Process Engineer II

Insmed Incorporated • Bridgewater Township, NJ

393d

About The Position

The Process Engineer II at Insmed is responsible for process development, characterization, and technology transfer activities related to pharmaceutical products. This role involves working collaboratively within a scientifically driven team to optimize manufacturing processes, ensuring compliance with safety and regulatory standards while managing external vendors and contractors.

Requirements

• 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 'hands on' 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 and innovative 'can do' attitude is required.

Nice To Haves

• Experience managing third party vendors is a plus.

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.
• 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 development and manufacturing services and products.
• Provide SME support while working with CDMOs and CMOs.
• Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals.
• Prepare protocols, procedures, technical reports, and oral presentations.
• Maintain lab supplies and inventory for onsite lab experiments in order to ensure lab readiness.

Benefits

• 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
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree