Description

Company Description

Insmed 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.

Recognitions

Consistently Ranked Science 's Top Employer

Insmed 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 Work®

We 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.

Overview

The Senior Scientist will be a part of a multidisciplinary team of scientists focused on the analytical procedure development and product characterization for ground-breaking gene therapies. They will act as a primary liaison between R&D and Analytical Development for knowledge transfer to develop appropriate Vector Genome titer assays prior to elevation of a drug candidate to CMC development status. In addition, the senior scientist will develop NGS sample preparation methods and perform both Short Read (Illumina) and Long Read (PacBio) NGS sequencing on AAV drug product, cell lines, and other R&D and CMC NGS targets/sequencing needs such as characterizing gene edited potency assay cell lines. They will work closely with our in-house bioinformatics team located in the UK to develop and implement an AAV bioinformatics pipeline for analyzing Insmed Gene Therapy products. The Senior Scientist will develop, improve, implement, transfer and co-validate robust Vector genome titer assays with a receiving laboratory (QC internal/external). They may also be involved in supporting process development activities with potency assay testing and participate in CMC team and governance team activities as needed.

Responsibilities

• Act as the primary liaison with R&D Vector Genome Titer method development and NGS sequencing needs.
• Serve as a subject-matter-expert for Vg Titer and NGS assays and data interpretation.
• Participates as an Analytical Lead on Product Development Teams and Global Asset Teams as needed.
• Accountable for execution of program development from technical development, through manufacturing operations and culminating in the successful preparation of regulatory submissions.
• Execute or oversee execution of protocols to characterize AAV drug products, potency assay cell lines and qualify/validate Vg titer assays.
• Responsible for defining and authoring defensible Vg titer assay design as well as nucleic acid sequencing characterization for regulatory interactions (briefing books, etc) and filings (INDs/BLAs). Will act as a SME during interactions with health authorities as needed.
• Define and implement state-of-the art technology PCR and NGS sequencing technology for characterizing all facets of our drug products. Also use NGS sequencing to characterize potency assay genetic integrity and stability.
• Working with different molecular biology techniques including DNA Sequencing, NGS library preparation, nucleic acid purification, and manipulation, PCR and qPCR
• Design, execute and troubleshot Next-Generation Sequencing (NGS) assays including nucleic acid (DNA/RNA) purification, and library preparation for various sequencing applications including Whole-Genome Sequencing (WGS), Whole-Exome Sequencing (WES), mRNA-sequencing, target-enrichment, and amplicon sequencing.
• Analyze sample and library quality using quantitative fluorescent dye methods including qubit and qPCR and qualitative capillary electrophoresis methods. Conduct sample and NGS library quality measurements to ensure assay performance using q-PCR, qubit, fragment-analyzer, and tape station.
• Operate, maintain, and troubleshoot different SR (Illumina) and LR (PacBio) NGS sequencing instrument platforms
• Perform, collaborate with internal SMEs to oversee in-house and outsourcing of molecular biology needs including primer/probe manufacture, recombinant cloning and preparation of express vectors, RT-PCR, ddPCR, NGS (short and long read), other standard or gene editing [CRISPR, Integrases, etc] base molecular biology techniques.
• Write and review protocols, SOPs, reports and other product development documents
• Conceptualize, construct, validate, and implement sample preparation platforms for a variety of amplification and sequencing targets.
• Maintain accurate, detailed, and timely records of analytical procedure development, experimental data, and data analysis.
• Perform data review to ensure accuracy, completeness, and validity.
• Participate in cross-disciplinary mentoring and training of associate scientists.
• Present scientific results to the larger Insmed research and technical operations groups, and external scientific community, as needed.
• Assist with coordination and day-to-day management of site operations.
• Work with the Bioinformatics team to develop and improves tools and pipelines.

Requirements:

• Must have a Bachelor degree or foreign equivalent in Molecular Biology, Biochemistry or a related field plus five (5) years of progressively responsible experience in the position offered, a Master's degree in the stated field of study plus two (2) years of progressively responsible experience in the position offered, or PhD in biochemistry, molecular biology, bioengineering, or related field with 5+ years of postdoctoral experience including Vector Genome titer by method ddPCR as well as Short and Long read nucleic acid sequencing method development experience
• Deep technical understanding of and hands-on experience with molecular biology, recombinant DNA technology, gene editing techniques, and protein biochemistry.
• Expertise with nucleic acid sample preparation, primer /probe design and NGS sequencing required.
• Familiarity with commercial-of-the-shelf bioinformatics pipeline interfaces (eg. GeneData) is a plus. ONT experience is also desirable.
• Expertise with routine protein characterization methods including but not limited to spectroscopy, SDS-PAGE, western blot, ELISA, Capillary Electrophoresis, etc.
• Proven track record in methods development, including experimental design, execution, and evaluation.
• Must have excellent communication skills (verbal and written).
• Highly organized with a strong attention to detail, clarity, accuracy, and conciseness.
• Strong analytical and problem-solving skills.
• Must successfully exhibit Insmed's five (5) core corporate competencies of: Integrity, Collaboration, Accountability, Passion, and Respect; along with any other position specific competencies.
• The successful candidate will thrive in a dynamic work environment and show commitment to diversity in individuals and ideas.
• Domestic and/or International travel required 20%

Salary Range

$115,000 - $161,867 a year

Compensation & Benefits

At 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 Information

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. 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 at TotalRewards@insmed.com and 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.