Proclinical is currently recruiting for a Tech Transfer Lead with a leading biotechnology company located in Gaithersburg, MD. Successful candidate will be responsible for drug substance CMC-related activities across the company product portfolio, including development, tech transfer, manufacturing, and supply of clinical drug substance (DS). The ideal candidate will be a highly motivated individual with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities.
Job Responsibilities:
- Responsibility for drug substance technology transfer activities from preclinical development through commercial supply.
- Identification, selection and management of Contract Development and Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacture and supply of DS in support of ongoing clinical programs.
- Delivery of robust, scalable and cost-effective manufacturing processes that meet or exceed the target clinical profile.
- In coordination with Quality Assurance, implement stage appropriate analytical methods and protocols and ensure that all CDMOs are using systems and processes in compliance with all relevant regulatory standards.
- Oversee execution of the validation of DS processes as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations.
- Assisting with the writing and reviewing documents for INDs / regulatory section submissions.
- 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 related to vaccine drug substance and key intermediates e.g. media, buffers and cleaning solutions.
- Collaboration with other CMC team members to build and execute the CMC development plan.
Skills and Requirements:
- MS or BS in engineering, chemistry, biology, or related discipline, plus at least 4 years of 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.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Phil Sawyer at (+1) 617-545-5923 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
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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