Associate Director MST
Associate Director MST
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1 Vacancy
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 patientsfirst 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 Sciences 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. Thats why weve been named the No. 1 company to work for in the biopharma industry in Sciences 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 Workcertified 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
Responsibilities
- CMO oversight: Realtime oversight of CMOs of technology transfer optimization and validation of manufacturing operations and manufacturing.
- Process Development & Optimization: Design develop and optimize spray drying and other drug product processes for pharmaceutical APIs and formulations.
- ScaleUp & Tech Transfer: Lead the transition of spray drying and other drug product processes from pilot and commercial scale to primary and secondary CMOs.
- Equipment & Operations: Troubleshoot spray drying and other drug product process equipment ensuring efficiency and compliance with GMP regulations.
- Process Validation: Develop and complete validation protocols (IQ OQ PQ) for spray drying and other drug product processes. Prepare finalized spray dry formulation for product registration validation and commercial readiness.
- CrossFunctional Collaboration: Work closely with formulation scientists manufacturing teams and regulatory affairs to ensure smooth product development and commercialization.
- Regulatory Compliance: Ensure all processes align with FDA EMA and ICH guidelines for pharmaceutical manufacturing.
- Data Analysis & Reporting: Analyze process data identify critical process parameters and prepare technical reports for internal and regulatory submissions.
- Requirements:
- Minimum 7 years of experience in pharmaceutical process engineering leading teams tasked with implementation of pharmaceutical manufacturing technology improvements within a regulated environment.
- Bachelors degree in Chemical Engineering or equivalent field is required; an advance degree is preferred.
- Experience with commercial CMO operations.
- Strong background in spray drying technology for pharmaceutical applications; a background in capsule filling and blister primary packaging is a plus.
- Working knowledge of quality systems validation principles engineering design and statistical process control fundamentals.
- Shown ability to identify assess and solve problems using root cause analysis methodology and document investigation and outcomes in a compliant manner.
- Familiarity with DOE (Design of Experiments) and statistical process control.
- Experience with GMP manufacturing technology transfer process scaleup and validation.
- High energy innovative can do attitude is required.
- Ability to work independently remote from central leadership.
- Strong interpersonal skills and the ability to work in a fast paced multidisciplinary environment.
- Strong verbal and written communication skills are essential.
Salary Range
Compensation & Benefits
At Insmed were committed to investing in every team members total wellbeing 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 timeoff plans
- Competitive compensation package including bonus
- Equity Awards (LongTerm 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 atand let us know the nature of your request and your contact information. Requests for accommodation will be considered on a casebycase 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.
Required Experience:
Director
Employment Type
Unclear
