Study Lead - GMP Lab, Small Molecule

About the role

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.

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.
• Collaute, 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.
• Absorb and apply standard troubleshooting approaches to resolve routine technical issues, leveraging existing knowledge, historical data, and subject matter expert (SME) guidance as needed.
• Identify and communicate risks to project timelines, data quality, or deliverables, and escalates appropriately.
• 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.

Requirements

• 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 5+ years).
• Knowledge, Skills, Abilities: Knowledge of routine analytical testing and applicable technology/instrumentation, Excellent organizational skills with the ability to adapt and adjust to changing priorities while maintaining focus, composure and productivity, Versed in data analysis to identify trends or outliers, Ability to manage multiple assignments with challenging/conflicting deadlines, Proficient in Microsoft suite applications (eg: Word, Excel, PowerBI, PowerPoint,Teams, Sharepoint), Familiarity of data collection software leveraged for analytical testing, Strong attention to detail and problem-solving skills, Effective written and verbal communication skills including technical writing, Demonstrated experience in identification and resolution of conflicts in a professional environment, Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others, Demonstrated ability to receive and apply constructive feedback, Demonstrated ability to train, coach and mentor junior staff, Working knowledge of GMP requirements and data integrity principles.

Environmental Conditions

Able to lift and move objects up to 25 pounds, Able to work in non-traditional work environments, May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials