SHE Manager - Manufacturing

Seeking a mid-level SHE Manager to support the Manufacturing Sciences and Biopharmaceutical Development Laboratories at our Gaithersburg campus.  This position provides comprehensive exposure to clean rooms, and laboratory operations while building foundational expertise in risk assessment, regulatory compliance, and safety program execution with opportunities for professional growth and specialization development

This role will be expected to perform assignments independently collaborating across functions to ensure compliance with applicable regulations and company standards while driving continuous improvement and sustainability initiatives.    

This role executes risk assessments, completes event investigations, management of change assessments, maintains safety protocols, and promotes a culture of safety excellence based on Human and Organizational Performance (HOP) principles while ensuring regulatory compliance and supporting continuous improvement initiatives. 

The position is ideal for someone with at least a basic understanding of laboratory and/or clean room operations looking to expand their technical skill set in the safety arena. Initial duties will be based on experience.  A successful candidate will play a key role in maintaining compliance, providing continuous improvement to goals and objectives, and achieving best practice wherever feasible. Candidates must be comfortable performing work in a clean room or research laboratory environment.  Mentorship will be provided; however, candidate will be expected to take initiative and supplement mentorship with independent learning, research, and collaboration.

Responsibilities

• Identify and evaluate potential hazards in clinical manufacturing and laboratory environments while supporting the business in conducting comprehensive risk assessments for new processes, equipment installations, and operational changes. Develop strategies to minimize risk exposure and ensure workplace safety compliance across R&D operations.
• Support business partners in investigating work-related events including injuries, illnesses, spills, and near-miss incidents to determine root causes. Prepare detailed reports documenting findings and assist in implementing and tracking corrective actions to prevent recurrence while ensuring compliance with regulatory reporting requirements.
• Develop and maintain SHE protocols, standard operating procedures, and safety documentation while ensuring alignment with regulatory requirements and company standards. Support the execution of site License to Operate requirements.
• Perform inspections and program self-audits of labs, facilities, and operations; document findings, communicate results, and follow up on corrective actions to ensure timely closure and compliance while striving to drive continuous improvement initiatives.
• Support safety meetings, documentation reviews, and SHE communications across various platforms to promote safety awareness and engagement.
• Provide SHE assessment on new equipment, process changes, and renovations through the Management of Change program.
• Share safety alerts, one-point lessons, and HOP-based learning to reinforce a proactive safety culture.
• Promote environmental sustainability initiatives including waste reduction, energy conservation, and pollution control programs while supporting the organization's environmental compliance requirements and sustainability goals.
• Partner with researchers, operations, engineering, and service providers to integrate SHE into day-to-day work; communicate clearly and professionally across levels
• Maintain records, reports and documents in electronic safety management system. (AZ SHE System/Enablon)
• Compile data for SHE performance metrics and benchmarking.

On-call coverage is required for this role. Employees may be scheduled to participate in an on-call rotation and must be available outside standard working hours, including evenings, weekends, and holidays, as needed to support business-critical activities.

Required

• Education: Bachelor's degree in scientific/engineering or SHE related field 
• Experience: Minimum 4 years in laboratory, research, and biopharma R&D/Clinical Manufacturing.
• Technical Skills: Strong computer/technology skills with basic understanding of risk assessment methodologies. Experience with Enablon SHE management t system.
• Communication: Excellent written and verbal communication skills with ability to interact effectively with all organizational levels and handle conversations with customers of varying levels
• Analytical Abilities: Demonstrated ability to gather data, analyse information,
• Safety Knowledge: Basic understanding of laboratory safety principles, regulatory requirements, and safety management systems
• Problem Solving: Demonstrates logical and orderly thought process, attention to detail, effective time management, and ability to articulate opinions

Desired

• Certifications: ASP (Associate Safety Professional) or other early career safety certifications
• Technology Skills: Knowledge of SharePoint, Enablon, or other SHE management systems
• Industry Experience: Experience in pharmaceuticals, biotechnology operations and regulatory requirements.  Prior experience in clean rooms (GMP) facilities
• Leadership Experience: Previous experience leading safety initiatives or small teams
• Professional Skills: Prior experience with accident investigations, root cause analysis, or corrective action implementation

The annual base pay for this position ranges from $96,475- $144,713 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

When we put unexpected teams in the same room, we unleash ambitious thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility.  Join us in our unique and ambitious world.

If you're ready to make a significant impact on patients' lives by joining a team that follows the science with curiosity and courage, apply today!

Date Posted

31-Mar-2026

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.