Job 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 Lead Analytical Development Operations function to build out the process development support testing function within analytical development. Will develop systems and processes to facilitate rapid, high throughput testing. As the Sending Unit, will facilitate transfer of analytical procedures to a Receiving Unit (internal or external QC). May act as a program lead on a PDT as required by the business.
Responsibilities The Analytical Development Operations associate director is responsible for building a team to take care of the operational aspects of analytical testing to support process development to enable rapid development of upstream, downstream and formulation development processes. Will support method transfer and validation as needed. Support the biotechnology product lifecycle, from early-stage research through commercial launch. Involves hands-on laboratory work, analytical procedure optimization, troubleshooting, and data analysis and collaboration with all process development teams to ensure accurate and reliable analytical data. Performs technology assessment to enable high throughput analyses, automation opportunities, and easy to operate solutions to enable rapid process development. May act as a Process Development Team representative as an Analytical Lead for a drug program.
Key Responsibilities: Responsibilities include developing and optimizing analytical methods using techniques like HPLC, Capillary Electrophoresis, ELISA, ddPCR, and various spectroscopic equipment. This involves assessing properties of AAV drug candidates and troubleshooting technical issues. Contributes to method qualification and validation according to regulatory guidelines such as ICH, FDA, and cGMP, evaluating method characteristics like specificity, sensitivity, accuracy, and precision. Manages research and process development samples, manages a group that performs routine testing, and maintains detailed records. Analyzing data, preparing reports, and using statistical software for trend analysis are also key duties. Collaboration with R&D, Process Development, Quality Control, and Regulatory Affairs is essential, as is facilitating technology transfers and mentoring junior staff. Maintaining laboratory equipment, ensuring safety and regulatory compliance, and supporting audits are also part of the role.
Qualifications: A Bachelor's, Master's, or Ph.D. in a relevant scientific field such as Biochemistry, Chemistry, or Biotechnology is typically required. Essential qualifications include strong knowledge of analytical chemistry and biotechnology, along with experience in method development, validation, and implementation. Proficiency in various analytical techniques and instrumentation is necessary, as is knowledge of regulatory guidelines like cGMP and ICH, and data integrity principles such as ALCOA. Strong data analysis, problem-solving, communication, and interpersonal skills are also important. The ability to work both independently and as part of a team is crucial. Experience with laboratory data management systems (LIMS) and statistical software is preferred.
Salary Range 139000-195200
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 employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. 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.
Job Tags
Full time, Local area, Flexible hours,