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Process Development Scientist - Purification
Job Opportunity at
Spark Therapeutics, Inc
Posted on Feb 7
The Process Development Scientist-Purification is key team member in the development of Spark’s fully scalable purification processes of recombinant adeno-associated viral vectors (rAAV). She/he will actively participate in the process validation (PV) project.
The major responsibilities are, but not limited, to following:
Work with other PD scientist team members to develop fully scalable purification process of rAAV vectors.
Design and conduct experiments to optimize purification conditions to improve rAAV yield and vector purity.
Design and perform analytical assays to determine rAAV productivity, vector purity and potency; deliver reproducible & high quality experimental data, produce experimental reports timely.
Design and perform experiments (with guidance from lead scientist and/or other senior team members) to enable scale up purification process; qualify integrated downstream process and assist to transfer the downstream technologies to Spark manufacturing team (internal and/or external.) Provide technical support in downstream operations to Spark’s manufacturing teams, participate in troubleshooting as needed.
Participate in the manufacture process validation (PV) project. Write process validation protocols with limited guidance, design and conduct experiments and analyze experimental data of PV project. Assist in writing of PV reports.
Ongoing basis, execute routine lab work including cell culture, various filtration, column chromatography, and analytical experiments.
Maintain documentation with a high level of detail, close-out experiments in a timely manner, write up experimental reports; work with the PD team members to maintain a professional working environment
Work in the labs to perform experiments described above in the primary job duties
Design experiments, organize, discuss, and record experimental data.
Generate technical reports, prepare presentation slides, bring forward the new idea, and so on.
Trainings, lab meetings and administration work
Expertise in downstream process development operations, hands-on experience with column chromatography, tangential flow filtration, column packing for purification of biologics (experience in viral vector or vaccine is preferred) from research scale to large-scales. Familiar with a wide variety of downstream process technologies and instruments applicable to large scale purification.
Strong analytical skills and problem-solving capabilities; familiar with general lab techniques, including PCR, Q-PCR, SDS-PAGE/Western blot, and ELISA.
Proven ability to work independently in hands-on laboratory setting, self-motivated to learn and develop new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
Excellent communication (oral and written) skills, familiar with computer software commonly used in bio/pharma industries. Work with colleagues as a team player.
Ph. D. in biochemistry, cell biology, or chemical/bioengineering
Minimum of 3 years of relevant work experience in Post-doctoral training or bio/pharma industry
Must have demonstrated working experience with downstream process development including purification of biologics using column chromatography techniques.
Experience in biotech industry for quality control and analytical development is preferred.
Experience with viral vector or vaccine purification and downstream process development is preferred.
First authorship in fine scientific journals is plus.
Knowledge of cGMP manufacturing and experience of DOE is plus.
WHO WE ARE:
Transforming Patient’s Lives. Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.
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