity and documentation standards. The ideal candidate will have a strong foundation in analytical chemistry, a commitment to quality, and the ability to work effectively within a regulated Quality Control laboratory. This position's responsibilities will include, but not be limited to the following: * Perform routine analytical testing of raw materials, in-process samples, finished drug products, and stability samples using approved QC methods. * Execute wet chemistry and instrumental analyses in compliance with validated methods, specifications, and cGMP requirements. * Accurately document laboratory activities, results, and calculations in laboratory notebooks and electronic systems in accordance with ALCOA+ data integrity principles. * Operate assigned analytical instruments and perform routine checks, calibrations, and basic troubleshooting in accordance with SOPs. * Support stability programs, laboratory investigations (including deviations and OOS events), and analytical data review activities under supervision. * Maintain laboratory organization, sample traceability, and inspection readiness while adhering to all applicable safety and regulatory requirements. We are looking for applicants with: * Bachelor's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a closely related scientific discipline required. * 0-3 years of analytical laboratory experience in a pharmaceutical, biotechnology, or regulated laboratory environment; academic laboratory experience will be considered. * Working knowledge of analytical techniques such as HPLC/UPLC, UV-Vis spectroscopy, pH, Karl Fischer, TOC, dissolution, or particle size analysis. * Understanding of good documentation practices and data integrity expectations within a QC laboratory. * Strong organizational, analytical, and communication skills with a high attention to detail. What we offer: * 401(k) with company match * Health, vision, and dental Insurance * Childcare expense reimbursement * Tuition reimbursement * Annual bonus eligibility * Annual merit increases * Paid Time Off and Flexible Holidays Penn Life Sciences is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status. We encourage you to apply if you feel that you are a match! We look forward to hearing from you.

FLSA Status: Non-exempt/Hourly Schedule: 8:00AM - 4:30PM, Monday - Friday. Occasional 2nd shift work required Are you interested in growing your laboratory career at a fast-paced and expanding environmental testing laboratory? If so, we may have a great role for you; Criterion's Laboratory Analyst (PLM) role primarily performs precise and timely analysis of asbestos bulk samples using polarized light microscopy techniques. This role is responsible for adhering to quality assurance and quality control standards, following Criterion Laboratories' Laboratory Safety Procedures, ensuring a clean work environment, and fostering effective collaboration within a team environment. Essential Duties and Responsibilities: Uses polarized light microscopy to conduct detailed analysis of bulk samples for the identification and quantification of asbestos fibers. Adheres to established analytical protocols and procedures to ensure reliable and reproducible results. Maintains rigorous quality assurance practices to uphold data integrity and compliance with regulatory requirements. Adheres to safety protocols to ensure a secure work environment for all personnel. Maintains cleanliness and organization of the workspace to prevent contamination and ensure optimal working conditions. Collaborates effectively with team members to achieve departmental objectives and contribute to a positive team culture. Participates in training programs and stays abreast of advancements in polarized light microscopy techniques and asbestos analysis methodologies. Requirements Required Knowledge and Experience: At least six (6) months experience performing analyses via polarized light microscopy Familiarity with regulatory requirements and standards pertaining to asbestos analysis is preferred. Strong attention to detail and the ability to maintain accuracy under tight deadlines. Excellent organizational and communication skills, both verbal and written. Demonstrated ability to work both independently and collaboratively within a team environment. Commitment to maintaining high safety standards and promoting a culture of safety in the workplace. Required Education, Certifications, and Licenses: Bachelor's degree in a relevant scientific field (e.g., Geology, Biology, Chemistry, Environmental Science) and/or an equivalent amount of education and experience. Physical and Mental Requirements: Ability to perform microscopy work for extended periods, including sitting or standing. Capability to lift and handle sample containers and equipment (up to 25 pounds).

Why Stokes? Stokes Healthcare is a privately-owned business comprised of three divisions: Stokes Pharmacy (503A pharmacy), Epicur Pharma (503B facility) and STEP labs. The these divisions operate out of separate facilities in Mount Laurel, NJ, following different regulations and are guided by different principles. Stokes Pharmacy was founded in 1975. The pharmacy formulates custom prescription medicines for both humans and animals. The business has grown from a small, hometown operation in Medford, New Jersey, to a respected pharmacy serving the entire U.S., enabled by sophisticated online ordering and overnight shipping capabilities. In 2016, Stokes Healthcare built a world-class facility (which became Epicur Pharma), as a testament to the commitment to providing the highest level of quality. Adding a unique offering to the veterinary industry, Epicur Pharma is an FDA Registered 503B Outsourcing Facility, producing drugs such as Tacrolimus Eyedrops, Buprenorphine Injection and Gabapentin tablets. Epicur follows Current Good Manufacturing Practices (cGMP) which are the same rules and regulations followed by commercial manufacturers. Epicur Pharma is proud to be a pioneer in animal drug standards, offering the largest selection of manufactured drugs that are traditionally compounded. Epicur products are distributed directly to veterinary hospitals from our manufacturing facility and offered through Stokes Pharmacy for individual patient prescriptions. STEP Labs is a GMP-compliant laboratory that delivers accurate, reliable analytical testing for manufactured pharmaceutical products. Equipped with advanced instrumentation and operated under strict regulatory standards, STEP Labs provides comprehensive services in microbiological and chemistry analysis with a focus on quality, data integrity, and timely results. Stokes Healthcare has built a reputation for unwavering quality and superb service by holding fast to the founders' commitment to traditional craftsmanship, combined with today's most advanced knowledge and technologies. In a field where many corporate-owned pharmacies try to compete on price, Stokes has always put safety and quality first because patients' lives depend on it. At Stokes, we offer competitive salaries and a comprehensive benefits package that includes medical, dental and vision coverage, life insurance, Health Reimbursement Account, Flexible Spending Account, 401(K) retirement savings plan with a generous employer match, a bonus program, paid holidays, vacation and personal time, and an excellent working environment. We are conveniently located in Mount Laurel, New Jersey, just minutes from Philadelphia and the NJ shore. Job Title Microbiology Analyst I FLSA Status Non-exempt Job Summary The Microbiology Analyst I is responsible for supporting microbiology procedures, assisting in investigations, and performing routine analysis of raw material and finished product according to established specifications and procedures. Starting at $20/hour based on experience plus twice a year cash bonuses. Essential Duties and Responsibilities include the following. Other duties may be assigned. Assist in method validation for sterility, bioburden, and endotoxin of drug products including, but not limited to, injections, ophthalmic preparations, oral tablets, and oral liquids Perform and/or assist in investigations related to sterility assurance and environmental monitoring Perform routine analysis of finished product and raw material according to established specifications and procedures relating to: Sterility Bioburden Endotoxin AET Growth Promotion Perform atypical particulate inspection on finished product Support sampling and microbiological testing on facility water (WFI, CS, etc.) Review and approve data related to sterility, bioburden, AET, and endotoxin testing of finished product and/or raw materials Perform technical review of test results for completeness and compliance to cGMP to ensure that documentation, controls and traceability are in place to maintain integrity Prepare and review preparation of media, reagents, test samples and equipment as required Prepare microorganisms for identification Understand and demonstrate aseptic technique Maintain laboratory cleanliness and inventory of microbiology supplies Familiar with GxP (Good Manufacturing Practice, Good Laboratory Practice and Good Documentation Practice) Assist with environmental monitoring and microbiological trend reports Required Education and Experience B.S. degree in Microbiology, Biology or related scientific field Minimum 1 year of experience in a microbiology laboratory or pharmaceutical industry Knowledge of good analytical and laboratory techniques, GxP, USP and FDA requirements Knowledge in statistical data analysis and its application to pharmaceutical or compounding processes and quality controls Must exhibit good analytical, writing (GDP), interpersonal and organizational skills Must be able to meet deadlines Must be detail oriented and have multi-tasking capabilities with ability to prioritize Must exhibit strong computer skills including but not limited to software packages supporting statistical data analysis, word processing, and project management programs Must have the ability to work in a fast-paced environment Must exhibit excellent problem resolution skills Must be able to work independently and as part of a team Must exhibit punctuality and low absenteeism Must be able to sit, stand, reach and walk for prolonged periods of time Eligibility Qualifications Must develop knowledge of 21 CFR Part 210 and 211 for cGMP operations Must be capable of wearing all protective gear (gown, hair bonnet, mask, beard cover, gloves, goggles) and maintain good personal hygiene (makeup, jewelry and other cosmetics are prohibited from the production areas) May be necessary to work extended hours as needed May require weekend work Competencies Communication Proficiency Time Management Organizational Skills Problem Solving/Analysis Quality Results Driven Technical Capacity Thoroughness Supervisory Responsibility This position has no supervisory responsibilities. Work Environment This job operates primarily in a controlled laboratory environment. This position requires the use of standard office equipment, and frequent standing and walking. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Able to sit and/or stand 8-10 hours or more per day as needed May sit, stand, stoop, bend and walk intermittently during the day; may be necessary to work extended hours as needed Finger dexterity to operate office equipment required Ability to lift up to twenty (20) pounds on occasion Position Type and Expected Hours of Work This is a full-time Mon-Fri 7AM-3:30PM position. Because of the nature of the business, work schedules may vary at times. Travel No travel is expected for this position. Disclaimer The above job description is intended to describe the general nature and level of work being performed by employees assigned to this job. It is not designed to capture or illustrate a comprehensive list of all responsibilities, duties, and skills required of employees assigned to this job. AAP/EEO Statement Stokes Healthcare is an Equal Employment Opportunity and Affirmative Action Employer. Monday - Friday 7AM to 3:30PM

A primary focus of this role is creating and modifying LIMS test plans to support QC activities while adhering to regulatory and data integrity guidelines. The LIMS Coordinator is responsible for tracking and managing laboratory inventories within the LIMS system and to perform and verify daily verification of laboratory data for accuracy and completeness, ensuring compliance with GxP standards before submission for review. Essential Functions: * Register samples and input relevant test results, instrument data, and laboratory information into the LIMS system as per QC procedures. * Manage laboratory inventories, ensuring timely replenishment and accurate record-keeping within the LIMS system as well as generate and run standard reports from the LIMS system for Laboratory Resource tracking. * Perform and verify daily verification data for accuracy and completeness before submitting it for review. * Create, troubleshoot and modify LIMS Test, worksheets, and test plans as needed to support QC activities. * Train new peers in LIMS operations, including sample manager and resource modules. * Assist QC personnel with sample registration and label generation using the LIMS software Additional Responsibilities: * Performs other functions as required or assigned. * Hands on to follow compendial (USP/EP/BP/JP) procedures for wet chemical tests. * Must understand and apply cGMP requirements applicable to quality control laboratory. * Follow up on sample status and testing progress within the LIMS system. * Participate in continuous improvement initiatives to optimize LIMS functionality and workflows.

Job DescriptionDescription: FLSA Status: Non-exempt/Hourly Schedule: 8:00AM - 4:30PM, Monday - Friday. Occasional 2nd shift work required Are you interested in growing your laboratory career at a fast-paced and expanding environmental testing laboratory? If so, we may have a great role for you; Criterion's Laboratory Analyst (PLM) role primarily performs precise and timely analysis of asbestos bulk samples using polarized light microscopy techniques. This role is responsible for adhering to quality assurance and quality control standards, following Criterion Laboratories' Laboratory Safety Procedures, ensuring a clean work environment, and fostering effective collaboration within a team environment. Essential Duties and Responsibilities: Uses polarized light microscopy to conduct detailed analysis of bulk samples for the identification and quantification of asbestos fibers. Adheres to established analytical protocols and procedures to ensure reliable and reproducible results. Maintains rigorous quality assurance practices to uphold data integrity and compliance with regulatory requirements. Adheres to safety protocols to ensure a secure work environment for all personnel. Maintains cleanliness and organization of the workspace to prevent contamination and ensure optimal working conditions. Collaborates effectively with team members to achieve departmental objectives and contribute to a positive team culture. Participates in training programs and stays abreast of advancements in polarized light microscopy techniques and asbestos analysis methodologies. Requirements: Required Knowledge and Experience: At least six (6) months experience performing analyses via polarized light microscopy Familiarity with regulatory requirements and standards pertaining to asbestos analysis is preferred. Strong attention to detail and the ability to maintain accuracy under tight deadlines. Excellent organizational and communication skills, both verbal and written. Demonstrated ability to work both independently and collaboratively within a team environment. Commitment to maintaining high safety standards and promoting a culture of safety in the workplace. Required Education, Certifications, and Licenses: Bachelor's degree in a relevant scientific field (e.g., Geology, Biology, Chemistry, Environmental Science) and/or an equivalent amount of education and experience. Physical and Mental Requirements: Ability to perform microscopy work for extended periods, including sitting or standing. Capability to lift and handle sample containers and equipment (up to 25 pounds).

SGS is the world's leading Testing, Inspection and Certification company. We operate a network of over 2,700 laboratories and business facilities across 119 countries, supported by a team of 99,250 dedicated professionals. With over 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, safety and compliance. Our brand promise, when you need to be sure , underscores our commitment to reliability, integrity and trust - enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and trusted specialized brands, including Brightsight, Bluesign, Maine Pointe and Nutrasource. SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH0002497458, Reuters SGSN.S, Bloomberg SGSN:SW). Our Dayton, NJ laboratory is looking for a Laboratory Analyst to join their Volatiles team! The Laboratory Analyst prepares and analyzes samples with accuracy and precision in accordance to SGS' analytical SOPs. The Laboratory Analyst works independently and as part of a team to meet daily production targets and ensure hold times and turnaround times are met. The Laboratory Analyst understands and applies basic analytical chemistry principles. The Laboratory Analyst always follows safe laboratory practices and maintains a safe working environment. Job functions: After appropriate training independently prepares and analyzes samples according to SGS' analytical SOPs using instrumentation specific to the department and analytical methodologies Performs routine operation, maintenance, calibration of laboratory instruments/equipment May assist with validation and MDL studies. Assists with investigation, and preparation of responses to client inquiries and CARs. Inputs and maintains technical information as needed to support the laboratory functions/operations. Maintains Laboratory Notebook where applicable. Adheres to internal standards, policies and procedures. Performs other duties as assigned. Qualifications Associate Degree in a Chemistry or similar scientific discipline and 0-2 years of experience in Analytical Chemistry Laboratories OR 3 years of relevant experience (i.e. Sample Prep) (Required) Bachelor's Degree in a Chemistry or similar scientific discipline and 1-2 years of years' relevant experience in Analytical Chemistry Laboratories (Preferred) Basic mathematical and reasoning skills (Required) Experience with Microsoft Office (Excel, Outlook, Word) (Required) Experience with LIMS (Preferred) Ability to lift/carry/push and/or pull upwards of 25 lbs on a frequent basis (Required) Additional Information SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required. This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time. If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call ************ for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.

Under the general direction of the Quality Control Manager, the Quality Control Inspector is responsible for the inspection of products with the objective of meeting quality initiatives in a diverse manufacturing environment. This is a full-time, on-site, non-exempt position. Essential Functions - To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Document Receiving, First-Piece, In-Process and Final Inspections on AS9102 and similar reporting formats Roaming In-Process Inspections on the floor Visual inspections for general workmanship Manually balloon customer prints and create inspection reports, as needed Assist in calibration activities, as needed Prepare documentation packages, as needed Qualifications Experience/Education Able to read and understand blueprints with an emphasis of GD&T Able to use micrometers, dial indicators, optical comparators and height gages for inspecting dimensions as fine as .0002” Able to use attribute gages such as pins, thread gages Able to read and understand Military and other specifications. Have strong verbal and written communication skills Have a keen eye for detail CMM experience a plus Physical ability to stand for long periods Willingness to assist in all other duties as assigned

Job Title - QC Senior Scientist, Stability and Reference Standard Specialist WuXi Biologics is a is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. WuXi Biologics' achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD culture of Passion, Reward, Opportunity, Unity, and Determination. WuXi Biologics offers exciting job opportunities and careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies Job Summary The Senior QC Scientist will lead and manage GMP Quality Control (QC) stability programs and reference standard (RS) lifecycle activities in support of clinical and/or commercial manufacturing. This role provides technical leadership in stability study design, protocol authorship, data review, trending, and client deliverables. The Senior QC Scientist will serve as a subject matter expert (SME) for stability and reference standards, ensuring compliance with GMP and regulatory expectations. Responsibilities: * Lead and manage QC stability study programs, including sample receipt, aliquoting, storage, pulling, distribution, and lifecycle oversight * Author, review, and approve stability study protocols, reports, and related GMP documentation * Perform technical review and approval of stability test results, worksheets, and trend analyses * Ensure timely preparation and delivery of stability reports and Certificates of Analysis (CoAs) to external clients * Monitor, trend, and interpret stability data; identify atypical results and lead investigations or impact assessments as needed * Serve as SME for stability studies and reference standard management during audits, inspections, and client interactions * Oversee reference standard receipt, aliquoting, storage, inventory control, distribution, qualification, and requalification * Author and approve reference standard aliquoting, qualification, and requalification protocols and reports * Ensure reference standards remain qualified and available to support uninterrupted GMP testing * Drive continuous improvement initiatives related to stability, reference standards, and GMP documentation * Coordinate with QC Functional Leads (QCFL) to ensure timely cleanup, reconciliation, and disposal of project-related stability and reference standard samples upon project completion * Support QC inventory management activities, including documentation control and archival * Perform all activities in compliance with applicable safety policies, quality systems, and cGMP requirements * Mentor junior QC staff and provide technical guidance * Perform other duties as assigned by management to support overall QC operations Qualifications: Education and Experience: * Bachelor's degree in chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline (Master's or PhD preferred) * 5+ years of GMP Quality Control experience, with demonstrated expertise in stability studies and/or reference standards * Strong knowledge of GMP regulations, data integrity principles, and ICH stability guidelines * Proven experience authoring and approving GMP protocols, reports, and technical documentation * Excellent technical writing, communication, and time management skills * Ability to independently manage complex projects and multiple priorities in a fast-paced, regulated environment End-to-end management of GMP stability studies, including sample receipt, aliquoting, storage, pulling, distribution, and lifecycle oversight * Authoring, reviewing, and approving stability study protocols, reports, and Certificates of Analysis (CoAs) * Stability data trending, evaluation, and interpretation in alignment with ICH guidelines (e.g., ICH Q1A/Q1E) * Investigation and documentation of atypical, OOS, and OOT results * Reference standard (RS) lifecycle management, including receipt, aliquoting, storage, inventory control, qualification, and requalification * Authoring and approval of RS aliquoting, qualification, and requalification protocols and reports * Technical review and approval of analytical test results, raw data, and worksheets * Strong knowledge of cGMP regulations (21 CFR Parts 210/211) and data integrity principles (ALCOA+) * GMP documentation authoring and review, including SOPs, protocols, reports, deviations, and change controls * Proficiency with LIMS, stability databases, and electronic quality management systems * Advanced data analysis and trending using Microsoft Excel or equivalent tools Preferred Experience: * Experience serving as a subject matter expert during regulatory inspections and client audits * Familiarity with statistical tools or software for stability trending and data evaluation * Experience supporting clinical and/or commercial product stability programs * Experience working in a CDMO or client-facing QC environment * Knowledge of global regulatory expectations (FDA, EMA, ICH) * Experience driving continuous improvement or process optimization initiatives * Familiarity with electronic laboratory notebooks (ELN) and digital documentation systems Communication Skills: * Proficiency in English is required. Excellent communications skills (verbal, written, and presentation skills). Must be able to collaborate with clients and internal, and support cross functions to achieve alignment and work effectively. The pay range for this position is 60,200-96,300 The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

**General Description:** Perform QC Chemistry laboratory activities with a primary focus on capillary electrophoresis techniques to support GMP manufacturing, testing, and release of material, intermediates and finished biological products (monoclonal antibodies) under FDA/EU regulations, applicable International Regulations, and BeOne Medicines' processes and procedures. **Essential Functions of the Job:** + Perform routine and non-routine testing using capillary electrophoresis techniques (e.g., CE-SDS, CZE, ic IEF) in the QC Chemistry laboratory to ensure timely and compliant generation and reporting of in-process, release, and stability test results in support of manufacturing operations. + Review, interpret, and report analytical data in accordance with GMP regulations and internal procedures. + Lead troubleshooting efforts for analytical methods and instrumentation related to CE. + Conduct laboratory investigations, including OOS, Out of Trend, deviations, and invalid assays. + Implement corrective actions and preventive actions (CAPAs). + Participate in transfer and method validation activities, including protocol preparation, protocol execution, and report preparation. + Support routine operations, including but not limited to instrument qualification and maintenance, SOP generation and revision, test record keeping, etc. + Maintain equipment in a qualified and calibrated state, coordinating with metrology or vendors as needed. + Manage inventory of reagents and supplies for the laboratory. + Participate in internal and external GMP audits, as needed. + Train other junior level analysts and new hires on CE instrumentation, GMP practices, and data analysis. + Serving as subject matter expert in one or more areas of required testing. + Interacts with all levels of BeOne employees. + Undertake other duties as required. **Education/Experience Required:** + Bachelor's or above in Chemistry, Biochemistry, or Biotechnology related scientific discipline. + Minimum of 4+ years of working experience in an FDA-regulated biotechnology, pharmaceutical company are required. + Working knowledge and experience with chemistry analytical methods such as HPLC, GC, TOC, Capillary Electrophoresis (CGE-Reduced, CGE-Non-Reduced, and Capillary Zone Electrophoresis), etc. + Familiar with Waters Empower Chromatography Data System. + Familiar with instrument and equipment validation. Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level. Working knowledge with USP/EP and cGMP/EU GMP regulations. + Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level. + Credible and confident communicator (written and verbal) at all levels. + Strong analytical and problem-solving ability. + Hands-on approach, with a 'can do' attitude. + Ability to prioritize, demonstrating good time management skills. + Excellent attention to detail, with the ability to work accurately in a busy and demanding environment. + Self-motivated, with the ability to work proactively using own initiative. + Committed to learning and development. **Computer Skills:** + Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint). **Travel:** + Must be willing to travel approximately 10%. + Ability to work on a computer for extended periods of time. **Global Competencies** : When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. + Collaborative SpiritFosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs Inclusively + Bold IngenuityDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces Change + Driving ExcellenceResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with Clarity All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Tris Pharma, Inc. (******************* is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology. Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success. Our Quality Control Department is growing and we have openings for QC Analytical Chemists at various levels requiring multiple levels of experience. Title and salary commensurate with experience. These are 1st shift position working Monday-Friday in our Monmouth Junction, NJ laboratories. ESSENTIAL FUNCTIONS * Carries out responsibilities in accordance with company policies, SOPs and state, federal and local laws * Performs testing of raw materials, in-process (IP), finished products (FP) and/or stability sample (ST) samples including dissolution, assay, content/blend uniformity, particle size distribution and other tests according to the analytical methods, USP procedures in a regulated laboratory environment. Chemist I also performs analytical method transfers and method verifications * Analyzes and interprets test results * Operates general analytical instruments during raw material, IP and FP testing such as High Pressure Liquid Chromatography (HPLC), Ultra Violet visible spectroscopy (UV/Vis), automatic titration, Infra-Red Spectroscopy (IR), Atomic Absorption (AA), Thin Layer Chromatography (TLC) and dissolution apparatus (Distek) * Assists with the identification and troubleshooting of problems with instrumentation and analytical preparations * Complies with all company policies and procedures, including safety rules and regulations * Adheres to GMPs and current Good Documentation Practices (GDPs) Requirements Associate QC Analytical Chemist - Bachelors degree in Chemistry or related science field and 0-3 years lab experience in a cGMP related industry. * Hands-on experience with analytical instrumentation (i.e., UV, IR, HPLC, GC and/or dissolution instruments) in a pharmaceutical, biotechnology or academic setting Anticipated salary range: $60-65k/yr. QC Analytical Chemist I -Bachelor's Degree in Chemistry or related science field and minimum 1-5 years lab experience in a cGMP related industry. * Hands-on experience with analytical instrumentation (i.e., UV, IR, HPLC, GC and/or dissolution instruments) in a pharmaceutical or biotechnology setting * Strong hands-on experience performing and interpreting Related Compounds analysis (Impurity analysis) * Demonstrated ability to apply good laboratory techniques while maintaining efficiencies required in a QC lab Anticipated salary range: $65-75k/yr.. Chemist II - Bachelors degree in Chemistry or related science field and minimum 2-6 years lab experience in a cGMP related industry. Anticipated salary range: $75-85k/yr. Chemist III - Bachelors degree in Chemistry or related science field and minimum 3-7 years lab experience in a cGMP related industry. Anticipated salary range: $80-90k/yr. Base salary offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity. Additional benefits: In addition to base salary, all full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups. Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-onsite