Manager, Lab Operations (Analytical Development)
Insmed Incorporated

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

The Manager, Laboratory operations will manage the internal analytical laboratory and oversee analytical activities performed at CROs/CDMOs associated with method development, qualification/validation, transfer and characterization for drug substance, drug product and reference standards. The Manager must possess a good understanding of pharmaceutical development processes from pre-clinical development through life-cycle management. This position will also manage metrology functions for analytical laboratory and will be responsible for defining, leading, and managing calibration function. These responsibilities include running the day-to-day operations of the laboratory including equipment qualification and maintenance. The Manager will also serve as business owner for all computerized systems and will serve an active role in CSV activities including, but not limited to, review and approval of relevant CSV documents.

Responsibilities

• Manages direct reports including project assignments, team role assignments, formal quarterly performance reviews, assisting with career development of direct reports, documenting operational tasks, and reporting to upper-level management.
• Oversees all analytical development lab operations, including oversight of the maintenance and qualifications of all analytical instrumentation as well as approving and managing spend for lab consumable purchases. This will include authorship, review, and approval of technical documents such as qualification protocols and SOPs as well as the design and setup of new lab expansions.
• Serves as the analytical development SME for internal and external cross-functional projects .
• Communicates results of experiments and presents findings to cross-functional project teams.
• Evaluates, designs, and performs method validation, employing phase-appropriate approaches at different stages including Commercial for assay, purity, identification of impurity and degradation products, reference standard qualification and physical (solid-state) characterization of drug product and drug substance.
• Prepares and approves technical documents (analytical test methods, experimental plans, SOPs, method development reports, validation protocols and reports).
• Serves as the analytical development business owner for computerized system. As the AD Business owner, responsibilities will include, but not be limited to, serving as the system administrator for analytical software such as Empower 3; review and approval of all documents; coordinating with appropriate IT groups to troubleshoot any issues that may arise.
• Builds 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.

Requirements

• 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 pharmaceutical industry.
• 2+ years of experience managing direct reports including prior experience with training and mentoring other technical staff.
• Expertise in analytical method development. Proficiency with AQbD method development is a plus.
• Experienced in analytical characterization of multiple dosage forms including solid oral, liquid dosage, inhalation and combination products.
• Experience with analytical instrumentation such as HPLC/UPLC, SEC, CAD, SEM, Dissolution, GC, and KF are a must. Experience with SEC-MALS and MS are a plus.
• 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.
• Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Proficient with System Administration of analytical software such as Waters Empower 3, BMRAM R4, and Waters Connect. Experience with third party drivers like SII for Empower is a plus.
• Proficiency with additional software like Veeva EDMS, Microsoft Projects, Minitab, and Workday is a plus.
• Must have strong communication skills.
• 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.
• Up to 5% travel based on vendor requirements.

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Travel Requirements

up to 5%

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 $111,000.00 to $156,133.00 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 withcompanymatch
• 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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