Thermo Fisher Scientific jobs in Greenville, NC - 102 jobs

The Staff QA Engineer will lead the quality oversight of validation activities with a strategic focus on continuous improvement and regulatory compliance. This senior-level position involves leadership, mentorship, and high-level coordination of validation processes across multiple sites. **Typical work hours are Monday - Friday from 8a - 5p, but the role also requires this individual to have on-call weekends based on a predefined schedule for urgent off-hours questions.** **Key Responsibilities:** + Lead QA validation activities related to Facilities, Utilities, Engineering, Quality Control, and Operational equipment. + Provide strategic quality oversight of facility and equipment commissioning and other activities. + Review and approve: + Equipment Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) protocols and reports. + Validation related deviations and discrepancies. + Process Validation (PV), Cleaning Validation, and Computer System related protocols and reports. + Lead QA support for risk assessment, FMEA, and change controls governing validation related activity. + Coordinate and lead validation activities with multi-functional team members to ensure efficiency and compliance with regulations. + Develop and maintain a safety and quality culture. + Mentor and train junior QAV Engineers. + Drive continuous improvement initiatives in validation processes. **Qualifications:** + BS/BA in a scientific or related field required, preferably in Biology/Chemistry or Engineering. Advanced degree preferred. + 5+ years of experience in Quality and/or Validation. + 7+ years of cGMP experience in the pharmaceutical industry, Steriles manufacturing experience strongly preferred. + Proven ability to lead and mentor multi-functional teams. + Strong leadership skills and ability to work within a matrix organization. + Ability to support and lead multi-functional and multi-site initiatives involving integration. + Excellent written and oral communication skills; ability to communicate effectively with Senior Leadership and all levels below. + Ability to prioritize, align and simplify, demonstrate enthusiasm, take accountability and drive for results. + In-depth knowledge of cGMPs, technical writing, data management collection, and analysis. + Exceptional interpersonal skills, including teamwork, facilitation, and negotiation. + Ability to work independently, with a pro-active mentality to mitigate risk We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team! Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

(Internal Job Title - Sr. Field Service Technician) P&G Professional is the commercial division of Procter & Gamble focused on improving the lives of our consumers away from home. We provide the hospitality, foodservice, and long-term care industries chemical programs and solutions that keep their facilities clean and safe. The Senior Field Service Technician (FST) is a field based position working independently to install, troubleshoot, repair, and maintain our chemical dispensing equipment as well as other equipment used in commercial foodservice or laundry operations. The goal is to deliver exceptional service (not sales) in a way that delivers customer retention and superior customer service. This is a full-time position with Procter & Gamble that includes a competitive healthcare plan and retirement benefits. P&G Professional is expanding rapidly across North America and this position offers the opportunity to join a great company that can offer significant career opportunities as we continue to grow. Job Qualifications The ideal candidate would have a great work ethic and a willingness to learn new skills with provided training. This candidate would have a basic understanding in electronics, plumbing, maintenance or mechanical systems with the ability to troubleshoot with root cause analysis. Moderate working knowledge of appropriate tools, data, implements and service needs. Proficient in laptop and cell phone technology to include but not limited to Salesforce, Microsoft Word and Excel. Candidate must have a valid driver's license. Occasional overnight travel is required. Essential Job Functions * Work Schedule is a 5 day work week / 8 hours per day but may include: 12-hour shifts, occasional weekends, and night shifts * Lift, lower and carry objects up to 50 lbs. * Push and pull objects up to 50 lbs. * Climb a vertical ladder. Ability to go up and down * Climb up and down stairs * Stand, sit, and/or walk for long periods of time, twist, bend at the knees , stoop, kneel, squat, crawl, and reach for purposes of installing and maintaining equipment. Surface: Concrete, asphalt (uneven surfaces). * Operate a computer keyboard to input and access data, and phone * The ability to give and discern the various visual and audible alarms and signals for equipment startup, evacuation, and fires * Candidate must be able to operate a motor vehicle, and spend approximately 30% of the day in the car traveling from accounts safely in city, rural and expressway conditions * Must have a valid driver's license. * The ability to work in extreme temperatures both hot and cold, generally in warehouse conditions including wide variances in temperature, dust and dirt. Other Requirements * Candidate must live in specified city * On-call Coverage which may include occasional weekends, holidays, and night shifts Compensation for roles at P&G varies depending on a wide array of non-discriminatory factors including but not limited to the specific office location, role, degree/credentials, relevant skill set, and level of relevant experience. At P&G compensation decisions are dependent on the facts and circumstances of each case. Total rewards at P&G include salary + bonus (if applicable) + benefits. Your recruiter may be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the hiring process. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, disability status, age, sexual orientation, gender identity and expression, marital status, citizenship, HIV/AIDS status or any other legally protected factor. Immigration Sponsorship is not available for this role. For more information regarding who is eligible for hire at P&G along with other work authorization FAQ's, please click HERE. Procter & Gamble participates in e-verify as required by law. Qualified individuals will not be disadvantaged based on being unemployed. Job Schedule Full time Job Number R000140313 Job Segmentation Plant Technicians Starting Pay / Salary Range $24.18 / hour

The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization. *Relocation assistance is NOT provided. *Must be legally authorized to work in the United States without sponsorship. *Must be able to pass a comprehensive background check, which includes a drug screening. **POSITION SUMMARY** The Sterility Assurance Manager is accountable for sterility assurance across site and will own/promote/define the systems listed as key responsibilities for assigned areas of operation. **Key Responsibilities:** + Contamination control strategy (define/own/maintain for the assigned areas) + Define, oversee, and improve the EM program + Oversee the Media Fill Program + Lead the aseptic Comportment/Training/Oversight + Oversee sterilization processes + Implement and Lead risk assessments and improvement programs against current and future expectations + Lead sophisticated investigations into issues impacting Sterility Assurance (i.e. Adverse EM trends, media fill failures) + Review & approve any Major/Critical deviations and change proposals with Sterility Assurance impact for the assigned areas. + Staying up to date with the best approach and sharing that knowledge (10% of time should be dedicated to this) + Act as Subject Matter Authority (SME) with regulators / clients (i.e. key part of audits) + Act as SME for new product introduction and for applicable capital projects (i.e. new lines/processes) + Implementing standard methodology (i.e. ensuring understanding / compliance with updated Annex 1 - leading the transition and any risk assessments we need + Represent site on the Sterile Working Group, and facilitate harmonizing practices across sites in the network + Audit other sterile sites and suppliers providing microbiological service or sterile materials (as required) + Follows all job-related safety and other training requirements. **Qualifications:** + Bachelor of Science Degree in relevant area; e.g. Microbiology, Applied Biology, or similar required. + 7 years of experience Microbiology experience is crucially required for this role. (Preferably, Micro Laboratory or Environmental Monitoring experience, and ideally within a sterile pharmaceutical manufacturing facility). + 5 years of leadership experience required. + Experience in a pharmaceutical quality function, preferably in a sterile manufacturing site. + Detailed knowledge of aseptic processing, and ideally will have practical experience in an active aseptic manufacturing operation. + Knowledge of aseptic process simulations (media fills). + Experience with pharmaceutical industry technology, especially from a validation, technical or laboratory role would be useful. **Knowledge, Skills, Abilities** + Involvement in capital projects (new build/refurbishment of sterile lines) would be beneficial. + Familiarity with U.S. FDA, EU Annex-1 and other regulations and guidance. + Strong investigative skills, preferably familiar with Root Cause Analysis methods. + Leadership experience, and supervisory experience is helpful. + Shown expertise with audits and client-facing roles. + Outstanding technical writing skills + Influencing + cGMP Compliance + Strong sense of diplomacy and assertiveness + Quality Judgement + Effective time management and prioritization skills. + Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters. + Outstanding attention to detail and organizational skills. + Self-starter, mature, independent and conscientious. Ability to work in a fast-paced environment under pressure, able to multi-task and is results-oriented. Demonstrates ability to maintain a high degree of confidentiality. + Requires discretion and independent judgment. **PHYSICAL REQUIREMENTS:** Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. **What We Offer** We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! **Compensation** + Competitive Pay + Annual performance-based bonus + Annual merit performance-based increase **Excellent Benefits** + Benefits & Total Rewards | Thermo Fisher Scientific + Medical, Dental, & Vision benefits-effective Day 1 + Paid Time Off & Designated Paid Holidays + 401K + Tuition Reimbursement + Employee Referral Bonus + Career Advancement Opportunities Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

This role is part of the Site and Patient Engagement team within Trial Operations at the client. The Patient Recruitment & Retention Strategy Lead encompasses strategic leadership and oversight of patient recruitment efforts across multiple clinical trials/indications across the client. This role will work with the global clinical team and leaders to understand patient recruitment needs at a disease and study level and developing appropriate solutions. The role is crucial in ensuring the successful recruitment and retention of participants in clinical trials. Expected travel: 10-15%. **ROLES AND RESPONSIBILITIES** + **Strategic Planning:** Develop and execute comprehensive patient recruitment strategies with the objectives and timelines of each clinical trial. This involves analyzing study protocols, understanding the target patient populations and identifying effective recruitment channels. Partners with study leaders and cross-functional partners on the diversity strategy and actively contributes to the indication-specific diversity plan. + **Stakeholder Collaboration:** Collaborate with Indication Development Teams and cross-functional partners, including Trial Operations, medical affairs, regulatory affairs, global patient advocacy, and Global Sourcing & Vendor Alliance Management (GloSAM). Ensure alignment of recruitment strategies with study protocols and regulatory requirements. Provide coaching and mentoring to other team members Provide input to procedures/SOPs/Wis and related documents. Participate in workstreams. + **Budget Management:** Manage recruitment budgets for multiple clinical trials in coordination with the appropriate Clinical Operations Development Lead (CODL). + **Vendor Management** : Oversee relationships with external vendors and recruitment agencies involved in patient outreach, screening and enrollment activities. Evaluate vendor performance. This includes the review and coordination of all approvals of patient recruitment materials. Collaborate with GloSAM to negotiate contracts and Quality team to ensure compliance. + **Data Analysis and Metrics Reporting:** Utilize data analytics tools to track recruitment metrics, monitor progress and identify trends. Implement quantitative methods for measuring the impact of specific recruitment tactics. Leverage metrics to inform recruitment strategy across IDTs and implement continuous improvement Collaborate with data science partners on how we can leverage data science approaches and data sources for identifying geographic regions of interest and site and patient identification to optimize recruitment strategy. Generate regular reports for senior management and study teams providing insights and recommendations for optimization. + **Ethical and Regulatory Compliance:** Ensure that all recruitment activities adhere to ethical standards, regulatory requirements and Good clinical Practice (GCP) guidelines. + **Continuous Improvement:** Implement process improvements and best practices to enhance recruitment efficiency and effectiveness. Ensure best practices and lessons learned are shared across trials/indications/assets. Stay abreast of industry trends, emerging technologies and innovative recruitment solutions. + **Patient Engagement and Retention** : Develop strategies that engage patients throughout the clinical trial lifecycle, fostering a positive experience and positioning the client as Sponsor of Choice for clinical trial participation. + **Risk Management:** Identify potential risks and challenges related to patient recruitment and collaborate with CRO/vendor to develop contingency plans to ensure study timelines are met. **SKILLS AND COMPETENCIES** + Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical trial + Ability to work with vendors and external stakeholders with timely communications + Highly organized with a positive attitude; Works well through change and shifting priorities + Strong planning, organizational and project management skills + Ability to communicate effectively and professionally **EDUCATION, EXPERIENCE AND QUALIFICATIONS** + Bachelor's degree in a scientific, marketing or communications discipline + 10+ years of experience + Relevant industry experience (pharma, biotech, CRO required + Experience implementing or overseeing patient recruitment strategy + Experience leading implementation and strategy development teams and working in a global environment + Auto-immune and/or oncology clinical trial background is a plus Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Work Schedule** 12 hr shift/nights **Environmental Conditions** Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, No contact lens allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Will work with hazardous/toxic materials **Job Description** As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. **Location/Division Specific Information:** Greenville, NC/DPD **How Will You Make an Impact?:** As a Formulation Technician II, you will play a vital role in producing sterile injectables and working on moderate-scale problems that require analysis and critical thinking. You will follow written and verbal instructions to ensure that pharmaceutical products are manufactured in accordance with industry guidelines and regulations. **Night and day full time shifts available. Shift hours are 6pm-6am or 6am-6pm on a 2-2-3 rotating schedule.** **A Day in the Life:** + Ensure pharmaceutical products are manufactured in strict accordance with area SOPs and current cGMP. + Verify and document production activities in batch records, logbooks, and controlled forms. + Complete tasks vital to manufacturing drug products in an aseptic filling area, including cleaning cGMP areas, performing line changeovers, parts preparation, filter integrity testing, operating parts washers and autoclaves, performing tray loading and unloading, operating the filling isolator, and general material handling. + Troubleshoot equipment alarms. **Education:** High school diploma or equivalent required. **Experience:** Required: Minimum of 1 year of work experience in a manufacturing, operations, production, lab setting or related field Preferred: Experience in a cGMP environment **Knowledge, Skills, Abilities:** + Ability to excel in a team environment, follow standard operating procedures, and perform repetitive work duties + Basic math skills. + Good verbal/written communication. + Attention to detail while maintaining a quality product. **Physical Requirements / Work Environment** + Work in a clean-room environment with controlled temperature, humidity, and low ambient noise. + Wear appropriate gowning and personal protective equipment. + Infrequently lift and manipulate up to 50 pounds unassisted. + Stand and move about, including reaching, bending, stooping, grasping. + Use hand tools and equipment. **What We Offer:** Compensation Competitive Pay Performance Related Bonus where eligible Annual merit performance-based increase Excellent Benefits Medical benefits Paid Time Off/Annual Leave Employee Referral Bonus Career Advancement Opportunities Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. **This role will support our Real-World Evidence/Data Analytics group.** DESCRIPTION: Join our sales team as a Sales Lead Development Representative and contribute to business growth for Thermo Fisher Scientific's clinical research services. In this role, you'll be an important first point of contact, working collaboratively with field representatives and internal teams to generate valuable opportunities. You'll engage with prospective clients, secure meetings, and contribute to pipeline development through skilled lead generation and relationship building. This position offers an opportunity to represent our industry-leading capabilities while supporting the delivery of life-changing therapies worldwide. **Essential Functions and Other Job Information:** + Delivers measurable contributions to the department by engaging new clients or contacts, securing client meetings and new opportunities (RFPs). + Drives RFP pipeline and hit rates through lead generation, pipeline development, and territory management. + Tracks and maintain all activity in the customer relationship management (CRM) database. + Supports marketing initiatives including conferences by scheduling meetings and managing follow up items. **REQUIREMENTS:** + Bachelor's degree required, 1 year minimum of sales, business development, experience in CRO /Life Science field I **_n some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role._** **Knowledge and Skills:** + Ability to develop and execute territory management strategies + Excellent relationship building skills with both internal and external stakeholders + Superior written and verbal communication abilities + Proficiency with CRM systems and Microsoft Office Suite + Strong organizational and time management skills + Demonstrated ability to work independently and prioritize effectively + Experience in pharmaceutical, biotech, or clinical research industry preferred + Track record of meeting or exceeding sales targets + Ability to collaborate effectively in a matrix environment + Strong problem-solving and analytical skills + Ability to manage multiple projects while maintaining quality + Travel required + Ability to be stationary for extended periods - Ability to lift and carry up to 20 lbs occasionally - Strong attention to detail and accurate data management capabilities - Regular and consistent attendance required Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. How will you make an impact? The MSAT Sr Director provides scientific leadership to ensure compliance, resilience & competitiveness of Thermo Fisher's commercialized Grow, Value Optimization and Late Lifecycle portfolio. The successful candidate is a Subject Matter Expert (SME) in Large and Small Molecule Drug Products and directs a team of Molecular Biologists, Chemical & Process Engineers, and Scientists. This team leads strategic, tactical and operational technical projects for the commercialized product portfolio, working closely with operations, QA, QC, and various supply chain and development functions. This role builds strong partnerships with functions such as Sales, Business Marketing, Quality, Planning, Regulatory, Procurement etc. This leader has a strong scientific background and drives successful commercialization of the current and future portfolio. They ensure successful New Product Introduction by prioritizing resources. The team manages Life Cycle Management projects, such as supply chain resilience, process optimization, and innovative improvements for efficiency, competitiveness, compliance, and health authority advocacy. The Sr Director possesses a strong approach for people leadership and talent development resulting in the continuous uplift in team technical capability and project delivery excellence. What will you do? Own the site's technical continuous improvement strategy in collaboration with Site Leadership. Encourage a team supporting projects at all stages of the product life cycle, delivering the following aspects: * Budget responsibility for team and related activities * Define and own lab experiments * Post PPQ, full ownership of all continuous process validation activities * Lead and coordinate large-scale technical projects from initiation to completion, defining scope, objectives, actions, timelines, and budget, and collaborating with cross-functional teams for successful execution. Prioritize projects to support supply chain and the value optimization targets. Lead strategic change management initiatives, engaging and influencing key partners at all levels of the organization. Develop and implement communication plans for successful adoption and implementation. How will you get here? * A degree in engineering, science, or a related field - Masters or PhD preferred. * 15 years of expertise in pharmaceutical processes for both conventional and enabling dosage forms, including DP characterization, stability profile understanding, and linking DP characteristics with bio-pharmaceutical performance. * A minimum of 5 years people leader experience, including technical and non-technical coaching and mentoring. * Knowledge and experience with both current and new technologies in chemical synthesis, biologics, and new modalities. * Strong experience and track record in technical transfer activities in commercial and clinical space to favor agility and fast time to market in a high VUCA environment (volatile, uncertain, complex, ambiguous). * Proven record of translating creative and innovative approaches into problem solutions and the timely project advancement. * Applied critical thinking and vision for the future with a strong record of analyzing and interpreting complex situations to provide clear direction. * Effective communicator with experience in collaborations and interactions, building strong relationships with partners and customers, including connections to academic and industry networks. About Thermo Fisher Scientific Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer! Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 130,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit ********************* If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance! Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Work Schedule** 12 hr shift/nights **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) **Job Description** **Position Summary:** Join a team that is unwavering in its commitment to delivering outstanding technical support and expertise to sterile pharmaceutical production 24/7! As a Process Engineer II, you will be pivotal in guaranteeing seamless operations by assisting with customer technical transfers, modifying current processes, and supporting auxiliary systems. Your efforts will be instrumental in driving process improvements to enhance safety, reduce costs, improve quality, and increase Overall Equipment Efficiency (OEE). Work closely with Engineering, Operations, Maintenance, Validation, and Quality teams to ensure compliance with regulations and cultivate a workplace that is free from injuries. **This is a 12-hour rotating night shift position, 6pm - 6am, following a 2-2-3 schedule.** **Key Responsibilities:** + Provide technical expertise and support to meet business unit objectives and improve OEE, maintaining system construction and documentation. + Diagnose and resolve complex process and equipment interactions to ensure system readiness, often collaborating with other teams and communicating resolutions to leadership. + Act as the Subject Matter Expert (SME) regarding equipment and process functionality for Production and Utilities. + Develop process flow diagrams, problem-solving guides, and advanced troubleshooting aids to increase efficiencies and repeatability, and train internal resources. + Offer SME input during the development of CAPEX Equipment Upgrades for compliance and efficiency on Sterile Fill/Finish equipment. + Coordinate planned interruptions for processing areas/building during shutdowns as required. + Develop, modify, and approve process equipment recipes while adhering to SOPs. + Offer data assistance for production and quality inquiries, suggesting resolutions and enhancement possibilities. + Collaborate with Engineering, Operations, Maintenance, Quality, and Safety teams on the production floor, dedicating 70-90% of your time during shifts. + Collaborate with collaborators to prioritize activities and resolve conflicts. + Document conditions, actions, and results of work performed in logbooks and shift reports. + Drive Continuous Improvements using metrics, TPM, 5S, and the PPI process. **Frequent Contacts:** Internal + Customer Facing Process Engineer, Maintenance, and Operations Colleagues. External + Equipment and Supply Vendors **Minimum Requirements/Qualifications:** + Associate's degree in Mechanical, Electrical, or Industrial Engineering + Three years of experience in processes. + Ideally 1+ years of Process Improvement experience applying Six Sigma, Lean, 5S, and Trend Analysis approaches. + Experience in regulated manufacturing environments within Biotechnology, Pharmaceutical, or Medical Device industries is a plus. + Knowledge of Data Integrity principles for automation systems and audit trail data is advantageous. + Outstanding attention to detail and organizational skills to manage time and prioritize tasks. + Strong verbal and written communication skills, along with the ability to establish and maintain effective working relationships. **Other Job Requirements:** + Adhere to OHS policies and procedures to ensure a safe and healthy workplace environment. + Perform other duties as assigned. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Work Schedule 12 hr shift/nights Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Loud Noises (Equipment/Machinery), Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Location/Division Specific Information: Greenville, NC How Will You Make an Impact?: Sets-up, operates, and maintains the classified environments and manufacturing equipment for pharmaceutical products. Requires proficiency in; cleaning, preparing equipment and components for operations, operating and troubleshooting mechanical equipment, following approved procedures and proper documentation. Position is a 12-hour shift from 6pm-6am or 6am-6pm on a 3-2-2 rotation. Overtime will be required. A Day in the Life: * Ensures operations are performed in a safe and responsible manner striving to create an injury-free and incident-free workplace. * Ensures pharmaceutical products in manufacturing are in accordance to Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMPs) and other batch related activities. Verifies and documents production activities in batch records, logbooks, etc. * Assists in troubleshooting operational and production problems in order to identify appropriate corrective actions. * Maintains/cleans classified environments/areas. * Communicates and works to resolve any production, quality or safety issues. * Complies with all job-related safety, cGMP, and other department procedural requirements. * Participates in the On the Job (OJT) training program, area safety initiatives, and area lean manufacturing initiatives. * Perform other related duties as required by the job or directed by the supervisor. * Trains new employees. * Performs other duties as assigned Education: High school diploma or equivalent required. Experience: Required: Minimum of 1 year of work experience in a manufacturing, operations, production, lab setting or related field Preferred: Experience in a cGMP environment Knowledge, Skills, Abilities: * Excels in a team environment. * Basic math skills. * Good verbal/written communication. * Attention to detail while maintaining a quality product. * Ability to perform repetitive work duties. * Ability to follow SOPs. Physical Requirements / Work Environment Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of medium weights of 25-50 pounds; occasionally pushing and pulling 50-100+ pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Ability to climb stairs and ladders. Full range of motion in upper and lower extremities. What We Offer: Compensation Competitive Pay Performance Related Bonus where eligible Annual merit performance-based increase Excellent Benefits Medical benefits Paid Time Off/Annual Leave Employee Referral Bonus Career Advancement Opportunities

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. **Location/Division Specific Information** Our detailed, goal-oriented Pharmacovigilance colleagues manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring. As part of your work with beginning-to-end trial experience, you will expand your knowledge and experience working on clinical trials through every stage of drug development. This includes management and oversight of all contracted services. Must be legally authorized to work in the United States without sponsorship. **Discover Impactful Work:** The Associate/Medical Director provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities. Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports ( e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR) **A day in the Life:** **General Support:** + Ensures tasks delegated to PVG are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific WPDs for assigned projects. Adheres to PPD's corporate policies and SOPs/WPDs. + Provides medical consultation to team members and answer all study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately. + Provides therapeutic training and protocol training on assigned studies, as requested. + Assists in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete. **Clinical Trial Support:** + Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies. + Discusses all medical concerns with principal investigators and clients (e.g.discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study. + Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported by study sites. + Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns. **Marketed Products Support:** + Manages signal detection activities, scientifically reviews aggregate reports, contributes to label updates, supports dossier maintenance and risk management activities. + Medically reviews adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc) as contracted. **Keys to Success:** **Education and Experience:** + MD or equivalent required. Active medical licensure preferred but not required. Candidates should have clinical experience in Neurology and formal training in Neurology (i.e residency and/or fellowship), along with patient treatment experience (comparable to 2 years) **For Medical Director Level:** + MD or equivalent required. Active medical licensure preferred but not required. Candidates should have a combination of clinical experience **and industry experience** as follows: + Candidates should have clinical experience in Neurology and formal training in Neurology (i.e residency and/or fellowship), along with patient treatment experience (comparable to 2 years)and one of the following: + Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry; Or + Direct experience in safety/Pharmacovigilance (comparable to 2 years) + Experience preference towards individuals with clinical development/medical monitoring In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Job leveling at Associate Medical Director or Medical Director will be determined during the consideration process, inclusive of education, experience, therapeutic area(s), and interview results. **Knowledge, Skills and Abilities:** + Therapeutic expertise across one or more medical specialty or sub-specialties + Strong decision-making, problem solving, organizational skills and analytical skills + Excellent oral and written communication skills + Working knowledge of relevant safety databases (e.g. Medra) + Flexibility to travel domestically and internationally + Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information + Proficiency in basic computer applications + Fluent in spoken and written English + Excellent interpersonal, influencing and team building skills + Understanding guidelines (FDA, ICH, EMA and GCP) + Working knowledge of biostatistics, data management, and clinical operations procedures + Ability to act as a mentor/trainer to other staff **Physical Requirements / Work Environment:** + Work is performed in an office environment with exposure to electrical office equipment + Occasional drives to site locations with occasional travel both domestic and international + Frequently stationary for 6-8 hours per day + Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists + Frequent mobility required + Occasional crouching, stooping, bending and twisting of upper body and neck + Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. + Ability to access and use a variety of computer software developed both in-house and off-the-shelf + Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences + Frequently interacts with others to obtain or relate information to diverse groups + Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration + Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task + Regular and consistent attendance **Benefits** We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Join Us and Make a Difference!** At Thermo Fisher Scientific, your work will make a global impact. From protecting the environment to ensuring food safety and supporting life-saving cancer research, we address the world's toughest challenges. **About The Role:** We need a committed Staff R&D Scientist to lead and assist in developing, optimizing, and validating innovative manufacturing processes. The main focus will be on Oral Solid Dose (OSD) Continuous Manufacturing. You will conduct experiments, analyze data, support product validations, and ensure smooth technology transfers to meet client and regulatory requirements. Experience applying data science or statistical analysis tools (e.g., Python, MATLAB) to support process development and optimization is highly desirable. Your expertise will be essential in achieving our ambitious goals and making a significant industry impact. **Key Responsibilities:** + Develop, scale up, and optimize OSD manufacturing processes, focusing on both continuous and batch operations. + Design and run experiments using statistical and data science tools to enhance process and product performance. + Serve as the technical lead in client discussions, providing scientific rationale for process decisions. + Lead technology transfers from R&D to commercial manufacturing with a focus on robustness and compliance. + Collaborate with quality, operations, validation, and analytical teams to advance development and commercialization. + Apply emerging technologies and industry trends to drive innovation and efficiency. + Maintain compliance with regulatory, safety, and quality standards throughout development activities. **Education:** Bachelor's degree in chemical engineering, chemistry, pharmacy, or a related field with 4+ years of experience, preferrable within oral solid dose, Master's degree with 2+ years, or Ph.D. with no experience required. **Experience:** + Proven experience in manufacturing, specifically in product or process development. This includes scale-up and technology transfer for immediate and controlled-release dosage forms. + In-depth knowledge of GMP, process validation, and regulatory requirements. + Strong problem-solving, communication, and project management skills. + Proficiency in programming languages such as Python or MATLAB. + Solid understanding of statistical tools and their application in process development. + Advanced knowledge of continuous manufacturing is preferred. **Why Thermo Fisher Scientific?** + Career Development: Opportunities for learning, growth, and leadership. + Benefits: Competitive pay, healthcare, retirement plans, and more. + Inclusive Culture: We value different perspectives and cultivate an encouraging environment. + Purposeful Work: Join a team that's making a tangible difference in the world. Do you thrive in dynamic environments and love solving sophisticated challenges? If so, we want to hear from you. **Reasonable Accommodations** We are committed to providing reasonable accommodations to individuals with disabilities. If you require assistance during the application process, please contact our HR team. Thermo Fisher Scientific is an Equal Opportunity Employer. We value diversity and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Work Schedule** 12 hr shift/nights **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) **Job Description** Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our global organization of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit ******************** . **GROUP/DIVISION SUMMARY** The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization. **POSITION SUMMARY** In this position, you'll drive quality execution across the sterile operations including manufacturing, filling, packaging and inspection, and associated non batch specific activities in for both commercial and product development services products. Additionally, this position will provide quality guidance and expertise for implementation of practical process improvements and continuous improvement initiatives. **Typical hours are 6p - 6a, on a 2-2-3 rotation.** **Key Responsibilities:** + Perform daily quality assessments of facility, personnel, and documentation both classified and non-classified areas to uncover errors or deficiencies, assure quality, and compliance per site procedures and cGMPs. + Daily interaction with employees to assist with troubleshooting, documentation corrections/notes, and guidance with aseptic technique + Champions quality culture by aiding personnel in understanding application of policies and controls + Participates in RAPID event response and provides quality guidance for deviation events + Advances deviation events to the appropriate area and quality management + Performs quality review and approval of procedures, training documents, and forms of moderate to high complexity + Performs quality review and approval of deviation and change control of moderate to high complexity + Participates as the quality assurance representative in Root Cause Analysis to support deviation investigations of moderate to high complexity + Performs quality batch record review + Aids in identification of continuous improvement opportunities; Participates in practical process improvement initiatives **Qualifications:** + Bachelor's degree, preferably in technology, engineering or microbiology related field required. + 5+ years of experience with previous experience in Quality Assurance or Quality control or Operations/Manufacturing required + Previous experience in pharmaceutical industry, preferably with QA oversight experience within an aseptic or steriles filling and manufacturing operation strongly preferred. Experience in other GMP environments may be considered (i.e. ISO 9001) + An equivalent combination of education and relevant experience may be considered. + Ability to capture data, analyze & troubleshoot process issues, equipment problems along with production leadership + Ability to troubleshoot process and equipment issues + Hard-working, demonstrated ownership & responsibility; + Ability to lead, support & empower a team/peers + Technical Writing experience + Professional certifications (ex: CQA) and training (Six Sigma) are a plus + Primary responsibilities require consistent production floor presence which necessitate physical fitness for prolonged standing, walking, and repetitive bending, and aseptic and non-aseptic gowning. **Physical Requirements:** Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations. Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time Manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds. Arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time. Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time. Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally. **Benefits:** We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

COMPANY INFORMATION Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $45 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our distributed team of more than 130,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. Thermo Fisher Scientific is an equal opportunity employer. For more information, please visit ********************* GROUP/DIVISION SUMMARY The Drug Product Division (DPD), a business within the Pharma Services Group, operates as a Contract Development and Manufacturing Organization (CDMO) for large & specialty pharma and biotech companies. The business offers development services & commercial production of drugs, improving the life of millions of patients every day. POSITION SUMMARY As a Director, Manufacturing Engineering Steriles, you will support the 3 steriles manufacturing sites in North America. This is a technical role that supports the commercial operations including root cause analysis and problem solving on infrastructure and machine issues on the sites. You will remove roadblocks and drive intensity to the operations, maintenance activities, and capital project. You will be responsible for working alongside the sites to guarantee capital project execution, establishment, and oversight for all major investments to align with the business plans. This role will be a key connection to the DPD- EU team growing consistency in the sterile network. You will collaborate with Quality, IT, Supply Chain, and Sustainability teams to ensure that the Capital, Engineering, and Maintenance teams adhere to policies, master planning, shutdown planning, and meet company commitments. This is an outstanding change to create an impact with Thermo Fisher Scientific. KEY RESPONSIBILITIES Technical Support Machine/ Site Infrastructure Master Planning and Business continuity planning Asset Life Cycle Maintenance Excellence Program Fit and Finish Programs Data and information exchange Capital project governance New Asset Start up and Readiness Improve use of GEPs to drive standardization QUALIFICATIONS AND REQUIREMENTS Education + Bachelors degree in Engineering or related field + Masters Degree is desirable Experience: + 10+ years experience in Engineering with a proven track record + Knowledge and experience with Sterile Pharmaceutical manufacturing and regulations Knowledge, Skills, Abilities: + Outstanding leadership and management skills. + Ability to implement global standards. + Strong analytical and problem-solving skills. + Experience in leading teams and/or initiatives is helpful. + Self-directed with strong partner development skills. + Ability to lead and influence in a matrix and global environment. + Consistent in delivering results. **Compensation and Benefits** The salary range estimated for this position based in North Carolina is $160,100.00-$225,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: + A choice of national medical and dental plans, and a national vision plan, including health incentive programs + Employee assistance and family support programs, including commuter benefits and tuition reimbursement + At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy + Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan + Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: ***************************************************** Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

As the GCP Compliance and Process Lead at Thermo Fisher Scientific, you will play a pivotal role in driving world-class quality and compliance strategies. This is an exceptionally outstanding opportunity to influence and improve our healthcare operations, ensuring flawless execution of regulatory standards. Your expertise will be crucial in determining and successfully implementing advanced quality assurance processes. **Role:** GCP Process Lead, FSP Dedicated **Location:** Remote, USA **Key Responsibilities** + Facilitate and manage cross-functional teams' GCP inspection readiness activities throughout the study lifecycle. + Embed real-time inspection readiness strategies into daily operations, collaborating with study teams. + Provide just-in-timeguidanceon key operating model processes and required documentation, prioritizing real-time inspection readiness. + Manage and guide teams on inspection readiness planning, developing and maintaining readiness plans and tools. + Facilitate the development of key inspection deliverables, including functional presentations and study team preparation for audits. + Ensure high-quality deliverables for global studies by guiding adherence to operational processes and documentation. + Champion proactive prioritization of inspection readiness, focusing on GCP process excellence. + Engage with subject matter experts in inspection readiness activities and study-level risk assessments. + Coordinate and manage TMF performance and processes, ensuring compliance and inspection readiness. + Lead and participate in meetings for assigned projects, ensuring effective communication and addressing customer concerns. + Maintain project management documentation, including plans, timelines, and progress reports. + Coordinate activities to enable study team readiness for internal audits and regulatory inspections. + Manage functional teams during inspections, collaborate with SMEs, and ensure timely follow-up **Qualifications** + Good understanding of clinical trial processes related to sponsor and CRO activities, including but not limited to sponsor oversight, issue management, site management, and clinical monitoring + Preferred experience with inspection preparation, including hands on regulatory inspection activities + Minimum of6+ years clinical research experience in pharmaceutical or biotechnology field; with at least two years specifically supporting clinical Quality & Compliance + Solid knowledge of drug development, clinical trial management, and/or GCP compliance processes + Proven awareness of sponsor oversight requirements and regulations + Experience with CROs and outsourced clinical trial activities, sponsor experience preferred + Experience in problem solving, negotiations, and collaborative team building and other collaborators is required + Strong understanding of regulatory requirements within clinical trials, industry standards, and related documentation needs + Bachelor's degree preferred or commensurate with experience + Must be able to efficiently apply computer software programs like Microsoft Office for general use, project management, and presentations + Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel + Domestic/international travel (5-20%) may be required **Inclusion and Collaboration** At Thermo Fisher Scientific, we value diverse experiences, backgrounds, and perspectives. Our inclusive culture fosters collaboration and innovation, empowering each team member to contribute to our mission of advancing science and healthcare. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. DESCRIPTION: As a Systems Analyst III at Thermo Fisher Scientific, you will play a crucial role in supporting and enhancing our enterprise systems and applications that enable organizational success. You'll collaborate with cross-functional teams to analyze business requirements, design solutions, and implement system improvements while ensuring compliance with regulatory standards. You'll leverage your technical expertise and business acumen to resolve complex issues, lead projects, and drive continuous improvement initiatives. This role offers opportunities to make meaningful contributions through innovative solutions while working with current technologies. REQUIREMENTS: - Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in systems analysis, business requirements gathering, and solution design - Preferred Fields of Study: Computer Science, Information Technology, Engineering, Business Administration or related field - Professional certifications in relevant technologies or methodologies preferred - Strong knowledge of ERP systems (SAP, JD Edwards, Oracle) and enterprise applications - Expertise in data analysis, reporting tools, and database technologies (SQL, Oracle) - Experience with GxP regulations, CFR Part 11 compliance, and validated systems in regulated environments - Proven ability to translate complex business requirements into technical specifications - Advanced project management skills and experience leading cross-functional initiatives - Strong analytical and problem-solving capabilities - Excellent communication and interpersonal skills for collaborating with teams - Demonstrated ability to work independently and handle multiple priorities - Proficiency with Microsoft Office suite and relevant technical tools - Experience with ITIL processes and change management - Knowledge of software development lifecycle methodologies (Agile, Waterfall) - Ability to guide team members and provide technical leadership - Language skills: Fluent in English; additional languages beneficial Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Greenville, NC The Business Manager develops and maintains the relationship with commercial clients, through understanding the client's organization and business needs. This role enhances client service and satisfaction in the overall best interest of the company. They build a foundational relationship with business accounts which represent a high level of volume and complexity in a site. This role generates business growth through identifying and developing business opportunities with our existing clients and partnership with Sales. Key Responsibilities * Develop and manage the strategic business relationship with existing and new clients. * Build client relationships, partnerships, and identifying growth opportunities with existing clients. * Facilitate the execution of the portfolio management strategy for a program of clients and/or projects. * Serve as escalation point for critical needs, prioritization, and decision making. * Work closely with project team members to ensure best in class service for the client. * Drive contract compliance; generate and negotiate new contracts and updates to existing contracts with input from the Portfolio Manager, Business Development Executives, and site leadership. * Manage Demand portion of S&OP processes; use business intelligence and client input to drive long-term demand and capacity scenario planning. Assist in development of annual operating plan. * Determine solutions aligned with site strategy as well as business and client requirements; understand how the technical and business specifics contribute to this overall strategy Education & Experience * Bachelor's degree in science or business is required. Master's degree in business or science is helpful. * Five years of previous related experience in project management, account management, sales or marketing with internal or external client-facing responsibilities. * Experience with budgeting and forecasting is required. Knowledge, Skills, Abilities * Some understanding of project management principles is required. * Knowledge of pharmaceutical or contract manufacturing industry is strongly preferred. * Outstanding communication skills; capable of maintaining optimistic communication with clients and internal customers, while handling complex situations. * Highly skilled at conflict resolution and negotiation.

**Work Schedule** 12 hr shift/days **Environmental Conditions** Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) **Job Description** When you are part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have a real-world impact, and you'll be supported in achieving your career goals. **Location/Division Specific Information** Greenville, NC Pharmaceutical Group/Drug Product Development **Day Shift 6AM - 6PM 2/2/3 rotation** **How will you make an impact?** Lead the Steriles North manufacturing team providing technical, mechanical and leadership to the operations activities in the assigned. Supervises operations employees of high-quality pharmaceutical products according to schedules, cost, and quality standards, while maintaining employee engagement, safety performance, and ensuring adherence to all regulatory control and documentation procedures. **Role and Responsibilities:** · Help to ensure successful start-up of new Sterile facility by being a member of the site project team. · Ensures new processes/procedures are developed and implemented in a timely manner to coincide with daring project timelines. · Assists with building and training the production team that will staff the new Sterile Filling lines. · Provides leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving interpersonal goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and crafting a climate where staff are motivated to do their best. · Supervises employees in day-to-day operations by spending at least 50% of available time collaborating with employees to ensure that every product unit is of high quality and exceeds all current Good Manufacturing Practices (cGMPs). · Ensures that production schedule is met by distributing workload in accordance with changing priorities. · Ensures production operations are properly controlled and regulatory compliance requirements are met by ensuring batch documentation is accurate, Standard Operating Procedures (SOPs) are accurate, training is current, critical documentation templates are accurate, equipment is in good repair and current calibration, and high standards of housekeeping are maintained in all areas of responsibility. · Evaluates/solves operation problems by reviewing the area of concern, developing potential solutions, technically evaluating, or testing the solutions, and preparing summary reports/recommendations for management. · Assures compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing, and maintaining systems. · Prepares performance reviews for all employees and evaluates personnel performance according to performance management process. Provides feedback for continuous improvement. Holds staff accountable and employs coaching process as required. Assists in hiring staff as needed. Maintains a work environment with cultivate partnership and supports the company's continuous improvement process. · Provides training and/or opportunities for career development of staff. **Education:** Bachelor's degree in Science, Engineering, Administration, or other STEM related program is required. Experience: Minimum four (4) years of technical and/or manufacturing experience. One (1) to five (5) years of supervisory experience preferred. Experience in project management and leading start-up, preferable. Experience with life virus vaccine techniques and procedures Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered. **Knowledge, Skills, Abilities:** Knowledge in GMP's and FDA regulations. Technical writing experience, preferred. Technical and operational knowledge of start-up of aseptic environment for live virus vaccines. Strong decision-making skills. The ability to handle multiple ongoing activities and ability to prioritize tasks. Outstanding attention to detail and organizational skills. Capable of flourishing in a fast-paced environment, able to handle pressure and effectively manage multiple tasks. Demonstrates ability to maintain a high degree of confidentiality. Excellent social skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters. Highly effective verbal and technical written communication skills. Able to create SOP's, work instructions and manufacturing process. Demonstrated ability to manage and lead professional staff in order to achieve goals, evaluate and resolve complex technical problems. Ability to motivate, energize, and retain key staff by direct interactions with supervisors and staff. Lead by example set the example for others to follow At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Summarized Purpose: Thermo Fisher Scientific Clinical Research Group is a leading CRO. The Clinical Research Group (CRG) has again been recognized for excellence in the 2025 CRO Leadership Awards. This is the 14th consecutive year the business has been honored through this award program, which is based on a survey of pharmaceutical and biotech professionals conducted for Clinical Leader and Life Science Leader magazines We are recruiting a Sr. Global Marketing Manager to lead business-to-business (B2B) marketing efforts for our Medical Communications programs and our Patient First Digital Solutions (PFDS).In collaboration with the Global Market Development Director, the Global Marketing Manager is responsible for creating and executing customer-centric, B2B strategic marketing plans to effectively, and competitively, position the Thermo Fisher Clinical Research Group in the market. The individual in this role will be responsible for partnering closely with business leaders to create strategic marketing plans that support delivery of business goals. **Essential Functions and Other Job Information:** + In collaboration with the Global Market Development Director, help develop and implement differentiated enterprise-level B2B marketing programs around our Medical Communications and PFDS business that enable business strategy, drive awareness, demand generation, and revenue growth: + Develop marketing plan and/or campaign budgets for Med Comm (and PFDS) business solutions, including developing and updating value propositions, messaging, and positioning documents for commercial communications + Address sponsors' needs and pain points around the challenges of clinical research site selection through marketing programs that demonstrate our understanding of study protocol complexities and schedules. + Develop foundational commercial materials to support general selling of our solutions + Understand the selling resourcing model across the business and help optimize the marketing mix to support this + Support the development and implementation of marketing deliverables, including compelling value propositions, promotional positioning, messaging materials and selling resources/collateral + Develop and maintain all marketing campaign activities, in line with marketing budgets, and monitor KPIs to assess campaign success; regularly review and optimize plans in close collaboration with business stakeholders based on identified KPIs + Share best practices with marketing colleagues across Clinical solutions and TAs. + Partner with internal and external agencies, and establish strong working relationships to align across all marketing verticals, including Content Marketing, Marketing Tech & Operations, ABM and Brand Execution, to develop and launch marketing campaigns + Monitor marketing programs to measure performance against plan, budget, and key performance indicators, provide marketing performance updates to marketing and business leadership, and make recommendations to optimize marketing performance based on results + Support brand presence at major conferences and events **Education and Experience:** + Bachelor's degree required in Science, Health Sciences or Business + MBA an advantage + 2-3 years pharmaceutical/CRO/medical device experience with knowledge of the industry and healthcare environment + **_n some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role._** **Knowledge, Skills and Abilities:** + Prior brand marketing background with strong history of achievement and performance, and solid working knowledge of sales and marketing relationships + Strong interpersonal skills are required, as well as excellent verbal communication and presentation skills + Experience working across cultures and partnering with colleagues who represent a diverse selection of experiences and skills + Ability to effectively prioritize, manage, and deliver multiple projects under pressure + Effective planning, analytical, organizational and project management skills + Demonstrated ability to manage outside agencies in order to fulfill project objectives + Understanding of corporate brand and ability to work within set brand guidelines + Strong skills in Microsoft Office suite Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Role Overview Complete Technology Transfer activities by performing manufacturing process development for Injectables products to commercial lines. Using experimental design, establish formulation processes, product pathway and select components for successful scaleup. Support client calls, prepare necessary documentation (including but not limited to work orders, protocols, summaries, with minimum supervision), and provides scientific justification as needed and update status of project work. Discover Impactful Work! Technically supports day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant. Leads technical/scientific process/product/project activities to implement strategies and technical solutions. Drives creation of processes, single use systems, and equipment designs for clinical, scale up, and/or registration batches, including technology transfer of projects from clients. Makes decisions that involve direct application of technical knowledge. A Day in the Life. Design, implement, and evaluate studies, lead tech transfer, commercial scale-up and support process validation. Represent the organization on formal technical and scientific forums. Lead and/or participate in problem solving and project work for formulations, equipment and processes. Write/revise work orders for new processes, FORMs, reports, memos, and protocols as required. Independently manage projects, proficient in evaluating and organizing all technical aspects of the project to achieve necessary landmarks and turning points. Support manufacturing operations, change controls, investigations as subject matter expert (SME), resolve accurate CAPAs. Assess material changes and determine change impact. Support development of proposals and timelines for projects, leading relevant client meetings. Review new bid quotes, protocols, technical documents, results, and reports. Support implementation of Electronic Batch Records Keys to Success Education: Bachelor's of Science in Chemistry, Biochemistry, Biology, Pharmaceutical or related physical science. Experience: Bachelors and 3+ years confirmed experience CMO or Pharmaceutical product development experience PREFERRED Equivalency: Equivalent combinations of education, training, and meaningful work experience may be considered. Knowledge, Skills, Abilities: Advanced knowledge of variety of aspects of a subject area and working knowledge of principles and concepts in other relevant technical subject areas. Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry. Detailed knowledge of Good Manufacturing Practices. Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Excellent critical and logical thinking skills. Effective written, interpersonal, and presentation skills, including leading technical discussions with internal and external clients. Ability to work on multiple projects simultaneously. Proficiency at developing knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures. Capability to keep current with scientific literature and industry trends relating to process technologies. Ability to develop technical solutions. Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods.