Technology Transfer Manager in US-Remote

1 year assignment (from start date)

The role is Remote (must be within range of either site NJ and NC)

- Yes- travel from home to the site in Greenville NC is reimbursed (Domestic travel to manufacturing site required, up to 25%. (Travel to Greenville, NC about 1x a month with short notice).

Fully Remote role - however, ideal candidate will be within 240 miles of Greenville NC (half day drive to manufacturing site.)

Duties:

• This role is for an SME in aseptic drug product manufacturing who will be responsible to lead the coordination of activities to transfer the drug product fill-finish process to the manufacturing site.
• The process consists of compounding, filling, and optical inspection.
• In this role the incumbent is charged with leading complex Technology Transfers and Process Performance Qualification (process validation) that drive reliability and sustainability of our products at external manufacturers.
• This person will provide the technical insight and team leadership role to effectively deliver qualification of equipment, methods, hold times, and manufacturing processes aligned with the supply chain network strategy.
• This role will partner with External Manufacturers and Client Innovative Medicine Quality, Planning, and Partnership & External Supply.
• The team will ensure processes are flawlessly introduced into the supply chain network and ongoing production consistently satisfies quality and regulatory needs.

The incumbent must be able to:

• Work independently to drive and execute projects of a complex nature where analysis of situations or data requires an in-depth evaluation of factors in multifunctional areas
• Communicate efficiently with their core team
• Influence other functions/levels outside of own group and effectively leads cross functional and cross organizational teams to generally attain expected results for all parties.
•  Travel to the manufacturer(s) as needed to provide on-site support or oversight, especially during production of qualification batches.
• The incumbent should be an expert in biologic drug product manufacturing processes.
• Hands-on experience in other areas such as Quality, R&D and Manufacturing Operation is highly desirable.
• Process validation knowledge for pharmaceutical ingredients or products is desirable.

Tasks and responsibilities:

• Lead complex technology transfers with a focus on right-first-time execution and risk management.
• Perform as SME to identify technical areas for improvement, and supply chain improvement
• Lead drug product Process Performance Qualification and preparation of regulatory reports.
• Support the internal and external teams to assure ensure manufacturing site readiness, reliability and sustainability.
• As needed, provide SME input on complex investigations, root cause identification, product impact assessment and corrective and preventive actions implementation.
• Represent Client Innovative Medicine Supply Chain in interfacing with external manufacturing company.
• Manages international sample shipments, execution of shipping route verification studies per SOPs, supports investigations and CAPAs as technical expert in the Drug Product manufacturing process.
• Reviews and approves batch records, validation protocols, data, and reports.

COMPETENCY (knowledge, skills, abilities and experience required):

Specific knowledge:

Proven track record in in at least three of these areas:

• Project leadership
• Pharmaceutical process development
• New product introduction
• Technology transfer
• Process validation
• Production support.
• Demonstrated technical competency and experience with biologic drug product
• Demonstrated experience in managing technology transfers and/or Life Cycle Management projects and investigations.
• Partnering with R&D and Client to improve the fit for plant and commercialization of new products into the supply chain.

Personal and interpersonal skills / Leadership skills

• Demonstrated leadership in providing integration of activities, information across multifunctional groups and sites.
• Planning and logistics skills capable of effective integration of deliverables at the manufacturing site level.
• Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix teams.
• Ability to influence and lead peers, superiors, and external partners, including interaction with senior management.
• Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly.
• Ability to manage complexity and change.

Personal attitude and mindset

• Motivated, self-starter able to work independently with demonstrated problem solving skills.
• Drives for innovation and change to ensure competitiveness.
• Can-do mentality: takes initiative, creates a result-oriented working spirit in his/her team.

DEGREE:

• Engineer or Scientist, MSc or equivalent in a technical field (Chemistry, Pharmaceutics, Biological Sciences, Chemical Engineering) with +4 years of experience in biopharmaceuticals, or Bachelors + 8 years

LANGUAGES:

• Fluent in written and spoken English

PHYSICAL REQUIREMENTS/WORKING CONDITIONS:

• Works in an international environment across different time zones
• Travel: ~25% of time based on role and specific business goals
• Virtual Network interactions, utilizing available infrastructure to communicate with Key Partners and Stakeholders

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