Scientist l, Analytical Operations

About the role

Manage projects related to laboratory instrumentation, Data Integrity, and ancillary lab systems. Author, review, and contribute to quality related documentation. Collaborate and coordinate with internal and external partners to maintain alignment on project scope, timelines, and deliverables. Ensure critical lab priorities are delivered in a timely manner to support pipeline activities. Maintain a deep knowledge of instrument processes and support process improvement updates where needed. Prepare for and support audits on instrumentation and data integrity topics, including follow-on activities. Maintain activities supported by ARD LC IMT.

Responsibilities

• Manage and multitask instrument activities to support the pipeline and escalate concerns appropriately.
• Maintain a deep knowledge of instrument processes and support process improvement updates where needed.
• Support other cGMP quality activities within function as needed.
• May have opportunity to lead, develop, and coach temporary workers and summer interns.
• Drive/coordinate operational decision making on a site basis.
• Adapt to changing environments and balance priorities.
• Support project development of technological innovations by providing guidance on regulatory / cGMP expectations for novel analytical instrumentation.
• Build strong relationships with peers to create and implement cross-departmental operational strategies.
• Know the business to influence long-range strategies.
• Create a learning environment, open to suggestions and experimentation.
• Deal comfortably with uncertainty, ambiguity, and risk ensuring alignment with corporate/regulatory policies/standards.
• Raise the bar and drive the function to efficient/reliable execution.
• Learn fast, grasp the essence, and change course quickly where indicated.

Requirements

• Bachelor’s Degree or equivalent education with 5 years of experience, or Master’s Degree or equivalent education with 2 years of experience.
• Demonstrated theoretical and practical knowledge and experience in analytical development including international pharmaceutical regulations and cGMPs.

Qualifications

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: â - The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. â - We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. â - This job is eligible to participate in our short-term incentive programs. â Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. â

Benefits

Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

Schedule

Role is exclusively performed at a site or office and onsite presence is required. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.

Pay

$75,000 - $142,500 USD