Celgene Manager, Lab Services, EH&S 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 Manager, Laboratory Services oversees the successful operation of facility, laboratory and business functions at multi‐use sites through interaction with internal team members and customers as well as external service providers. The incumbent in this role, accomplishes goals through direct leadership of a team of experienced professionals who have authority to make daily decisions that impact their own work assignments. The individual manages multiple projects and ongoing work activities of moderate complexity to ensure on time and within budget completion. May have authority over a portion of a departmental budget. In addition to advising staff to answer questions and resolve issues, the incumbent provides guidance, coaching and training as necessary to ensure a broad base of knowledge and continuous development of the staff. The incumbent may recommend modifications to policies or procedures to senior functional management that impact their immediate function or organizational unit.
Manages all site Laboratory services operation to ensure optimal function, aesthetics and condition at primary site and provides supplemental tactical support to satellite sites, as needed.
Institute processes to optimize success, streamline activities while at all times understanding and listening to the needs of the customer.
Manages the receipt and verification of all incoming chemicals and laboratory supplies, delivery of chemicals and pick‐up of properly packaged chemical and medical waste. Manages the maintenance and update of site chemical inventory systems.
Manages all site laboratory services, maintenance, support and outsourced staff functions associated with the proper operation of the entire site, including shipping and receiving of chemical and laboratory supplies, and waste management
Manage and ensure that laboratory non‐chemical stock rooms are organized and directs the restocking process to ensure material availability, operational uptime and customer satisfaction.
Manage the bar-coding and storage of chemical materials and adhere to the requirements of the Celgene Chemical Inventory Management System to ensure visibility at all times on the identification, quantity and location of chemicals.
Ability to understand and develop workflows in and around GMP facilities
Able to draft processes and write procedures in GMP compliant format
Experience in audit preparedness
Ability to develop base budget requirements
Ability to review current processes and address compliance gaps and issues and recommend and realign procedures accordingly
Manage the work-force needs to keep abreast of the business needs
Partner with the business to determine and communicate waste and sample pathways that align with the GMP requirements but do not compromise EHS regulatory requirements.
Ensure chemical and medical waste storage areas are inspection on a frequency and records maintained.
Assists with laboratory services vendor service contracts including coordinating the RFQ/RFP process, pricing and services negotiation, and scope of work, as well as coordinating work schedules
Effectively leads, manages and develops staff.
Oversees direct full time and contract staff on day to day assignment of work. Executes and directs work within and through the electronic work order system by approving, assigning and properly closing / reviewing work.
Manages, coaches and develops internal staff to enhance their growth potential. Provides clear direction and priorities; clarifies roles and responsibilities; accurately assesses strengths and development needs of staff; gives timely, specific feedback and helpful coaching; provides challenging opportunities for development
Manages all employee performance / development goals; completes required employee assessments and provides corrective feedback when necessary
Reviews and approves all time sheets for hourly staff
Manages all internal and external contractor staff. Act as the liaison with the business function and continuously respond and adjust to the needs of the business
Initiates, manages and leads cross‐functional/cross‐site projects of medium to large scope and complexity.
Supports research programs by altering, modifying or maintaining laboratory systems to serve site requirements.
Recommends, drives and approves the implementation of major changes to laboratory service systems, in order to improve laboratory safety enhancements as well as reduce carbon footprint
Provides expert SME knowledge, and direction as Laboratory Services site representative during interactions with all cross functional groups, as required
Interfaces with Corporate Services, EHS and IT in support of laboratory/ manufacturing projects and cross functional initiatives.
Provides business process and administrative task oversight for contract and budgetary management, procurement system, and documentation.
Manages Laboratory Services operating budget within target goals and drives the forecasting of project, capital and expense budgets. Estimates, reports and manages to a site expense and capital budget.
Performs contract management including scope of work, cost assessment, and documentation.
Collaborates with Legal and Strategic Sourcing to ensure corporate and vendor contract terms are met
Oversees the Laboratory Services component of accident and incident workplace investigations, conducting root cause analysis and instituting appropriate corrective actions
Reviews and communicates monthly metric reports and monitors and evaluates department operational targets. Creates action plans as required
Oversees the chemical inventory management system(CIMS) including oversight on control zones and relevant communications as appropriate.
Drives the development of Laboratory Services procedures, work practices, best practices and guidance documents
Promotes and provides excellent customer service and support.
Experience in process mapping in order to optimize resources
Regularly reviews and ensures prompt response to work orders and service requests while maintaining a high level of customer satisfaction. Ensures proper response to Customer requests are completed and documented in a professional manner.
Provides expert technical support and guidance on laboratory services‐related issues and may advise senior management on courses of action, as required. Interfaces with customers to ensure all expectations are being met
Ability to understand and communicate appropriate responses to laboratory type emergencies
Maintains a positive relationship with all the members of the Corporate Services department and our site customers while promoting a positive team environment.
Work closely with NJ-EHS and assist and support all programs as appropriate
Comply with GEHS Directives and ensure adherence to requirements set forth therein.
Promotes and maintains compliance with corporate, safety, security and regulatory policies.
Ensures compliance with all federal, state, local and company policies, rules and regulations relating to Wastewater and Hazardous Waste. Manages compliance reports and inspections as needed. Work closely with Environmental Manager.and colleagues.
Strongly supports with management of Federal, State and Local safety and environmental regulatory compliance and transportation regulations in the Storage of Chemicals and Hazardous Waste.
Develops a documentation management system for Laboratory Services that aligns with and support all safety and environmental procedures.
Reviews in conjunction with EHS the laboratory services files including permits, certificates and maintenance records to ensurecompliance.
Builds and promotes a culture of safety and responsible EHS behavior with employee involvement, positive reinforcement, clear communications and real repercussions for flagrant disregard of safety procedures.
Develops training requirements to ensure compliance including review and approval of staff training curriculums to support a GMP manufacturing environment. Prepares a training matrix for Laboratory Services employees and maintains required training records, including but not limited to, DOT, IATA Shipping OSHA and NJDEP/EPA RCRA Hazardous waste.
Partners closely with both safety and environmental colleagues to ensure alignment of programs and support all applicable permits.
Required Competencies‐Knowledge, Skills, and Abilities
Knowledge, Skills & Abilities:
Firm understanding of local, state and federal building codes in conjunction with NFPA, OSHA and other basic safety training Knowledge of OSHA standards relating to general industry. Knowledge of DOT and EPA regulations for the transport and storage of chemical Products. Good knowledge of relevant policies, procedures and strategies to promote effective local, state or federal environmental health and safety operations for the protection of people, property and the environment
Solid understanding of chemical safety information and Chemical Storage, Chemical and Medical Waste storage and EHS procedures in the workplace
Excellent knowledge and utilization of relevant industrial hygiene and safety equipment
Proficient understanding of industrial hygiene principles and the application of data to the physical workplace
Knowledge of lab systems, engineering controls and operations.
Past experience in determining waste profiles and demonstrate the ability to understand environmental impact
Experience in preparation of PPE Hazard Assessments and associated communication
Proficient knowledge of chemical inventory software and work‐order tracking applications. Work order and preventative maintenance system program knowledge a plus
Ability to determine, collect and communicate leading indicators to track trends and demonstrate alignment and support of the business needs
Strong financial acumen and experience in capital and expense budget forecasting and management
Provide technical guidance for development of emergency response procedures. Specifically spill cleanup/response and hazardous waste management including reporting
Solid written and strong verbal communication skills along with advanced presentation skills. Highly proficient at writing well‐formulated emails, notifications and reports. Ability to effectively communicate employees, contractors and vendors.
A minimum of 10years experience with technical writing and document development / generation.
Ability to develop Laboratory Services training curricula that is both appropriate and relevant in a GMP environment
Past experience in Process Hazard Analysis
Ability to spearhead and drive forward a world class document management system
Strong interpersonal skills with experience dealing with a diverse workforce to work in an environment where individual initiative and accountability to the team are required.
Ability to drive execution and lead a team
Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously. Ability to work under pressure and meet strict deadlines
Ability to review facility drawings and communicate laboratory service facility requirements taking into account applicable codes and process safety considerations.
Experience coordinating outside contractors in support of laboratory services operations, maintenance and ancillary systems
Play an active and leading role in contractor pre-qualification to ensure adherence to all EHS and Laboratory Services requirements
Strong computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook and the ability to learn new software, such as CIMS etc
Competence with FDA / cGXP environments and associated compliance regulations
Must be resourceful at information gathering and effectively communicate this information
Advanced in technical problem solving.
Education & Experience:
BS or equivalent degree.
Minimum of 10 years in pharmaceutical, or equivalent laboratory services/ shipping receiving field.
10 years experience in managing staff.
Experience in GMP manufacturing environment from clinical through to commercial.
Experience in cleanroom, sterile, aseptic work environments
Must have a minimum of 10 years experience in cGxP regulatory environments.
40 hour HAZWOPER training and 8 hour refreshers. 29 CFR 1910.120(e)
Hazardous materials transportation. 49 CFR 172.704(1)(2)(3)(4)
Blood‐borne pathogens training. 29 CFR 1910.1030
Must have a valid Driver’s License
Physical / Mental Demands:
Occasional stooping, bending, stretching , pushing, pulling, reaching and/or or light lifting greater than
50lbs may be required.
Ability to sit, stand, walk and move within workspace for extended periods.
Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling.
Ability to work safely in an environment with potential exposure to hazardous, radioactive or infectious materials and waste.
Ability to work safely in an environment with exposure to high temperatures / pressures, steam, compressed gasses, various noise levels and high voltage energy supplies.
Ability to work safely when working alone, or working with others.
Work required in and around laboratory and regulated environments.
Working in and around chemicals.
Working in and around confined spaces.
Ability to perform work on elevated work platforms.
This position requires regular medical surveillance and may require incumbent to wear a respirator or gown.
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.