Scientist, Bioprocess Development
San Mateo Metro Area, CA
We are looking for an experienced Process Development Scientist with specific expertise in protein purification and recovery. This individual should have a proven track record developing scalable purification processes and managing talented Associate-level direct reports. Successful candidates will be part of a growing interdisciplinary, dynamic and enthusiastic team responsible for further expanding company s biotherapeutic project portfolio and maximizing core technologies for the design, optimization and development of transformational protein therapeutics. This individual will also use his/her experience and critical thinking skills to contribute to building an expanding process development group that can meet the demands of the organization. Strong experience in developing purification processes ready for transfer to CDMOs and overseeing scale up and manufacturing of clinical grade drug substance is required.
The Process Development Scientist will be responsible for:
Development of purification processes for newly evolved enzymes expressed in a variety of microbial and mammalian hosts.
Troubleshoot and adapt analytical methods to quantify yield, activity, and purity at various stages of the manufacturing process
Characterization of the physicochemical properties of newly evolved enzymes such as pI, molecular size, pH and temperature stability to provide relevant information purification development.
Development of unit operations at the bench -scale (10L) such as, centrifugation, homogenization, precipitation, ultra-filtration, depth filtration and chromatography.
Production of purified enzymes for animal studies, reference standards, and preliminary stability studies.
Working within multidisciplinary project teams to design and execute process development campaigns, interpreting data, and working with other team members to integrate results into process designs and overall project plans.
Troubleshoot and maintain analytical and process equipment.
Identify and evaluate new technologies for downstream processing and analysis.
Authoring and review of equipment and process SOPs.
Education: BS, MS or Ph.D. in Biophysics, Biochemistry, or Biological Science, BS with 10+ years, MS with 6+ years or Ph.D. with 0-3 years industry experience in purifying and analyzing enzymes
Strong technical background and direct hands-on experience with downstream processing unit operations such as preparative chromatography, centrifugation, homogenization, micro filtration, ultra-filtration, sterile filtration, etc.
Sound understanding of protein biochemistry and recombinant protein expression in microbial and mammalian hosts relevant to downstream purification.
Independently investigate complex analytical problems and provide robust solutions
Proficient at protein purification using affinity, size exclusion, ion exchange, and hydrophobic interaction chromatography using AKTA FPLC systems.
Experimental design and data analysis capabilities including Design of Experiments (DOE).
Understanding of engineering issues involved in scale up and possesses both practical and analytical skills to implement relevant scale down models.
Ability to prioritize responsibilities, multi-task and remain flexible with changing needs.
Must be motivated and able to work under tight deadlines.
Excellent interpersonal and communication (oral and written) skills, documentation, organization, good record keeping, writing reports and SOPs.
Able to work effectively in cross functional teams to solve manufacturing problems or implement improved procedures.
Mentor and supervise staff as well as work effectively with management teams.
Some travel to manufacturing sites will be required