Manager, Parenteral ExM MS&T (m/f/d)

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 Manager/Engineer of External Manufacturing Technology will provide technical support for manufacturing of BMS parenteral drug products at Contract Manufacturing Organizations (CMO’s) in the US, 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 report into the Associate Director of Biologics Drug Product External Manufacturing located in Boudry, Switzerland. This position will be located in Boudry, Switzerland.

Key Responsibilities

• Participation in CMO/vendor selection with Procurement, Quality, and other business functions.
• 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
• Technical input, authoring, and approval of CMC documents, support CMC query resolution with Global Health Authorities, and support of plant inspections.
• 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.

Knowledge/ Skills

Education:

• 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 preferred.

Experience / Knowledge Desired:

• Strong technical knowledge (subject matter expert) of sterile manufacturing processes and technology, with a minimum of 4 years of experience preferably in a manufacturing plant and/or secondarily in a manufacturing, science, and technology department.
• Knowledge of SOPs, cGMPs and GLPs and the know how to work and manage within a regulatory environment.
• Experience with the execution of Technology Transfer and scale up programs for commercial drug product manufacturing processes.
• Strong technical writing skills and ability to design, author, and execute process development, qualification and validation protocols (e.g. PPQ) consistent with current Global Health Authority requirements.
• Experience with formal risk assessment and investigational tools such as pFMEA, Ishikawa Fish Bone, as well as statistical analysis knowledge
• Requires approximately 25-35% travel, mostly to CMO sites and includes international. May require Person in Plant (PIP) temporary assignments, where location at site is up to 75% for a temporary time period

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 matrix environment
• Strong ability in negotiating and influencing without authority in complex, high impact situations
• Strong presentation and communication skills both, oral and written

BMS Bio-Pharma Behaviours Required:

• ACCOUNTABILITY: We own our outcomes and the outcomes of other
• SPEED: We act with urgency and agility
• INNOVATION: We embrace new ideas
• PASSION - We pursue excellence to help patients prevail

• d stands for diverse, meaning that BMS welcomes every employee independent of gender, age, sexual orientation, ethnicity, religion

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.