Quality Control Scientist jobs at AGC Biologics - 14 jobs

Nature and Scope The QC Environmental Monitoring Supervisor works with Environmental Monitoring (EM) Technicians in the activities associated with the manufacture of sterile pharmaceuticals in accordance with company Standard Operating Procedures, cGMPs and all other company policies. The Supervisor will liaise with Production/Compounding Supervisor and Production/Filling Supervisor to ensure the necessary support required by those areas is provided. The Supervisor will oversee the environmental monitoring program and will provide training, guidance, and support to EM Technicians. The Supervisor will coordinate day-to-day activities and the scheduling of EM Technicians and provide input and assistance to other departments as needed. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Under the direction of the Microbiology Manager, supervise the environmental monitoring program and technicians. Responsible for completing and maintaining gown qualification and gown training other staff members (Hilliard). Provide technical and administrative support for all activities related to environmental monitoring, and documentation. Coordinates work projects with the Microbiology Manager to appropriately schedule EM workload to meet department/site requirements. Schedule employees with respect to workload to improve efficiency. As required assist EM technicians in sampling and other environmental monitoring responsibilities. Reviews SOP's as necessary, recommend changes, update and initiate change controls as needed. Review EM paperwork accuracy and completeness and submit to laboratory with plates for incubation in timely fashion. Issue and perform internal investigations, deviations or event reports and ensure the closure of such reports for nonconforming results, in a timely manner Perform and maintain environmental monitoring tracking and trending of data in timely manner and present report to Microbiology Manager. Ensure and check the media and material inventory required for the environmental monitoring program and order supplies as necessary. Closely interact with and support manufacturing and quality personnel in all aspects of environmental monitoring. Assist Manager with timely completion of quarterly and other periodic projects and reports. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications 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, skill and/or ability required. High School Diploma or GED equivalent required. Bachelor's Degree in microbiology, biology or Environmental Sciences or related scientific field preferred. 2 -3 years experience in a pharmaceutical aseptic processing environment, production QA, aseptic testing, medical device or food industry in area of microbiology or a combination required. Previous experience working in environmental monitoring/sampling, writing EM protocols and EM investigations, water sampling, performing PQ of new EM and water systems, and gown qualification program required. Experience with instruments like Met One, APC, air ideal, MAS 100, MAS 100 CG, Lighthouse System, or PMS system is required. Minimum 1-2 years of lead or supervisory experience preferred. Must flexible with working hours dependable and able to work overtime as needed, according to the production schedule. Demonstrate responsibility and accountability working within in a multi-disciplinary team environment. Ability to mentor subordinates. Excellent computer skills and proficient in Microsoft Word, Excel, and Outlook. Excellent communications skills both verbal and written. Needs to be adaptable and maintain the ability to be flexible in an ever changing and challenging environment. Sense of ownership and ability to take responsibility Ability to work overtime as needed. Physical Environment and Requirements Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision. Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. Employee must be able to occasionally lift and/or move up to 25 pounds. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

We are looking to fill a **Scientist 3 -** **Third Shift** **Analytical Chemist Pilot Plant** position working as **a full-time employee of Parexel FSP on long-term assignment** onsite at one of our clients located in **Rahway, NJ** . This position offers full benefits, sick time, 401K, paid holidays, and paid time off. **Description** The Scientist III **Third Shift** - Analytical Chemist Pilot Plant operates and maintains a myriad of analytical instrumentation and other duties as assigned by the client. **Responsibilities** + Experience in routine and real-time testing for high-performance liquid chromatography (HPLC), gas chromatography (GC), ultraviolet (UV) spectroscopy, infrared (IR) spectroscopy, titrations, Karl Fischer (KF) testing, and other wet chemistry methods + Experience in HPLC and GC is required with an interest in expanding the knowledge and background in method development and optimization, validation, data analysis, and sample preparation techniques + Routine use of modern analytical techniques such as HPLC, GC, KF, ultraviolet-visible spectroscopy (UV-VIS), and IR spectroscopy + Comfortable working in a cGMP environment; knowledgeable in various GMP analytical activities, such as documentation procedures, abiding by relevant department SOPs and generation and second scientist review of GMP data + Experience with automated liquid handling systems (Tecan) for high throughput testing + Experience with a myriad of software platforms used in the compilation, processing, and reporting of data, such as Waters Empower, Relational Laboratory Information Management System (RLIMS), Lab X, etc. **Qualifications** + BA/BS (3-5 yrs.) of relevant experience in n chemistry or a related discipline testing lab + MS (1-2 yrs.) of relevant experience in chemistry or a related discipline testing lab **Desired Skills and Experience** + Effective organizational, multi-tasking, and oral/written communications skills + Ability to work under pressure and provide reliable results with quick turnarounds + Consistently deliver high quality and fully compliant results and interact with a diverse customer base daily + Proficient in written and spoken English, is required **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. **Come join us!** \#LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Chemist III. In this role, you will be responsible for executing testing in the Chemistry laboratory at Bedford site in Hikma to include: TOC and Conductivity for WFI, Nitrates via wet methods, identification by FTIR, chromatography analysis, in-process testing by instrumental and wet chemistry techniques, and learning any other new testing capabilities within QC Laboratory Operations. The Chemist III is also responsible for designing test protocol for equipment and method qualification/validation activities. Furthermore, the Chemist III is responsible for writing quality records as needed and documenting all work according to cGMP and cGLP standards. Chemist III is responsible for designing training program for simple to complex Chemistry analysis, and training Chemist I-II, or QC Laboratory Technician to execute routine laboratory testing. Key Responsibilities: * Ensure the laboratory is kept in a safe working environment and in compliance with OSHA and other laboratory safety standards. * Perform TOC and Conductivity for WFI, Nitrates via wet methods, identification by FTIR, Karl Fischer Titration, chromatography analysis, in-process testing by instrumental and wet chemistry techniques. * Participate in introducing new laboratory capabilities within QC Laboratory Operations. * Support the QC Equipment Validation and Calibration Programs for the site. Ensure the systems are robust and compliant with current industry practices and cGMP/cGLP requirements. * With minimal supervision able to qualify laboratory equipment to include authoring and execution of IQ/OQ/PQ protocols and reports. * Conduct testing in support of method validation/verification, method and tech transfer, routine and non-routine testing as part of investigation support. * Serve as point of contact for specified laboratory workflow (e.g. SOPs, test procedures, method/equipment validation, reports, logbooks, laboratory metrics evaluation, etc.) and coordinate activities with Analytical Chemists to meet specified due date. * Review and approve laboratory test data, SOP's, test procedures, method/equipment validation protocols and reports. * Perform laboratory cleaning routinely in preparation of laboratory inspections including regulatory inspections and to ensure good housekeeping is followed. * Able to execute test methods according to regulatory guidance such as USP/EP, using appropriate analysis protocol as guidance. * Provide support in laboratory metrics maintenance, and provide recommendation for continuous improvement in QC Laboratory. Participate in implementation initiatives as needed. * Document all work performed according to applicable Current Good Documentation Practices and cGLP's. * Recommend and initiate preventive and corrective action with regard to product non-conformances and quality system activities as they relate to the Chemistry laboratory activities. * Support activities associated with investigations related to cGLP and cGMP analytical processes for HhHikma Pharmaceuticals. * Independently initiate and author laboratory investigations as needed. * Manage and escalate Quality issues to QC Manager, or appropriate designee. * Train and coach Chemist I-II or QC Laboratory Technician to perform lab testing using applicable OJT documents. * Author OJT, SOPs, testing protocol for Chemistry Analysis at simple to complex level. * Ensure processes and products are in compliance with all local, state, and federal rules and regulations. * Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination. * 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, compendia, USFDA and OSHA. Support the update of methods and instrument qualifications accordingly. * Maintain a clean work environment with regards to cleaning schedules and good housekeeping standards. * Perform additional tasks in relation to quality issues as agreed with the QC Manager. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: * Bachelor Degree in Science or related discipline (chemistry or chemical engineering) * Minimum 5 years of previous working experience at similar position. Prior experience working with quality systems in cGMP environment is preferred * Thorough understanding of CGMP's and FDA requirements for laboratory operations * Proven ability to troubleshoot laboratory instrument issues, and mentor peers to perform specified tasks * Proven ability to understand the anatomy of laboratory systems and provide insight to laboratory management. * Experience with participating in continuous improvement initiatives * Prior experience with project management is preferred. * Strong analytical, attention to detail, and interpersonal skills Compensation: Base Salary: $62,700 to $130,300 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process. What We Offer*: * Annual performance bonus, commission, and share potential * Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute * A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries * 3 personal days (prorated based on hire date) * 11 company paid holidays * Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits * Employee discount program * Wellbeing rewards program * Safety and Quality is a top organizational priority * Career advancement and growth opportunities * Tuition reimbursement * Paid maternity and parental leave * Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. Location: Bedford, OH, US, 44146 Nearest Major Market: Cleveland

Scientist - Container Closure Integrity Development Our company's Device Product & Process Development (DPPD) Team focuses on the design, development, and commercialization of novel biologic/drug/vaccine-device combination products for safe and effective delivery to their intended sites of action. The DPPD Team oversees the development of the device constituent within our pipeline of combination products, spanning various therapeutic areas and routes of administration, including inhalation, implantation, and injection. The DPPD within our Company Research Labs is seeking a talented, self-motivated, and highly collaborative Scientist with knowledge of container closure integrity (CCI) technology and experience with test method development, testing, and method validation for various product images (vials, syringes, cartridges, and injectors) and secondary packaging. The candidate will develop methods for our company's device and combination product pipeline, inclusive of small molecule, biologics, and vaccine products. Key Responsibilities Function as an analytical subject matter expert (SME), troubleshooting and optimizing analytical methods, with a focus on container closure integrity methods Provide technical leadership and mentorship to junior scientists and team members. Develop, validate, and execute feasibility container closure integrity (CCI) studies for complex combination devices & delivery systems Author technical reports and testing protocols Review technical data to ensure compliance with cGMP standards Collaborate with cross-functional teams to ensure successful tech transfer of analytical methods between QC labs Minimum Education Requirement B.S./M.S in Mechanical Engineering, Biomedical Engineering, Industrial & Systems Engineering, Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field/discipline with a minimum of 1 year of relevant work experience in the pharmaceutical, biotechnology, or medical device industries Required Experience | Knowledge | Skills: Relevant analytical execution, development, validation, and/or quality control (QC) for container closure integrity as it pertains to small molecule, biologics, and vaccine products. Ability to learn new techniques, troubleshooting assays, author and review technical documents Excellent organizational skills to manage multiple projects Preferred Experience | Knowledge | Skills: Hands-on experience in container closure integrity technology (CCIT) method development, validation, and troubleshooting for injectable therapeutics. Candidate should be familiar with the following CCIT technologies for this purpose: dye ingress, high voltage leak detection, vacuum and pressure decay, laser headspace analysis Good technical understanding of USP Good technical, communication (oral and written), interpersonal, and teamwork skills. Ability to effectively identify and communicate risks. Experience with other analytical methodologies #eligiblefor ERP AR&D Required Skills: Accountability, Accountability, Analytical Chemistry, Biocompatibility, Biomedical Engineering, Biomedical Sciences, Biopharmaceutical Industry, Biotechnology, Clinical Supply Chain Management, Combination Products, Cross-Functional Planning, Data Analysis, Human Factor Engineering, Innovation, Interpersonal Relationships, Machine Learning (ML), Manufacturing Processes, Materials Science, Mechanical Engineering, Mechanical Testing, Medical Device Technologies, Medical Product Development, Pharmacology, Production Process Development, Prototyping {+ 4 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $87,300.00 - $137,400.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 25% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/28/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Scientist II. This position will be part of the Translational Research and Medicine-Oncology team, with a primary focus on advancing translational research to support oncology programs in clinical trial stages. This individual will be responsible for designing, oversighting, and interpretating translational studies to understand mechanism of action, resistance pathways, and potential new indications. The candidate may also be involved in biomarker analysis to support these translational objectives. **Job Duties and Responsibilities** + Develop hypotheses by integrating insights from scientific literature, preclinical and clinical data + Design experiments to support identification of mechanism of action, resistance mechanisms, and potential indications + Manage translational research and biomarker studies conducted with CROs and academic investigators to ensure high-quality, timely delivery of data + Maintain organized, detailed logs of studies and data to ensure accuracy, reproducibility, and compliance with regulatory standards + Present data and insights in internal meetings and cross-functional program team discussions **Key Core Competencies** + Scientific curiosity with ability to generate and test hypotheses that inform drug development + Excellent problem-solving and critical-thinking skills to interpret complex data + Strong organizational skills and attention to detail in managing studies, data, and documentation + Strong project management and vendor oversight skills + Adaptability and resilience in a fast-paced, evolving research environment **Education and Experience** + PhD degree in a related field of science (Biology, Biochemistry, Molecular & Cellular biology, Cancer Biology, Immunology) + 1-3 years of postdoctoral or industry research experience + Familiarity with oncology research preferred + Experience with common biomarker platforms (e.g. NGS, flow cytometry, IHC) preferred The base salary range for this role is $102,000 to $127,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Nature and Scope The QC Microbiology Supervisor works with Microbiologists, Microbiology Technicians and Microbiology Assistants in the activities associated with the Microbiological testing required in support of sterile pharmaceuticals in accordance with company Standard Operating Procedures, cGMPs and all other company policies. The incumbent will act as a company associate in ensuring the Microbiology laboratory meets schedules and forecasts in a timely, efficient manner, while maintaining neat and accurate records. The Microbiology Supervisor will oversee the day-to-day functions of the Microbiological laboratory providing training, guidance, and support as required. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Ensure all work is performed and documented in accordance with existing company policies, procedures, and Current Good Manufacturing Practices, health, and safety requirements. Under the direction of the Microbiology Manager, supervise the Microbiology support testing team functions, Microbiologists, and technicians. Provide technical and administrative support for all activities related to Microbiological testing and documentation. Coordinates/conduct projects and special studies with the Microbiology Manager to meet department/site requirements. Schedule employees with respect to workload to improve efficiency. Conduct laboratory testing for customer complaints and internal investigations. Ensure all microbiological documentation is complete, neat, accurate and completed in timely manner. Issue and perform investigations, deviations, or event reports, CAPAs and ensure the closure in a timely manner. Train, provide technical assistance and guidance to microbiologists and technicians. Reviews, revise and prepares SOP's and/or Protocols as necessary, recommend changes, update, and initiate change controls. Ensure tracking of support testing and release the results in timely manner. Review environmental monitoring tracking and trending of data in timely manner and present report to Microbiology Manager. Perform GAP Assessment on Microbiology procedures and keep them in compliance. Ensure and maintain the inventory required for the Microbiology laboratory and order supplies. Ensure that the laboratory is clean and sanitized. Assist Manager with timely completion of quarterly and other periodic projects and reports. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications 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, skill and/or ability required. Bachelor's degree in microbiology, Biology, or equivalent Life Science curriculum required. Minimum of 5 years of experience working in a cGMP compliant pharmaceutical Microbiology Laboratory. Minimum 2 years of supervisory or lead experience required. Experience with Water testing, Sterility suitability & testing of the finished products and Raw Materials, Bacterial Endotoxin Suitability & testing, Container Closure Testing, filter integrity testing, Microbial Limit Testing and Microbial Enumeration testing. Experience with Analytical Instruments such as Vitek, Balances, pH Meter, autoclave, BET, Sterility Isolators, Active Air Samplers, Particle Counters, LIMS, BSC, Incubators, etc. Experience with Trackwise for Deviations, CAPAs and Veeva CR process. Ability to lead a microbiology group towards department target goals. Experience with Microbiologist I, Microbiologist II, Microbiologist III and Microbiologist Lead duties and responsibilities. Demonstrate responsibility and accountability working within in a multi-disciplinary team environment ability to mentor subordinates. Organized individual with strong attention to detail. Excellent computer skills and proficient in Microsoft office software. Excellent communications skills both verbal and written. Needs to be adaptable and maintain the ability to be flexible in an ever changing and challenging environment. Sense of ownership and ability to take responsibility. Ability to work overtime, weekends and holidays as needed. Physical Environment and Requirements Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision. Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. Employee must be able to occasionally lift and/or move up to 25 pounds. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

**Scientist - Container Closure Integrity Development** Our company's Device Product & Process Development (DPPD) Team focuses on the design, development, and commercialization of novel biologic/drug/vaccine-device combination products for safe and effective delivery to their intended sites of action. The DPPD Team oversees the development of the device constituent within our pipeline of combination products, spanning various therapeutic areas and routes of administration, including inhalation, implantation, and injection. The DPPD within our Company Research Labs is seeking a talented, self-motivated, and highly collaborative Scientist with knowledge of container closure integrity (CCI) technology and experience with test method development, testing, and method validation for various product images (vials, syringes, cartridges, and injectors) and secondary packaging. The candidate will develop methods for our company's device and combination product pipeline, inclusive of small molecule, biologics, and vaccine products. **Key Responsibilities** + Function as an analytical subject matter expert (SME), troubleshooting and optimizing analytical methods, with a focus on container closure integrity methods + Provide technical leadership and mentorship to junior scientists and team members. + Develop, validate, and execute feasibility container closure integrity (CCI) studies for complex combination devices & delivery systems + Author technical reports and testing protocols + Review technical data to ensure compliance with cGMP standards + Collaborate with cross-functional teams to ensure successful tech transfer of analytical methods between QC labs **Minimum Education Requirement** + B.S./M.S in Mechanical Engineering, Biomedical Engineering, Industrial & Systems Engineering, Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field/discipline with a minimum of 1 year of relevant work experience in the pharmaceutical, biotechnology, or medical device industries **Required** **Experience | Knowledge | Skills:** + Relevant analytical execution, development, validation, and/or quality control (QC) for container closure integrity as it pertains to small molecule, biologics, and vaccine products. + Ability to learn new techniques, troubleshooting assays, author and review technical documents + Excellent organizational skills to manage multiple projects **Preferred Experience | Knowledge | Skills:** + Hands-on experience in container closure integrity technology (CCIT) method development, validation, and troubleshooting for injectable therapeutics. Candidate should be familiar with the following CCIT technologies for this purpose: dye ingress, high voltage leak detection, vacuum and pressure decay, laser headspace analysis + Good technical understanding of USP + Good technical, communication (oral and written), interpersonal, and teamwork skills. + Ability to effectively identify and communicate risks. + Experience with other analytical methodologies \#eligiblefor ERP AR&D **Required Skills:** Accountability, Accountability, Analytical Chemistry, Biocompatibility, Biomedical Engineering, Biomedical Sciences, Biopharmaceutical Industry, Biotechnology, Clinical Supply Chain Management, Combination Products, Cross-Functional Planning, Data Analysis, Human Factor Engineering, Innovation, Interpersonal Relationships, Machine Learning (ML), Manufacturing Processes, Materials Science, Mechanical Engineering, Mechanical Testing, Medical Device Technologies, Medical Product Development, Pharmacology, Production Process Development, Prototyping {+ 4 more} **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $87,300.00 - $137,400.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 25% **Flexible Work Arrangements:** Not Applicable **Shift:** Not Indicated **Valid Driving License:** No **Hazardous Material(s):** n/a **Job Posting End Date:** 01/28/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R381483

Do you have a passion for Artificial Intelligence (AI) and are looking to make a difference in how the latest clinical trials progress into the market? Do you have a background in data science and/or computer science with experience working with AI tools for interactive AI applications across various IT systems? If so, we have an exciting opportunity for you to help take the reins of a groundbreaking project at Medpace. We are currently seeking a professional with direct experience interacting with artificial intelligence (AI) tools such as NLP, LLM, IA etc. This professional will be expected to lead the programming and fine-tuning of various AI tools and help IT teams to implement them into new applications. This professional will work collaboratively across the organization with multiple teams to help design the roadmap for how AI can improve efficiency of company processes and provide insights and assistance to users. Applicants should have sufficient technical skills to help lead these types of AI projects independently and to train technical teams for support. Responsibilities * Lead the ideation, research, PoC programming and then support programming and fine-tuning of various AI tools with the IT team to implement them into new applications; * Lead the identification and development of AI tools such as NLP, LLM, and IA; * Design, develop, and implement artificial intelligence (AI) models and algorithms for various applications; * Work on a broad set of tasks encompassing various forms of machine intelligence (e.g., machine learning, algorithms, neural networks, computer vision, robotics) to develop AI models for specific applications; * Train AI models using various algorithms and techniques, optimizing for accuracy, efficiency, and interpretability; * Deploy AI solutions into production environments, ensuring scalability, reliability, and integration with existing systems; * Continuously improve models based on feedback and performance metrics; * Lead AI team activities in educating Medpace AI users in the best development, training and deployment of AI tools including various forms of machine intelligence; and * Participate in educating, training and development of more junior team members. Qualifications * PhD in Artificial Intelligence, Computer or Data Science, or related field; * Preferably several years of experience working with different AI capabilities and showcasing your passion both at work and outside work in the development of highly complex AI models (NLP, LLMs, Deep learning etc); * Technical proficiency in programming languages and frameworks commonly used in NLP and AI (e.g., Python, TensorFlow, PyTorch); * Excellent communication skills to collaborate effectively with cross-functional teams; * Demonstrated ability to lead projects independently and mentor technical teams; * A passion for staying up-to-date with the latest advancements in NLP and AI technologies; and * Analytical thinker with great attention to detail. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. This position provides high quality statistical programming analysis and reporting and regulatory submission deliverables for Real World Evidence (RWE) projects across our Company's Biostatistics and Research Decision Sciences (BARDS) group. The statistical programmer utilizes multiple programming languages including SAS, SQL and R to manipulate electronic healthcare databases to discover disease prevalence and risk factors, describe drug utilization patterns and disease progression, support market research, and answer clinical development questions. In this role, the statistical programmer will work with other programming colleagues to gather and interpret user requirements from BARDS epidemiologists, retrieve the required data from electronic healthcare databases, and develop disease cohorts, analytical datasets, tables and figures under the guidance of a senior level programmer. The statistical programmer will also perform validation activities following departmental SOPs. Position Qualifications: Education Minimum Requirement: BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, Data Science or related field plus 2-4 years programming experience in SAS and/or R MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, Data Science or related field plus programming experience in SAS and/or R. Department Required Skills and Experience: Effective interpersonal skills and ability to negotiate and collaborate effectively Effective written, oral, and presentation skills Completes tasks independently, manages timelines Position Specific Required Skills and Experience: Experience in SAS and\or R programming including data manipulation, or statistical analysis, or graphics or tabulation techniques Designs and develops programming algorithms Ability to quickly and effectively learn new programming techniques and data structures Takes direction effectively and completes programming tasks under the guidance of a senior programmer at a project level Demonstrated success in the assurance of quality work Willingness to work in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements Strategic thinking - ability to turn strategy into tactical activities Team oriented with demonstrated history of teamwork and collaboration, enjoying diversity, respect and integrity An interest to advance career by investing in development activities and taking on tasks with increasing levels of challenge and responsibility Preferred Experience and Skills: An understanding of observational research or statistical terminology and concepts Ability to comprehend analysis plans which may describe observational research and statistical methodology to be programmed Knowledge or experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings) Knowledge or experience in design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices SAS programming experience including data steps, procedures, SAS/MACRO; R programming experience including development of functions and packages Knowledge of efficiency techniques for manipulating large databases including complex data preprocessing, filtering and manipulation; knowledge of sample strategies for large databases Experience with other programming languages or scripting such Python Unix operating system experience; SQL experience; systems and database experience Working knowledge of reporting processes (SOPs) and software development life cycle (SDLC) Experience working with coding systems such as ICD-9, ICD-10, NDC, and LOINC Ability and interest to work across cultures and geographies Experience working in a regulated environment Experience in process improvement Knowledge of the concepts of data standards such as CDISC ADaM or Common Data Model Ability to anticipate stakeholder requirements · eligiblefor ERP SPjobs BARDS2020 VETJOBS EBRG Required Skills: Data Management, Data Modeling, Numerical Analysis, Stakeholder Relationship Management, Waterfall Model Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $96,200.00 - $151,400.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/28/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

We are looking to fill a microbiologist position (environmental monitoring focus) working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients in Rahway, NJ. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer sponsorship. **Qualifications** + Bachelor's degree required; concentration in a scientific or applied discipline strongly preferred + A minimum of two years of experience in pharmaceutical microbiology related position required (occasional overtime) **Required Skills and Experience** + Experience in working in a GMP Pharmaceutical environment with specific experience environmental monitoring + Proven technical writing skills (SOPs, protocols) **Responsibilities** ENVIRONMENTAL MONITORING + Proficiency in the pharmaceutical microbiology laboratory workflow for EM collection and testing, reporting and trending + Sampling EM rooms, surface and air + Collection and testing water samples + Weekly water trends- visually to be able to report back to the source area + Equipment responsibilities with metrology oversight, automation, etc + MODA USE + Responsible for writing annual reports + Responsible for writing trend reports + Able to clearly interpret adverse vs desirable data + Mold investigations and studies + PSIM work + Biological indicator analysis and certification + Disinfection studies where appropriate + Critical thinking with data MICROBIOLOGICAL PRODUCT ANALYSIS + Analyze samples and compile meaningful data + Perform Investigations and prepare/respond to CAPA + Review, revise Test Procedures/Standard Operating Procedures + Ad Hoc work + Rotational on-call assignments for responding to alarms MICROBIOLOGICAL ACTIVITIES Include (but not limited to): + Receive, verify & Log in samples + Return templates and shipping paperwork when and where appropriate + Prepare and ship materials offsite for ID/testing (when applicable) + Stock culture management and quality control of same + Biological indicator management + Bioburden testing + Water sampling + Microbiological media management and quality control of same + Sterilization activities + Research experiments as deemed appropriate by client management + Method Validation/Qualification + Other microbiological activities CALIBRATIONS: + Execute "Before-Use" calibrations prior to performing testing + Review calibration data within the ELN + Prepare and submit equipment for calibrations (offsite or onsite) + Complete calibration/PM paperwork GMP ACTIVITIES: + Prepare GMP documentation as requested by management + Perform laboratory sanitizations and ensure cleanliness of laboratory workspace + Perform equipment sanitizations (incubators / hoods / refrigerators) + Purchase supplies (GMP) + Prepare and send documents to Records Center INVESTIGATIONS: + Initiate, facilitate, and perform Investigations and NOEs (Notice of Event-NOE) for Environmental samples [NOE for Microbiological Environment Event (MEN)] + Inform management of non-conforming events AUDITS: + Participate in audits (Regulatory, In-house, Corporate) + Participate in self-inspections and safety inspections + Retrieve data when requested by Microbiology management TRAINING: + Complete assigned training when required + Ensure training is complete prior to performing tasks + The role is intended to be a 40-hour-per-week position. **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. Come join us! \#LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Be a part of the legacy: Postdoctoral Research Fellow Program Our Research Laboratories' Postdoctoral Research Fellow Program aims to be a best-in-industry program for industrial postdoctoral researchers, designed to provide you with an academic focus in a commercial environment. With the resources, reach, and expertise of a large pharmaceutical company, postdoctoral researchers will be positioned to excel in an institution committed to breakthrough innovation in research and discovery. Position summary The Precision Genetics group in the Data, AI and Genome Sciences Department seeks a Postdoctoral Research Fellow to drive computational work on a translational project developing a reusable multi-omics and AI/ML framework to discover mechanism-based companion diagnostic (CDx) biomarkers that predict treatment response in autoimmune diseases. The role combines organoid drug-profiling, multi-modal functional assays, single-cell and spatial transcriptomics, and development of interpretable AI/ML models to identify predictive biomarkers and benchmark model fidelity against clinical datasets. Key responsibilities Analyze multi-modal pre- and post-treatment readouts, including epithelial barrier assays, cytokine profiling, single-cell RNA-seq, and spatial transcriptomics (e.g., 10x Visium, GeoMx, Stereo-seq). Develop, benchmark, and maintain reproducible computational pipelines for bulk, single-cell, and spatial transcriptomics data processing (QC, alignment, cell-type annotation, and spatial analyses). Implement multi-omic integration strategies combining spatial transcriptomics, single-cell expression, cell composition estimates, and genotype/SNP data. Design, train, evaluate, and interpret AI/ML models (supervised and unsupervised) for predictive biomarker discovery and companion diagnostic candidate prioritization, emphasizing feature selection and model explainability. Document methods, workflows, and results thoroughly; prepare and contribute to manuscripts, conference presentations, and IP/translation activities as appropriate. Collaborate effectively with wet-lab scientists, clinicians, and computational colleagues, present results to the team and stakeholders. Required qualifications Ph.D. or completion within 6 months in Computational Biology, Bioinformatics, Systems Biology, Genomics, Biomedical Engineering, Computer Science (with bioinformatics experience), or related discipline. Demonstrated experience analyzing single-cell and/or spatial transcriptomics data processing, clustering, differential expression, spatial analysis). Proven ability to apply advanced AI/ML to biomedical data for biomarker discovery/patient stratification, using rigorous evaluation and reproducible Python/R pipelines Strong programming skills in Python and/or R and familiarity with relevant libraries/tools (Seurat, Scanpy, Squidpy, Bioconductor, scikit-learn, PyTorch/TensorFlow). Strong statistical skills and experience working with high-dimensional biological data; excellent data visualization abilities. Excellent written and oral communication skills and evidence of productivity appropriate to career stage (publications, code repositories, or preprints). Proven ability to work collaboratively in interdisciplinary teams and manage multiple projects concurrently. Preferred qualifications Hands-on experience generating single-cell or spatial transcriptomics datasets from organoid models (10x Visium, Nanostring GeoMx, MERFISH, Stereo-seq) or close collaboration with teams that generate such data. Familiarity with genotype/SNP data processing and integration (GWAS summary statistics, imputation, genotype-phenotype association analyses). Experience with cloud platforms (AWS) and high-performance computing (HPC) environments. Prior experience in translational biomarker discovery or developing clinically oriented predictive models. postdoctoralopportunities Required Skills: Bioinformatics, Computational Analysis, Datasets, Large Scale Data Processing, Scientific Writing, Single-Cell Genomics, Wet Lab Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 02/6/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. This position provides high quality statistical programming analysis and reporting and regulatory submission deliverables for Real World Evidence (RWE) projects across our Company's Biostatistics and Research Decision Sciences (BARDS) group. The statistical programmer utilizes multiple programming languages including SAS, SQL and R to manipulate electronic healthcare databases to discover disease prevalence and risk factors, describe drug utilization patterns and disease progression, support market research, and answer clinical development questions. In this role, the statistical programmer will work with other programming colleagues to gather and interpret user requirements from BARDS epidemiologists, retrieve the required data from electronic healthcare databases, and develop disease cohorts, analytical datasets, tables and figures under the guidance of a senior level programmer. The statistical programmer will also perform validation activities following departmental SOPs. **Position Qualifications** **:** **Education Minimum Requirement:** + BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, Data Science or related field plus 2-4 years programming experience in SAS and/or R + MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, Data Science or related field plus programming experience in SAS and/or R. **Department Required Skills and Experience:** + Effective interpersonal skills and ability to negotiate and collaborate effectively + Effective written, oral, and presentation skills + Completes tasks independently, manages timelines **Position Specific Required Skills and Experience:** + Experience in SAS and\or R programming including data manipulation, or statistical analysis, or graphics or tabulation techniques + Designs and develops programming algorithms + Ability to quickly and effectively learn new programming techniques and data structures + Takes direction effectively and completes programming tasks under the guidance of a senior programmer at a project level + Demonstrated success in the assurance of quality work + Willingness to work in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements + Strategic thinking - ability to turn strategy into tactical activities + Team oriented with demonstrated history of teamwork and collaboration, enjoying diversity, respect and integrity + An interest to advance career by investing in development activities and taking on tasks with increasing levels of challenge and responsibility **Preferred Experience and Skills:** + An understanding of observational research or statistical terminology and concepts + Ability to comprehend analysis plans which may describe observational research and statistical methodology to be programmed + Knowledge or experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings) + Knowledge or experience in design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices + SAS programming experience including data steps, procedures, SAS/MACRO; R programming experience including development of functions and packages + Knowledge of efficiency techniques for manipulating large databases including complex data preprocessing, filtering and manipulation; knowledge of sample strategies for large databases + Experience with other programming languages or scripting such Python + Unix operating system experience; SQL experience; systems and database experience + Working knowledge of reporting processes (SOPs) and software development life cycle (SDLC) + Experience working with coding systems such as ICD-9, ICD-10, NDC, and LOINC + Ability and interest to work across cultures and geographies + Experience working in a regulated environment + Experience in process improvement + Knowledge of the concepts of data standards such as CDISC ADaM or Common Data Model + Ability to anticipate stakeholder requirements · eligiblefor ERP SPjobs BARDS2020 VETJOBS EBRG **Required Skills:** Data Management, Data Modeling, Numerical Analysis, Stakeholder Relationship Management, Waterfall Model **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $96,200.00 - $151,400.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** Domestic **VISA Sponsorship:** Yes **Travel Requirements:** 10% **Flexible Work Arrangements:** Hybrid **Shift:** Not Indicated **Valid Driving License:** No **Hazardous Material(s):** n/a **Job Posting End Date:** 01/28/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R381992

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. This position provides high quality statistical programming analysis and reporting and regulatory submission deliverables for Real World Evidence (RWE) projects across our Company's Biostatistics and Research Decision Sciences (BARDS) group. The statistical programmer utilizes multiple programming languages including SAS, SQL and R to manipulate electronic healthcare databases to discover disease prevalence and risk factors, describe drug utilization patterns and disease progression, support market research, and answer clinical development questions. In this role, the statistical programmer will work with other programming colleagues to gather and interpret user requirements from BARDS epidemiologists, retrieve the required data from electronic healthcare databases, and develop disease cohorts, analytical datasets, tables and figures under the guidance of a senior level programmer. The statistical programmer will also perform validation activities following departmental SOPs. **Position Qualifications** **:** **Education Minimum Requirement:** + BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, Data Science or related field plus 2-4 years programming experience in SAS and/or R + MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, Data Science or related field plus programming experience in SAS and/or R. **Department Required Skills and Experience:** + Effective interpersonal skills and ability to negotiate and collaborate effectively + Effective written, oral, and presentation skills + Completes tasks independently, manages timelines **Position Specific Required Skills and Experience:** + Experience in SAS and\or R programming including data manipulation, or statistical analysis, or graphics or tabulation techniques + Designs and develops programming algorithms + Ability to quickly and effectively learn new programming techniques and data structures + Takes direction effectively and completes programming tasks under the guidance of a senior programmer at a project level + Demonstrated success in the assurance of quality work + Willingness to work in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements + Strategic thinking - ability to turn strategy into tactical activities + Team oriented with demonstrated history of teamwork and collaboration, enjoying diversity, respect and integrity + An interest to advance career by investing in development activities and taking on tasks with increasing levels of challenge and responsibility **Preferred Experience and Skills:** + An understanding of observational research or statistical terminology and concepts + Ability to comprehend analysis plans which may describe observational research and statistical methodology to be programmed + Knowledge or experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings) + Knowledge or experience in design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices + SAS programming experience including data steps, procedures, SAS/MACRO; R programming experience including development of functions and packages + Knowledge of efficiency techniques for manipulating large databases including complex data preprocessing, filtering and manipulation; knowledge of sample strategies for large databases + Experience with other programming languages or scripting such Python + Unix operating system experience; SQL experience; systems and database experience + Working knowledge of reporting processes (SOPs) and software development life cycle (SDLC) + Experience working with coding systems such as ICD-9, ICD-10, NDC, and LOINC + Ability and interest to work across cultures and geographies + Experience working in a regulated environment + Experience in process improvement + Knowledge of the concepts of data standards such as CDISC ADaM or Common Data Model + Ability to anticipate stakeholder requirements · eligiblefor ERP SPjobs BARDS2020 VETJOBS EBRG **Required Skills:** Data Management, Data Modeling, Numerical Analysis, Stakeholder Relationship Management, Waterfall Model **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $96,200.00 - $151,400.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** Domestic **VISA Sponsorship:** Yes **Travel Requirements:** 10% **Flexible Work Arrangements:** Hybrid **Shift:** Not Indicated **Valid Driving License:** No **Hazardous Material(s):** n/a **Job Posting End Date:** 01/28/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R381992