The Process Development group is looking for a highly motivated Associate to support downstream process development initiatives. The successful candidate will be an integral part of a fast paced group responsible for developing purification processes for the manufacture of clinical AAV gene therapies. Responsibilities will include helping to develop multiple unit operatioins, including clarification, TFF, and chromatography, with an emphasis on chromatographic separations. The ideal candidate will have some experience in purification of biologics in either a research or development setting. Conducting research involving biochemical assays, effectively communicating results through high quality technical reports and oral presentations, and collaboration with your team is an integral part of this position. Experience with biologic and/or gene therapies is strongly preferred.
Essential Duties and Responsibilities
- Plan and execute studies related to the recovery and purification of AAV from cell harvest through final formulation.
- Perform in-process assays such as qPCR and ELISA.
- Accurately interpret experimental data, perform statistical analysis, formulate conclusions, and communicate data with colleagues.
- Plan and execute pilot scale production to support process development and research activities.
- Author, review and provide technical support for manufacturing SOPs and MPRs.
- Manage two or more projects in parallel and reach set goals.
- Ability to collaborate with others while maintaining a strong capability in independent, critical thought.
- Strong organizational skills are required and must be able to work as part of a team.
- BS or equivalent in scientific discipline and min of 2-4 years related lab experience or MS or equivalent with 1-2 years of experience
- General biological lab experience
- Experience with mammalian and/or insect cell culture technology
- Experience with development of purification processes for AAV and/or other viral vectors or vaccines is highly preferred.
- A strong background in the fundamentals and scale-up of chromatographic based separations with biologic molecules strongly preferred.
- Familiarity with tangential flow filtration systems, hollow fibers members, and flat sheet cassettes strongly preferrecd.
- GXP experience
Other Skills and Abilities
- Advanced communication and organizational skills
- Advanced interpersonal skills and the ability to work with individuals across all organizational levels
- Attention to detail and accuracy
- Demonstration of detailed record keeping and data documentation
- Demonstrated project management skills
- Ability to read, analyze, write and interpret technical procedures, publications, intellectual property and/or government documents
- Working knowledge of GLP, GDP, GCP and GMP regulations and their ISO counterparts and ICH Guidelines
- High level of proficiency with Microsoft Office programs and with Statistical software
- Less than 10% travel. Any travel will be reimbursed in accordance with company policy.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping, and stretching. Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. A normal range of hearing and vision correctable to 20/20 is required. Occasional lifting up to 30 pounds is required.