Scientist/ Senior Engineer Process Development (small molecule)
Job Description:Scientist/ Senior Engineer Process Development (small molecule) 2009553
Location: Waltham, MA (Hybrid)
Therapeutic Area: Oncology
Job Overview: This position involves leading process development, tech transfer, and manufacturing activities for our clients novel oncology platform collaborating with various internal and external stakeholders, and contributing to the development of promising early and late stage therapeutics.
Primary Job Responsibilities:
- Oversee and lead outsourced process development activities for development and manufacturing of drug substance and drug product components in alignment with CMC strategy and project timelines.
- Design, review, and report on development studies of drug substance intermediate and final drug product acting as an independent technical leader.
- Interact with contract manufacturers and development organizations as a representative driving external development, tech transfer, and clinical manufacturing activities.
- M.S. in (Biochemistry, Chemistry, Chemical Engineering, etc.) and possess 3+ years of industry experience, or alternatively a BS with 5+ years of industry experience
- Strong technical experience in process development and technology transfer of small molecules is required, including hands-on expertise in chromatography and analytical characterization methods including HPLC/UPLC, size exclusion chromatography, UV/vis.
- Demonstrated experience working directly with or overseeing CDMOs or experience as Person in Plant is required along with a strong foundation in process development and tech transfer.
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.