Associate Director, MS&T Position Available In Somerset, New Jersey

Job Description:

Company Description Insmed is a global biopharmaceutical companyon a mission to transform the lives of patients living with seriousand rare diseases. Our most valuable resource is our employees, andeverything we do is motivated by a patients-first mentality. We arededicated to growing our team with talented individuals from aroundthe world who are willing to challenge the status quo, solveproblems, and work collaboratively with a sense of urgency andcompassion. Guided by our core values of collaboration,accountability, passion, respect, and integrity, we aim to fosteran inclusive, diverse, and flexible work environment, where ouremployees are recognized for leaning in and rolling up theirsleeves. If you share our vision and want to work with the mostdedicated people in the biopharma industry, come to Insmed toaccelerate your career. Recognitions Consistently Ranked Science ‘sTop Employer Insmed is dedicated to creating a collaborativeenvironment where our team can thrive. Every day, our employeesturn their passion for science and research into innovativesolutions for patients. That’s why we’ve been named the No. 1company to work for in the biopharma industry in Science ‘s TopEmployers survey for four years in a row. A Certified Great Placeto Work® We believe our company is truly special, and our employeesagree. In July 2024, we became Great Place to Work-certified in theU.S. for the fourth year in a row. We are also honored to have beenlisted on the Best Workplaces in Biopharma™, Best Workplaces in NewYork™, PEOPLE® Companies That Care, Best Workplaces for Women™,Best Workplaces for Millennials™, and Best Medium Workplaces™lists. Overview The Associate Director, MS&T will beresponsible for the development, optimization, and scale-up ofspray drying processes for pharmaceutical formulations. You willcollaborate with cross-functional teams, including R D,manufacturing, quality assurance, regulatory CMC, and contractmanufacturing organizations (CMOs), to ensure robust and compliantproduction processes. Responsibilities CMO oversight : Real-timeoversight of CMOs execution of technology transfer, optimization,and validation of manufacturing operations and manufacturing.

Process Development & Optimization :

Design, develop, and optimizespray drying and other drug product processes for pharmaceuticalAPIs and formulations.

Scale-Up & Tech Transfer :

Lead thetransition of spray drying and other drug product processes frompilot and commercial scale to primary and secondary CMOs.

Equipment& Operations :

Troubleshoot spray drying and other drug productprocess equipment, ensuring efficiency and compliance with GMPregulations.

Process Validation :

Develop and complete validationprotocols (IQ, OQ, PQ) for spray drying and other drug productprocesses. Prepare finalized spray dry formulation for productregistration, validation, and commercial readiness.

Cross-Functional Collaboration :

Work closely with formulationscientists, manufacturing teams, and regulatory affairs to ensuresmooth product development and commercialization.

RegulatoryCompliance :

Ensure all processes align with FDA, EMA, and ICHguidelines for pharmaceutical manufacturing. Data Analysis ℜporting : Analyze process data, identify critical processparameters, and prepare technical reports for internal andregulatory submissions.

Requirements:

Minimum 7 years of experiencein pharmaceutical process engineering, leading teams tasked withimplementation of pharmaceutical manufacturing technologyimprovements within a regulated environment. Bachelor’s degree inChemical Engineering or equivalent field is required; an advancedegree is preferred. Experience with commercial CMO operations.

Strong background in spray drying technology for pharmaceuticalapplications; a background in capsule filling and blister primarypackaging is a plus. Working knowledge of quality systems,validation principles, engineering design, and statistical processcontrol fundamentals. Shown ability to identify, assess, and solveproblems using root cause analysis methodology and documentinvestigation and outcomes in a compliant manner. Familiarity withDOE (Design of Experiments) and statistical process control.

Experience with GMP manufacturing, technology transfer, processscale-up, and validation. High energy, innovative “can do” attitudeis required. Ability to work independently, remote from centralleadership. Strong interpersonal skills and the ability to work ina fast paced, multidisciplinary environment. Strong verbal andwritten communication skills are essential. Salary Range $139,000 -$195,200 a year Compensation & Benefits At Insmed, we’re committedto investing in every team member’s total well-being, now and inthe future. Our benefit programs vary by country but we offer thefollowing to all Insmed team members, regardless of geographiclocation: Flexible approach to how we work Health benefits andtime-off plans Competitive compensation package, including bonusEquity 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 Opportunityemployer. We do not discriminate in hiring on the basis of physicalor mental disability, protected veteran status, or any othercharacteristic protected by federal, state, or local law. Allqualified applicants will receive consideration for employmentwithout regard to sex, gender identity, sexual orientation, race,color, religion, national origin, disability, protected Veteranstatus, age, or any other characteristic protected by law.

Unsolicited resumes from agencies should not be forwarded toInsmed. Insmed will not be responsible for any fees arising fromthe use of resumes through this source. Insmed will only pay a feeto agencies if a formal agreement between Insmed and the agency hasbeen established. The Human Resources department is responsible forall recruitment activities; please contact us directly to beconsidered for a formal agreement. Insmed is committed to providingaccess, equal opportunity, and reasonable accommodation forindividuals with disabilities in employment, its services,programs, and activities. To request reasonable accommodation toparticipate in the job application or interview process, pleasecontact us by email at TotalRewards@insmed.com and let us know thenature of your request and your contact information. Requests foraccommodation will be considered on a case-by-case basis. Pleasenote that only inquiries concerning a request for reasonableaccommodation will be responded to from this email address.

Applications are accepted for 5 calendar days from the date postedor until the position is filled.