Assistant Principal Scientist, Analytical Development—Cell Line Engineering

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 Assistant Principal Scientist will be a part of a multidisciplinary team of scientists focused on the analytical procedure development, pre-formulation development, and characterization of ground-breaking gene therapy products. They will act as a primary liaison between R&D and Analytical Development for transfer of research bioassays into the CMC space prior to elevation of a drug candidate to CMC development status. They will collaborate with R&D and lead cell line engineering efforts focused on CMC bioassay development activities to ensure an appropriate Mechanism of Action potency assay is introduced into the control system prior to BLA submission. They will be involved in evaluating selecting the appropriate cell line(s), based on the drug product MoA. They will be involved in engineering cell lines (knock out/knock in) for potency bioassay. The Assoc. Principal Scientist will develop, improve, implement, transfer and co-validate cell-based potency assays with a receiving laboratory (QC internal/external). They will 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 on potency assay transfer into Analytical Development.

Serve as a subject-matter-expert for cell-based potency assay cell line engineering, development and banking.

Participates as an Analytical Lead on Product Development Teams and Global Asset Teams as needed.

Be accountable for execution of program development from technical development, through manufacturing operations and culminating in the successful preparation of regulatory submissions.

Execute or oversees execution of protocols to generate and characterize cell lines and qualify/validate cell-based potency assays.

Responsible for defining and authoring defensible potency strategies for regulatory interactions (briefing books, etc) and filings (INDs/BLAs). Will act as a SME during interactions with health authorities.

Define and implement state-of-the art technology to develop potency assay cell lines, pools, and single cell clone selection where possible. Characterizing said cell lines to meet GxP requirements surrounding genetic stability.

Define required experiments for gene editing [knock out/knock in], receptor cell surface expression as it relates to development of early and late phase potency assays.

Determine required experiments and approaches for cell culture and maintenance processes, including stable and transient transfections, selections, clone isolation, screening, genetic stability and cell banking.

Performs, collaborates with internal SMEs or oversees outsourcing of molecular biology including 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 screening platforms to enable candidate selection from engineered cell line variants.

Develop, validate, and deploy quantitative functional assays to characterize protein performance in vitro.

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.

Position Requirements:PhD in biochemistry, molecular biology, bioengineering, or related field with 6+ years of postdoctoral experience including cell line engineering and potency assay development

Deep technical understanding of and hands-on experience with molecular biology, recombinant DNA technology, gene editing techniques, and protein biochemistry.

Expertise with recombinant antibody screening and selection.

Expertise with routine protein characterization methods including but not limited to spectroscopy, SDS-PAGE, western blot, ELISA.

Proven track record in methods development, including experimental design, execution, and evaluation.

Cell culture, protein chromatography, electrophoresis, ELISA, flow cytometry, PCR, spectroscopy, fluorimetry, etc.

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 a commitment to diversity in individuals and ideas.

20% travel required.

Salary Range:

$127,000 - $178,533 a year

Compensation & Benefits:

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