What are the responsibilities and job description for the Senior Manager, Clinical Drug Product MS&T 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:
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 Senior Manager, Drug Product Manufacturing Science & Technology, will support the technical, process development and production of parenteral drug products at external contract manufacturing organizations for Sarepta's Gene therapy & RNA programs. The candidate will partner with CMOs and internal groups to establish robust technical relationships related to the development and manufacturing of drug products. The candidate will be responsible for the development and technology transfer of manufacturing processes, as well as providing day-to-day support for GMP manufacturing. This position will provide expertise in the areas of process development, validation, aseptic fill/finish, lyo development, product life cycle management, technology transfer, primary packaging, visual inspection and process analytics.The Opportunity to Make a Difference
- Lead/support tech transfer projects to external vendors for commercial and clinical programs
- Act as technical SME to support commercial drug product manufacturing at external contract manufacturing (CMO) organizations
- Author and manage change controls, CAPAs, and investigations related to drug product manufacturing
- Work directly with external contract manufacturing (CMO) organizations to develop robust manufacturing processes/systems
- Work with CMOs and external OEMs to develop process control strategies
- Partner with analytical development, QC, and QA groups to progress key development activities
- Partner with DP development to develop and/or characterize lyophilization processes
- Partner with DP development to develop vial and syringe liquid filling processes
- Lead cross functional teams to support clinical and commercial drug product activities
- Author and review CMC regulatory submission documents for clinical and commercial products
- Develop the continued process verification (CPV) program for commercial parenteral drug product manufacturing products
More about You
- B.S./M.S. in chemical/biochemical engineering, pharmaceutical sciences, or organic/physical/analytical chemistry, with 5 yrs. experience
- This role requires a minimum of 5 years experience in sterile drug product process development, continued process verification, technology transfer, validation and GMP manufacturing
- Experience developing and managing technical relationships with external contract manufacturing organizations
- Expertise in GMP facilities and equipment design/engineering concepts
- Well-developed understanding of formulation approaches
- Experience supporting/developing blow-fill-seal unit processes
- Experience in leading cross functional teams to deliver keys projects
- Experience with risk assessments and risk-based decision making
- Experience with regulations and requirements such as cGMP, ICH, USP, JP
- Experience with statistical software for the purpose of managing CPV
- Domestic and international travel required
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.
Salary : $132,000 - $165,000
