- 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.
- Participate in establishing sample plans, managing in-process and release test samples
- Participate in establishing stability plans, managing stability tests and reference standards
- 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.Experience with JMP statistical software a plus.
Qualifications - BS or equivalent in relevant discipline with a minimum of 4 years of relevant industry experience or Master's degree in relevant discipline with a minimum of 3 years of relevant industry experience
- 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. #LI-KM LI-onsite
Travel RequirementsUpto 10% Domestic and/or International travel required for method transfer activities
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 $84,000.00 to $118,667.00 per year
Compensation & BenefitsWe'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 InformationInsmed 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 until the position is filled.
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Scientist Quality Control Biological Assays - California, United States - Insmed Incorporated
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
Named Science's Top Employer in 2021, 2022, and 2023 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 were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row. A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in BiopharmaTM, Best Workplaces in New YorkTM, and Best Workplaces for MillennialsTM lists.
Overview
Insmed is seeking a Scientist, QC 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 scientist will be involved in transfer of method from Analytical Development into QC. The scientist 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:
