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Tech Transfer Process Manager

Company: Emergent BioSolutions
Location: Baltimore
Posted on: July 15, 2019

Job Description:

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
I: Job Summary The Technical Transfer Process Leader within the Manufacturing Sciences & Technology department is responsible for ensuring leadership of technical transfer of product manufacturing from one site to another and to/from Customers and/or potential 3rd parties from the process perspective. The complexity of the work demands a solid technical background across a variety of scientific disciplines and fundamentals on technical transfer which includes manufacturing process technologies, biopharmaceutical best practices, lyophilization, formulation development, validation, statistical analysis, regulatory submissions, analytical methods, among others.

More specifically, this role leads the activities for process and product transfers from the technical perspective. This lead work closely with technical/management representatives from other Emergent sites, Customers, as well as cross functional teams on the Camden site. This team leader has critical interaction with the Project Management and Business Development team. The nature of these transfers is often technically challenging and and requires strong leadership attention to quality, time and budget.

Most importantly, strong people leadership and communication skills are essential for the leader of this team. This position includes leading a team comprised of engineers and/or scientists covering a diverse range of experience and education levels. It is essential that this leader creates and engaging workplace with a strong focus on developing and empowering people.

II: Responsibilites Business



  • Participate on MS&T Leadership Team to ensure appropriate alignment of resources to technical challenges and routine operational needs
  • 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.

    Technical



    • 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:




      • Initiate change control in system and ensure approval and closure
      • Write Manufacturing Process Transfer Plan/Report including check list for equipment, process, materials, components, among others.
      • Equipment qualification status completed by responsible department
      • Lab equipment qualification & reference standards calibration completed by responsible department
      • Coordinate Trial, Engineering, Clinical and Regulatory Batches according to defined protocol
      • Execute process validation / monitoring phase
      • Ensure that equipment cleaning procedures are written and cleaning validation plan is in place.
      • Ensure process studies are written and executed based on risk assessments (Holding, Filter Functions, Formulation, Filling Studies)
      • Ensure that key procedures (e.g., cleaning validation, sterilization) are properly established (including initiation of HSE reviews /audits /requirements where necessary)
      • Initiate Follow Up Stability Testing (FUST) internally and with external labs where applicable
      • Initiate Raw Material supplier qualification as needed
      • Verify requirement to audit external sites with HSE and global QA



      • 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




          People Management/Employee Development



          • Builds a strong working environment that promotes our core values and progresses our culture in a positive manner (healthy cross-functional teamwork)
          • Must be able to set and communicate department vision & direction that aligns to company & site strategy including setting of short and long-term department and individual goals
          • Capable of leading change in a positive manner through department
          • Ability to identify and manage talent through requisite HR systems (hiring, compensation, performance management and development) in ways that provide value to both company and emloyees

          • Manage the IPMP for direct reports and mentor associates to facilitate professional and departmental growth
          • Good interpersonal and communication skills (oral and written)
          • Effectively administer IPMP (utilizing SLII concepts) and monitor staff performance in alignment with defined expectations.
          • Must possess ability to negotiate and influence others internally and externally

            The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

            III: Education, Experience & Skills




            • A degree (Bachelor to Ph.D.) in a related field with a minimum of 8 years industry experience
            • Experience in managing scientists/engineers in a fast paced, challenging environment
            • Proven track record of management and leadership effectiveness
            • Strong knowledge of lean & QbD principles in a manufacturing environment with successful application experience
            • Diverse and demonstrated technical knowledge with strong risk management mindset
            • Strong technical and communication skills: oral/written and listening
            • Personal Competencies: Self-awareness, Integrity, Team Player, Adaptability
            • Computer skills (MS Office, JMP/MiniTab or equivalent statistical software, Visio, MS Project)




              IV: Physical/Mental Requirements Type/keyboard, visual acuity, good eye/hand coordination, stand, walk, sit, twist/turn, climb, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing, sense of smell, lift/carry 25lbs, and pull 25lbs. Use phone, copier, computer, copier, and hand tools. Organize/coordinate, analyze/interpret, calibrate precise measurements, problem-solve, make decisions, supervise, plan, communicate, prepare written communications, and prepare transaction documents. Work around noise above conversation level, in hot/cold temperatures, where ventilation is needed, in multiple locations, and with restricted access to laboratory.
              Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

              Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

              Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Keywords: Emergent BioSolutions, Baltimore , Tech Transfer Process Manager, Executive , Baltimore, Maryland

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