Lead Process Engineer CMO Operation Support
Lead Process Engineer CMO Operation Support
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$ 112000 - 140000
1 Vacancy
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 limbgirdle 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.
Were 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 worklife 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: 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 Sareptas diverse gene therapy portfolio and to deliver new treatments for patients. The ideal candidate should be versed in all CMC aspects in relate 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 ensuring CMO facilities equipment systems methods and processes in a validated state. He or she will help compliance through of effective Qualification/Validation policy and procedures and help driving 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 document results and review 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 lowerlevel personnel
- Works on complex issues where analysis of situations or data requires an indepth 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 longterm 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 inorder 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 highperforming crossfunctional partnerships and to lead matrix teams to advance complex projects to their completion
- Ability to multitask and function in a dynamic environment
- Excellent troubleshooting skills
- Excellent written and verbal communication
What Now
Were always looking for solutionoriented critical thinkers.
So if youre 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.
Required Experience:
Chief
Employment Type
Full-Time
