Senior Research Associate, Quality Control
Overview
Insmed is seeking a QC Senior Research Associate with broad knowledge and expertise in cell-based potency assays, molecular biology assays, and chemical/biochemical assays as applied to AAV gene therapy products. The QC Senior Research Associate will be involved in transfer of method from Analytical Development into QC. The QC Senior Research Associate will author and execute phase appropriate qualification/validation protocols and reports of QC methods to support product release and characterization. The role will perform potency analysis on lot release and stability samples for clinical phase Insmed AAV Gene Therapy products.
Responsibilities
Representative responsibilities will include, but not necessarily be limited to, the following:
• Collaborate with research, analytical development and process development teams to develop, qualify/validate AAV gene therapy cell-based biological potency assays, protein chemistry assays, and molecular biology assays for process monitoring and drug product release, specifically SDS-PAGE, western blot, droplet digital PCR or qPCR, culture of primary mammalian cells, and cell based potency assays.
• Participate in developing timelines, protocols and reports for assay transfers, qualifications / validations.
• Contribute to establishing material specifications for drug substance and drug products
• Author and review QC analytical SOPs, protocols, and reports as needed
• Ensure the timely execution of all routine QC testing, data review, and preparation of summary reports
• May act as an analytical lab representative on a CMC team.
• Perform quality management activities such as deviation, CAPA, change control, investigation of OOS, OOT and anomalous results within the company QMS according to established procedures.
• Maintain QC laboratory, track critical reagents and equipment logbooks, and ensure all the equipment is calibrated
• Software Use Expectations:
- Utilize the LIMS system to submit samples, enter data, and track samples.
- Utilize statistical analysis software to generate assay control charts and recommend assay acceptance criteria.
- Learn and become proficient in all laboratory instrument software to conduct testing.
QUALIFICATIONS• BS or equivalent with a minimum of 2 years of relevant industry experience or Master’s degree
• Experience in pharmaceutical industry with a GMP testing focus, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing, with experience in a GMP QC release testing role
• Experience in optimizing methods with particular emphasis on cell-based potency assay, molecular biology assay, and protein chemistry assays
• 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
• Excellent organizational and communication skills
• Experience with JMP statistical software a plus.
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 $80,000.00 to $105,800.00 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, regionally based
- Competitive compensation package including bonus
- Stock options and RSU awards
- Employee Stock Purchase Plan (ESPP)
- Flexible Vacation Policy
- Generous paid holiday schedule and winter break
ADDITIONAL U.S. BENEFITS:
- 401(k) plan with company match
- Medical, dental, and vision plans
- Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
- Company-provided short and long-term disability benefits
- Unique offerings of pet, legal, and supplemental life insurance
- Flexible spending accounts for medical and dependent care
- Accident and Hospital Indemnity insurance
- Employee Assistance Program (EAP)
- Mental Health on-line digital resource
- Well-being reimbursement
- Paid leave benefits for new parents
- Paid time off to volunteer
- On-site, no-cost fitness center at our U.S. headquarters
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.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.