What are the responsibilities and job description for the Safety Specialist position at Andelyn Biosciences, Inc?
Overview of Andelyn Biosciences
Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that specializes in advancing novel gene therapies from concept to commercialization. Located in Columbus, OH, the company operates out of the Andelyn Corporate Center (ACC) for clinical and commercial cGMP manufacturing of viral vectors and plasmids and the Andelyn Development Center (ADC) for preclinical non-cGMP activities.
Our Values are founded in our origin story.
The name “Andelyn” is a hybrid of two gene therapy patients who participated in pivotal Phase I clinical trials at Nationwide Children’s Hospital. Andrew received the first U.S. investigational gene therapy for Duchenne muscular dystrophy in 2006. Evelyn received experimental gene therapy for spinal muscular atrophy in 2015. “Andelyn” combines their names to represent all the families who have courageously participated in the research that makes today’s gene therapies possible.
Through this journey, we have been able to accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients. We are Pioneering Solutions that Turn Hope into Reality™ through our ACCTSions.
ACCOUNTABLE in our actions.
CURIOUS to discover.
COMPASSIONATE in our thinking.
TRUSTWORTHY in our communications.
SUPPORTIVE of one another.
Employees are expected to perform the following essential functions under the framework of our ACCTSions.
What you will do.
The Safety Specialist will play a key role in supporting the implementation and management of the Environmental Health and Safety (EHS) and Biosafety programs within the gene therapy manufacturing environment. This position will assist in ensuring compliance with safety regulations, conducting safety audits and inspections, and providing safety training to employees. The Safety Specialist will work closely with the
Biosafety & EHS Manager to foster a positive safety culture, helping to maintain a safe and compliant workplace.
Safety Program Support:
- Assist in the development and implementation of EHS and biosafety programs, policies, and procedures, ensuring compliance with local, state, and federal regulations (OSHA, EPA, CDC, NIH).
- Support the Biosafety & EHS Manager in maintaining and improving the company’s safety management system.
Training and Education:
- Conducting safety training programs for employees, including hazard recognition, chemical safety, laboratory safety, equipment safety, and emergency response protocols.
- Support the onboarding of new employees by conducting lab safety orientations and facilitating necessary safety training.
Safety Inspections and Audits:
- Conduct regular safety inspections and audits of facilities, equipment, and work practices to identify potential hazards.
- Document findings, track corrective actions, and ensure that necessary improvements are made to maintain a safe work environment.
Incident Management and Reporting:
- Investigates safety incidents, near misses, and accidents, and develop effective corrective actions.
- Monitor safety events and assist in maintaining the safety reporting system, ensuring timely and accurate documentation.
Emergency Response and Preparedness:
- Support the development and implementation of emergency response plans, including spill response, exposure protocols, and evacuation procedures.
- Participate in and/ or facilitates safety drills, ensuring staff preparedness and providing feedback on drill performance.
- Respond to emergency events such as spills, injuries, fires, or natural disasters.
Hazardous Materials and Waste Management:
- Manages hazardous materials, ensuring proper labeling, storage, and disposal.
- Support the hazardous waste program, ensuring compliance with environmental regulations regarding chemical and biological waste.
Collaboration and Continuous Improvement:
- Work closely with cross-functional teams (Manufacturing, Quality Assurance, etc.) to integrate safety practices into everyday operations.
- Contribute ideas and recommendations for improving the effectiveness of safety and biosafety programs.
Documentation and Record Keeping:
- Assist in maintaining safety records, ensuring that documentation is up-to-date and in compliance with regulatory requirements.
- Help track and document employee safety training and compliance.
Additional Responsibilities:
- Maintain knowledge of industry best practices, safety trends, and regulatory changes.
- Exercise discretion, judgment, and personal responsibility
- Demonstrate high level of integrity
- Maintain positive attitude
- Attention to detail in all job functions
- Performs in accordance with established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed
- Identifies problems and proposes solutions. Performs tasks as assigned by leadership
- Ability to work with some independence based on applicable experience
- Works in diverse and collaborative team environment utilizing clear communication to deliver high productivity and contributes to the success of team and goals
- Documentation of all activities performed according to SOPs
- Make decisions based on established procedures
- Nominal fiscal responsibility
- May require some travel.
- Other duties as assigned
What you bring to the team.
- Must possess a four-year degree. Degree in environmental health, safety, or a related field strongly preferred. Experience in a role directly supporting safety or biosafety may be considered in lieu of a related degree.
- No minimum experience required; Up to 3 years of experience in EHS desired.
- ASP, GSP, CHMM or other credentials preferred
- Working knowledge of OSHA, EPA, and State laws as related safety.
- DOT Hazmat training – OSHA 40-hour HAZWOPER preferred.
- Knowledge of large-scale production biosafety principles and practices is preferred.
- Ability to positively interact with regulatory agencies.
- Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change.
- Must be highly skilled in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting.
- Ability to work independently as well as collaboratively in a diverse and inclusive work environment. Must possess prior experience handling confidential information and the ability to maintain confidentiality.
What you can expect when working at Andelyn.
- The pride of contributing to the development and manufacturing of life-saving therapies
- The invaluable experience of being a part of building the foundation of a new organization.
- The opportunity to work alongside experts that have over 10 years in the gene therapy field.
- Competitive compensation
- Eligible day one for medical, dental and vision insurance plans with basic vision at 100% company-paid
- 160 hours of Paid Time Off annually
- 11 company-paid Paid Holidays plus 2 floating holidays annually.
- Company-paid Paid Life Insurance
- 401(k) Match
- Company Paid short and long-term disability.
- 4 weeks of Paid Parental Leave for birth and adoption
- Adoption Assistance
- Tuition Reimbursement and Student Loan Repayment Assistance
- Company Paid LinkedIn Learning access.
- Employee Assistance Programs
- Flexible work options (role specific)
Andelyn Biosciences embraces diversity and is an equal opportunity employer and does not discriminate based on race, religion, national origin, gender, gender identity, genetic information, sexual orientation, protected veteran status, disability, age, or another legally protected status. As an organization, we are committed to creating an environment where everyone ACCTS.
