Are you ready for an opportunity where you can make a real change? Our client is looking for a Senior Bioprocess Engineer to focus on Upstream Manufacturing for their biosimilar and biodefense therapeutic development programs. In this role, you will assist with process development, characterization, and transfer/scale-up to achieve cost effectiveness and improved product quality. You will also assist manufacturing operations in problem solving with regards to equipment and systems including deviation/event investigations and corrective/preventative action plan formulation and implementation. Additionally, you will interface with various departments to ensure processes and designs are compatible for new product technology transfer and to establish future process and equipment automation technology.

To be successful in this role, you will need to have several years of experience in cell culture (upstream) GMP manufacturing. Understanding of and experience with CFR 210/211, ICH guidelines, and other regulatory requirements is a plus. There is a high preference for the candidate to be familiar with disposable technology such as single-use bioreactors (SUBs) as well as process intensification such as microfiltration and/or ultrafiltration based perfusion (Repligen Xcell ATF). Experience in the preparation and delivery of oral and written presentations as well as participation in the preparation and submission of regulatory documents such as IND CMC sections is sought. Excellent communication skills and the ability to analyze and interpret data, design appropriately controlled experiments independently, and maintain up-to-date laboratory documentation are a must. Facility design experience is a plus as the company is planning a number of facility improvements and/or significant build-out in the coming year.

This is an excellent opportunity to gain valuable experience with an innovative, small, young Biotech company and build a career in the biopharmaceutical industry. Candidates should feel comfortable working in a high risk/potential high reward environment and able to work overtime and weekends as project needs are determined.

Minimum Qualifications:

• Bachelor or higher degree in engineering or life sciences (biochemical/chemical engineering degree preferred)

• Hands on experience in GMP cell culture biomanufacturing (5+ years)

• Excellent time management and proven ability to complete projects on time

• Excellent level of initiative and quest for knowledge

• Must be organized and self-motivated

• Must have excellent communication and writing skills

• Must love to learn!