OSD Manufacturing Operations, Senior Team Leader (3rd shift)
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.Position: Manufacturing Operations, Senior Team Leader (3rd shift)Location: Humacao - PR
- Leads a Manufacturing Production area Team to ensure that production, competitive cost, quality/regulatory, customer service requirements are met or exceeded.
- Plans and organizes the area work to achieve a High Performing Team environment. Manages the assigned operations area people staffing, performance assessment, merit increase /annual performance bonus, counseling/coaching/disciplinary & corrective actions, and takes action for performance improvement as well as career development.
- Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of Manufacturing Operations area. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Determines production schedule, updates schedule’s board, communicates daily schedule performance to team members and communicates the shift production information with other shifts leaders. Reduces cycle times and optimizes production scheduling by the use of innovation tools including.
- Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation.
- Trains the Team on any necessary compliance and quality requirements related with the area or the business. Reviews Batch Records (Paper/Electronic) and manages discrepancies.
- Collaborates effectively with other functional SMEs to ensure production goals are met and investigations are expeditiously completed. Participates in and may lead continuous improvement initiatives applying tools like: 5S, LEAN manufacturing and Six Sigma to improve quality, cost, safety and cycle time. Performs administrative duties for the assigned area that include team members attendance monitoring, attendance timecards approval, vacations scheduling and approval and overtime coordination to meet production requirements.
- Provides, in coordination with other departments, the guidance and resources to support technology transfer activities, equipment qualification, process validation, troubleshooting, clinical lots production, and process optimization.
- Participates in quality and safety investigations. Provides support to the regulatory affair reports, customer complaints, and area exception reports (e.g., Quality Investigation Reports, Quality Complimentary Reports, Change Request Forms, etc.).
- Ensures that area Team members comply with the established learning curriculum to achieve proper knowledge transfer/acquisition. Participates actively as a key contact member of the OSD operations areas in the internal and external audits.
- Provides input in the creation and revision of SOP’s, protocols, batch records and related documents to assure compliance with cGMP’s, company policies / procedures and documentation practices. Maintains control of all environmental/safety issues in the OSD Manufacturing operation areas. Serves as the back-up of the OSD Operations Manufacturing Manager, as requested.
- Maintains accurate tracking records and provides timely feedback to Manager regarding status of costs in the assigned area relating to overtime and waste.
- Monitors usage and expenses related to supplies and labor costs in the work area. Implements shop floor continuous improvement practices to meet financial standards. Promotes and models the BMS Core Behaviors, facilitating teamwork, providing coaching and feedback.
Qualifications & Experience
- BS Degree in Engineering /Biology/ Chemistry, Pharmacy or related sciences with three (3) years of experience in pharmaceutical OSD manufacturing processes; or BBA Degree in Business Administration with five (5) years of experience in pharmaceutical OSD manufacturing processes.
- Proven in-depth technical knowledge on Oral Solid Dosage Manufacturing processes•Proficient in regulatory / compliance areas of cGMPs, FDA regulations, EHS.
- Basic understanding of product cost structure, budgeting process and spending.
- Three (3) years of experience in a supervisory / managerial position.
- One (1) year experience in a very highly automated manufacturing operations environment (Electronic Batch Records/NIR-PAT Technology).
- Proven strong leadership skills managing performance to the attainment of high performing team •Knowledge and experience implementing Six Sigma and Lean Manufacturing.
- Strong business sense.
- Sense of urgency, accountability and agile decision making.
- Understanding of and capability to support financial and total quality/safety objectives.
- Assertiveness and uncompromising attitude with regard to the quality standardsThis is a list — style: List Paragraph.
- Exposed to various working environments which may potentially expose the incumbent, for which protective equipment is required.
- Some travel required to attend meetings and trainings.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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