Associate Director, CSO External Manufacturing (Remote by design)
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.
This is a key role supporting several critical projects in the BMS' External Manufacturing department within Clinical Supply Organization (CSO). The person successful in gaining the position will be responsible for cGMP Clinical Manufacturing Operations, process characterization, scale-up, and technology transfer activities of small molecule drug products (DPs) for the development of new pharmaceutical products.
- Key member of a dynamic scientifically driven team, dedicated to the development and optimization of robust clinical manufacturing processes for the drug products.
- Manage the end-to-end production of clinical trial materials (business/technical interface through delivery of supplies) through an external network of suppliers with capabilities in oral solid dose and specialty drug product manufacturing.
- Participate in quality audits to assess compliance to quality agreements and systems.
- Serve as Clinical Manufacturing representative on multidisciplinary CMC teams.
- Develop process development strategies in collaboration with scientists to define manufacturing processes for clinic & commercialization.
- Responsible for the design and execution of complex experiments to characterize drug product manufacturing processes utilizing various technologies.
- Lead the identification, development, and deployment of new instrumentation, technologies, and methodologies to support efficient and effective drug product process development.
- Manage drug product process development/technology transfer to Contract Research/ Manufacturing Organizations.
- Serve as a resource of scientific and technical expertise.
- Assume departmental responsibilities for assigned projects and equipment.
- Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals.
- Prepare technical reports, publications and oral presentations.
- B.S/M.S. Engineering or Science field with a minimum of 12 years of experience.
- Minimum 7-8 years of Pharma cGMP experience is required.
- Strong background in pharmaceutical development as it relates to formulation development and process development/optimization.
- Demonstrated expertise in leading scale-up and technology transfer, moving from laboratory to pilot plant and production scale.
- Experience across various solid oral dosage conventional and enabling manufacturing technologies.
- Demonstrated capability orchestrating development and execution of an experimental program to address issues of process robustness, productivity, and cost, integrating efforts with specialists in other technical disciplines.
- Demonstrated record of implementing novel and creative solutions to overcome process development obstacles.
- Thorough knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, engineering design, and statistical process control fundamentals.
- Knowledge of cGMPs during pharmaceutical development and commercial manufacturing.
- Demonstrated proficiency in balancing resource requirements within projects and among multiple assigned projects.
- Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment.
- Ability to work independently or in leading a team under deadline. Strong verbal and written communication skills are essential.
- Experience with broad CMC issues encountered in drug development, thorough understanding of applicable regulations.
- Ability to supervise, coach, and mentor junior-level engineers.
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.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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