Sr Director, QC & Analytical Development

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.

Overview

Insmed is seeking an Executive Director/Senior Director to lead QC and Analytical Development efforts in support of the Insmed Gene Therapy platform. Reporting to the Chief Scientific Officer, this individual will lead analytical development and will have expert skills in biological analytical chemistry and method development. This individual will be a strategic and motivated analytical method development scientist to help build and lead the analytical development laboratory and contribute to the overall CMC strategy of drug development. The ideal candidate is expected to lead the analytical development of gene therapy candidates from discovery through clinical development and commercial. This individual will direct and manage the internal analytical development laboratory as well as oversee work at contract labs. They must possess a deep understanding of the biotech development process from pre-clinical development through life-cycle management. The selected candidate will engage with cross-functional teams seeking to develop methods in support of new chemical entities in a variety of dosage forms to support Insmed’s platform. Update current products and enhance technical capabilities to support development activities; leverage existing technologies and resources to advance our characterization, testing, analysis, and clinical trial manufacturing capabilities; plan and lead analytical development projects from concept to manufacturing. As head of QC, this individual will be responsible for overseeing a QC laboratory to support product release. This role will oversee management of Quality Control operations at CMO and contract testing laboratories, including managing contract relationships in parallel with implementing in-house testing. Stability program, reference standard testing, in-process, and release testing will be required throughout the product lifecycle for all Insmed Programs.

This position is based onsite in San Diego, CA.

Responsibilities

Additional representative responsibilities will include, but not necessarily be limited to, the following:

• Acts as an analytical SME for internal product development using traditional and advanced analytical techniques including but not limited to Compendial methods (Appearance, HIAC, pH, Osmolality, bioburden, endotoxin, sterility), CE-SDS, ddPCR, ELISA, HPLC, ICP-MS, Capillary-based immunoassays, CCIT, rcAAV, TCID50, In-vitro Adventitious Virus assay, Mycoplasma testing.
• Manage and lead daily activities of the analytical laboratory and mentor and develop direct reports.
• Interprets complex data and solves scientifically challenging problems by providing direction and leadership.
• Interacts with internal partners, CMOs and contract laboratories during the technology transfers of analytical methods, clinical batch testing, stability testing and CMC compilation of assigned projects.
• Able to evaluate, design, and perform method development and validation employing phase-appropriate approaches at different stages of development (pre-clinical through Phase 3) for assay, purity, identification of impurity and degradation products, reference standard qualification and physical (solid-state) characterization of drug product and drug substance.
• Able to conduct pre-formulation and stability studies on lead compounds.
• Collect, analyze, and document results and prepare study reports.
• Communicate results of experiments with the potential to present findings to the project team.
• Able to work in a fast-paced, team-oriented environment to accelerate early drug development.
• Demonstrate familiarity with QBD approach to provide analytical support to drug substance and drug product manufacture.
• Closely coordinate with QA and Regulatory, as well as other CMC functions, Clinical and Toxicology regarding safety-related questions on APIs, components of APIs and formulations and materials used in processing.

Qualifications

• Advanced degree in a science or health care field with a preferred focus on chemistry, biochemistry, microbiology, or equivalent science program
• Minimum of 15 years of experience in the pharmaceutical industry with a GMP testing focus, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing, with at least 10 years in a GMP QC release testing role
• Significant experience in an FDA-regulated environment
• Entrepreneurial spirit, with strong willingness to take on new challenges required to bring novel medicines to the clinic.
• Strict adherence to environmental, health, and safety guidelines.

Travel Requirements

Up to 15% travel, both domestic and/or international.

Salary Range

Insmed takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees.

The base salary range for this job is from $200,000.00 to $280,000.00 per year

Compensation & Benefits

We’re committed to investing in every team member’s total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:

• Flexible approach to where and how we work
• Competitive compensation package including bonus.
• Stock options and RSU awards
• Employee stock purchase plan
• 401(k) plan with company match
• Professional Judgment Vacation Policy
• 11 paid holidays per year and Winter Break (typically between Christmas and New Year’s Day).

ADDITIONAL U.S. BENEFITS:

• Medical, dental, and vision plans
• Company-provided short- and long-term disability plans
• Company-provided life insurance
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity plans
• Supplemental AD&D
• Employee Assistance Program (EAP)
• Mental Health on-line digital resource
• On-site, no-cost fitness center at our U.S. headquarters
• Paid time off to volunteer

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.