Tech Transfer Lead

Proclinical is currently recruiting for a Tech Transfer Lead for an exciting and rapidly growing biotech company near Gaithersburg, MD. As the Tech Transfer Lead, you will be contributing to the development of the company's portfolio by being responsible for the development, tech transfer, manufacture and supply of clinical drug substance.

Job Responsibilities:

• Responsible for drug substance technology transfer activities from preclinical development through commercial supply.
• Identify, select and manage Contract Development and Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacture and supply of Drug Substance in support of ongoing clinical programs.
• Deliver robust, scalable and cost-effective manufacturing processes.
• Oversee execution of the validation of Drug Substance processes as required by cGMP, ICH and FDA regulations.
• Assist with the writing and reviewing documents for INDs.
• Prepare, review, or edit cGMP batch records, CMC regulatory, and Quality documents.
• Provide input on process development strategies, overseeing CDMO development through clinical and pre-commercial stages.
• Provide technical/team support and leadership for technology transfer, and qualification studies associated with the development and implementation of processes, systems and facilities.

Skills and Requirements:

• MS or BS in engineering, chemistry, biology, or related discipline.
• Previous experience in pharmaceutical or biological operations.
• Proven experience in collaborating in matrix teams in a technical environment.
• Strong program management and project management skills and adept at working collaboratively with cross functional teams.
• Strong interpersonal and communication skills.
• Knowledge of protein production and purification manufacturing technologies.
• Experience in oversight of CDMOs for process development, characterization, technology transfer, and release.
• Knowledge of CMC development from pre-clinical through clinical to commercialization.

If you are having difficulty in applying or if you have any questions, please contact Alex Tooulas at (+1) 917-284-9670 or a.tooulas@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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