Lead Process Engineer - CMO Operation Support

Sarepta Therapeutics; Burlington (MA); On-site; USD 112,000 - 140,000; Full time

Job summary

An established industry player is seeking a Lead Process Engineer to drive advancements in gene therapy. This role offers the chance to work on cutting-edge projects that aim to transform patient care. You will play a pivotal role in overseeing the compliance and operational efficiency of technology transfers and product launches. The ideal candidate will possess a strong background in engineering, MSAT, and regulatory compliance, with a passion for innovation and problem-solving. Join a team that values integrity and collaboration, and be part of a mission that truly makes a difference in the lives of patients.

Benefits

Physical and Emotional Wellness Programs

Financial Wellness Support

Caregiver Support

Comprehensive Benefits Package

Qualifications

• 8+ years MSAT experience with CMO interactions for B.S. or 7+ years for M.S.
• Advanced understanding of regulatory and cGMP requirements.

Responsibilities

• Conduct engineering projects from beginning to end, ensuring quality.
• Evaluate and select complex experimental techniques and improve processes.

Skills

Engineering Principles

Statistical Analysis

Project Management

Troubleshooting Skills

Communication Skills

Education

B.S. in Engineering or Life/Pharmaceutical Sciences

M.S. in Engineering or Life/Pharmaceutical Sciences

Tools

cGMP Compliance

Design of Experiments

Job description

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:

• Physical and Emotional Wellness
• Financial Wellness
• Support for Caregivers

For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us

The Importance of the Role

The Position:
With exciting advancement of multiple gene therapy programs from early clinical to pivotal and commercial stages, we are actively recruiting for a Lead Process Engineer of MSAT to support Sarepta’s diverse gene therapy portfolio and to deliver new treatments for patients. The ideal candidate should be versed in all CMC aspects in relation to early clinical, late stage and commercial programs.

The incumbent is accountable for providing some input to MSAT, Operations and Quality in support of technology transfers and product launches at multiple CMOs; and will help ensure CMO facilities, equipment, systems, methods and processes are in a validated state. He or she will help compliance through execution of effective Qualification/Validation policy and procedures, and help drive opportunities for increased business and operational efficiencies.

The Opportunity to Make a Difference

• Independently evaluates, selects and executes complex experimental, modeling and engineering techniques. Typically works on multiple projects simultaneously.
• Conduct engineering projects from beginning to end, including development of project plan.
• Responsible for protocols, reports and specifications. Compiles and analyzes data, documents results, and reviews documentation.
• Works cross functionally to enhance and improve processes.
• Maintains, monitors and ensures highest quality in services or products.
• Maintains advanced knowledge of industry trends and advancements.
• Develops and implements best practices and processes.
• Troubleshoots to resolve problems: root cause analysis, escalates issues as appropriate.
• Works under general supervision, and operates with appreciable latitude for day to day routine matters.
• May be assigned to a single, complex interdisciplinary research area or manage multiple moderately complex projects and assignments.
• Executes work independently or could lead part of a team from a technical perspective.
• Will train lower-level personnel.
• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Networks with key contacts outside own area of expertise.
• Contributes to the development of scientific & engineering concepts to achieve strategic objectives.
• Generally initiates, directs and executes development studies through collaborative efforts and through individual efforts that may have long-term impact.

More about You

• B.S. in Engineering or Life/Pharmaceutical Sciences with 8+ years MSAT experience with CMO interactions. Or M.S. in Engineering or Life/Pharmaceutical Sciences with 7+ years MSAT experience with CMO interactions.
• Advanced understanding of regulatory and cGMP requirements.
• Experience and track record of compliance in a highly regulated GMP environment.
• Ability to apply complex engineering principles and statistical analysis, including design of experiments, in order to solve processing issues and evaluate opportunities for process improvements.
• Advanced understanding of engineering controls and risk management.
• Ability to manage project resources and elevate relevant issues to project lead and line management.
• Demonstrated ability to work independently.
• Ability to build and maintain high-performing, cross-functional partnerships and to lead matrix teams to advance complex projects to their completion.
• Ability to multi-task and function in a dynamic environment.
• Excellent troubleshooting skills.
• Excellent written and verbal communication.

What Now?

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.

#LI-Hybrid

This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time. The targeted salary range for this position is $112,000 - $140,000 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.