Job Detail

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular,immunoscienceand fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

PRINCIPLE OBJECTIVE OF POSITION

The Sr. Scientist/Engineer of External Manufacturing Technology will provide technical support for manufacturing of BMS biologic 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 Cham - Steinhausen, Switzerland. This position will be located in Cham – Steinhausen, Switzerland. 

MAJOR DUTIES AND 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.

This is intended to be a general job description and should not be construed as all inclusive.

KNOWLEDGE / SKILL

Education:

• Strong technical knowledge of sterile manufacturing technology and processing techniques, with a minimum of 8 years of experience as a BS degree, 6 years of experience as a MS degree and 4 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 30-50% travel, mostly 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

BMS Bio-Pharma Behaviors Required:

• Decide & Act: Define a clear picture of the future and the plan for how to get there; hold people accountable for driving individual and team performance; execute while balancing operational and strategic perspectives; drive decision making to the right level; focus resources on the most important work.


• Connect & Collaborate: Remove silos and communication barriers; energize team to achieve shared goals.


• Innovation & Improve: Act as a catalyst for changes that improve business performance; create an environment in which innovation is encouraged and supported.


• Grow & Engage: Create and execute an actionable plan to grow, develop and engage each employee; communicate and reinforce link between each employee’s work and BMS strategy & mission; support work life considerations; create an inclusive culture that leverages colleagues unique interests and contributions; extend trust and provide autonomy for employees to own their work.

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 the resources to pursue their goals, both at work and in their personal lives.