Job Detail

The Associate Director of External Manufacturing Technology will provide senior level technical support for Parenteral manufacturing of BMS biologic drug products at Contract Manufacturing Organizations (CMO’s).  The individual may lead a small team of engineers and scientists to execute technical transfer and process maintenance activities at the CMO’s.

This position will report into the Head of Parenteral Drug Product Manufacturing Science and Technology, and have a matrix reporting relationship into the Head of the Bristol Myers Squibb Global Capabilities Hub. This position is located in Zug, Switzerland

Key Responsibilities include:

• Participation in CMO/vendor selection and strategy with Procurement, Quality, and other business functions. 


• Oversight and/or preparation of technical information packages, participation in due diligence and site assessments, technical evaluation of Supplier Proposal requests (RFP), and other business agreements


• Technical Transfer leadership to contract manufacturing organizations. This includes development and Sr. Management Endorsement of process development, comparability demonstration, and global registrational strategies to support  CMO implementation


• Review and approval of top level site technology documents such as Validation Master Plans, Process Risk assessments, etc.


• Leadership and hiring of small technical team of permanent and/or contract scientists/engineers to provide Person-in-Plant support for technical transfers and commercial manufacturing according to business agreements


• Provision of ongoing technical support and oversight for a portfolio of externally manufactured products, ensuring consistent security of supply.  This includes technical approval of change control proposals and review of manufacturing and process investigations


• Management of Product Owner Role at contract manufacturing sites.  This includes process capability analysis and Continuous Process Verification of key quality attributes and parameters for BMS biologic products, 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.


• Advanced technical support and scientific communication to Global Health Authorities in support of CMC preparation, CMC query resolution, and plant inspections


• Employment of resources and processes (OPEX etc) to improve processing efficiency and to ensure optimised technical support for manufacturing, technical transfer and scale-up of processes to commercial scale.

Qualifications:

Strong technical knowledge of sterile manufacturing technology and processing techniques, with a minimum of 10 years of experience in the Pharmaceutical or Biotechnology 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 and or PhD level degree is strongly preferred. Candidate must demonstrate strong oral and written communication skills, as well as leadership experience.

Key Skills and Experience include:

• Technical Expert in Biologics/sterile/liquid drug product (Lyo and RTU), fill, finish and inspection Operations.


• Demonstrated successes with Technology Transfer and scale up of commercial manufacturing processes.


• Thorough knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, engineering design and process control fundamentals.


• Strong understanding of project management systems and tools


• Thorough understanding of regulations, familiarity of regulatory environment and industry trends for parenteral drug products


• Working competency of Statistical Process Control and related tools.


• Very strong technical writing and verbal communication


• Demonstrated ability to
  
  
  
  • influence areas not under direct control to achieve objectives
  
  
  • work strategically, manage multiple programs and create a high performance work environment.
  
  
  • work in a matrix environment and effectively support the decentralized manufacturing function
  
  
  • build alignment with business partners including R&D and manufacturing regional and site leaders.
  
  
  • manage risk and make rapid decisions
  
  
  • budget, plan and manage resources efficiently
  
  

The position will require varying levels of travel- estimated at 30%.

A competitive benefits package will be offered for these positions commensurate with relevant experience.

Bristol-Myers Squibb is an equal opportunities employer.