Title: Manager/Director, Environmental Health and Safety
Location: Central New Jersey / Midtown Manhattan
Start Date: Immediate Hire
Reports to: Direct to VP Manufacturing
A Pharma Company is seeking a high energy, motivated candidate for EHS Manager/Director.
Candidate will join a well-funded, public, clinical-stage LVV and AAV gene therapy company (biologics) with a broad pipeline in multiple pediatric rare disease clinical indications in US & EU. The Company was one of the top performing biotech stocks in 2018.
In the Lead Site Safety role, this key individual has responsibility for all operational safety and security aspects of the facility, to include offices, wet laboratories for QC and Development, and Manufacturing Operations- which includes but is not limited to production, maintenance, warehousing, engineering, testing, and personnel management. All work must be within the bounds of appropriate quality and regulatory requirements suitable for cGMP manufacturing of clinical and commercial grade drug product. These tasks are accomplished directly or through oversight of subordinate personnel.
The ideal candidate will also have a strong passion and curiosity for science and gene therapy with desire to bring needed cures from bench to bedside. Demonstrated genuine interest and curiosity in research and science highly valued.
- Supports the Top Management in the issuance of HSE Policy and Guidelines;
- Supports the Top Management in the Organization roles and responsibilities definitions concerning safety;
- Supports the Top Management in the HSE Management System standard issue;
- Develops and ensures, in accordance with the Corporate guidelines, the implementation, updating, review and auditing of the Company HSE Systems;
- Develops and monitors the effective implementation of appropriate Safety and Environment System procedures and provide for their updating in line with changes in Legislation and Company Directives;
- Provides for motivation and familiarization of all Company personnel respecting the importance of complying with Company system procedures and all Safety requirements;
- Assists the Company in their dealings with Regulatory Agencies in all issues concerned with Health and Safety at work;
- Conducts safety audits both internal and external;
- Takes part in accident / incident investigation;
- Carries out analysis of accident / incident statistics, identifying trends and suggesting improvement plans;
- Provides technical support to Senior Management on any safety related subjects;
- Carries out any in-house safety training;
- Carries out safety audits on Sub-contractors;
- Liaises between Regulatory Agencies or other Auditors on safety related issues;
- Provides safety input on new projects and modification programs;
- Organizes and leads HAZOP meetings as needed prior to procurement and installation activities;
- Performs Risk Assessment;
- Preparation of Health and Safety documentation, including obtaining appropriate certifications and licenses necessary for operations;
- Provides Safety support and advice, including supervision on preparation of plans and procedures for initial contract start up activities in addition to ongoing activities or changes thereof;
- Bachelor Degree in Science/Engineering, Industrial Hygene, or equivalent with additional professional qualifications in EHS and Fire & Safety Management Systems;
- 5 or more years of experience in EHS. Preference is for experience with General Safety and BioSafety in a biologics manufacturing environment;
- Working knowledge in EHS Management Systems, Environmental Discharges, Incident Command System, Business Continuity, Incident Investigation, EHS Auditing Techniques, BioSafety (BMBL/BSL); Familiarity with Federal, State, and Local safety and biosafety requirements, including licensures;
- Ability to communicate well;
- Experience building General Safety and/or BioSafety program(s) from scratch is a big plus;
Interested in joining our team?
Contact us today!
Resumes with cover letters may be submitted to email@example.com