Manager, MS&T

I. JOB SUMMARY

The Technical Transfer Manager is responsible for ensuring leadership of technical transfer ofproduct/process manufacturing from one site to another and to/from Customers and/orpotential 3rd parties. The incumbent is also responsible for technology transfer activities atsite level, including any scale-up, cost-reduction goals and product line efficiency of theproduct life cycle.

The complexity of the work demands strong technical background across a variety of scientificdisciplines and fundamentals on technical transfer which includes manufacturing processtechnologies and biopharmaceutical best practices. The incumbent work closely withtechnical/management representatives from other Emergent sites, Customers, as well as crossfunctional teams on the Rockville site. This individual has critical interaction with the ProjectManagement and Business Development team.

II. ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Maintain good working relationships with internal and external partners/customers with MS&T (Project Management, Business Development, QC, QA, Eng, Mfg, etc.)
• Responsible for working with applicable Project Managers to ensure departmental resources are appropriately allocated based on work scope and technical needs.
• Track and report status on KPIs relevant to Technical Transfer activities/responsibilities and ensure commitment to key stakeholders are met in a timely and quality manner.
• Manage technical aspects of technical transfer from the process perspective for products from one manufacturing site to another, third parties or Customer to site, including for example:
  
  
  
  • Supports the project team with respect to scaling up processes, new equipment and procedures, equipment and process validation, and manufacturing of development, stability, and process qualification batches.
  • Manage the research of new manufacturing technologies to further fine-tune technology transfer activities and overall process improvement.
  • Initiate change control in system and ensure approval and closure defined protocol.
  • Write Manufacturing Process Transfer Plan/Report including check list for equipment, process, materials, components, among others.
  • Ensure that key procedures (e.g., process, sterilization) are properly established (including initiation of EHS reviews /audits /requirements where necessary)
  • Author experimental design, tech transfer reports, and development reports.
  • Author manufacturing batch records and SOPs for new processes and equipment.
  
  
  
  
• Product transfer (scale-up):
  
  
  
  • Support Business Dev and Project Management for transfer to commercial site.
  • Technical assessment for in-licensing products (i.e., due diligence).
  • Involvement of MS&T experts in Technical Project Teams during development phases for manufacturing feasibility assessment.
  
  
  
  
• Lead optimization of manufacturing operations to reduce internal and client costs.
  
  
  
  • Assesses manufacturing processes by risk analysis method(s) and uses results to design robust manufacturing processes.
  • Research and implement new methods and technologies to enhance operations.
  • Prepares master batch records and protocols for the manufacture of development, stability, and process performance qualification batches. Translates development findings into manufacturing processes.
  • Provides technical assessment of changes in manufacturing through appropriate review of documentation and testing results.
  
  
  
  

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

• Minimum of a Bachelor of Science in Biology, Chemistry, Chemical Engineering, Biochemistry, or related life science
• 2-3 years of managerial experience or 5+ years of experience in pharmaceutical or biopharmaceutical manufacturing with strong knowledge on GMP/cGMP and FDA regulations in the Pharmaceutical Industry.
• Detail oriented with strong written and verbal communication skills. Requires proficient presentation and technical writing abilities.
• Diverse and demonstrated technical knowledge with strong risk management mindset.
• Ability to work independently, within prescribed guidelines, or as a team member.
• Ability to travel domestically and internationally as needed.
• Computer skills (MS Office, MS Word/Excel, Visio, MS Project)