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.
The External Manufacturing (ExM) business unit is responsible for the management of manufacturing and reliable supply across the Bristol-Myers Squibb global network. This includes management of, and working in conjunction with, third party drug operations (commonly known contract manufacturing operations) and internal manufacturing sites.
ExM's robust operating model is focused on evolving and continuously improving ways of working to take External Manufacturing to the next level, leveraging data and technology in an effort to deliver product to customers and patients at optimum speed, time and cost.
Bristol-Myers Squibb External Manufacturing is looking to recruit a permanent Senior Engineer, Parenteral ExM MS&T. The successful candidate will provide technical support for manufacturing of BMS biologic drug products at Contract Manufacturing Organizations (CMO's) in the EU, and abroad. The individual will act as single point of contact for technical matters at the CMO, and may perform Person in Plant duties (PIP) in support of technical transfer and commercial manufacturing activities.
This position will bebased in Boudry, Switzerland and report into the Associate Director, Parenteral ExM MS&T located in Cham - Steinhausen, Switzerland. Key Duties and Responsibilities:
- Technical single point of contact and BMS Site Implementation Lead to contract manufacturing organizations in support of technical transfers. This includes review and approval of site technology documents such as Engineering Studies, characterization Protocols, Validation Protocols, Process Risk assessments, etc. This likely will include Person in Plant (PIP) support
- Execution of Process Owner Role at contract manufacturing sites. This includes process capability analysis and Continuous Process Verification of key quality attributes and parameters at the CMO , identifying and executing process robustness improvement projects where required. Use of this knowledge to ensure timely, comprehensive and accurate process data reviews and to support generation of Annual Product Quality Review documents for commercial products.
- Leadership or support of critical manufacturing or complaint investigations that involve significant product impact including root cause analysis, CAPA generation, and impact assessment
- Participation on matrixed Technical Product Teams to drive technical process improvement strategies. Must generate presentations to support development, approval, and execution of technical plans
- Employment of resources and processes (OPEX etc) to improve processing efficiency and to ensure optimized technical support for manufacturing, technical transfer and scale-up of processes to commercial scale.
- Technical input, authoring, and approval of CMC documents, support CMC query resolution with Global Health Authorities, and support of plant inspections.
- Participation in CMO/vendor selection with Procurement, Quality, and other business functions.
This is intended to be a general job description and should not be construed as all inclusive.
Qualifications,Knowledge and Skills Required:
- Strong technical knowledge of sterile manufacturing technology and processing techniques, with a minimum of 10 years of experience as a BS degree, 8 years of experience as a MS degree and 6 years experience as a Ph. D is required.
- A bachelor's degree in relevant engineering or science discipline (chemical/mechanical/bioprocess engineering, biochemistry, pharmacy, microbiology or a related pharmaceutical science) is required. Masters or PhD level degree is strongly preferred.
Experience / Knowledge Desired:
- Subject matter expert in sterile manufacturing processes, with a strong knowledge of global regulatory requirements (e.g. FDA) related to the design and control of these processes.
- Knowledge of SOPs, cGMPs and GLPs and the know how to work and manage within a regulatory environment.
- Demonstrated experience with the execution of Technology Transfer and scale up programs for commercial drug product manufacturing processes.
- Strong technical writing skills.
- Demonstrated strong oral and written communication skills, along with demonstrated project management experience.
- Ability to work within and lead cross-functional technical teams, across multiple cultures.
- Demonstrated capability to design, author, and execute process development, qualification, and validation protocols (e.g. PPQ) consistent with current Global Health Authority requirements.
- Statistical analysis capability, including use of statistical software platforms (e.g. Minitab, JMP) to determine trends and variability across inter-batch data sets. Familiarity with Design of Experiments, Quality by Design, and Risk Assessment concepts commonly employed in pharmaceutical process development.
- Experience with formal risk assessment and investigational tools such as pFMEA, Ishikawa Fish Bone,
- Requires approximately ~40% travel, mostly between sites in switzerland and to CMO sites. May require Person in Plant (PIP) temporary assignments, where location at site is up to 75% for a temporary time period
- Demonstrated ability to
- influence areas not under direct control to achieve objectives
- work strategically, manage multiple programs consistent with department objectives
- Work well in a matrix environment and effectively support the decentralized manufacturing function
- build alignment with business partners including Procurement, Quality, and CMO stakeholders
- manage risk and make rapid decisions
Personal Competencies Desired/Required:
- Strong strategic and analytical thinking, problem solving and rapid decision making skills
- Demonstrated capability in implementing challenging goals, objectives and practices in a complex and ambiguous environment
- Strong ability in negotiating and influencing without authority in complex, high impact situations
- Strong presentation and communication skills both, oral and written
- International travel is required
This role involves ~40% traveling.
Why should you apply
- You will help patients in their fight against serious diseases
- You willbe part ofa company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
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.