Celgene EH&S Specialist - Training and Operations in Summit, New Jersey
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
The EH&S Specialist supports the successful operation of Environmental, Health & Safety (EHS) and Laboratory Services for East Coast (NJ, Cambridge and Kansas) by interacting cross functionally with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with projects impacting the EHS and Lab Services team and may provide project management leadership on tasks specific to their functional area. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor, personnel within their own work group and interdepartmentally to achieve departmental goals specifically around EHS training curriculum and matrixes along with EHS operations, while building trust and collaborative relationships inside and outside the immediate organization.
Position includes the application of knowledge, skills, tools, and techniques to coordinate activities to meet EHS training, documentation, document management, operations and contract/budget requirements.
The scope of work ranges from relational to technical, while the scope of initiatives is from EHS training directive to company-wide business initiatives.
Overall Departmental Management Responsibilities:
Act as Departmental Compliance Coordinator (Finance and Legal liaison)
Act as EHS Training Coordinator for NJ Celgene staff
Act as Departmental Coordinator (individual EHS/Lab Services and Corporate Services Staff curricula and annual review)
Act as Document Destruction Coordinator (liaise between EHS staff and legal department)
Assist as needed with the generation of PO’s and contracts
Act as a CelDox Author for department
Act as Document Management Coordinator for EHS/Lab Services
Relationship Management Responsibilities:
Manage EHS and Corporate Services training curricula to be deployed to NJ-based staff. This function includes on-boarding and off-boarding of staff in Learning Management System (Compliancewire)
Work with EHS and Corporate Services management to define scope of curricula for NJ sites. Curricula will be based on site, department and job function.
Liaise with West Coast based EHS and Corporate Services staff to communicate training initiatives to ensure parity in training across US sites.
Continue to liaise with regional and site personnel to ensure that new training is deployed when necessary (i.e., when new equipment or compounds are introduced to R&D site or new compounds are introduced to manufacturing site)
Act as ComplianceWire Site Administrator to manipulate data, generate reports and compile compliance data Globally.
Manage the input of training attendance records for training that is done outside of LSM
Update EHS training matrix on a periodic basis for Management – Update EHS Intranet Calendar
Work with EHS Management on required training for outside vendors – developing and, if needed, deploying training on Celgene standards and Policies.
Data Management (Celdox/Documentum):
Working with NJ EHS Management staff, assist in the creation and formatting of training materials, obtain necessary approvals (i.e., CelDox) and deploy as needed via ComplianceWire.
Manage EHS documents in Celdox.
Maintain EHS Shared Drive (Document Management)
Incident Management and Investigation:
Assist with reporting and investigation of any workplace injuries, illnesses, accidents, unsafe conditions, and significant near misses.
Upon notification of incident, conduct/participate in incident investigation to analyze root cause conditions and behaviors and determine corrective actions needed to be taken because of the investigation.
Notify senior management of any occurrence of serious incidents or significant near miss occurrences.
After an incident, make notifications to regulatory agencies, as stipulated by local and federal regulations: OSHA, local agencies, etc.
Complete and maintain appropriate documentation required to comply with OSHA.
Perform the necessary follow up and documentation until incident investigation closure.
Provide follow up to ensure completion of corrective actions.
Performs business process and administrative tasks including scope of work, cost assessment and documentation.
May provide primary or back up support for Oracle/ iProcurement; Purchase Orders, Contracts, AP, Budget and Budgetary/DEA Reports
Provides excellent customer service and support:
Responds to employee requests for all EHS/Lab Services matters
Provides technical support and guidance on EHS/Lab Services issues
Interfaces with customers to make sure that all expectations are being met.
Maintain a positive relationship with all the members of Corporate Services and employees while promoting a positive team environment.
May provide primary or back up support to all functions of the EHS team
Required Competencies-Knowledge, Skills, and Abilities:
Knowledge, Skills & Abilities:
Highly proficient skills in Celgene’s Learning Management System (Compliancewire). Able to perform Review/Approver/Author activities in CelDox at high level.
Strong skills in Celgene’s procurement and accounts payable systems (Oracle and Basware).
Strong knowledge of local, state and federal training requirements and ability to explain and communicate the same to targeted audience
Strong written and verbal communication skills along with excellent leadership skills that encourages empowerment and ownership within the team and organization. Extremely proficient at writing well‐ formulated emails, notifications and reports. Ability to effectively communicate with employees, contractors and vendors. Strong experience with technical writing and document development / generation.
Confidentiality and the ability to handle confidential material are critical to the position.
Must have excellent interpersonal skills at all management levels, excellent communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required
Experience dealing with a diverse workforce
Maintains a high level of multi‐tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitors tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook and the ability to learn new software systems put in place by Celgene management.
Strong knowledge with FDA / cGXP environments and associated compliance regulations as it applies to responsibilities
Must be able to work independently and react with little direction
Strong public speaking and training skills are required to conduct training and present training initiatives to management audience
Technical / Professional Business Knowledge
Team Player / Building Relationships
Mentor / Trainer
Creative problem solving/resolutions skills
Education & Experience:
Bachelors Degree in Business Administration preferred or equivalent related project and or business management experience
4 years prior experience in project coordination and administration
4 years of progressive broad-based information systems and business experience
5 years of experience in a GMP pharmaceutical environment
Physical / Mental Demands:
Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting to 20lbs
Ability to sit, stand, walk and move within workspace for extended periods
Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping, pushing and pulling
Ability to climb ladders and work in elevated areas.
Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
Ability to work safely in an environment with exposure to high temperature / pressure steam, and other fluids, compressed gasses, odors, various noise levels, moving parts, vibration, wet/slippery areas and high voltage energy supplies
Environment may include working at heights, in cold temperatures, and/or constricted spaces
Ability to work safely when working alone, or working with others.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.