Process Engineer II

Job Details 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 Biopharmaâ„¢, Best Workplaces in New Yorkâ„¢, PEOPLE® Companies That Care, Best Workplaces for Womenâ„¢, Best Workplaces for Millennialsâ„¢, and Best Medium Workplacesâ„¢ lists. Overview The Process Engineer II will have responsibility for process development, process characterization, scale-up, and technology transfer activities, supporting new and existing pharmaceutical products. Responsibilities Contribute to the design and execution of process development and process engineering experiments for fermentation /chromatography or other project related processes. Key member of a dynamic scientifically driven team, dedicated to the development and optimization of robust manufacturing processes for drug products. Key contributor to process development strategies to define manufacturing processes for clinical and commercial products. Apply fundamental engineering principles to characterize and solve process challenges across multiple unit operations, utilizing both experimental and process simulation/modeling approaches. Utilize appropriate research tools, instrumentation, technologies, and methodologies to support efficient and effective drug product process development. Manage external vendors and contractors as related to drug product manufacturing services and products. Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals. Prepare technical reports, publications and oral presentations. Position Requirements (Required and/or Preferred Skills, Experience, and Education): Bachelor's degree with 3+ years of pharmaceutical experience strongly preferred Strong background in fermentation/chromatography purification of biopharmaceutical proteins both small scale and large scale. Strong background operating fermentation / chromatography equipment in the preparation of proteins at small and large scale. Strong background in pharmaceutical development as it relates to process development/optimization. Demonstrated capability in execution of an experimental program to address issues of process robustness, productivity, and cost, integrating efforts with specialists in other technical disciplines. Demonstrated record of implementing novel and creative solutions to overcome process development obstacles. Working knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, engineering design, and statistical process control fundamentals. Working knowledge of GLPs and cGMPs during pharmaceutical development and commercial manufacturing. Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment. Strong verbal and written communication skills are essential. Experience managing third party vendors is a plus. High energy, innovative "can do" attitude is required. #LI-MM1 Salary Range $88,000 - $122,467 a 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 affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information or any other characteristic protected by law. 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 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. 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.

Created: 2024-10-29