Thermo Fisher Scientific jobs in Greenville, NC

**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, Cold Room/Freezers -22degreesF/-6degrees C, 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, Will work with hazardous/toxic materials **Job Description** **Title: Lead Packaging/Labeling Technician** 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. **Division/Site Specific Information** As part of the Drug Product Division (DPD), the Greenville, North Carolina site is a multi-purpose pharmaceutical development, manufacturing, and packaging campus. 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. This position is a 12-hour Night shift from 6pm-6am on a 3-2-2 rotation. Flexibility to work overtime as needed. **Discover Impactful Work:** As a Lead Packaging/Labeling Technician at Thermo Fisher Scientific, you'll play a vital role in ensuring our pharmaceutical products meet high standards. This position allows you to bring your skills to bear in a dynamic and collaborative environment, supplying to a healthier, cleaner, and safer world. **A Day in the Life:** + Receive daily assignments and manufacturing schedule from Supervisor. Assign work to self, processors and servicers so that schedule can be met. Coordinate work based on schedule. Advise supervisor if there is a problem meeting the schedule. + Ensure processors perform efficient manufacturing processes. Perform some manufacturing processes. Apply aseptic technique knowledge and ensure processors comply. + Maintain quality products and equipment in manufacturing. Observe and implement all current Good Manufacturing Practices (cGMPs), safety precautions and housekeeping practices in performing duties. Align with cGMP, Occupational Safety Health Agency (OSHA) and company rulings. Keep area neat and clean. + Assist supervisor in training in Standard Operating Procedures (SOPs), cGMPs, safety procedures. + Perform other duties as assigned. **Keys to Success:** **Education** + High school diploma or equivalent is required. **Experience** + At least 3 years of manufacturing experience preferred in a regulated environment required, preferably in Steriles. + Strong technical background highly preferred. **Knowledge, Skills, Abilities** + Knowledge of sterile operations including aseptic techniques, sterilization and compounding. + Strong leadership ability + Ability to efficiently collaborate to achieve goals and expectations. + Ability to learn quickly. + Ability to work independently + Ability to achieve and maintain qualifications to work in a clean-room environment. + Good attendance record. + Effective verbal and written communication skills. + Basic digital literacy. + Strong communication skills. + Flexibility with departmental work schedules, including overtime and all shift operations. **Physical Requirements** + Work in a clean-room which is a controlled environment for temperature and humidity having low ambient noise. + Wear gowning which includes: gloves, hair & beard net and face cover, safety glasses with no makeup / jewelry, and the like. + Use Personal Protective Equipment (PPE) and understand chemical hygiene. + Infrequently lift and manipulate up to 25 pounds max unassisted. + Stand and move about including reaching, bending, stooping, grasping. + Use hand tools and equipment including forceful gripping, grasping, pushing and pulling. + Job requires basic mobility and coordination to navigate office areas; ability to stand, walk, bend, and carry light to medium objects (10-35 pounds). **Benefits** We offer competitive remuneration, annual incentive plan bonus scheme, 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.

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 The Quality Assurance (QA) Supervisor, Batch Release oversees QA activities and programs such as auditing, record review, final product functions, document management, complaints, oversight of quality systems, and investigations within QA. This role provides leadership to assigned staff, ensuring compliance with regulatory requirements and maintaining high standards of quality. Key Responsibilities: * Champion Quality Culture: Aid personnel in understanding the application of policies and controls to promote a quality-focused culture. * Leadership and Empowerment: Lead organizational change, empower staff, and cultivate relationships to build effective teams. * Engagement and Motivation: Drive engagement and create a motivating climate to support staff in achieving personal career goals while meeting organizational goals. * Supervision: Supervise staff performing quality and manufacturing audits, record review, final product release functions, complaints, APR, validation, and investigations. * Quality Assurance: Ensure the quality of methods, processes, materials, and products through coordination and review of operations, staff training, and system/process improvements. * Technical Expertise: Provide technical expertise for systems and new product introduction. * Regulatory Compliance: Assure compliance with all applicable regulations by interpreting regulatory requirements and maintaining systems. * Resource Management: Lead resources by budgeting and ensuring staff availability to meet business needs. Participate in budget planning and cost-saving projects. * Performance Management: Ensure staff have performance plans with metrics in place, conduct performance reviews twice a year, and identify and handle performance/field issues. * Training and Development: Provide training and career development opportunities for staff. * Risk Assessment: Conduct risk assessments and take appropriate actions to ensure adequate controls for product quality, safety, and business risks. Qualifications: * Bachelor's degree required, preferably in a scientific related field. * 5+ years of experience in a cGMP manufacturing or QA Operations environment with strong knowledge of GMP operations and regulations. * 2+ years prior experience in manufacturing operations, preferably in pharmaceutical, food, or cosmetic industry. * 2+ years supervisory/leadership experience required. * Equivalent combinations of education, training, and relevant work experience may be considered. * Proficient in cGMPs applicability and decision making. * Familiarity with SAP, TrackWise, Electronic Document Management System (eDMS), and Laboratory Information Management Systems (LIMS) is an advantage. * Familiarity with concepts, practices, and procedures related to Batch Release activities. * Ability to manage and lead professional staff to achieve goals and resolve complex technical problems. * Strong organizational skills and attention to detail. * Self-starter, mature, independent, and dependable. * Ability to work in a fast-paced environment under pressure and multi-task. * High degree of confidentiality and discretion. * Effective time management and prioritization skills. * Excellent interpersonal skills to establish and maintain effective working relationships. * Highly effective verbal and written communication skills. 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. 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

(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

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.

**Summarized Purpose:** Drives pipeline for the company by working collaboratively with field representatives, internal leadership teams and prospective clients to generate new meetings and opportunities for an assigned territory. **This role will support our Real-World Evidence/Data Analytics team** **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. **Qualifications:** Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 yrs) **_In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role._** Knowledge, Skills and Abilities: + Strong ability to develop a territory management strategy, identify and develop sales leads within the territory, professionally present capabilities, and collaborate with others to hand-off the relationship internally + Ability to coordinate information from and follow-up with diverse sources in order to develop relationships with internal and external clients + Strong written and verbal communication skills to ensure professional interactions with internal and external clients + Ability to collaborate and integrate with various internal departments + Thorough knowledge and understanding of the industry, the company, and functional areas in order to strategically generate leads + Adept at sales automation systems and the Microsoft Office suite + Excellent organization and time management skills in prioritizing daily activities and responsibilities with focus on target + Ability to multitask in a fast paced environment + Excellent problem solving skills + Ability to work collaboratively within a matrixed team environment 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.

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) **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. **Excellent Benefits Package** Review our company's Total Rewards (****************************************************** Medical, Dental, & Vision benefits-effective Day 1 Paid Time Off & Holidays 401K Company Match up to 6% Tuition Reimbursement - eligible after 90 days! Employee Referral Bonus Employee Discount Program Recognition Program Charitable Gift Matching Company Paid Parental Leave Career Advancement Opportunities **Location/Division Specific Information** Greenville, NC **RELOCATION ASSISTANCE IS NOT PROVIDED** + **Must be legally authorized to work in the United States WITHOUT SPONSORSHIP OF ANY KIND NOW OR IN THE FUTURE.** + **Must be able to pass a comprehensive background check, which includes a drug screen.** We have industry-leading sterile injectable facilities providing solutions to take essential products from pre-clinical to the market. Pharmaceutical products come in many different dose forms including inhalations, oral dose, cream/ointment and injectables. **Key Responsibilities:** + Manage, lead, schedule, and complete multiple high-complexity projects with multidisciplinary departments to ensure flawless results. + Serve as the principal validation liaison, negotiating with clients on agreements and resolving significant validation, product, and regulatory issues. + Prepare, review, and approve production, validation, and audit reports, as well as master batch record documents, procedures, and rationales. + Evaluate new regulations and changes to existing ones, performing gap analysis to determine and address deficiencies. + Establish and implement systems to achieve process improvements and efficiencies. + Coordinate regulatory inspections performed by the FDA, MCA, and other agencies. + Defend policies, procedures, rationales, and methods during regulatory and client audits. + Establish and supervise quality programs and plans, such as validation, QAT, and supplier certification. **Qualifications:** + High School Diploma or equivalent experience required. + Bachelor's degree in Engineering or a Biological science-related field preferred. Four years of relevant experience may substitute for a degree. + Proven work experience in the pharmaceutical or regulated industry preferred. + Capability to thrive in a fast-paced environment while managing multiple tasks effectively. + Outstanding time management and prioritization skills. + Outstanding interpersonal skills for maintaining effective working relationships, with highly effective verbal and written communication skills. 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. **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.

**Work Schedule** First Shift (Days) **Environmental Conditions** Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Fluctuating Temps hot/cold, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) **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. **Greensboro, NC** _Candidates must reside within a 50-mile radius of Greensboro, NC. Additionally, the position requires the ability to respond to assigned customer sites within one hour of notification._ **How do we make an impact?** Unity Lab Services provides a single source for integrated lab service, support, and supply management. Our customized service offerings and world-class service experts have the flexibility and experience to uniquely address our customer's laboratory's business needs. **What will you do?** + Travel to provide support at multiple customer facilities for scheduled and unscheduled gaps in coverage; in some cases, for extended periods. + Inventory Management: Stock room, POU management, dispensing of products, etc. + Order Management: Order entry, order expediting, customer service support, etc. + Chemical Management Receive, register, and track chemical containers, etc. + Glass wash Operations: End-to-end glass wash sterilization processes including inspection of glassware, etc. + Dock and Shipping Management + Drive Process Improvement culture + May perform other responsibilities as assigned by management This role is a traveling position covering the XX region. Travel will be required 70-80% of the time. The ideal employee will be in either Greensboro, NC or the RTP, NC area. **Education** High school diploma or equivalent required. Bachelor's degree in a related field preferred, or a combination of education and experience that demonstrates the required skills. Military Service/Training in lieu of a degree may also be considered. **Experience** + 4 years of related experience within a laboratory setting is preferred. Experience working in customer service preferred. + GxP Experience and IATA/DOT certification, knowledge of OSHA General Industry requirements are also a plus. **Knowledge, Skills, Abilities** + Strong verbal and written communication skills, and desire to deliver excellent customer service. This includes maintaining a professional appearance and demeanor in all interactions and upholding Thermo Fisher Scientific's values. + Demonstrates computer proficiency and possesses intermediate skills in Microsoft Office suite of software. Uses organizational skills to multi-task and meet due dates as needed. + Demonstrates the ability to understand the complexity of various work environments and work safely following all policies and procedures. **Physical Requirements / Work Environment** + Work areas may include spaces where chemical-based allergens are in use (such as penicillin, tetracycline, etc.) + Depending on the area of the building, personal protective equipment must be worn, including lab coats, coveralls, hoods, facemasks, hairnets, safety gloves, steel-toe shoes (required for all colleagues), bump hats, and/or safety glasses. + Regularly required to lift 30 - 40lbs, and up to 50lbs occasionally. + Regularly use equipment including pushcarts, pallet jacks, mobile cylinders, forklifts, etc. to push/pull up to 100lbs + Regularly required to stand, walk and conduct manual material handling (twisting, bending, reaching, lifting, etc.) for prolonged periods. + Ability to work in environments with varied temperatures (cold rooms, outside, etc.) + Ability to work overtime or independently as needed. **Benefits** We offer competitive remuneration, 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! **Apply today! ****************************** Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does 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.

The Drug Product Division (DPD) is one of the three divisions that make up the Pharma Services Group (PSG) in the Biopharma Services (BPS) Sector at Thermo Fisher. We have more than 9,000 colleagues across 13 sites who specialize in taking sterile injectable, oral solid dose and softgel drug products from development to commercialization. As the Contract Development Manufacturing Organization (CDMO) market leader, we have built a reputation for scientific and technical excellence, and DPD has benefitted from capital investments in capacity expansion and new capabilities to ensure our long-term growth as we continue to meet our customers' evolving needs. * 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. How Will You Make an Impact The Senior Quality Specialist - Project Lead at Thermo Fisher Scientific plays a crucial role in providing technical leadership and Quality oversight for a Sterile Manufacturing Environment, ensuring compliance with pharmaceutical regulations. This position is responsible for maintaining full company compliance to prevent regulatory actions that could hinder product quality, lead to stoppages, or impact customer satisfaction. A Day in the Life * Leads projects of moderate complexity, conducting compliance assessments, making decisions on regulatory requirements, drafting new procedures, and ensuring adherence to current regulations. * Oversees the quality of methods, processes, materials, and products by coordinating and reviewing group operations, providing staff training, and assessing/improving systems and processes. * Responsible for reviewing and approving procedures, training documents, forms, deviation, and change control of moderate to high complexity. * Performs risk assessments and takes appropriate actions to ensure adequate controls related to product quality, safety, and business risks. * Act as a technical resource for system support and new product introduction by interpreting regulatory requirements and establishing systems. * Makes decisions on compliance issues within facilities, equipment, manufacturing, and support areas, considering the level of risks related to compliance and product quality. Education * Bachelor degree required, preferably in technology, engineering, scientific field or related area required. Experience * 7+ years of experience in Quality Assurance, Quality Control, or Operations/Manufacturing required. Knowledge, Skills, Abilities * Project management expertise * Strong knowledge of regulatory requirements and quality standards * Excellent interpersonal and leadership abilities, attention to detail, organizational skills, effective communication skills, negotiation skills, and understanding of quality systems and technical writing. * Professional certifications (e.g., CQA) and training in Six Sigma are beneficial. * Demonstrated commitment to fundamental principles of Integrity, Respect, and Excellence is essential. * Ability to work independently and to remain firm in complex situations is required in this fast-paced environment. 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 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 Hourly Pay Rate * Additional shift differential for 2nd shift and 3rd shift positions * 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 Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today: **************************** 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. Accessibility/Disability Access Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at ***************. Please include your contact information and specific details about your required accommodation to support you during the job application process. * This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. **Discover Impactful Work:** Provides operational leadership for the department, overseeing innovative solutions including regulatory expertise and client interface to provide strategic regulatory intelligence and guidance for product development from preclinical through registration and product optimization. Oversees projects and participates in strategic initiatives, acts as lead subject matter expert. Acts as liaison with internal and external clients in the provision and marketing of regulatory services. **A day in the Life:** - Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Promotes all aspects of the company's Equal Employment Opportunity policy and Affirmative Action Plan. Assures department adherence to good ethical and regulatory standards. - Provides regulatory consulting and strategic advice to internal and external clients to determine the most appropriate regulatory and product development strategy for their products. Provides project specific strategy, technical expertise and coordination oversight for key clients' projects. Serves as the executive contact for key clients for all issues, including attendance at regulatory authority meetings and other public relations functions, which may be held face-to-face (F2F) or virtually. Ensures quality performance for key/managed projects. - Oversees project budgeting/forecasting to include creative input as to shifting of resources, allocations etc. to respond to a change in scope of personnel requirements to stay within project budget. Leads and participates in project meetings. - Ensures identification of out-of-scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modification. - Collaborates with business development and senior management in pricing and securing new business by making presentations to clients, developing and reviewing bid proposal texts and budgets and conducting contract negotiation through to closure with the client and BD. Actively engages in business development activities looking to attract collaborative and stand-alone projects. - Pursues existing clients who have a need for services to win more business. - Contributes to development and implementation of global/regional function/plans. - Ensures compliance with relevant organizational and department Standard Operating Procedures (SOPs) and Work Instructions (WIs). - Develops strategy and leads the development and implementation of processes and procedures to increase productivity and accuracy within the team. **Keys to Success:** **Education and Experience:** + Bachelor's degree or equivalent and relevant formal academic / vocational qualification + Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years). + 5+ years of management responsibility + Strong leadership skills _In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role._ **Knowledge, Skills, Abilities** -Mastery of English language, communication and negotiation skills, both oral and written, as well as local language where applicable. - Sharp attention to detail and quality with advanced editorial and proofreading skills. - Accomplished interpersonal skills to work effectively in a team environment and act as a liaison with other departments. -Advanced computer skills including the use of Microsoft Word, Excel, PowerPoint, Adobe Acrobat, and the capability to learn new technologies. -Excellent organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities, and handle multiple projects. -Professional negotiation skills. -Capable of working independently and exercising independent judgment to assess sponsor regulatory needs, propose innovative regulatory strategies, work with project team members to produce compliant deliverables, and ensure audit readiness. -Advanced understanding of global/regional/national requirements and regulatory affairs procedures for clinical trial authorization, licensing, and lifecycle management. -Expert knowledge of ICH and other global regulatory guidelines, with in-depth expertise in regulatory specialty areas such as preclinical, clinical, CMC, MDD, publishing, etc. -Advanced understanding of medical terminology, statistical concepts, and guidelines. -Sharp analytical, investigative, and problem-solving skills. -Advanced understanding of budgeting and forecasting, with the ability to interpret data. -Recognized executive presence with consultation and presentation skills. -Key representative of the company and clients at regulatory authority meetings and other public relation functions. -Effective critical and strategic thinking skills. -Capable of developing, supervising, evaluating, and mentoring departmental personnel, as well as delegating tasks and facilitating the completion of assignments. -Capable of contributing to global and regional functions implementation, resourcing, development, and expansion. -Capable of driving innovation in developing new ideas related to process improvements. -Excellent judgment, analytical, decision-making, and interpersonal skills to manage complex projects in parallel and manage rapidly changing priorities. -Capable of independently learning new technologies and providing strategies for tools/systems improvement to meet global regulatory requirements. -Capable of identifying and assessing risks and impacts to core functions. **Physical Requirements / Work Environment** Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: + Work is performed in an office environment with exposure to electrical office equipment. + Occasional drives to site locations, frequent travels 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. + Moderate 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 complex 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, relates sensitive information to diverse groups both internally & externally. + Ability to apply abstract principles to solve complex conceptual issues. Requires multiple periods of intense concentration. + Performs a wide range of complex 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. 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, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Warehouse, Will work with hazardous/toxic materials Job Description A successful person will perform Environmental Monitoring tasks in support of Steriles production within classified areas. The individual is encouraged to follow the 4i Values that are held in high regards by the company when completing their work. The four values are integrity, innovation, intensity, and involvement. The job function includes aseptic technique which requires the individual to gain knowledge of aseptic gowning as well as working in cleanrooms in order to monitor the area while sterile products are filled and manufactured. Typical shift hours are 6pm-6am on a 2-2-3 rotating schedule. Key Responsibilities: * Perform analyses including instrumental and automated methods using prescribed procedures and techniques. * Generate valid data, report results on appropriate database compared to established specifications while adhering to GMPs. * Compare laboratory results with specifications for acceptability and determine if repetition or OOS is required. * Maintain equipment and troubleshoot instrumentation problems, procedural problems or production problems. * Review and understand SOPs and analytical procedures as needed. * Schedule activities to meet target dates for customer needs. * Follow all job-related safety and other training requirements. * Performs tasks as assigned by area supervision or designee. * Able to withstand extended periods of standing and/or walking and bending. Qualifications: * Bachelor's degree in a biology/ related field is preferred. An associate's degree in a science related field, preferably Biology, is minimally required. * 1+ years related experience performing chemical tests with chromatographic, spectroscopic, or other analytical techniques, working knowledge of EMPOWER is a plus. 2 years of experience preferred. * Knowledge of MS Excel, Word, and Access and is familiar using each program. * Excellent problem solving and critical thinking skills are a plus when performing this job. * Organization and detailed planning skills are seen as major pros for this job function. * Strong attention to detail and ability to follow standard procedures * As our supported area of the company is a fast paced environment a person who enjoys a constantly evolving environment will do well. * Good knowledge of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs are a plus. * Good interpersonal and communication skills (both oral and written). * Ability to apply mathematical operations. Physical Requirements: Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations. Ability to stand, walk, stoop, kneel, squat, crouch periodically for prolonged periods of time. Ability to lift, carry, and/or move light to medium weights of 25-50 pounds, occasionally pushing or 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. 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. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today! **************************** 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. Accessibility/disability access Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at ***************. Please include your contact information and specific details about your required accommodation to support you during the job application process. This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. **Summarized Purpose:** Contributes to the achievement of financial and business objectives through accurate and timely financial analysis and reporting. Works cross-functionally with operations, commercial finance, and finance to resolve issues related to any of the following: revenue, costs, contract values, billing, balance sheet management, financial reporting, financial tools and processes. **Essential Functions:** **-** Administers the daily financial management of project portfolio and/or special assignments. - Identifies issues related to contract modifications, contract values, and contract deliverables. - Performs analysis of budget to actual data on monthly, quarterly, and annual bases and for revenue calculations and forecasting; and/or prepares payment schedules/invoice back-ups and/or process invoices maintaining cash neutrality; and/or performs regular reconciliations and analysis of revenues and billing on a project and company level; and/or creates trackers, financial tools, dashboards and provides technical solutions by manipulating large datasets and compiling data. - Analyzes cost assignments, ensuring that all assigned projects adhere to accepted cost accounting standards. - Coordinates and supervises deliverables of assigned projects and manages outcomes to corporate targets. - Tracks, maintains and/or interpret project information and budgets within the project accounting system; and/or takes part in reviewing and development of financial reports, tools, systems, policies and processes in support of financial management process and improved efficiency. - Coordinates with other staff to ensure sponsors are invoiced in a timely and accurate manner; all amounts are collected, any remaining final balances are appropriately cleared; and/or the agreed financial processes are followed. - Supports management in assessing and minimizing the risk on revenue and gross profit and/or balances associated with assigned balance sheet accounts and/or financial processes and tools. - Interacts with leadership through the presentation of database extracts and datasets, tools, models, data analysis, and dashboards. **Qualifications:** **Education and Experience:** + Bachelor's degree or equivalent and relevant formal academic / vocational qualification. + Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years). + _In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role._ **Knowledge, Skills, and Abilities:** **-** Ability to function as an effective and respected partner to internal clients. - Ability to adapt quickly to new systems and processes. - Confidence to handle sensitive information and make sound recommendations. - Ability to juggle multiple tasks while still delivering high quality results. - Good analytical and quantitative skills and ability to handle data effectively. - Strong written and oral communication skills. - Strong organizational and project administration skills. - High level of proficiency in Microsoft Excel and PowerPoint for analysis and presentation of data, for roles with more technical focus previous experience with SharePoint / VBA / SQL / Power BI / RPA (comparable to 1+ years) will be an advantage. **-** Solid understanding of accounting/financial principles and regulations/legal requirements, for roles with more accounting focus a professional accounting qualification - ACCA / CPA / CIMA or equivalent will be an advantage. **Salary Transparency:** The salary range estimated for this position is $56,000 - $62,000. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer. We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally include: - A choice of national medical and dental plans, and a national vision plan - A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HSAs) or Health Savings Account (HSA) -Tax-advantaged savings and spending accounts and commuter benefits - Employee assistance programs - 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, short- and long-term disability, and volunteer rime off in accordance with company policy. - Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan **Accessibility/Disability** **Access:** We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. **EEO & Affirmative Action:** Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability 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/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.

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.

When you're 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 real-world impact, and you'll be supported in achieving your career goals. Our staff members are committed to making a difference in our organization, for our client partners and the patients we serve. We seek individuals with proven competencies and strong character to help lead our organization now and into the future. **How you'll make an impact:** The **Finance Leadership Development Program (FLDP)** is an outstanding, accelerated opportunity to develop the vital skills for a career as a Finance leader at Thermo Fisher Scientific. The program is led by a dedicated Program Manager with oversight by the CFO and company Finance Leadership Team. **FLDP** participants will have the opportunity for multiple assignments over two (2) years that provide strategic direction in different facets of Finance while allowing for exposure to our core processes, technologies, and leaders. Participants will gain proficiency with our diverse functional areas, business units, products / services, and regions. Additional learning opportunities include: formal development sessions; dedicated Executive Mentorship; utilization of our Practical Process Improvement (PPI) methodology; and a network of outstanding Leadership Development Program alumni across the organization Our **Finance Intern** program is a 10-12 week internship crafted for Business students and pipelines our **FLDP** . Our **Finance Interns** are matched to projects based on their abilities and current business needs. All projects are developed by our Senior Leadership Team and have significant strategic and/or operating importance to the business unit to which they are assigned. Summer projects may include the following functional areas / business operations: + Corporate Finance + Commercial Finance + Finance Data & Analytics + Financial Planning & Analysis + General Accounting + Internal Audit + Operations Finance + Strategic Pricing **Start Date & Location:** This internship is set to begin on either May 18th or June 15th, 2026 for a duration of 10-12 weeks - dependent upon student availability per academic calendars. Individuals will finalizing housing and transportation prior to internship commencement. **Compensation & Relocation:** Our undergraduate Finance internships offer an hourly rate between $21.50 - $28.75 dependent upon the location you are supporting (aligned to respective cost-of-living guidelines). **How will you get here?** + Undergraduate student completing a Business-related degree between December 2026 and June 2027. + 0 years of work experience required; previous related internships preferred. + Consistent track record of results demonstrating integrity, innovation, involvement, and intensity. + Energized through championing change, driven in getting results, and savvy in navigating ambiguity. + Excellent interpersonal communication skills with a high degree of emotional intelligence. If this sounds like you, we'd love to hear from you! **To qualify, applicants must be legally authorized to work in the United States and should not require sponsorship (current or future) for employment visa status. Thermo Fisher does not offer employment in this position to holders of F-1, J-1, H-1, OPT, and CPT Visas for the purpose of obtaining practical experience.** **Compensation and Benefits** The hourly pay range estimated for this position Intern II based in California is $21.50-$28.75. 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.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $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 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. The PPD clinical research business of Thermo Fisher Scientific is a leading provider of global CRO solutions. We provide comprehensive drug development, laboratory and lifecycle services to customers across pharmaceutical, biotechnology, medical device, academic and government entities. By harnessing innovative technology and expertise, we work to empower our customers to bring therapies to market, faster. We have an exciting new opening for a **Digital Product Portfolio Head** (known internally as Sr Director, Digital Product) to own the strategy, prioritization, and value realization for an end-to-end digital domain, specifically clinical trial execution, supporting and building new products that spans study start to final regulatory delivery. This role is responsible for leading Product Managers and UX Designers- and partnering in a matrix with Engineering, Data Science, and Quality- and will incubate internal products and solutions, quantify ROI through measurable efficiency gains, and guide readiness for future external monetization. Reporting to the VP/Head of Digital Products, you are accountable for domain vision, business-case development, roadmap execution, user outcomes, and regulatory compliance (21 CFR Part 11, ICH-GCP, GDPR, HIPAA). This is a home-based role (or hybrid) for candidates in the US (East Coast preferred). Travel is estimated up to 25% for site visits, customer meetings, and team onboarding across Europe, India, and North America. **Key Responsibilities:** **Strategic Roadmap & Vision** + Craft a 3-year vision that accelerates trial timelines and differentiates PPD. + Translate vision into rolling 12-month roadmaps aligned to corporate OKRs and business objectives. + Continuously monitor industry trends, competitor strategies, and technological advancements to ensure the product portfolio remains competitive and innovative. **Business-Case & ROI Development** + Build investment dossiers (TAM, cost-benefit, payback, NPV) for new initiatives. + Establish value-tracking metrics (cycle-time reduction, FTE hours saved, quality KPIs) and partner with Finance to baseline and report realized gains. + Develop comprehensive financial models with partnership from finance and operations to support strategic decisions and present these models to senior leadership and stakeholders. **Product Life-Cycle & Delivery Oversight** + Lead discovery, prioritization, backlog refinement, and acceptance criteria. + Co-own sprint cadence and release readiness with Engineering Leaders. + Ensure robust product lifecycle management processes are in place, from ideation through to product retirement. **People & Org Leadership** + Line-manage Product Managers / Senior PMs and UX Leads. + Coach craft mastery, career paths, and a user-centric, data-driven culture across US, UK, Eastern Europe, and India hubs. + Foster a collaborative and inclusive team environment that encourages innovation and continuous improvement. **Stakeholder & Customer Engagement** + Serve as a liaison to study teams, investigators, sponsors, and regulatory/quality partners; champion voice-of-customer and usability. + Develop and maintain strong relationships with key stakeholders to ensure alignment and support for product initiatives. **Governance & Compliance** + Own validation strategy (CSV, Part 11), privacy impact assessments, and security posture with Quality, Security, and Engineering Qualified candidates will have a demonstrated record of developing business cases and ROI models for digital initiatives (≥$10M) and steering them through funding gates. Experience partnering with engineering organizations to deliver complex, regulated products will be critical, as well as a deep understanding of clinical-trial operations (recruitment, start-up, clinical operations, data management, RBM, safety) and associated regulations. **Product-Management Leadership Competencies:** **Strategic Product Visioning:** Turn ambiguous goals into a crisp 3-year vision and phased roadmap balancing internal efficiency and future market revenue. **Portfolio Prioritization & Resource Allocation:** Apply RICE/WSJF at portfolio scale; reallocate team capacity based on live ROI and risk data. **User-Centric Discovery & Validation:** Lead problem interviews, journey mapping, rapid MVP/A-B experiments to de-risk before heavy build. **Data-Driven Decision-Making:** Define North-Star & leading metrics; build self-serve dashboards so squads can course-correct. **Product Storytelling & Influence** : Craft narratives linking clinical-outcome gains to business value; secure funding via clear storytelling. **Cross-Functional Leadership (no authority):** Align Engineering, QA, and Compliance on priorities through shared OKRs; resolve conflicts by influence. **Coaching & Talent Development** : Mentor PMs, run product leadership meetings, drive craft reviews and growth culture. **Operational Excellence / Product Ops** : Implement intake triage, release readiness, KPI hygiene; partner with Engineering on cycle-time tracking. **Regulated-Market Lifecycle** : Integrate Design Controls, CSV, privacy-by-design from ideation onward; balance agility with validation. **Financial & Business-Case Mastery:** Build TAM, NPV, payback models; translates cost-avoidance into CFO-grade ROI narratives. **Go-to-Market & Change Management:** Shape launch and adoption plans; lead internal change-management playbooks for study teams. **Innovation Scouting** : Inject emerging tech (AI/ML, decentralised trials) into roadmap through structured discovery. **Required Qualifications:** + Bachelor's in Life Sciences, Computer Science, Engineering, or related; MBA / MS preferred. + Previous experience in product or business management leadership in software/SaaS that provides the knowledge, skills, and abilities to perform the job (comparable to 15 years' experience). + 5+ years' experience leading staff + In some cases, an equivalency, consisting of appropriate education, training, and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role. **Preferred Qualifications** + Leadership experience in a CRO, eClinical tech provider, or digital-health start-up. + Exposure to AI/ML in commercial software. + Pragmatic Institute PMC, Agile/Scrum, SAFe or equivalent certification. + Published thought leadership on digital clinical-trial innovation. **Knowledge, Skills and Abilities:** + Proven ability to lead and influence engineers, designers, analysts, and stakeholders. + Experience building intuitive user experiences at scale. + Experience in AI/ML + Familiarity with agile tools (e.g., Jira, Aha!, Azure DevOps). + Demonstrated experience managing detailed product execution within large, matrixed organizations. + Skilled at managing up and aligning with stakeholders. + Skilled at executive-level storytelling, roadmaps and tradeoff discussions. + Exceptional skill in translating complex business requirements into intuitive, impactful software features that exceed customer expectations. + Deep understanding of clinical trial processes, clinical data management, and leveraging AI technologies to address data complexities. + Proven ability to leverage user insights and data analytics to drive feature development and continuous improvement. + Outstanding English communication and stakeholder management abilities, capable of clearly articulating detailed product requirements and vision. **Location:** United States. 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. At Thermo Fisher Scientific, we are committed to fostering a healthy and harmonious workplace for our employees. We understand the importance of creating an environment that allows individuals to excel. Please see below for the required qualifications for this position, which also includes the possibility of equivalent experience: + Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. + Able to work upright and stationary for typical working hours. + Ability to use and learn standard office equipment and technology with proficiency. + Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. + International travel up to 25% The annual salary range estimated for this position is $180,000- $275,000 USD. 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 **Compensation and Benefits** The salary range estimated for this position based in North Carolina is $183,900.00-$275,000.00. 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.

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.