Technical Specialist, Drug Product Development - LBO
- Summit, NJ
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Bristol Myers Squibb 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.
Bristol Myers Squibb is seeking to hire a Technical Specialist to support the Drug Product Development (DPD) non-GMP process area. This position will report to the Manager, DPD LBO and work closely with other members of the Summit, NJ LBO leadership team.
This position provides the candidate with the tactical responsibility of operating day to day activities as well as project based tasks in the Drug Product Development Process area, which includes but not limited to organizing the weekly processing area schedule, managing material inventories, material/equipment ordering/receipt, coordinating multiple area activities with formulation scientists, lab support, maintenance, calibration personnel and managing of external service providers.
The position will offer strategic development exposure allowing the candidate to be involved with the writing of department procedures for operations activities, assist with equipment/capital purchase discussions, support long-term departmental objectives, and also serve as a trainer, mentoring junior department members. Candidate must have ability to successfully interact with internal and external partners. Hands-on experience and mechanical aptitude skills are required.
- Supervises some of the daily operations of the Drug Product Development Facility.
- Assists/Prepares weekly process schedule for DPD Facility.
- Coordinates as needed equipment and area for utilizations, cleaning, set-up and maintenance activities.
- Assures subsequent equipment and area cleaning post activities per established procedures.
- Orders and maintains chemical and consumables inventories.
- Serves as trainer to junior technician staff in areas of her/his expertise.
- Interfaces with lab support staff, maintenance and calibration personnel in support of department operations as required to perform assigned tasks.
- Coordinates preventative maintenance / calibration activities with process schedule for external service provider and internal craftspeople.
- Supports departmental objectives - Compliance, Environmental Health and Safety, budget, capital and equipment ordering, procedural directions.
- Partners with internal and external resources as necessary in support of department objectives.
- Capable of working with potentially hazardous material in isolator / containment and / or gowning with personal protective equipment.
- Firm understanding of Root Cause Analysis and CA/PA methodologies.
- Ability to lift up to 80 lbs when required in support of responsibilities regarding equipment installs/preventative maintenance activities.
- Participates in the planning and preparation of Capital equipment purchases.
- Participates in the planning and preparation of equipment installations in the facility. Assist with start-up/qualification activities (IQ/OQ/PQ) as needed.
- Authors Standard Operating Procedures and work practices in support of department's objectives.
- Collaborates and maintains strong working relationships with colleagues in departments external from DPD.
- Writes developmental reports as necessary.
- Supports DPD LBO as required to facilitate project timelines and department objectives.
- Supports directives from area management to facilitate tactical and strategic operational and department objectives.
- Attends DPD Technical Reviews and communicates the knowledge with team.
- Reinforces BMS culture and values, and drives change where needed to increase alignment with those goals.
- Develops staff through coaching, training, and other relevant experiences. Builds high performance teams.
- Provides constructive and timely feedback and coaching to enhance personnel performance.
- Guides the reallocation of roles and responsibilities across team members to facilitate both goal achievement and personal development.
- Guides and coaches others in managing through change.
- Oral Solid Dosage Development, GMP Process, Facilities Operations, prior supervisory experience preferred.
- Ability to work in isolator / containment apparatus, or while gowned with personal protective equipment.
- Excellent communication skills (oral & written).
- Ability to train, mentor and partner with colleagues.
- Demonstrates strong equipment, process and problem solving capabilities.
- Hands-on experience and mechanical aptitude skills required.
- Capable of leading by example in support of performance and values objectives.
- Superior proficiency with computer software programs / applications.
- Demonstrates initiative for advancement within department / organization
- Has the skills to balance technical needs, resource requirements, and other business considerations across multiple assigned projects.
- Has demonstrated strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment. Ability to work with a sense of urgency, independently or in leading a team under deadline.
EDUCATION AND EXPERIENCE (As Applicable)
- HS Diploma or Trade Certificate with minimum of 12 years relevant experience.
- Associates Degree with minimum of 8 years relevant experience.
- Bachelor of Science Degree with minimum of 4 years relevant experience.
- MS Degree with minimum 2 years relevant experience.
- Oral Solid Dosage Development, Validation and Qualification, Procedure Development and QA experience preferred.
- Excellent communication, interpersonal and management skills to collaborate on and direct the work of others on assigned projects (including both internal teams and external collaborators).
- Direct or indirect supervisory experience.
Work is performed both in a typical office and in a process development manufacturing environment. Some work is performed seated, but manufacturing related work requires intermittent standing and walking for up to 40% of the time. Manufacturing work involves working around potentially hazardous material (solvents, development drug substances, and excipients).
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
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