Technology Transfer Specialist

Reporting directly to the Senior Manager of Manufacturing Sciences and Technology, the Technology Transfer Specialist will provide cross-functional support for the tech transfer of programs to ensure customer deliverables are fulfilled and program timelines are met.

Key Responsibilities

• Facilitate Tech Transfer activities throughout the lifecycle of the program. These include working cross-functionally with Process Sciences (PD, AD, and MST), Operations, Quality, Supply Chain, Program Management, and Business Development.
• Ensure projects are managed effectively and efficiently within the mutually agreed upon deliverables and timelines.
• Responsible for receipt of all tech transfer-related documents including, but not limited to Process Description, Process Flow Diagrams, Analytical Methods, Bill of Materials, Cell Banks, etc.
• Establish business processes with defined deliverables for functional areas at each stage of development.
• Coordinate and liaise with Client to communicate gaps in the transfer of materials and documentation.
• Identify gaps, risks, potential program impacts, and project gating activities during tech transfer and scale-up by evaluating program timeline against existing resources.
• Work with supply chain on the procurement of all raw materials (critical and non-critical) and consumables to support development and manufacturing activities.
• Identify third-party contracts required for outsourced testing.
• Interacts with clients and works with team supervisors to ensure that collaboration goals are met.
• Provide sound guidance to team members, fostering a culture of collaboration and scientific excellence.

Education and Experience

• Ph.D. or Master’s with 5+ years, or Bachelor’s with 10+ years of experience within related discipline.
• Expertise in the process and analytical Technology Transfer activities to support the development and release of biologic drug substances.
• Experience with managing third-party laboratories for outsourced analytics.
• Proven track record working cross-functionally on project-related deliverables.

Knowledge and Skills

• Must have in-depth knowledge of all tech transfer-related activities, including process, analytical, manufacturing, quality requirements.
• Experience with Facility Fit, Safety, and GMP requirements for the manufacture of bio-therapeutic Drug Substances and/or Drug Products.
• Outstanding people skills: ability to form and lead multiple highly functional teams and build strong relationships with cross-functional team members and lead through influence.
• Superior ability with customer relations both technically and from a business perspective.
• Project management skills and ability to track and manage multiple projects.
• Exceptional organizational and time management skills.
• Facilitate with organizational agility supporting production of biological pharmaceuticals or related products.
• Must possess good to excellent writing and PC skills with a knowledge base in Microsoft Word, Excel, Power Point, and Project.
• Ability to take responsibility and have a “get the job done” mentality in a high-energy, high-intensity, results-oriented environment.
• Excellent verbal and written communication skills; strong presentation skills.
• Ability to make good judgements and quick decisions regarding project needs and timelines.
• Resolve and negotiate conflicts or problems with tact, diplomacy, and composure.
• Improve efficiencies by maintaining full alignment with Process Sciences, Quality, Supply Chain and Program Management.
• Working knowledge of FDA and other regulatory agency guidelines.

Physical Requirements and Working Environment

• Flexibility is required for working hours. Some weekend work may be needed and earlier or later start/finish times may also be required.
• Must be able to communicate effectively, both verbally and written
• The essential functions of the job are usually performed in a well-lit, ventilated, environmentally controlled facility where the noise level in the work environment is usually moderate.
• This position may involve a combination of office and laboratory environments and automated equipment and be required to wear PPE.
• While performing the job duties, the employee is regularly required to sit, stand, work on a computer, reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus. The employee must have the manual dexterity and manual ability to effectively use computer terminals.
• Work required to be performed in the Scorpius job site.
• May require travel up 20% (customer sites, other Scorpius sites, conferences, etc.)