Study Lead - Small Molecule

We need to output HTML fragment with sections for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. The posting includes: Work Schedule Standard (Mon-Fri) Environmental Conditions... etc. Also includes "Work Schedule Standard (Mon-Fri)" which is schedule info. Also includes "Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE required..." That's work environment. Also includes "Study Lead Department: Small Molecule Location: Middleton, Wisconsin Additional Details: Onsite; Full-Time". That's location, onsite, full-time. Also includes "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." That's requirements. Also includes "At Thermo Fisher Scientific, you’ll discover meaningful work..." that's about the role/company description. Also includes "Role Overview:" and "Role Responsibilities:" and "Key Requirements:" sections. Also includes "Work Environment" section. Also includes "Our Mission..." etc. Benefits, Pay not mentioned. So we should not create Benefits, Pay sections. Schedule: we have "Work Schedule Standard (Mon-Fri)" and "Onsite; Full-Time". So we can include a Schedule section with that info. Also maybe a Qualifications section? The posting has "Education and Experience:" under Key Requirements. Could treat as Requirements or Qualifications. The instruction: Use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Skills). We need to decide which sections to include based on content. Likely include About the role (company mission description), Responsibilities (Role Responsibilities), Requirements (Key Requirements includes Education and Experience, Knowledge, Skills, Abilities), Skills (maybe separate but we can combine). Qualifications maybe overlapping with Requirements. To avoid thin sections, we can combine Education/Experience and Knowledge/Skills/Abilities into Requirements. Skills maybe not separate. Could include a Skills section for specific skills like Microsoft suite, data analysis, etc. But we already have those in Key Requirements. Might be better to have Requirements covering education/experience and knowledge/skills. Skills could be omitted to avoid thin. Qualifications maybe not needed. Let's include: About the role, Responsibilities, Requirements, Schedule, Work Environment (maybe as part of About? but we have a Work Environment section with physical demands). Could make a separate section "Work Environment" but not in allowed headings list. The allowed headings list includes only those specific ones; we should not create other headings. So we must fit content into allowed headings. Work Environment details could go under About the role or Requirements? Probably under About the role (description of role). But we have schedule separate. Could put environmental conditions under Requirements? Not ideal. However instructions: "Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It says e.g., implying these are examples, but we should use those headings when appropriate. It doesn't forbid other headings, but says use those for section headings. Likely we should stick to those. So we need to map content to those headings. We have: - About the role: company mission, overview, what they do, maybe the Role Overview paragraph. - Responsibilities: Role Responsibilities bullet list. - Requirements: Education and Experience, Knowledge, Skills, Abilities, plus legal authorization, background check, etc. - Qualifications: maybe not needed; could combine with Requirements. - Skills: maybe separate list of technical skills (Microsoft suite, data collection software, etc.) but we already have those in Requirements. Could still create Skills section with those specifics. - Benefits: none. - Pay: none. - Schedule: Work Schedule Standard (Mon-Fri); Onsite; Full-Time. We also have location (Middleton, Wisconsin) and department (Small Molecule). Could fit under About the role or Requirements? Probably About the role. We must not repeat job title as heading. Not include Job ID etc. We must remove boilerplate: EEO, accessibility, apply link, etc. We must preserve all substantive information. Let's extract substantive content: From posting: 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.) Study Lead Department: Small Molecule Location: Middleton, Wisconsin Additional Details: Onsite; Full-Time This is a fully onsite role based at our GMP Laboratory in Middleton, WI. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. 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, 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. Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations! Role Overview: The Study Lead is responsible for managing multiple routine projects (release, stability, and quality control), interacting with clients and internal stakeholders to communicate updates, providing deliverables, reviewing and evaluating data, writing scientific reports and protocols, and managing quality records. This role ensures adherence with the regulatory guidelines and scientific conduct of routine testing. The Study Lead directs and oversees testing and troubleshooting on established methods using multiple analytical instruments and detection techniques, evaluates/trends and interprets data, and records data in adherence with Thermo Fisher Scientific, Inc. SOPs and any additional lab or client specific requirements. This role drives routine study execution and technical client communication for established methods and defined scopes but does not independently determine scientific conclusions for non-routine (development, validation, transfer, etc.), or method lifecycle-impacting issues. When investigation outcomes exceed routine complexity, technical direction is consulted from the Senior Study Lead or Staff Scientist + in accordance with Decision Making Framework and Standard Work. The Study Lead is accountable for timely and accurate delivery of routine study outputs, ensuring data integrity, adherence to SOPs and regulatory requirements, and escalating issues to stakeholders and senior technical staff in accordance with established decision frameworks. Role Responsibilities: Collaborate with internal stakeholders to translate project requirements into study design plans and manage project timelines and deliverables.Reinforces best practices through example and delivery of routine study activities.Communicate project plans, status updates, deliverables, and routine technical findings to internal stakeholders and clients, escalating risks, concerns, or non-routine issues as appropriate.Manages multiple routine projects, interacts with clients and internal stakeholders to communicate updates, provides deliverables, reviews and evaluates data, writes reports and protocols, and oversees quality records.Provide guidance, resources, mentoring, and/or training to laboratory staff, fostering independent routine test execution and troubleshooting.Prepare and/or review routine study protocols, project status reports, final study reports, and other project-related technical documents inclusive of quality records.Collate, organize, and evaluate/trend data to ensure accuracy, integrity, and compliance with protocols, methods, and SOPs.Monitor daily project-related operations to ensure adherence to SOPs, company policies, and regulatory standards, reporting non-compliance issues to management.Assist in risk assessments, recommend risk mitigation strategies,and advise clients on study design.Support continuous improvement initiatives, identify technical obstacles, and implement process improvement strategies.Participate in project problem-solving sessions, escalate issues when necessary, and incorporate appropriate resources or SMEs to drive effective solutioning.Executes/oversees studies within established methods, protocols, and decision frameworks, escalating non-routine, complex, or ambiguous issues to senior technical staff.Accountable for timely and accurate delivery of routine project outputs, ensuring data integrity and compliance with SOPs, regulatory requirements, and client expectations.Applies standard troubleshooting approaches to resolve routine technical issues, leveraging existing knowledge, historical data, and subject matter expert (SME) guidance as needed.Identifies and communicates risks to project timelines, data quality, or deliverables, and escalates appropriately.Support audit readiness by ensuring study documentation, data, and records are complete, accurate, and inspection-ready; participate in client audits or site visits and address audit findings under guidance from senior staff. Key Requirements: Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ 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, Abilities Knowledge of routine analytical testing and applicable technology/instrumentationExcellent organizational skills with the ability to adapt and adjust to changing priorities while maintaining focus, composure and productivityVersed in data analysis to identify trends or outliersAbility to manage multiple assignments with challenging/conflicting deadlinesProficient in Microsoft suite applications (eg: Word, Excel, PowerBI, PowerPoint,Teams, Sharepoint)Familiarity of data collection software leveraged for analytical testingStrong attention to detail and problem-solving skillsEffective written and verbal communication skills including technical writingDemonstrated experience in identification and resolution of conflicts in a professional environmentAbility to maintain a high degree of confidentiality with client information and dataAbility to attain, maintain and apply a working knowledge of applicable procedural documentsDemonstrated positive attitude, enthusiasm toward work, and the ability to work well with othersDemonstrated ability to receive and apply constructive feedbackAbility to train, coach and mentor junior staffWorking knowledge of GMP requirements and data integrity principles. 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: 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 and/or standing for typical working hours.Able to lift and move objects up to 25 pounds.Able to work in non-traditional work environments.Able to use and learn standard office equipment and technology with proficiency.May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. 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! http://jobs.thermofisher.com 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