Proclinical is currently recruiting for a MS&T Engineer with a leading biotechnology company located in Gaithersburg, MD. Successful candidate will be responsible for technical oversight of external development and manufacturing activities for vaccine drug substances (DS).
- Partnering with Contract Development and Manufacturing Organizations (CDMOs) to oversee drug substance development and manufacturing activities.
- Provide input on process development strategies, overseeing CDMO development through clinical and pre-commercial stages.
- Preparing, reviewing, or approving process flow diagrams, development reports, and master batch records.
- 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 validation, CMC regulatory, and Quality documents.
- Collaboration with other CMC team members to build and execute the CMC development plan.
- Trending of drug substance process data, identification and investigation of adverse trends.
- Partnering with CDMO representatives to investigate process and analytical deviations.
Skills and Requirements:
- MS or BS in engineering, chemistry, biology, or related discipline, plus at least 2 years of experience in vaccine or biologic manufacturing operations.
- Proven experience in collaborating in matrix teams in a technical environment.
- Strong 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.
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.