Celgene Associate Manager, Equipment Commissioning & Qualification Delivery 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.
ASSOCIATE MANAGER, EQUIPMENT COMMISSIONING & QUALIFICATION DELIVERY
Purpose of the Position:
The Associate Manager, Equipment Commissioning & Qualification Delivery supports the successful operation of facility, laboratory and business functions at multi‐use sites through interaction with internal team members and peer‐level customers as well as external service providers. The incumbent in this role supervises entry, junior, and experienced level professionals to accomplish daily tasks and short‐term projects according to established policies and procedures. The individual manages multiple projects and ongoing work activities of low to moderate complexity to ensure on time completion. In addition to answering questions and resolving issues for staff, the incumbent spends a small portion of their time on individual work. The incumbent may recommend modifications to work processes or procedures to functional management that impact their immediate function or organizational unit.
Lead a team of up to 5 people.
Assist with interviewing internal and / or external personnel to fill necessary roles.
Provide direction to internal and external team members.
Manage the workload of team members to ensure appropriate work life balance.
Delegate, develop and motivate direct and contract reports.
Set goals for and deliver personnel performance reviews for direct reports.
Ensure team members are appropriately trained for duties being performed.
Promote and ensure the safety of all team members and adherence to site EHS procedures and guidelines.
Ensure the team is in full compliance with local, site and global Celgene policies and procedures.
Commissioning and Qualification Activities
Directly manage Equipment Commissioning & Qualification equipment qualification teams.
Manage and allocate resources responsible for teams performing validation activities of new equipment and standalone laboratory computerized systems and/or changes to existing equipment and standalone computerized systems.
Manage project teams with emphasis on solutions to technical and compliance challenges in all phases of the System Lifecycle.
Oversee the Development/Review/Approval of SOPs, WPs, test protocols, validation deliverables, and plans as needed.
Ensure resources performing validation activities are knowledgeable of and in tune with latest industry regulations and initiatives.
Provide input and guidance for change strategy, risk assessment, testing and compliance gaps.
Promotes and provides excellent customer service and support
Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.
Provides technical support and guidance on equipment and computer systems qualification and validations issues. Interfaces with customers to ensure all expectations are being met.
Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.
Communication and Management of Timelines
Manage staff workload of multiple projects and priorities across the many different departments that the ECQ organization serves.
Develop an effective mechanism for communicating the current status of all laboratory systems maintained by ECQ to all affected stakeholders.
Continually seeks opportunities to increase internal client satisfaction and deepen client relationships.
Ensure equipment, facilities and programs are maintained in compliance.
Act as departmental lead and SME in both internal and regulatory audits.
Required Competencies‐Knowledge, Skills, and Abilities:
Knowledge, Skills & Abilities:
Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and Oral Solid Dosage clinical manufacturing.
Ability to develop, delegate and motivate others including direct and indirect reports.
Understanding of scheduling fundamentals and execution.
Strong written and verbal communication skills.
Excellent interpersonal skills with experience dealing with a diverse workforce.
Strong multi‐tasking ability in conjunction with proven organizational skills. 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.
Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
Working knowledge of scheduling software and systems, and inventory management systems.
Ability to create and analyze meaningful metrics.
Team Player / Building Relationships
Action and detail oriented
Education & Experience:
BS in Engineering or Science related discipline preferred.
Minimum of 5 years’ experience in FDA-regulated industry.
Minimum of 5 years’ experience managing personnel and/ or projects.
Strong instrumentation background and experience in laboratory and manufacturing operations.
Knowledge of cGMP in the pharmaceutical industry.
Excellent computer skills including knowledge of calibration management and environmental monitoring systems
Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.
Experience interacting with regulatory agents, external and/or internal auditors in a compliance audit environment with direct interaction including face to face interaction and response to audit questions.
Must have strong interpersonal and 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
3 years of managing direct reports.
Physical / Mental Demands:
Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs
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.
Primarily office environment, but will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.
Ability to work safely and effectively 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.