Senior Manager, Large Molecule- Analytical Development

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 three 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 Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.

Overview

The Senior Manager, Large Molecule- Analytical Development will be responsible for managing the internal analytical laboratory and overseeing analytical activities conducted at CROs / CDMOs.

This includes method development, qualification / validation, method transfer, and characterization of drug substances, drug products, and reference standards.

Applicants must have advanced expertise in bioanalytical chemistry and method development. They will work closely with a multidisciplinary team of scientists dedicated to developing innovative protein drug candidates.

Specifically, the candidate will lead and supervise activities related to the development, optimization, and qualification of analytical methods supporting biologics R&D projects.

The ideal candidate should have a comprehensive understanding of the pharmaceutical development process from pre-clinical stages through life-cycle management and be prepared to collaborate with cross-functional teams working on developing methods for Insmed's new biochemical entities.

Responsibilities

• Serve as the analytical subject matter expert (SME) for internal product development, employing a range of analytical techniques such as chromatography (HPLC, UPLC, SEC), mass spectrometry (LC-MS), and other standard methodologies to support preclinical stage large molecule projects.
• Experience in establishing specifications and conducting comparability studies for biologics projects.
• Lead method development, analytical testing and method qualification initiatives, encompassing protocol preparation, SOP review, technical report generation, and memo composition.
• Develop and implement methodologies and strategies for the quantitation, characterization, and stability testing of drug substances and drug products.
• Hands on experience and deep understanding of techniques like Peptide mapping, HPLC / UPLC (IEX, SE, RP), SEC-MALS, DLS, DSC, CD & CE-SDS along with assays for HCP, Bioburden and Endotoxin detection.
• Responsible to develop bio-analytical methods for testing and characterization of protein therapeutics such as ELISA, SPR, BLI and various cell-based assays.
• Overviewing and generating reliable and interpreting data, using analytical instruments that include plate-readers, UV / Vis spectrophotometers, cell-counters, RT-PCR and microscope.
• Design and execute experiments to characterize biochemical and biophysical properties of protein therapeutics.
• Collaborate efforts in protein engineering to optimize stability, solubility, and other critical properties.
• Able to evaluate, design and perform method development and qualification employing phase-appropriate approaches at different stages of development.
• Working knowledge of half-life extension methods such as PASylation and PEGylation
• Deliver scientific direction and leadership in the creation, enhancement, and qualification of methodologies, alongside overseeing technical transfer, product comparability, and stability initiatives, all pertaining to Insmed's large molecule portfolio.
• Guide and support scientists in developing methods, qualifying processes, and resolving issues with laboratory instruments.
• Maintain accurate, detailed, and timely records of method development and analytical data.
• Able to manage authoring of analytical sections of INDs, CTAs, BLAs, health authority responses and participations in regulatory interactions.
• Interact with internal partners, CROs and contract laboratories during the development of analytical methods, stability testing, and preparation or overview of technical transfer documents.
• Cross-functional liaison working closely with internal stakeholders, including communication of potential issues / obstacles.
• Present scientific results to the cross-functional teams
• Manages direct reports including project assignments, team role assignments, quarterly performance review, assisting with career development of direct reports, documenting operational tasks, and reporting to upper-level management.
• Serves as the analytical development SME of large molecule for internal and external cross-functional projects .
• Build strong relationships with external vendors to learn and evaluate new and upcoming technologies, including scheduling lunch-and-learns.
• Able to work in a fast-paced, team-oriented environment with accelerated timelines.

Position Requirement :

• B.S or M.S. in Chemistry, Biochemistry or related discipline with 10+ years of experience or PhD with 3+ years of experience in the Biopharmaceutical industry.
• 2+ years of experience managing direct reports including prior experience with training and mentoring other technical staff.
• Ability to define problems, collect data, and draw valid conclusions.
• Hands on experience using and interpreting data from various analytical techniques including but not limited to chromatography (HPLC, UPLC, SEC, GC, etc.

mass spectroscopy (LC-MS, GC-MS, etc.); experience with Waters / Empower is preferred. Experience with SEC-MALS and MS being advantageous.

• Strong statistical skills with a good understanding of basic and intermediate statistical tests.
• Good understanding of GxP, CMC, ICH and compendial (USP / EP / JP) regulatory requirements.
• Excellent presentation skills both verbal and written.
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
• Must successfully exhibit Insmed's five (5) core values of Collaboration, Accountability, Passion, Respect, and Integrity along with any other position specific competencies.
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.
• Travel :
• Up to 10% travel based on vendor requirements.

Travel Requirements

Up to 10%

Salary Range

$111,000 - $156,133 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
• 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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