Principal Process Scientist - Investigation Site Lead (R1553992-en-us)
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.
- Accountable for the track and lead the manufacturing process lifecycle for all growth products manufactured at the Manati site.
- Leads a team of scientists who lead the process validation exercises, and site CMC documentation for all commercial products.
- This group also provides process support, including investigational efforts, and implementation of change controls, for commercial products.
- Must comply with all Security Guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
- Executes Manati New Product Introduction Framework for products within his or her portfolio, including project plan development, team formation and charters for new product transfers occurring at Manati.
- Supervise, track, and provides leadership and direction for a highly effective, interactive technical Team of scientists /operational process support specialists who provides operational, scientific expertise and compliance knowledge support to the Manufacturing Operations who lead the investigation process
- Supports the Investigation Site Lead
- Leads, motivates, mentors, and provides technical leadership to process scientists, and develops team members to meet and exceed plant and company goals and objectives.
- Develops and executes technology transfer plans in support of new products, effectively integrating site time and event schedules to priorities established through corporate structures.
- Provides support to the Lead Investigation Team by tracking action to ensure quality event closure. Provide Investigation status to different forums and senior management.
- Partners with Innovation Technologies group, Information Management, Engineering Maintenance, and Manufacturing to ensure equipment and automation are capable to deliver the manufacturing processes transferred.
- Assures effective integration of plans and resources to achieve timeliness of process support, productivity, and technology transfer and validation activities associated to product portfolio.
- Performs Design of Experiments and Process Risk Assessment (FMEA’) activities to establish appropriate process control strategies
- Performs as Subject Matter Expert in liquid, lyophilized and syringe parenteral processes, and formulation, maintaining a current knowledge base on best industry practices.
- Partners with the site management team in the identification of best practices in industry related to technology transfers, pharmaceutical technology to create a competitive advantage.
- Develops and maintains effective working relationships with other division groups in support of technology transfer, validation, productivity, and process support activities.
- Assists in the development and control of the Start Up Budget for the site.
- Performs as the communication liaison for the transfer, validation, optimization, and daily support activities for the assigned product portfolio.
- Performs as the site liaison and primary author for process sections of CMC submissions.
- May represent the site and lead site Technology Transfer Teams to assure timely delivery of targets.
- May be the approver on validation and experimental protocols.
Qualifications & Experience
- Bachelor’s degree in Pharmacy, Engineering, Chemistry, or Science,
- Seven (7) years of directly related experience in Technical Services work within the pharmaceutical Industry.
- Three (3) years experience in parenteral manufacturing of protein therapeutics (biologics) strongly preferred, along with demonstrated knowledge of how these products behave in parenteral processes.
- Excellent organizational, project manager skills and the ability to successfully manage a multitude of technical projects.
- Engineering principles aptitude
- Ability to effectively lead a cross functional site teams towards execution of technical transfer activities.
- Ability to work in a fast paced, complex, and changing environment.
- Ability to manage personnel and financial resources.
- Strong knowledge and practical experience in manufacturing processes, technologies, and processing equipment, CGMP’s and FDA regulations and trends.
- Strong project management skills and experiences.
- Excellent analytical and strategic thinking skills and experiences.
- Demonstrated lead management, interpersonal and teamwork skills. Strong mentor, with excellent people development skills and track record.
- Outstanding communication skills, both in English and Spanish (oral, written).
- Subject Matter Expertise in Industrial Parenteral Formulation and filling process.
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.
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