Job Information
Astellas Pharma Specialist, Environmental Health & Safety in Sanford, North Carolina
About Astellas Gene Therapies
Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly-created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.astellasgenetherapies.com
Our Values:
Be BOLD (Find a Way)
Care Deeply – for our patients, each other and our work
#GSD (Get Stuff Done)
What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.
The Role
The Specialist, Environmental Health & Safety (EHS) will support the development and implementation of EHS improvement programs focused on preventing occupational injuries and illnesses, environmental impact, and operational hazards and risks. This role represents EHS matters to regulatory agencies, inspectors, partners, and project teams, working closely with other line unit functions, consultants, and contractors as required. The EHS Specialist will deliver training; identify, evaluate, and eliminate hazards; and ensure compliance with government regulations and standards for EHS within the biotechnology industry. This position will provide support to the Facilities and Engineering team including but not limited to reports, inspections, and waste management. The role is primarily located in Sanford, NC.
Responsibilities
Support adherence to the compliance calendar including assuring permit renewals, reporting on hazardous materials, hazardous and medical waste management, wastewater and exhaust air treatment, storm water pollution prevention program, and waste minimization; maintain records in accordance with acceptable standards and assure appropriate confidentiality.
Uphold emergency response, risk management, business continuity, and support in planning and coordination of emergency response team preparations and drills.
Support regulated waste management program including third party contracts and recordkeeping.
Maintain the chemical inventory management program including chemical procurement monitoring, and monitoring inventory, storage, and handling.
Develop and conduct EHS training for employees and contractors, including orientation for new hires and service providers.
Support the EHS compliance inspection and safety suggestion programs, including capturing, tracking, communicating, and resolving compliance issues and employee concerns respectively.
Oversee the safety forum including membership and agenda development; create EHS performance metrics for communication and facilitation of continuous improvement and sustainability initiatives.
Enforce the contractor management program, ensuring compliance during maintenance and project activities; connect with project teams to influence EHS compliance during design phases particularly through effective process hazards analyses and mitigations.
Author procedures for adhering to local, state, and federal EHS regulations and implementation of injury/illness prevention strategies; perform new product, process, equipment reviews to ensure they meet EHS requirements and perform risk assessments as needed in manufacturing and laboratory environments to address employee exposure, ergonomics, and other compliance concerns.
Engage with EHS vendors/contractors as needed to initiate, develop, and/or renew contracts and service obligations.
Required Qualifications
Bachelor’s degree in EHS or related engineering field with a minimum of 5 years’ experience in an EHS and a minimum of 1-2 years’ experience within the biotech or pharmaceutical industry OR associate degree with EHS or related field of study with 6 years’ experience in an EHS and a minimum of 1-2 years’ experience within the biotech or pharmaceutical industry
Ability to lead and manage projects with attention to detail and prioritization, working cross-functionally and on appointed teams, and managing external vendors/contractors.
Proven experience representing EHS matters to regulatory agencies, inspectors, partners, and project teams.
Experience with EHS Management Systems, Emergency Response Program Leadership, Process and Job Hazard Analyses, Process Ergonomics, Industrial Hygiene, written program development, classroom and LMS training development, permitting, and reporting, and updating hazardous materials inventory.
Knowledge of GMP cleanroom environments, Federal and State OSHA & EPA regulations, NFPA, and local county regulations and codes
Strong interpersonal, written, and verbal communication skills
Strong computer skills working with standard MS Office suite applications and experience with sustainability metrics and reporting.
Will support and demonstrate quality standards to ensure data of highest quality.
Works closely with team and other functional key stakeholders on the Astellas AGT Technical Operations team to execute work and will be expected to perform other duties and/or special projects as assigned
Preferred Qualifications
ASP/CSP, CIH or similar certification; First aid, CPR/AED training Strong analytical, critical-thinking, and problem-solving skills, with demonstrated application in incident investigations including assessment of emergency scenarios and evaluate suitable protective actions.
OSHA 30-hour General Industry, OSHA 30-hour Construction Industry
HazWOPER 40hr/Supervisor training
ISO14001/45001 auditor training
Experience with rare diseases, neuromuscular diseases and/or gene therapy products
Experience in a small company and high growth, fast-paced environment
Benefits:
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.
#LI-KT1
Category Sanford TC
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans