Senior Director, Analytical Development, Separation Science and Protein Chemistr
Sarepta Therapeutics, Bedford, MA, United States
Senior Director, Analytical Development, Separation Science and Protein Chemistry page is loaded## Senior Director, Analytical Development, Separation Science and Protein Chemistryremote type:
Onsitelocations:
Bedford, MAtime type:
Full timeposted on:
Posted 4 Days Agojob requisition id:
R-03183The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. 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 CaregiversFor a full list of our comprehensive benefits, see our website:**The Importance of the Role**The Senior Director will oversee the development of HPLC and Mass spectrometry based analytical methods for RNA (Phosphorodiamidate Morpholino Oligomer and Silencing RNA) Drug substance, Drug Product including in-process, release and stability testing. The individual will direct and manage the activities related to mass spectrometry based protein analysis for the AAV based product line and ADC (siRNA) programs. The person would oversee the activities in developing purity and impurity characterization methods and excipient analysis.
This role will represent Analytical Development in high level internal meetings and coordinate method transfers to internal QC laboratories and external GMP testing sites. The Senior Director will oversee the creation of protocols for freeze–thaw studies, accelerated degradation studies, and method qualification and validation in collaboration with the Sarepta Head of Quality Control or their designee. They will also support troubleshooting of analytical methods at CROs/CTOs and may facilitate the transfer of complex analytical assays into Sarepta’s GMP laboratories.
Additionally, the Senior Director will lead the writing and compilation of regulatory documents to support product development and registration.**The Opportunity to Make a Difference*** Manage a team of scientists to efficiently deliver on corporate goals and project timelines.* Evaluate analytical methods to support in‐process, drug substance, drug product, and stability testing across the siRNA, PMO, and AAV portfolios.* Act as a company liaison with contract laboratories, coordinating method transfers and overseeing method qualification and validation activities.* Assess QC needs and generate essential testing documentation, including SOPs, change controls, laboratory investigations, out‐of‐specification (OOS) investigations, deviations, and QC trending reports for testing results and assay performance.* Collaborate with Quality Assurance to prepare, review, and manage change controls, deviations, and other quality event documentation.* Write and edit regulatory documents, including eCTD sections for IND, NDA, and BLA submissions.* Demonstrate strong leadership and managerial capabilities, supervising a team of 5–10 Analytical Development analysts, both onsite and remote.* Ensure laboratory operations supporting product release activities comply with cGMP standards.**More about You*** MS in Biology, Chemistry, Molecular Biology, or a related discipline with 15+ years of relevant experience, or PhD in Biology, Chemistry, Molecular Biology, or a related field with 10+ years of relevant experience, or an equivalent combination of education and laboratory experience.* 10+ years of experience in analytical method development, including advanced expertise in HPLC/UPLC and mass spectrometry–based methods.* Exceptional written and verbal communication skills, with the ability to clearly convey complex scientific and regulatory concepts.* Experience representing organizations in regulatory interactions, including face‐to‐face meetings, pre‐approval inspections (PAIs), and preparation of written responses across a global regulatory portfolio.* Demonstrated product lifecycle management experience across clinical and commercial stages.* Strong collaboration and teamwork skills, with the ability to support cross‐functional peers and maintain a safe, efficient, and compliant laboratory environment.* Experience working with contract laboratories and external vendors (CROs/CMOs) is highly desirable.* Ability to travel approximately 15%.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-Onsite#LI-ES1This position requires work on site at one of Sarepta’s facilities in the United States.The targeted salary range for this position is $222,400 - $278,000 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. #J-18808-Ljbffr
Onsitelocations:
Bedford, MAtime type:
Full timeposted on:
Posted 4 Days Agojob requisition id:
R-03183The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. 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 CaregiversFor a full list of our comprehensive benefits, see our website:**The Importance of the Role**The Senior Director will oversee the development of HPLC and Mass spectrometry based analytical methods for RNA (Phosphorodiamidate Morpholino Oligomer and Silencing RNA) Drug substance, Drug Product including in-process, release and stability testing. The individual will direct and manage the activities related to mass spectrometry based protein analysis for the AAV based product line and ADC (siRNA) programs. The person would oversee the activities in developing purity and impurity characterization methods and excipient analysis.
This role will represent Analytical Development in high level internal meetings and coordinate method transfers to internal QC laboratories and external GMP testing sites. The Senior Director will oversee the creation of protocols for freeze–thaw studies, accelerated degradation studies, and method qualification and validation in collaboration with the Sarepta Head of Quality Control or their designee. They will also support troubleshooting of analytical methods at CROs/CTOs and may facilitate the transfer of complex analytical assays into Sarepta’s GMP laboratories.
Additionally, the Senior Director will lead the writing and compilation of regulatory documents to support product development and registration.**The Opportunity to Make a Difference*** Manage a team of scientists to efficiently deliver on corporate goals and project timelines.* Evaluate analytical methods to support in‐process, drug substance, drug product, and stability testing across the siRNA, PMO, and AAV portfolios.* Act as a company liaison with contract laboratories, coordinating method transfers and overseeing method qualification and validation activities.* Assess QC needs and generate essential testing documentation, including SOPs, change controls, laboratory investigations, out‐of‐specification (OOS) investigations, deviations, and QC trending reports for testing results and assay performance.* Collaborate with Quality Assurance to prepare, review, and manage change controls, deviations, and other quality event documentation.* Write and edit regulatory documents, including eCTD sections for IND, NDA, and BLA submissions.* Demonstrate strong leadership and managerial capabilities, supervising a team of 5–10 Analytical Development analysts, both onsite and remote.* Ensure laboratory operations supporting product release activities comply with cGMP standards.**More about You*** MS in Biology, Chemistry, Molecular Biology, or a related discipline with 15+ years of relevant experience, or PhD in Biology, Chemistry, Molecular Biology, or a related field with 10+ years of relevant experience, or an equivalent combination of education and laboratory experience.* 10+ years of experience in analytical method development, including advanced expertise in HPLC/UPLC and mass spectrometry–based methods.* Exceptional written and verbal communication skills, with the ability to clearly convey complex scientific and regulatory concepts.* Experience representing organizations in regulatory interactions, including face‐to‐face meetings, pre‐approval inspections (PAIs), and preparation of written responses across a global regulatory portfolio.* Demonstrated product lifecycle management experience across clinical and commercial stages.* Strong collaboration and teamwork skills, with the ability to support cross‐functional peers and maintain a safe, efficient, and compliant laboratory environment.* Experience working with contract laboratories and external vendors (CROs/CMOs) is highly desirable.* Ability to travel approximately 15%.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-Onsite#LI-ES1This position requires work on site at one of Sarepta’s facilities in the United States.The targeted salary range for this position is $222,400 - $278,000 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. #J-18808-Ljbffr