Shift Leader, Non Sterile Operations
- Manatí, Puerto Rico
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.
Lead the Non-Sterile Operations Process Team supporting (Inspection Operations and Technology, Packaging Operations, and Medical Device Assembly Operations) by providing leadership and direction for the projects implementation of sterile growth products (serialization, automated inspection, automated assembly and packaging, new product launches, and/or any other strategic initiative).Provides guidance to the Inspection Operations and Technology, Packaging Operations, and Medical Device Assembly processes in order to meet production, quality and safety requirements. This position must comply with all Security guidelines, Environmental Health and Safety regulations, regulatory/compliance requirements, and the current Good Manufacturing Practices required by the job function.
MAJOR DUTIES AND RESPONSIBILITIES
1- Ensures Process Support personnel complies with the established curriculum to achieve proper knowledge transfer and personnel qualification.
2- Ensures operations process support (i.e. shop floor controller) coordinate the production scheduling with the area planners and quality personnel, to organize and comply with daily production goals.
3- Ensures that area equipment is well maintained, including but not limited to calibrations and preventive maintenances, in order to achieve optimal operational performance while maintaining regulatory and compliance requirements.
4- Participates actively in the preparation of the department budget and effectively manages company funds and actives.
5- Collaborates with NPL, local and corporate MS&T, Eng, QA, PT, PMO, Drug Product Sub-Teams to achieve non-sterile strategic growth product projects milestones.
6- Ensures a streamlined and continuous operation between Inspection, Assembly and Packaging Operations.
7- Co-Manage Tier 2 and active participation in Tier 3 meetings related to Inspection, Assembly & Packaging activities while keeping alignment of tools utilized on boards against latest OpEx guidelines. Accountable to monitors, evaluates and communicates area performance metrics for processes, cost and quality control.
8- Lead the Non Sterile Area Quarterly Business Review related to Inspection, Assembly & Packaging activities.
9- Own productivity initiative programs by identifying efficiencies in the Operational areas and providing resources to support Productivity teams.
10- Ensure adequate support to the regulatory affair reports, customer complaints, and area exception reports (e.g., Quality Investigation Reports, Quality Complimentary Reports, Change Request Forms, etc.).
11- Participates actively as a key stakeholder of Sterile and/or Non Sterile operations in internal and external audits.
12- Participate on Operations Quality GEMBA walk-downs and support managing close-out of generated actions
13- Ensures all technology transfer activities, equipment qualification and process validation, troubleshooting clinical lots production, and process optimization by providing the necessary process expertise.
14- Monitors, evaluates and communicates area performance metrics for processes, cost and quality control.
15-Improves current processes in order to optimize product efficiency/yields.
16- Supports the creation and revision of SOP's, WPP's special test protocols and related documents to assure compliance with cGMP's, Company policies / procedures and documentation practices.
17- Promotes and models the BMS Core Behaviors, facilitating teamwork, providing coaching, feedback etc.
18- Supports all site Initiatives and any other assignments based on business needs.
19- Performs as back up in the absence of the Site Director Drug Product Non-Sterile Operations as needed.
- The incumbent will be making timely key decisions related to the Inspection, Packaging and Assembly manufacturing processes on a daily basis.
- The incumbent will manage the Site Packaging Robustness program aligned with MS&T global strategy. Focus of this program is to continuously pursuing prevention of quality events and complaints.
- The incumbent will be the Operations liaison between local and corporate MS&T and Packaging Technology groups ensuring that projects impacting the Non Sterile Area are properly executed within project's milestones. Incumbent will lead all operating principles within the implementation of projects such as but not limited to; operating procedures, staffing changes recommendations as required, operator's training needs, line readiness prior commercialization among others.
- Active participation on Drug Product Sub-Teams in representation of Non Sterile Operations team.
- Must have in-depth technical knowledge of the visual / vision inspection and packaging of aseptically filled vials (liquid and lyophilized) and syringes, in order to make sound technical decisions which could have a significant impact on product quality, cost and overall efficiencies, including equipment and technologies.
- Provides recommendations regarding procedure implementation and revision, upgrades to existing equipment and upgrading of facilities, modification of inspection and packaging processes as necessary.
- The incumbent will drive EH&S program activities associated to Non Sterile Area to ensure full alignment with regulations.
- Make decisions regarding personnel administration aspects such as hiring, performance evaluation, disciplinary actions, training and development and terminations among other administrative functions. It is expected that the incumbent will make difficult resources allocation recommendations / decisions consistent with priorities creating new ideas and processes, delivering results, driving for continuous innovation.
Describe the nature of supervision received, the degree to which procedures, methods and goals are outlined by the supervisor, and the immediacy of supervisor, and the immediacy of supervision:
- The incumbent is expected to work with minimum supervision, reporting on status & performance on a periodic basis to the Site Director Drug Product Non-Sterile Operations.
- Position is expected to operate fully autonomously and self-directed.
- Support from Site Director Non-Sterile Operations is on an as needed basis or when barriers are encountered with supporting departments or very significant technical or cost issues.
CONTACTS Describe the most important working relationships of this position. Include the frequency, level, and the purpose of contacts necessary for effective performance:
- Frequent contacts with all Manufacturing and support departments (Engineering, Quality Control / Quality Assurance, Finance, Manufacturing Science and Technology, Compliance, Supply Chain, Human Resources, Security) at Manati and within the Puerto Rico and Corporate Technical Operations is required.
- Occasional contacts with external support teams (Global Packaging Technology and Manufacturing Science and Technology) is required to receive endorsement of process changes in Non Sterile Area.
- Works closely with Operations Area Managers to improve current processes in order to optimize product efficiency/yields.
- Regular interaction with internal / external auditors, government agencies, and other regulatory agencies or institutions.
KNOWLEDGE / SKILL
- BS Degree in Chemistry, Biology, Engineering, Pharmacy or related sciences.
- Ten (10) years of experience in inspection and packaging / assembly processes including liquid and lyophilized vials and pre-filled syringes within pharmaceutical environment and five (5) years of them in a managerial position.
- Experience in new product launch activities related to packaging, including combination products (medical devices).
- Extensive experience (more than five years) managing Parenteral products inspection, including development of inspection methodologies for actual and new products.
- Strong leadership skills while maintaining effective communication and interactions with superiors and colleagues.
- Team oriented with excellent interpersonal skills.
- Strong business sense; understanding of and capability to support both financial and total quality objectives.
- Assertiveness and uncompromising attitude with regard to the quality standards applied in the day-to day activities.
- Ability to leverage both internal and external resources from various levels.
- Proficient in regulatory / compliance areas of cGMPs, FDA regulations, EHS.
- Strong interpersonal and teamwork skills; ability to develop and maintain effective professional relations with colleagues at all levels across the organization; ability to integrate actions toward objectives.
- Excellent and effective communication skills in both English and Spanish.
- Experience in writing technical reports and T&E's, executive summary type presentations to senior management and technically detailed presentations to specialized technical groups such as Manufacturing Science & Technology, Supply Chain, Engineering and QC/QA.
A.Describe exposure to any hazards / disagreeable conditions in the work environment:
- Exposed to various working environments which may potentially expose the incumbent, for which protective equipment is required.
B. Travel required (describe nature and frequency):
- Some travel required to attend meetings and trainings.
C. Overnight absences required (per typical month):
- As required.
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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