Assoc Director, Upstream Manufacturing
Insmed Incorporated

Job Info

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Company Description

Insmed is a growing global biopharmaceutical company powered by our purpose to deliver life-altering therapies to small patient populations experiencing big health problems. Our most valuable resource is our employees, and a patients-first mentality guides everything we do. Today, we are building a world-class team of talented individuals who are willing to challenge the status quo, solve problems, and work collaboratively and with a sense of urgency.

Come join us if you are ready to roll up your sleeves and be recognized for your efforts while working alongside team members who share your passion for serving patients and their families.

Recognitions

Named Science's 2021 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 were named the No. 1 company to work for in the biopharma industry in Science's 2021 Top Employers Survey.

A Certified Great Place to Work

We believe we have built something truly special at Insmed, and our employees agree. Each day, we show up for each other and for the patients we serve. That's why we were recently certified as a Great Place to Work in the U.S.

Overview

We are seeking a highly skilled manager and expert in upstream processes used in the manufacture of viral vectors for gene therapy.
In this role you will be responsible for input into cell culture and transfection process development and oversight of upstream clinical manufacturing for gene therapy programs. You will join a motivated group of researchers in a very collaborative environment. As part of this group, your professional, as well as your scientific growth, are encouraged and developed.

Fill finish experience and or tech transfer skills are preferred, but not necessary. Familiarity with filling operations and a desire to train others in a cGMP environment is desired.

Responsibilities

Additional representative responsibilities will include, but not necessarily be limited to, the following:

• Responsible for facility start-up activities related to clinical manufacture of viral vector gene therapies including but not limited to: equipment commissioning, standard operating procedure and production documentation development, staff onboarding, training development and oversight, and GMP operations.
• Supervises staff to execute clinical manufacturing activities to support gene therapy programs;
• Position may oversee clinical fill finish area depending on candidate experience and demonstrated skills;
• Provides strategic input into the evaluation of new technologies for use in commercially viable manufacturing processes;
• Builds strong team and fosters collaboration and culture consistent with Insmed core values;
• Author, review, or approve Standard Operating Procedures, technical reports, process descriptions, including data interpretation and procedures suitable for inclusion in pre-IND, IND, or equivalent regulatory submission;
• Participate in multi-disciplinary projects with multi-cultural teams, and guide project and business strategies;
• Exercise judgment in selecting methods, techniques and evaluation criteria to obtain high quality results on time and on budget;
• Update team members on background and status of projects by giving oral updates or internal presentations;
• Actively seek opportunities for continuous improvement;
• Assist other departments and performs all other duties as assigned.

Qualifications

• B.Sc. or M.Sc. in life sciences, chemical engineering, biochemistry, or related field;
• 12+ years of experience working in a biopharmaceutical laboratory focusing on viral vector production;
• Must be familiar with change control systems and technical assessment of change in a current Good Manufacturing Practice (cGMP) production environment Lead technology transfer and technical oversight of processes to cGMP facility;
• Significant knowledge of cell culture process techniques to support pre-clinical and clinical programs at all development stages, including cell expansion, bioreactor operation, transfection, and harvest;
• Ability to adapt to change and effectively deliver under pressure and time constraints, while maintaining a high level of work quality.
• Experience with direct and/or indirect leadership experience of teams and/or projects, including coaching and developing people
• Strategic, end-to-end thinking
• Experience in regulated or Good Manufacturing Practice (GMP) manufacturing and/or technical support of manufacturing operations
• Experience with aseptic processing operations such as bulk production, formulation, and vial filling
• Experience with deviation management and associated systems

Travel Requirements

Up to 5% travel, both domestic and/or international

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.

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