General Description:

This is an individual position for CMC and Project management of initial start of facility and tech transfer that requires advanced technology expertise in biological cell culture, purification and/or drug product process. Of equal importance, it is the ability to develop rapport internal and external to CMC. This role will directly support Project Management, Technology Transfer, Regulatory Filings/Inspections. This position plays a PM and CMC leading role in Technology Transfer and CMC regulatory filings by setting clear objectives and empowering their team. This position involves close collaboration within regulatory CMC, MS&T, Process Development, Manufacturing, Quality Control, Quality Assurance, and Regulatory groups.

Technical/Skills Required:

• Project management skills related to internal and external teams for equipment CQV and technology transfer.

• Broad understanding of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies, and distribution across multiple regions.

• Process and equipment knowledge related to cell culture and/or purification as well as analytical instruments commonly used in manufacturing

• Experienced in Tech Transfer and solving manufacturing related issues

• Accountable for availability of clinical and commercial supplies, timely development of high-quality regulatory filing content, development of robust manufacturing processes and analytical methods and completion of all necessary validation activities within a matrix structure with the expertise areas and external partners to deliver new drug applications in multiple markets.

• Experienced in the regulations and guidelines of the FDA, EMA, ICH, PDA

• History of supporting regulatory inspections.

Working Experience:

• BS or higher in science, biochemistry, biotechnology, biology, chemical engineering and/or related discipline

• 7+ years of experience in the pharmaceutical/biotechnology PM and CMC management of development and commercial programs

• Experienced in biological manufacturing upstream and/or downstream and/or drug product manufacturing development and production operations

• Ability to operate effectively within an entrepreneurial and science-driven company environment; self-motivated, delivery-oriented, assertive, able to inspire others, driven and hands-on with unquestionable integrity and the highest ethical standards

• Familiarity with EMA and FDA regulatory requirements for submissions

• Broad knowledge of drug development, CMC, preclinical and clinical requirements

• Experience in effectively managing scientific groups and projects

• Demonstrated effective communication, oral and written, in a multi-disciplinary, project-driven work environment

• Demonstrated skill in leading project teams tasked with resolving complex production related issues

• Good written and communication skills

• Familiar with software such as Microsoft Office including Microsoft Project, Visio, etc.

Physical Requirements:

• Must be able to stand for long periods, up to 8 to 10 hours/day

• Must be able to work scheduled 40 hours with the ability to work overtime as needed

• Must be comfortable in working in varying temperatures

• Environment requires dedicated gowns, depending on project schedule

• Willing to work any shift

• On-site work (not remote work)

Supervisory Responsibilities:

• N/A

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.