Massachusetts Jobs

Senior Specialist - Environmental Health & Safety

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.

AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.

Astellas is announcing a Senior Specialist - Environmental Health & Safety opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

The Senior 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 Senior Specialist, EHS 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. They will develop and lead the Emergency Response Team and Safety Committee, generate metrics for visibility of compliance, sustainability, and continuous improvement initiative performance.

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 safety committee, including planning and coordinating emergency response team preparations and drills.

• Oversee 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 committee 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.

Quantitative Dimensions:

The Senior Specialist, Environmental Health & Safety (EHS) will be responsible for the support, development, and implementation of EHS improvement programs focused on preventing occupational injuries and illnesses, environmental impact, and operational hazards and risks. Through training staff, suppliers, and contractors, creating and leading the Emergency Response Team and Safety Committee, and maintaining records, reports, inspections, and generating metrics to disclose compliance, sustainability, and continuous improvement performance.

Organizational Context:

The Senior Specialist, EHS will typically report to the Associate Director, Facilities and Engineering. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization.

Required Qualifications:

• Bachelor’s degree in EHS or related engineering field with a minimum of 8 years’ experience in an EHS and a minimum of 3 years’ experience within the biotech or pharmaceutical industry.

• ASP/CSP 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.

• 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 Technical Operations team to execute work and will be expected to perform other duties and/or special projects as assigned.

Preferred Qualifications:

• Experience with rare diseases, neuromuscular diseases and/or gene therapy products

• Experience in a small company and high growth, fast-paced environment

• OSHA 30-hour General Industry, OSHA 30-hour Construction Industry

• CAIH/CIH or similar certification

• HazWOPER 40hr/Supervisor training

• SO14001/45001 auditor training

Working Conditions:

• This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20 lbs.

• This is an on-site role working in a cGMP regulated manufacturing facility.

• On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities (0-5%.)

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.

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Category Massachusetts TC

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans