Sr Scientist, Downstream Process Development

Company: Initial Therapeutics, Inc.
Location: San Diego
Posted on: May 24, 2025

Job Description:

Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.RecognitionsConsistently Ranked Science's Top EmployerInsmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science's Top Employers survey for four years in a row.A Certified Great Place to WorkWe believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma, Best Workplaces in New York, PEOPLE Companies That Care, Best Workplaces for Women, Best Workplaces for Millennials, and Best Medium Workplaces lists.OverviewWe are seeking a highly motivated expert in purification process development of viral vector gene therapy products. In this role you will join a motivated and skilled team responsible for performing experiments ranging from purification development and optimization, process characterization and clinical manufacturing investigation support. As part of this collaborative group, your professional and scientific growth are encouraged and developed. There are many exciting pipeline programs and initiatives to keep you challenged and engaged. If you are a driven and astute scientist who is motivated to bring life-changing medicine to patients, then this is the role for you.Responsibilities

• Execute technical strategies for purification process development to support pre-clinical and clinical programs at all development stages, including process development, optimization, technology transfer, and process characterization of cGMP processes for viral vectors.
• Take responsibility for the design and execution of purification process development studies.
• Independently design, execute, and interpret purification experiments including clarification, tangential flow filtration, column packing, and chromatography.
• Evaluate new technologies for use in commercially viable manufacturing processes.
• May participate in the process execution within a Pilot Plant non-GMP manufacturing environment.
• Review batch records, SOPs, raw material specifications, protocols and author development reports.
• Demonstrated experience with process validation and scale-down models for biopharmaceutical processes, including interpretation of results and reporting that stands up to regulatory inspection.
• Demonstrated expert knowledge of scale-up principles with respect to viral vector purification.
• Work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
• Author Standard Operating Procedures, technical reports, process descriptions, including data interpretation and procedures suitable for inclusion in IND, NDA, or equivalent regulatory submissions.
• Must be familiar with BSL-II lab safety requirements.
• Participate in multi-disciplinary projects with multi-cultural teams, and guide project and business strategies.
• Facilitate collaboration with both internal and external drug substance analytical, quality control, quality assurance, and manufacturing teams.
• Exercise judgment in selecting methods, techniques and evaluation criteria to obtain high quality results on time and on budget.
• Update group members on background and status of projects by giving oral updates or internal presentations.
• Actively seek opportunities for continuous improvement.
• Assist other departments and perform all other duties as assigned.
  Requirements:
  • Requires a minimum of 8 years of related experience with a Bachelor's degree; or 6 years and a Master's degree; or a PhD with 3 years experience in life sciences, chemical engineering, biochemistry, or related field.
  • Experience working in a biopharmaceutical laboratory focusing on viral vector purification process development.
  • Demonstrated understanding of process development and cGMP production operations.
  • Experienced in early stage clinical to commercial environments, as well as contract development and manufacturing.
  • Demonstrated history of hands-on ability, problem solving, and independent experimental design and execution.
  • Demonstrated technical proficiency and knowledge of scientific concepts.
  • Ability to adapt to change and effectively deliver under pressure and time constraints, while maintaining a high level of work quality.
  • Ability to present scientific data and concepts to CMC team members and leadership.
  • Knowledgeable of analytical techniques used to determine product quality and characterization of biologics.Travel RequirementsThis position is based onsite in our San Diego locationSalary Range$111,000 - $156,133 a yearCompensation & BenefitsAt Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:
    • Flexible approach to how we work
    • Health benefits and time-off plans
    • Competitive compensation package, including bonus
    • Equity Awards (Long-Term Incentives)
    • Employee Stock Purchase Plan (ESPP)For more information on U.S. benefits click here.Additional InformationInsmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email atTotalRewards@insmed.comand let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.Applications are accepted for 5 calendar days from the date posted or until the position is filled.
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Keywords: Initial Therapeutics, Inc., Calexico , Sr Scientist, Downstream Process Development, Other , San Diego, California