Associate Director, Tech Ops (Process Chemistry)

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 Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.

Overview:

Associate Director, Tech Ops (Process Chemistry) will have responsibility for the management of API/Intermediate/RSM manufacturing operations at Insmed’s CMOs including tech transfer, process optimization, clinical/commercial manufacturing, process characterization and validation, and manufacturing CMC development strategy. Remote (only in corp. office for purposeful meetings)

Responsibilities:

Responsibilities (Essential Role Responsibilities):Responsible for being the Technical Operations liaison to the Insmed research team for lead optimization and early development programs. This position will be the dynamic cross functional interaction between lead optimization research and early CMC development.

Responsible for the management of API/Intermediate/RSM manufacturing operations at Insmed’s CMOs including oversight of tech transfer, scale-up, process optimization, clinical/commercial manufacturing and ensuring the continued refinement and enhancements of the manufacturing process.

Responsible for technical support as Insmed’s internal SME, technical review of quality documentation, management of schedule/raw material consumption/budgets, and management of any process improvement related projects

Position Requirements (Required and/or Preferred Skills, Experience and Education):8+ years experience managing development and execution of API manufacturing processes (preferably of products marketed in the US, EU, JP)

5+ years experience leading teams tasked with implementation of pharmaceutical manufacturing technology improvements within a regulated environment

Experience managing CMO operations

Experience in New Chemical Entity (NCE) including total synthesis, physical organic chemistry

Working knowledge of quality systems, validation principles, engineering design, and statistical process control fundamentals.

Experience with providing technical authoring of CMC drug substance sections of regulatory filings and dossiers.

Sound awareness of Regulatory, Quality Assurance, and cGMP requirements

High energy, innovative “can do” attitude is required

Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment. Strong verbal and written communication skills are essential.

MS or PhD in Pharmaceutical Sciences, Organic Chemistry, Chemical Engineering, or similar

Travel:Up to 10% travel based on vendor requirementsRemote (only in corp. office for purposeful meetings)

Travel Requirements:

up to 10%

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 $(phone number removed) to $(phone number removed) per 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

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 Information:

Insmed 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 for 5 calendar days from the date posted or until the position is filled

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Permanent