What are the responsibilities and job description for the Engineer, Gene Therapy Process Development position at Sarepta Therapeutics?
Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
The Importance of the Role
The engineer will make critical contributions towards the development and lifecycle management of Sarepta’s Gene Therapy platform within the downstream process development team. They will be primarily responsible for contributing to the development, characterization, optimization, scale-up and transfer of the downstream processes to generate purified viral vectors for therapeutic use. This individual will be performing lab-based downstream process development activities. The engineer will be expected to work effectively with other downstream engineers, as well as colleagues in the process analytics, upstream, pilot and manufacturing organizations.
The Opportunity to Make a Difference
We’re always looking for solution-oriented, critical thinkers.
So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
This position requires work on site at one of Sarepta’s facilities in the United States.
The targeted salary range for this position is $76,000 - $95,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
The Importance of the Role
The engineer will make critical contributions towards the development and lifecycle management of Sarepta’s Gene Therapy platform within the downstream process development team. They will be primarily responsible for contributing to the development, characterization, optimization, scale-up and transfer of the downstream processes to generate purified viral vectors for therapeutic use. This individual will be performing lab-based downstream process development activities. The engineer will be expected to work effectively with other downstream engineers, as well as colleagues in the process analytics, upstream, pilot and manufacturing organizations.
The Opportunity to Make a Difference
- Independently perform clarification, filtration (Normal & Tangential), and chromatography operations with minimal guidance.
- Generate experimental study designs with some guidance.
- Independently conduct sample submission, data compilation and analysis of experimental data sets.
- Prepare solutions, buffers, and media as needed.
- Supports process scale-up and technical transfer as needed.
- Contribute to downstream development operational improvement initiatives, maintains lab equipment, inventory management and laboratory organization.
- Collaborate cross functionally with teams across departments.
- Adhere to company and department SOPs on lab operations and good documentation practice, and EHS lab safety regulations with the highest standards.
- Support drafting and review of technical reports, SOPs as appropriate under general supervision.
- Demonstrate strong work ethic and be an effective team player who consistently exemplifies Sarepta values: patient-first, action, unconventional thinking, talent and integrity.
- B.S. degree in Biochemistry, Biotechnology, Chemical Engineering, or similar with 2 years of lab experience. M.S. in Biochemistry, Biotechnology, Chemical Engineering, or similar with 1 years of related experience.
- Hands-on experience or education in concepts, practices and procedures of biologics process development (e.g. mAb, AAV, LV, etc.).
- Strong understanding of chromatographic separation is preferred.
- Hands-on experience with AKTA purification systems and common TFF & filtration systems.
- Familiarity of common analytical laboratory practices like PCR, SEC, ELISA assays.
- Strong ability to apply basic engineering principles and statistical tools for troubleshooting and data analysis. Experience with statistical software like JMP or Statistica is preferred.
- Experience in writing, revising, and following SOPs and MBRs preferred.
- Computer skills including Microsoft Excel, Word and Outlook.
- Strong organizational skills and attention to detail are necessary.
- Able to multi-task and perform effectively under tight deadlines.
- Effective communication and listening skills are required.
- Familiar with GxP requirements (e.g. cGMP) and working in a regulated field is preferred.
- Ability to lift and carry up to 50 lbs.
We’re always looking for solution-oriented, critical thinkers.
So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
This position requires work on site at one of Sarepta’s facilities in the United States.
The targeted salary range for this position is $76,000 - $95,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
Salary : $76,000 - $95,000