Laboratory Analyst jobs at Eurofins

The Pharma Method Development and Validation Chemist will perform studies for the development of immediate release and controlled release tablet and capsules dosage formulations, topical formulations (creams and gels) and liquid formulations. Develop methods per ICH/USP requirements for excipient, API and final formulations of solid oral dosages form. Writes method protocols for full validation and verifications to USP methods. Does forced degradation studies. Can make a method from scratch and or improves such by fine tuning the method parameters to meet USP or vendor specifications. Works with QC to due testing . However, main job is taking a tech pack and making method validation protocols for submitting into ANDA . Perform testing on raw materials and in-process and finished dosage forms. Write technical documents including laboratory notebooks, batch records, project summaries, development reports, sampling and testing protocols, planned deviation reports, incident reports, and change control forms. Maintain technical documents in the formulation development department. Calibrate in-process testing equipment, interpret and analyze experimental data, identify the next steps to be taken and perform scale-up and technology transfers of formulations from research and development to the submission/clinical to production/commercial scale batches. Direct the work of scientists and technicians in the formulation department, reviewing their laboratory notebooks, batch records, project summaries, product development reports and standard operating procedures. Attend project meetings. Manage R&D projects and report project progress to the project manager. Communicate the status of various batches to the production, QA, RA and QC departments and to clients, as needed. Assist in FDA filings. Review project contracts. Assist IT in development and implementation of the database system. Bachelor's Degree in Chemistry required. Proficiency in computer usage and Microsoft Office required. Job Type: Full-time Required experience: Chemistry: 4 years

Company Information: Tedor is a privately held pharmaceutical company a CDMO that develops drug product for both innovator and established companies. We are customer-focused oral solid dose CDMO with a strong track record of meeting aggressive development and commercialization timelines Over the past 20 years we have helped customers received many product approvals.We attribute this success to our company-wide focus on quality, customer service, and meeting timelines. Everything we do, and how we do it, is focused on helping our clients to achieve their product objectives. Position Summary: The role of the Quality Control Chemist is a vital role that is essential to manage and execute the quality testing that is required for drug substance on the commercial market. Quality Control Chemist will also be responsible for method validation and release & stability testing for clinical trial and commercial drug products; therefore, verifying all products and/or substances meet acceptable quality standards and that they are in accordance with the company's policies & procedures, FDA policies & procedures, and any applicable cGMP requirements. Additionally, ensuring compliance, accuracy, and timeliness of specified testing processes, environmental monitoring, data review, data analysis, and data trending of all raw materials, finished formulations, stability samples, client-based & company-based projects, method development, equipment calibrations/qualification and/or transfers, and cleaning study qualifications are all essential responsibilities. Quality Control Chemists are expected to collaborate with QC Analysts and Development Chemists while performing the QC Chemist position. This is a full-time, non-exempt position that includes a competitive salary, and strong benefits. The Quality Control Chemist will report Directly to the Quality Control Manager or Director. Position Description: Responsibilities Head the collaboration between QC and Developmental Chemists personnel but also cross department collaboration regarding drug product development, commercial operations, commercial manufacturing, Quality Assurance, and Analytical Development. Evaluation of QC laboratory operational execution and resources needed to preform tests. Generate, review and revise QC GMP documentation (SOPs, protocols, technical reports, specifications, etc.) as needed. Revise and manage technical transfer of methods from internal labs for raw material analysis, in-process testing, as well as API and Drug Product testing under supervision of the Director. Review and report all QC data and generate Certificates of Analysis. Monitor and trend QC data generated by internal and contract testing labs. Initiate ICH stability study protocols, execute and generate of interim reports. Manage, write, and review Out of Specification/Atypical results/Out of Trend investigations, deviations, and CAPAs. Investigate and troubleshoot method issues. Review relevant sections of regulatory filings. Monitor calibration schedule. Contact vendors. Schedule visits for PM/Calib and repairs. Assist vendors on site. Coordinate stability operation activities and ensure quality products and systems. Determine stability sample requirements, develop stability protocols and oversee execution of stability protocols. Monitor stability chambers and chart recorders on a daily basis to confirm environmental conditions for acceptance with established specifications. Prepare stability data graphs to estimate expiration dates and verify product shelf life. Evaluate stability trends and prepare reports. Equipment Qualification, including data integrity program. Position Type & Expected Hours of Work This is a full-time, non-exempt position requiring a minimum of 40 hours of work per week, Monday through Thursday and some in person Friday's.. Some responsibilities may require work outside of normal office hours. Work Environment Level 2: Office Environment and Laboratory Environment The work environment characteristics described here are representative of those a teammate encounters while performing the essential functions of this role and within the daily operations of a professional office environment. Reasonable accommodations may be made to enable employees with disabilities to perform essential functions. This job operates in a professional office environment, as well as the laboratory environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, as well as standard laboratory equipment and instrumentation. An employee in this role will be exposed to standard hazards founds within a laboratory environment such as chemicals; bloodborne pathogens; fumes; select agents; confined spaces. Proper laboratory attire and safety gear such as protective eyewear; laboratory coat; appropriate gloves must be observed. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. This role requires standard physical demands within a standard office and laboratory environment where sustained periods of standing, sitting, or walking will be part of an employee's daily routine, whether they are at their desk or in the laboratory. While performing the duties of this role, an employee is regularly required to talk or hear; use hands or fingers to handle or feel; reach with arms; bend or stoop; climb stairs; crawl or crouch; kneel; push or pull; type on a keyboard; use a computer mouse. Lastly, an employee must be able to lift ten (10) pounds. Travel Limited travel is expected for this position. Required Education & Experience B.S. in Chemistry or Pharmaceutical Science, or other related discipline such as life sciences, drug product development. Five to Seven (3 - 5) years of work/laboratory experience in the pharmaceutical industry, Quality Control (QC). 3 + years of experience in a regulated manufacturing or QC laboratory environment of analytical methods for pharmaceutical products Experience in QC testing of pharmaceutical and/or biologic products in a GMP environment. Solid understanding of GMP compliance, Quality Control CMC requirements for ANDAs, and other regulatory filings Excellent interpersonal, verbal, and written communication skills Demonstrated collaborative skills and prior leadership roles or positions Comfortable in a fast-paced, small company environment, ability to adjust workload based upon changing priorities Technical knowledge Strong Microsoft Word, Excel, and Office skills Experience in contracting testing laboratories Preferred Experience & Experience BS in relevant life science, scientific, or engineering discipline Three to Five (3 - 5) years of work/laboratory experience in the pharmaceutical industry, Quality Control (QC). Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. All duties, responsibilities, and activities may be subject to change at any time with or without notice. EEO Statement: Tedor Pharma, Inc. is proud to be an Equal Employment Opportunity and Affirmative Action employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminated based upon race, religion, color, marital status, national origin, gender, sexual orientation, gender identity, gender expression, age, status as a protected veteran, ancestry, medical condition, pregnancy, genetic information, status as an individual with any mental and/or physical disabilities, or any other status protected under federal, state, or local law.

Kelly is currently seeking an Analytics & Data Science Laboratory Technician for a long-term opportunity in Midland, Michigan! The Laboratory Technician supports customer fluid analysis by conducting laboratory analyses, as needed, which provide critical data. The Lab Tech also prepares samples, performs preventive maintenance of laboratory instrumentation and uses data systems to acquire data, and reports results to the client. This role requires established basic laboratory skills to perform a range of routine lab activities using existing standard operating procedures and or analytical scientific methods. Do you have what it takes?! Primary Responsibilities:Develop a thorough understanding of the operations of laboratory equipment and methods. This includes refractive index, gas chromatography, liquid chromatography, ion chromatography, inductively coupled plasma atomic emission spectroscopy, titration for pH and reserve alkalinity. Responsible for managing, then safely executing laboratory work requests, maintaining and running relevant laboratory apparatus and testing equipment and documenting data. Understands the value of high quality data and utilizes good laboratory techniques and practices to generate such data. Accurately and reliably records readings and observations using relevant equipment and instruments. Organizes and prepares data tables and charts to present data collected in studies supported. Independently interprets data and promptly communicates unexpected results to the team. Responsible for calibration/standardization, safe operation, and routine maintenance of simple and complex instruments, and systems. Troubleshoots faulty equipment effects repairs or initiates repair processes as appropriate. Evaluates and revises procedures to improve efficiency, effectiveness, or safety. Makes proposals and recommendations for equipment/systems modifications. Promptly and effectively communicates issues to lab owner in order to enable or accelerate problem resolution. Actively participate in work group team meetings to address safety, process improvement, problem solving, and other work group, department, and functional topics. Takes personal responsibility for Environment, Health and Safety (EH&S) compliance within the team or work group. Maintain inventories of consumable materials, chemicals, and supplies related to activities. Required Qualifications:Proficiency in Microsoft applications, such as Word and Excel, and have the ability to learn new systems quickly. Proficiency in basic chemicals laboratory operation and basic Environmental Health and Safety (EH&S) requirements such as safe operating procedures and management of change is preferred. Strong understanding and commitment to their own and the safety of others. Must have strong multi-tasking, problem solving and time management skills. Be an effective collaborator and contributing member of the local work team. Must be willing and able to work in such environments wearing safety equipment, such as goggles, Lab coats, dust masks and steel-toed shoes. Must be willing and able to stand or walk for extended periods of time. Experience Preferred:Completion of Vocational Education or Upper Secondary Education (i.e. High School Diploma) plus laboratory, manufacturing or other related experience. Post Upper Secondary Education coursework in chemistry or related coursework.

The Associate Analytical Technician supports manufacturing operations by performing laboratory analyses, maintaining analytical systems, and ensuring data integrity. This role is ideal for individuals who are detail-oriented, safety-conscious, and eager to grow in a technical laboratory environment. Key Responsibilities: Train under senior team members to perform routine analyses until proficiency is demonstrated. Collect samples in accordance with the Sample Plan and standard operating procedures. Conduct laboratory analyses to support plant operations and product quality. Evaluate the validity of routine analytical data and take appropriate corrective actions. Monitor analytical systems and escalate issues as needed. Perform basic preventive maintenance and calibration of laboratory instruments. Implement and qualify new analytical equipment and methods. Document, communicate, and archive analytical results and data accurately. Follow Environmental Health & Safety (EH&S) and Operating Discipline Management System (ODMS) procedures. Suggest improvements to laboratory processes, tools, and workflows. Maintain lab cleanliness and inventory through regular housekeeping tasks. Escalate non-routine requests or issues to appropriate team members. Preferred Skills & Qualifications: Understanding of analytical/scientific methods and laboratory best practices. Ability to troubleshoot and adapt to non-routine lab analyses. Familiarity with data systems and statistical evaluation tools. Strong attention to detail and commitment to safety and quality. Effective communication and collaboration skills. Schedule: This Lab Tech position is on a Rotating shift schedule but you will have different hours during training. This position will follow a rotating shift schedule with AM and PM shifts switching every two weeks.

We are looking for a dedicated and passionate individual to join our team as a Laboratory Technician in our METHOCELTM Quality Control lab in Plaquemine, LA. In this role you will be responsible for performing routine analyses, evaluating results, and calibrating and maintaining analytical systems to provide analytical data to produce and release products including Pharmaceutical Excipients and Industrial Specialty products. The ideal candidate will have: · Relevant laboratory experience. (Experience with biology, bioscience, biotechnology, biochemistry, chemistry, or aseptic techniques is a plus.) · Can demonstrate mechanical aptitude and problem-solving skills. · Strong written and verbal communication skills plus ability to work and collaborate with a team. · Basic computer skills. (Experience with computer-based systems such as LIMS, Electronic Logbook, etc. is a plus.) Strong sense of self-motivation and ability to work under minimal supervision. · Ability to prioritize and troubleshoot issues under pressure. · Strong initiative, ability to work independently and the ability to multi-task. · Strong interpersonal skills, allowing them to work with a variety of roles within the manufacturing plant and analytical organization. · Must be able to work and interact effectively as a member of a team. · Must have the ability to learn and apply technical concepts related to laboratory instruments, sample analyses and data interpretation. · Bachelor's degree in a technical or science field desired. 20 hours College Chemistry or relevant work experience is required. Job Requirements · Follow procedures related to EH&S and to the Analytical Work Process · Adhere to good laboratory practices · Adhere to cGMP and good documentation practices requirements. · Perform routine analyses according to documented procedures · Evaluate correctness of data · Document and communicate laboratory results

We are looking to fill a **Scientist II or III - Metrology Specialist** 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. **This position does not offer sponsorship.** **Metrology specialist is responsible for the oversight of regulated and non-regulated laboratory equipment** . This role will oversee the lifecycle of the lab instrumentation covering acquisition and installation, performance or coordination of routine maintenance, computer system validation, and regulated systems retirement **Qualifications -** B.S./M.S. in Chemistry, Biochemistry, Engineering, or a related discipline + **Scientist II** - B.S. with 1-2 years of relevant experience or M.S. with 0-1 years of relevant experience + **Scientist III** - B.S. with 3-5 years of relevant experience or M.S. with 1-2 years of relevant experience **Responsibilities** + Prepare, review, and approve instrument/equipment documentation such as master equipment lists, qualification documentation, and calibration documentation + Coordinate service activities across a variety of vendors and service engineers while building and maintaining strong working relationships + Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or perform maintenance or calibration activities + Participate in computer system validation activities associated with new or upgraded equipment or software packages + Support the purchase, installation, and equipment qualification of new laboratory equipment + Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training and cross-site support + Originate and progress Notice of Event (NOE) and Change Management (CM) records + Perform and document investigations and assist in developing/implementing CAPA plans + Represent the laboratory on all aspects of laboratory equipment during audits + Ensure compliance with all regulatory requirements (cGMP) and internal policies and procedures **Required Skills and Experience** + Experience working within a regulated (GMP) laboratory + **Experience maintaining or operating laboratory equipment including HPLCs, GCs, UVs, dissolution systems, or other specialized computerized systems** + Familiarity with standalone computer system validation requirements + Highly organized, and capable of multi-tasking to manage a variety of laboratory equipment or system related schedules, documents, and maintenance tasks + Capable of working independently under moderate supervision + Strong verbal and written communication skills + Strong interpersonal skills. Comfortable interacting with a variety of on-site and off-site collaborators **Desired Skills and Experience** + Experience with maintenance of analytical instrumentation such as HPLC, UPLC, GC, UV, IR, Karl Fischer, and dissolution with ability to troubleshoot them. + Experience with computerized standalone systems GMP validation requirements + Familiarity with authoring relevant instrument standard operating procedures (SOPs) **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 looking to fill a **Scientist 3 - Analytical Chemist** 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. **This position does not offer any sponsorship.** **Responsibilities** + General understanding of analytical method development and method validation + Hands-on experience with chromatographic analysis using various ultra-high-performance liquid chromatography (UPLC), high-performance liquid chromatography (HPLC), and gas chromatography (GC) techniques + General knowledge of separations science + Experience with Empower chromatographic software and with analysis of drug formulations + Hand-on experience with Fourier transform infrared (FTIR) spectroscopic analysis and ultraviolet-visible (UV-VIS) spectroscopic analysis + Skilled on method and instrument troubleshooting, specifically for HPLC and GC methods and systems **Required Skills** + Strong computer, scientific, and organizational skills + Excellent organization to multi-task and manage multiple ongoing projects in parallel including routine testing (for example, assay and impurity testing) and data processing and interpretation + Excellent communication (oral and written) and attention to detail + Proficient in written and spoken English, is required **Desired Skills and Experience** + Empower software + Analysis of drug products + Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude **Qualifications** + BS degree and 3-5 years of relevant experience, or + MS degree with at least 1-2 years relevant experience **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.

This position is responsible for support of CMC activities as well as working with Scientists and management for specific compound development at CritiTech in support of CritiTech product development and associated affiliates/partners for the global development and regulatory approval of New Chemical Entities (NCE's), Active Pharmaceutical Ingredients (APIs) and support of research and development of any/all product activities. RESPONSIBILITIES Participates in lab development in support of Chemistry, Manufacturing and Controls (CMC) section of NDA or SNDA by direction and interaction with Quality Operations/Regulatory Affairs and CritiTech. Provides analytical support for proof of concept studies, feasibility studies, routine manufacturing, and troubleshooting using CritiTech's Supercritical Precipitation equipment. Provides analytical support for proof of concept studies, feasibility studies, routine manufacturing, and troubleshooting using CritiTech's spray drying equipment. Perform production activities in support of clinical trials, including filling, environmental monitoring, visual inspection, and packaging of vials for further processing. Suggest changes and improvements to CritiTech's analytical services and product characterization, facilities, utilities, and other systems. Performs preventative maintenance and calibration checks on analytical equipment. Participates in the qualification of new equipment and facilities. Generates support data for CritiTech to be used in 3rd party development activities. Generates data in support of CMC documents, including out-of-specification (OOS) or deviation investigations, and helps execute action plans to meet sound scientific practices. Provides technical support for QO on complaint samples and manufacturing/packaging problems. Performs and assists in CritiTech compatibility and feasibility assessments for compounds being considered for development. Participate in the onsite review of data, facilities and laboratory operations of contract manufacturing and analytical laboratory. Suggests changes or edits to appropriate SOP's for CritiTech. Performs release and stability analytical testing with QO in the coordination and management of retest/expiration dating. Executes testing and lab work in support of technology transfer and stability protocols, stability packaging and manufacturing jobs for CritiTech activities. Other duties as assigned. EDUCATION, EXPERIENCE AND SKILLS Required BS in chemistry, biology, engineering or related pharmaceutical field with 3+ years industry background in pharmaceutical product development - or - MS in chemistry, biology, engineering or related pharmaceutical field with 2+ years industry background in pharmaceutical product development. 2+ years preparing and supporting CMC documentation for IND's and NDA's. Experience in working with people in a multi-disciplinary team environment. Preferred Advanced degree in chemistry or pharmacy or equivalent experience. Experience in pharmaceutics, analytical and organic chemistry. Experience in technology transfers to contract facilities. Experience with interactions with regulatory agencies. Experience in preparing and supporting Chemistry, Manufacturing and Control (CMC) documentation regulatory filings. KNOWLEDGE AND SKILLS Knowledgeable (including hands-on experience) in the use of analytical methods for active pharmaceutical ingredients and drug product (i.e. HPLC, GC, IR, etc.) and formulation development/manufacturing and the relation of these to overall pharmaceutical development. Knowledge and understanding of current Good Manufacturing Practices (cGMP) as well as other pertinent national regulations. Current knowledge of CMC regulatory and ICH guidelines. Knowledgeable in the overall drug development process. Knowledgeable in the application of compendia requirements and procedures to testing and developing pharmaceutical products. Leadership Skills - knowledge and interpersonal skills to help others towards the accomplishment of CritiTech's goals and objectives. Analytical and Problem-Solving Skills - ability to identify problems or opportunities using appropriate information; determines the causes and possible solutions to the problem. Teamwork - the ability to work well and manage personnel in a highly cross-functional team environment. Communication Skills - ability to express one's self clearly and concisely to CritiTech personnel over the phone or with others within the team; documents issues and/or concerns concisely and comprehensively; adjusts language and/or terminology appropriate for the audience. Interpersonal Flexibility - ability to adapt to other personalities in a respectful manner that is conducive to goal achievement. Knowledge Sharing - ability to capture knowledge within the organization; improves solutions, processes, an deliverables through the use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use. Resource Management - ability to work with internal and external resources and to coordinate individual goals and objectives to align with business imperatives.

Role Description The QO Lab Analyst position works effectively in a fast-paced, customer-oriented, team laboratory environment to analyze finished product samples prior to commercial release. This is a dynamic, growing lab within a growing manufacturing site with opportunity to learn new skills and to work cross-functionally. Performs, documents and record checks qualitative and quantitative assays on samples. The primary technologies in this lab are HPLC and dissolution. Interprets and evaluates data for accuracy, precision, trends, and potential GMP impact. Recommends and executes process improvements to continually improve laboratory performance. High productivity and the ability to multi-task coupled with a low error rate and attention to detail are critical characteristics of this position. Demonstrates flexibility/agility and engagement in a changing environment. The candidate is expected to display good laboratory technique to avoid cross-contamination or misidentification of samples. Ability to follow written procedures. May train others as skills and knowledge allow. Troubleshoot instrumentation as skills and knowledge allow. Participates in laboratory investigations as required. May participate in manufacturing QC support such as cleaning verification. SHIFT HOURS: 2:00pm-10:30pm. Overtime may occasionally be required. EDUCATION AND EXPERIENCE AAS, BA/BS, or MS in Chemistry, Biochemistry, or related science preferred. Related experience in Quality Control is preferred but not required. Preferred experience includes GMP documentation, drug product formulation, in-plant laboratory, Incoming Inspection, SAP, LIMS, HPLC, Dissolution, use of Empower3 Key characteristics of a successful candidate in this position: willingness and ability to learn, ability to work in a team environment, and attention to detail. Job duties involve occasional lifting (less than 35 lbs). Candidate must not be Cephalosporin/Penicillin sensitive. Full time RegularColleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

Job Title: Senior Laboratory Analyst About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. The Global Clinical Immunology (GCI) organization, part of Late Stage Global Immunology within Vaccines R&D, specializes in developing, validating, and deploying regulated bioanalytical assays to assess immune responses to vaccines throughout their lifecycle. Our mission is to provide specialized immunology expertise and generate robust clinical datasets that inform decision-making for both clinical development and post-licensure activities. Our GCLP-compliant bioanalytical laboratories are based in Swiftwater, PA. Main responsibilites Laboratory testing and support activities as assigned including: Routine and non-routine testing Maintenance of any associated testing documentation Experienced analysts may assist with data review and approval of clinical testing alongside senior personnel Sample/reagent handling Laboratory support activities including, but not limited to: Responsible for and/or performs lab and/or facility housekeeping, waste, and general maintenance Ensures that security and safety procedures and protocols are observed and followed. Monitors, maintains laboratory inventory; responsible for reagent/material orders, receipt and delivery of laboratory reagent/material and equipment. Train other analysts on assay methods and relevant associated procedures (i.e. equipment, data and sample handling, etc.) Regulatory/Quality Management: Ensures adherence to all applicable quality, corporate, safety, and regulatory requirements. Other: As assigned and under the direction of management, independently conducts more complex research activities in support of short- and long-term laboratory operational requirements. Any other related duties required by the research projects or management of the research laboratory or analytical facility. About You Education/experience: Bachelor's degree in Biological Sciences (B.Sc.) plus minimum 2 years of experience, or Master's degree in Biological Sciences (M.Sc.) plus minimum 1 year of relevant experience in the role Ability to operate in a BSL-3 environment while fully gowned Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All 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, gender identity or expression; 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. #GD-SP #LI-SP #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; 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. North America Applicants Only The salary range for this position is: $26,17 - $34,89 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.

**Job Title:** Senior Laboratory Analyst **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. The Global Clinical Immunology (GCI) organization, part of Late Stage Global Immunology within Vaccines R&D, specializes in developing, validating, and deploying regulated bioanalytical assays to assess immune responses to vaccines throughout their lifecycle. Our mission is to provide specialized immunology expertise and generate robust clinical datasets that inform decision-making for both clinical development and post-licensure activities. Our GCLP-compliant bioanalytical laboratories are based in Swiftwater, PA. **Main responsibilites** Laboratory testing and support activities as assigned including: + Routine and non-routine testing + Maintenance of any associated testing documentation + Experienced analysts may assist with data review and approval of clinical testing alongside senior personnel + Sample/reagent handling Laboratory support activities including, but not limited to: + Responsible for and/or performs lab and/or facility housekeeping, waste, and general maintenance + Ensures that security and safety procedures and protocols are observed and followed. + Monitors, maintains laboratory inventory; responsible for reagent/material orders, receipt and delivery of laboratory reagent/material and equipment. + Train other analysts on assay methods and relevant associated procedures (i.e. equipment, data and sample handling, etc.) Regulatory/Quality Management: + Ensures adherence to all applicable quality, corporate, safety, and regulatory requirements. Other: + As assigned and under the direction of management, independently conducts more complex research activities in support of short- and long-term laboratory operational requirements. + Any other related duties required by the research projects or management of the research laboratory or analytical facility. **About You** Education/experience: + Bachelor's degree in Biological Sciences (B.Sc.) plus minimum 2 years of experience, or Master's degree in Biological Sciences (M.Sc.) plus minimum 1 year of relevant experience in the role + Ability to operate in a BSL-3 environment while fully gowned **Why choose us?** + Bring the miracles of science to life alongside a supportive, future-focused team. + Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. + Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. + Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All 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, gender identity or expression; 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. \#GD-SP \#LI-SP \#vhd **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; 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. _North America Applicants Only_ The salary range for this position is: $26,17 - $34,89 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (********************************************************************************************************* . Global Terms & Conditions and Data Privacy Statement (*************************************************************** Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (***************************** As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary The Senior Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency and takes lead role in conducting all types of microbial analyses (including the most complex analyses) using all equipment. This position will have a role supporting pending ANDA submissions, product launches, complex investigations, onboarding of new equipment and technology, develops and executes training activities, and method lifecycle activities to achieve company goals and initiatives, and is considered an SME for these areas. Write and review SOPs, test methods, validation protocols and validation reports. The Scientist also provides mentoring to analysts. Job Description The Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency in conducting all types of microbial testing and analyses (including the most complex analyses). This position will have a significant role supporting improvements, training creation and executions, testing, and equipment onboarding. Write and review SOPs, test methods, validation protocols and reports. The Scientist also provides mentoring to Microbiologists. * Support microbial testing for commercial and pre-commercial products * Support method development, validation, and transfer activities * Perform complex microbial analyses using lab equipment * Investigate complex product issues and support product development * Manage method lifecycle activities * Write and review SOPs, test methods, and validation documents * Serve as a subject matter expert (SME) in microbial testing * Mentor Scientists and Microbiologists Key Responsibilities * Perform routine microbiological testing on raw materials, in-process samples, and finished products * Conduct or understanding of sterility, endotoxin, bioburden, microbial limit, and microbial identification tests * Analyze environmental monitoring samples from cleanrooms and production areas * Support Validation of microbial methods for product and raw material testing * Prepare protocols, reports, and test methods * Conduct testing to support development and stability studies * Present and review data with project teams * Review lab documentation and supplier technical documents * Use lab software and detect abnormalities during testing * Provide general lab support and maintain equipment * Troubleshoot instruments and perform follow-up analyses * Report and investigate out-of-specification results * Write and review SOPs and investigation reports that support root cause analysis * Recommend corrective and preventive actions (CAPA) * Support training of microbiologists and improve training process records * Maintain accurate records in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) * Ensure compliance with FDA and other regulatory standards * Follow safety procedures and handle hazardous materials properly * Uses laboratory software for analyses * Is alert to and detects abnormalities during performances of tests and reviews 65% Lab Equipment * Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, and housekeeping * Troubleshoots instrumentation and performs subsequent analyses 20% Investigations * Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action * Participates in root cause identification of complex laboratory investigations * Writes, edits, and reviews SOPs and laboratory investigations 10% Training * Trains microbiologists * Continuously updates knowledge with respect to the latest technologies related to Microbiology * Maintains assigned training records current and in-compliance * Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, methodologies and procedures 5% Compliance * Identifies need for SOPs and writes or revises, as appropriate * Performs work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting. Works in compliance with cGMP/cGLP regulations * Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs * Takes active role in auditing laboratory logbooks/documentation to ensure compliance * Follows internal processes related to controlled substances continuous Safety * Follows EH&S procedures to ensure a safe work environment * Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous Total 100% Qualifications Education & Experience Minimal acceptable level of education, work experience and certifications required for the job * Bachelor of Science Degree in Microbiology or related field with 6 years' relevant microbiological laboratory experience OR * Master's Degree in above disciplines with 4 years' relevant analytical lab experience OR * PhD in above disciplines with some relevant laboratory experience preferred Knowledge Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. * Has expanded knowledge of Microbial Testing such as bacterial endotoxin, sterility, microbial and visual examination, microbial identification, etc. * Full proficiency with various laboratory techniques/instruments: microplate readers, isolator technology, microbial identification systems, etc. * Thorough knowledge of applicable safety and standards guidelines, such as FDA, ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS * Has demonstrated competence in conducting microbial testing * Strong knowledge of aseptic technique and contamination control * Competency in Microsoft Office Suite Skills & Abilities Often referred to as "competencies", leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc. * Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information * Ability to display and analyze data in a logical manner * Strong verbal and written communication skills as well as good computer skills * Strong attention to details and accurate record keeping * Establish and maintain cooperative working relationships with others * Solid organizational skills * Ability to coach and mentor junior staff while developing their laboratory skills and technical capabilities * Ability to take initiative, set priorities and follow through on assignments Physical Requirements Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc. * Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals * Must occasionally lift and/or move up to 15-25 lbs. * Ability to wear personal protective equipment, including respirators, gloves, etc. * Specific visions abilities are required by this job include close vision and color vision * Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. EEO Statement: We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.

Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team! POSITION PURPOSE *This position is for 3rd Shift (Sun-Thurs, 11:00 pm-7:30 am)* Responsible for the accurate analysis of incoming raw materials utilizing current USP, Standard Operating Procedures (SOPs), Work Instructions (WIs), Nice Pak's / PDI Test Methods (NPTM), Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs). Assures tested raw materials have met the required specification criteria prior to release. Maintain accurate, complete, and traceable documentation related to analysis and disposition. ESSENTIAL FUNCTIONS AND BASIC DUTIES Testing Requirements: Performance of diversified chemical testing as needed by using current USP, Standard Operating Procedures (SOPs), Work Instructions (WIs), Nice Pak's / PDI Test Methods (NPTM), and or customer supply method on raw materials, the testing may include but not limited to: pH determination, viscosity, refractive index, specific gravity, etc. Conduct wet chemical titration to determine the percentage of activity on various solutions and raw materials Determine the active percentage of various components as required by specifications using of instruments (IR, UV, Auto-titrator, etc.) Perform identification of various chemicals or formulations as per methodology and requirements Perform daily calibration, reading, and recording of instruments within the Analytical Lab Test incoming raw chemicals, components and assure that all the required certification required is accurate and within specification. Assist in the sampling, testing and release of raw materials when needed REPORTING & ANALYSIS: Ensure that all results are accurately recorded in appropriate laboratory logs, designated forms and/or LIMS system. Lab Maintenance: Update management or designee with analytical supplies issue Clean laboratory at specified intervals by following appropriate SOP and/or WI Prepare and maintain laboratory test solutions and titrants Additional Requirements: Determine products' QC disposition from the lab Complete necessary forms, as needed PERFORMANCE MEASUREMENTS Test Raw Materials and release it in a timely manner Ensure sampling, testing, and release of raw materials is done efficiently. Maintain lab cleanliness in a timely manner. QUALIFICATIONS EDUCATION/CERTIFICATION: Bachelor's degree in Chemistry, Analytical Chemistry, other related science REQUIRED KNOWLEDGE: Must know Microsoft Office Suite (Outlook, Word, Excel) Be able to read, write and speak English Read and comprehend Company policies and procedures, including safety rules and regulations EXPERIENCE REQUIRED: A minimum of 0 - 3 years' work experience in a laboratory environment (Analytical Chemistry Lab preferred) or an equivalent combination of training and experience. SKILLS/ABILITIES: Ability to multi-task and have good time management skills. Must have good communication and customer service skills. WORKING CONDITIONS Incumbents in this class are subject to extended periods of sitting, standing, walking, lifting materials weighing up to 30 pounds, vision to monitor and moderate to loud noise levels. Incumbents may be exposed to or work with toxic materials, toxic gases, electrical hazards, dangerous tools and equipment. Work is performed in laboratory environment. Incumbents must be able to use personal protective equipment (e.g. respirators, gloves, etc.) SALARY RANGE $55,000 - $60,000 annually, plus bonus PDI is pleased to offer a comprehensive and affordable benefits program to our associates, which includes: Medical & prescription drug coverage Dental / Vision plan 401(k) savings plan with company match Basic and supplemental life insurance Flexible Spending Accounts (FSAs) Short- and long-term disability benefits Health Advocacy Program / Employee Assistance Program (EAP) Many other voluntary benefit plans such as: Legal assistance, critical illness, hospital indemnity and accident coverage, discounted home/auto/rental insurance, employee discounts and pet insurance At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide: Sick leave, generous vacation and holiday time, paid parental leave, summer hours, flex place/flex time options

Sun Pharma is the worlds fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology. **Job Summary:** The Formulation Technician is responsible for the formulation and dispensing of pharmaceutical products in accordance with current Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOPs) within a clean room environment. This role supports the production of Radio-pharmaceutical and dermatological products and ensures compliance with regulatory standards. **Schedule:** 2nd Shift: Monday - Friday, 1:30pm-10:00pm **Key Responsibilities** + Formulate and dispense pharmaceutical products in a clean room environment, including Radio-pharmaceutical and dermatological products. + Wash and sterilize equipment, tubing, filters, stoppers, vessels, vials, ampoules, and other related components. + Perform both automatic and manual manufacturing processes as required. + Conduct cleaning of manufacturing facilities and equipment to maintain sterile conditions. + Follow all company safety policies and procedures. + Prepare and set up glassware and laboratory equipment to ensure optimal conditions for production. + Accurately document data and review completed batch records to ensure products meet specifications. + Assist in the review and revision of SOPs and batch records as needed. + Monitor equipment under supervision and report any irregularities. + Complete all required documentation in compliance with FDA regulations. + Support the packaging and labeling facility during production downtime. + Perform other duties as assigned. **Work Conditions** + Office, laboratory, and controlled clean room environments. + Exposure to syringes, needles, and other pharmaceutical handling tools. **Physical Requirements** + Ability to stand, walk, sit, use hands and fingers, reach, push, stoop, kneel, crouch, or crawl. + Must be able to talk and hear clearly. + Visual capabilities including close vision, color vision, peripheral vision, depth perception, and ability to focus. + Ability to visually inspect small products and printed materials. + Operate laboratory equipment and office machines. + Wear required safety attire including lab coats and other PPE. + Lift and carry up to 50 lbs. **Travel Requirements** + Travel: None (0%) **Qualifications** **Education:** + High School Diploma or GED required. + Education in life sciences or a technical discipline preferred. **Skills & Competencies:** + Ability to work under direct supervision and follow clearly defined procedures. + Strong organizational and record-keeping skills. + Basic computer proficiency. + High attention to detail. + Effective verbal, written, and interpersonal communication skills. + Ability to visually inspect small products and printed materials. **Experience** + 25 years of related experience preferred. + Familiarity with SOPs, Master Batch Records, and cGMPs preferred. + Basic math, computer, and documentation skills required. + cGMP training is a plus. + Experience with aseptic fill/finish and formulation techniques preferred. + Prior work in a controlled environment and pharmaceutical setting preferred. _Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the_ _Long Term Incentive Plan_ _.Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time._ _The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors._ _The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s)._ _We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law._ **_Notice to Agency and Search Firm Representatives:_** _Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral._ We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

**Why Us?** We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. ** Summary** The Senior Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency and takes lead role in conducting all types of microbial analyses (including the most complex analyses) using all equipment. This position will have a role supporting pending ANDA submissions, product launches, complex investigations, onboarding of new equipment and technology, develops and executes training activities, and method lifecycle activities to achieve company goals and initiatives, and is considered an SME for these areas. Write and review SOPs, test methods, validation protocols and validation reports. The Scientist also provides mentoring to analysts. **Job Description** The Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency in conducting all types of microbial testing and analyses (including the most complex analyses). This position will have a significant role supporting improvements, training creation and executions, testing, and equipment onboarding. Write and review SOPs, test methods, validation protocols and reports. The Scientist also provides mentoring to Microbiologists. + Support microbial testing for commercial and pre-commercial products + Support method development, validation, and transfer activities + Perform complex microbial analyses using lab equipment + Investigate complex product issues and support product development + Manage method lifecycle activities + Write and review SOPs, test methods, and validation documents + Serve as a subject matter expert (SME) in microbial testing + Mentor Scientists and Microbiologists **Key Responsibilities** + Perform routine microbiological testing on raw materials, in-process samples, and finished products + Conduct or understanding of sterility, endotoxin, bioburden, microbial limit, and microbial identification tests + Analyze environmental monitoring samples from cleanrooms and production areas + Support Validation of microbial methods for product and raw material testing + Prepare protocols, reports, and test methods + Conduct testing to support development and stability studies + Present and review data with project teams + Review lab documentation and supplier technical documents + Use lab software and detect abnormalities during testing + Provide general lab support and maintain equipment + Troubleshoot instruments and perform follow-up analyses + Report and investigate out-of-specification results + Write and review SOPs and investigation reports that support root cause analysis + Recommend corrective and preventive actions (CAPA) + Support training of microbiologists and improve training process records + Maintain accurate records in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) + Ensure compliance with FDA and other regulatory standards + Follow safety procedures and handle hazardous materials properly + Uses laboratory software for analyses + Is alert to and detects abnormalities during performances of tests and reviews 65% Lab Equipment + Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, and housekeeping + Troubleshoots instrumentation and performs subsequent analyses 20% Investigations + Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action + Participates in root cause identification of complex laboratory investigations + Writes, edits, and reviews SOPs and laboratory investigations 10% Training + Trains microbiologists + Continuously updates knowledge with respect to the latest technologies related to Microbiology + Maintains assigned training records current and in-compliance + Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, methodologies and procedures 5% Compliance + Identifies need for SOPs and writes or revises, as appropriate + Performs work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting. Works in compliance with cGMP/cGLP regulations + Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs + Takes active role in auditing laboratory logbooks/documentation to ensure compliance + Follows internal processes related to controlled substances continuous Safety + Follows EH&S procedures to ensure a safe work environment + Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous Total 100% Qualifications Education & Experience _Minimal acceptable level of education, work experience and certifications required for the job_ + Bachelor of Science Degree in Microbiology or related field with 6 years' relevant microbiological laboratory experience OR + Master's Degree in above disciplines with 4 years' relevant analytical lab experience OR + PhD in above disciplines with some relevant laboratory experience preferred Knowledge _Proficiency in a body of information required for the job_ _e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc._ + Has expanded knowledge of Microbial Testing such as bacterial endotoxin, sterility, microbial and visual examination, microbial identification, etc. + Full proficiency with various laboratory techniques/instruments: microplate readers, isolator technology, microbial identification systems, etc. + Thorough knowledge of applicable safety and standards guidelines, such as FDA, ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS + Has demonstrated competence in conducting microbial testing + Strong knowledge of aseptic technique and contamination control + Competency in Microsoft Office Suite Skills & Abilities _Often referred to as "competencies", leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing_ _etc._ + Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information + Ability to display and analyze data in a logical manner + Strong verbal and written communication skills as well as good computer skills + Strong attention to details and accurate record keeping + Establish and maintain cooperative working relationships with others + Solid organizational skills + Ability to coach and mentor junior staff while developing their laboratory skills and technical capabilities + Ability to take initiative, set priorities and follow through on assignments Physical Requirements _Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc._ + Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals + Must occasionally lift and/or move up to 15-25 lbs. + Ability to wear personal protective equipment, including respirators, gloves, etc. + Specific visions abilities are required by this job include close vision and color vision + Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods **_Disclaimer:_** _The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required._ **EEO Statement:** We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary The Senior Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency and takes lead role in conducting all types of microbial analyses (including the most complex analyses) using all equipment. This position will have a role supporting pending ANDA submissions, product launches, complex investigations, onboarding of new equipment and technology, develops and executes training activities, and method lifecycle activities to achieve company goals and initiatives, and is considered an SME for these areas. Write and review SOPs, test methods, validation protocols and validation reports. The Scientist also provides mentoring to analysts. Job Description The Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency in conducting all types of microbial testing and analyses (including the most complex analyses). This position will have a significant role supporting improvements, training creation and executions, testing, and equipment onboarding. Write and review SOPs, test methods, validation protocols and reports. The Scientist also provides mentoring to Microbiologists. Support microbial testing for commercial and pre-commercial products Support method development, validation, and transfer activities Perform complex microbial analyses using lab equipment Investigate complex product issues and support product development Manage method lifecycle activities Write and review SOPs, test methods, and validation documents Serve as a subject matter expert (SME) in microbial testing Mentor Scientists and Microbiologists Key Responsibilities Perform routine microbiological testing on raw materials, in-process samples, and finished products Conduct or understanding of sterility, endotoxin, bioburden, microbial limit, and microbial identification tests Analyze environmental monitoring samples from cleanrooms and production areas Support Validation of microbial methods for product and raw material testing Prepare protocols, reports, and test methods Conduct testing to support development and stability studies Present and review data with project teams Review lab documentation and supplier technical documents Use lab software and detect abnormalities during testing Provide general lab support and maintain equipment Troubleshoot instruments and perform follow-up analyses Report and investigate out-of-specification results Write and review SOPs and investigation reports that support root cause analysis Recommend corrective and preventive actions (CAPA) Support training of microbiologists and improve training process records Maintain accurate records in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) Ensure compliance with FDA and other regulatory standards Follow safety procedures and handle hazardous materials properly Uses laboratory software for analyses Is alert to and detects abnormalities during performances of tests and reviews 65% Lab Equipment Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, and housekeeping Troubleshoots instrumentation and performs subsequent analyses 20% Investigations Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action Participates in root cause identification of complex laboratory investigations Writes, edits, and reviews SOPs and laboratory investigations 10% Training Trains microbiologists Continuously updates knowledge with respect to the latest technologies related to Microbiology Maintains assigned training records current and in-compliance Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, methodologies and procedures 5% Compliance Identifies need for SOPs and writes or revises, as appropriate Performs work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting. Works in compliance with cGMP/cGLP regulations Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs Takes active role in auditing laboratory logbooks/documentation to ensure compliance Follows internal processes related to controlled substances continuous Safety Follows EH&S procedures to ensure a safe work environment Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous Total 100% Qualifications Education & Experience Minimal acceptable level of education, work experience and certifications required for the job Bachelor of Science Degree in Microbiology or related field with 6 years' relevant microbiological laboratory experience OR Master's Degree in above disciplines with 4 years' relevant analytical lab experience OR PhD in above disciplines with some relevant laboratory experience preferred Knowledge Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. Has expanded knowledge of Microbial Testing such as bacterial endotoxin, sterility, microbial and visual examination, microbial identification, etc. Full proficiency with various laboratory techniques/instruments: microplate readers, isolator technology, microbial identification systems, etc. Thorough knowledge of applicable safety and standards guidelines, such as FDA, ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS Has demonstrated competence in conducting microbial testing Strong knowledge of aseptic technique and contamination control Competency in Microsoft Office Suite Skills & Abilities Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc. Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information Ability to display and analyze data in a logical manner Strong verbal and written communication skills as well as good computer skills Strong attention to details and accurate record keeping Establish and maintain cooperative working relationships with others Solid organizational skills Ability to coach and mentor junior staff while developing their laboratory skills and technical capabilities Ability to take initiative, set priorities and follow through on assignments Physical Requirements Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc. Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals Must occasionally lift and/or move up to 15-25 lbs. Ability to wear personal protective equipment, including respirators, gloves, etc. Specific visions abilities are required by this job include close vision and color vision Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. EEO Statement: We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Formulation Technician III mentors others in a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set inclusive of current GMP/ISO requirements and standards and following all safety Guidelines of PCI. With general supervision, the technician performs all manufacturing operations including but not limited to work functions in equipment prep, dispensing, dissolution, formulation, purification, and aseptic compounding activities for biopharma and medical device products. The incumbent must possess the ability to address non routine matters. Utilizes technical knowledge and experience to resolve complex manufacturing problems. Monitors personnel interaction to ensure proper behaviors. Escalates matters requiring resolution by management. Works with Master production records and standard operating procedures. Trains and guides less experienced personnel. Is a model of the Guardian values and behaviors. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. Maintains and adheres to safe work habits and all applicable PCI safety procedures and guidelines. Is proactive in identifying safety risks and alerts management to take corrective action Trains and mentors both peers and less experienced staff in the performance of proper formulation techniques Has ownership for the daily formulation activities to ensure all scheduled tasks/events are completed Is responsible for critical steps in the formulation process including but not limited to, lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention of errors that could lead to product and or finical loss Troubleshoots and resolve problems with equipment or processes in the course of performing job duties Adheres to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation Prepares equipment and components for sterilization and Lyophilization Operates processing equipment including autoclaves, depyrogenation ovens, vial washers, homogenizers, and others Maintains compliance, cleanliness and orderliness of operational areas per appropriate SOPs Collaborates with Supervisor and MTS during drafting of new manufacturing batch records and protocols. Completes Batch Records accurately and completely prior to submission to supervision for review Complies with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements Initiate and support revisions to SOPs and FORMs as needed Participates in investigations, and contribute to identifying corrective and preventative actions Cross trains to increase technical skills across the department Accountable for timely communication to management and clients of issues, challenges as well as opportunities for process improvements As a member of the manufacturing team, you will perform other manufacturing tasks for example filling, capping etc., as needed Inspire and constantly strive to make PCI a great place to work and respected for the quality of its people and products and clients Work with enabling groups to improve/implement processes Other duties as assigned Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions. Able to stand for long periods of time, the majority of the work shift Able to lift 30lbs repeatedly Able to wear PPE (mask, gloves, respiratory) Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Works directly with aseptic and non-aseptic personnel. Works closely with Quality Assurance, MTS, Validation etc. TRAVEL - < 10% Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. High School education, AS degree or BS degree in related field of study is preferred Experience and knowledge of formulation/compounding tools and equipment Minimum 4 years formulation/compounding work experience in a GMP environment, preferably in fill finish pharmaceutical operations Demonstrated ability to prioritize multiple projects and activities Strong interpersonal skills Strong working knowledge of MS Office suite is preferable Strong communication skills Attention to detail and positive attitude are key attributes Able to follow rules and regulations perfectly Resilient as well as flexible Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Sun Pharma is the world's fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology. Job Summary: The Formulation Technician is responsible for the formulation and dispensing of pharmaceutical products in accordance with current Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOPs) within a clean room environment. This role supports the production of Radio-pharmaceutical and dermatological products and ensures compliance with regulatory standards. Schedule: 2nd Shift: Monday - Friday, 1:30pm-10:00pm Key Responsibilities * Formulate and dispense pharmaceutical products in a clean room environment, including Radio-pharmaceutical and dermatological products. * Wash and sterilize equipment, tubing, filters, stoppers, vessels, vials, ampoules, and other related components. * Perform both automatic and manual manufacturing processes as required. * Conduct cleaning of manufacturing facilities and equipment to maintain sterile conditions. * Follow all company safety policies and procedures. * Prepare and set up glassware and laboratory equipment to ensure optimal conditions for production. * Accurately document data and review completed batch records to ensure products meet specifications. * Assist in the review and revision of SOPs and batch records as needed. * Monitor equipment under supervision and report any irregularities. * Complete all required documentation in compliance with FDA regulations. * Support the packaging and labeling facility during production downtime. * Perform other duties as assigned. Work Conditions * Office, laboratory, and controlled clean room environments. * Exposure to syringes, needles, and other pharmaceutical handling tools. Physical Requirements * Ability to stand, walk, sit, use hands and fingers, reach, push, stoop, kneel, crouch, or crawl. * Must be able to talk and hear clearly. * Visual capabilities including close vision, color vision, peripheral vision, depth perception, and ability to focus. * Ability to visually inspect small products and printed materials. * Operate laboratory equipment and office machines. * Wear required safety attire including lab coats and other PPE. * Lift and carry up to 50 lbs. Travel Requirements * Travel: None (0%) Qualifications Education: * High School Diploma or GED required. * Education in life sciences or a technical discipline preferred. Skills & Competencies: * Ability to work under direct supervision and follow clearly defined procedures. * Strong organizational and record-keeping skills. * Basic computer proficiency. * High attention to detail. * Effective verbal, written, and interpersonal communication skills. * Ability to visually inspect small products and printed materials. Experience * 2-5 years of related experience preferred. * Familiarity with SOPs, Master Batch Records, and cGMPs preferred. * Basic math, computer, and documentation skills required. * cGMP training is a plus. * Experience with aseptic fill/finish and formulation techniques preferred. * Prior work in a controlled environment and pharmaceutical setting preferred. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time. The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors. The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s). We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law. Notice to Agency and Search Firm Representatives: Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

Job Description This position functions primarily in a classified ISO-8 environment and requires the individual to wear appropriate PPE. This position will perform dispensing and formulation operations and perform other duties, such as cleaning, restocking, visual inspection, and labeling, as required and/or assigned. All assigned tasks must be conducted in adherence with all applicable procedures, cGMPs, company policies and any other quality or regulatory (Ex: OSHA, DEA, FDA, etc.) requirements. Facility is a multiple shift operation where variable shifts, including weekends, may be required. Schedule: Tuesday to Friday 3 PM Until 1:30 AM (or until work is completed) Pay: $25/hour SAFETY Strictly adhere to all cGMP, health and safety requirements, procedures, and corporate policies. Authorized to immediately stop any task that is determined to be an imminent hazard. Always promote and demonstrate safe work practices and adhere to PPE requirements. Safely handle chemicals, corrosives, solvents, and other pharmaceutical compounds. Demonstrate physical ability to lift a minimum of 50 lbs. and push/pull pallets, product cans, etc. multiple times per shift. PRIMARY RESPONSIBILITIES: Perform ISO-8 dispensing and formulation operations consistent with established protocols, procedures, and regulatory/cGMP requirements. Learn to utilize all relevant equipment/technology for formulation operations. Complete and document required training to gain proficiency for all assigned job tasks. Accurately and contemporaneously document all actions performed per GDP standards. Assist with classified and non-classified area cleaning and maintenance as required. Perform visual inspection, labeling, and additional support tasks as required. Make recommendations for process improvements. Possess the ability to master multiple processes across different areas. Recognize and respond appropriately to equipment/documentation issues and deviations; obtain appropriate clarification and guidance from leadership before proceeding. Maintain a quality focused, “Right First Time”, attitude. Arrive for work on-time, prepared to work in the classified environment for the majority of each shift. Operate with Integrity by maintaining high ethical standards. Treat all employees with trust, respect, and professionalism. Speak up and hold others accountable for high integrity by providing constructive feedback. Take accountability for individual and team mistakes and participate in related corrective actions. Ensure patient safety by understanding you and your team's impact on product quality. Excel within a diverse and high performing team. Remain open to new ideas and perspectives, communicate across shifts as required, and comply with site process to create a safe work environment. Demonstrate a passion to perform by meeting personal and departmental goals. Self-driven and self-accountable, performs required tasks, and progresses on qualifications within reasonable timelines. Demonstrate innovation abilities by identifying and speaking up about viable options for improvements and exploring and creating a path for implementation. High School Diploma or equivalent. Must pass a drug test. Must speak, write, and read English. Must be a team player. Must have excellent attention to detail. Prior Sterile Compounding and Pharmaceutical Industry experience. Prior experience operating manufacturing equipment/machinery. Knowledge of FDA guidelines, cGMP, and GDP. Willingness to participate in training and gain other certifications as needed. Knowledge of basic arithmetic and chemistry calculations. Ability to work in a fast-paced environment with dynamic priorities and demands. Excellent written and verbal communication skills. Desire to expand knowledge and grow with the company. Leadership ability.