Employment Type: Permanent Position

Job Category: Biomanufacturing

Department: Quality

Reports To (Position): Manager, Analytical QC Method Validation

Job Number: 2463977

Position Overview:

The applicant will be an experienced and highly motivated Analytical Method Validation Analyst to support the development, qualification, validation, and implementation of robust analytical methods for our products. This role will play a critical part in supporting the development pipeline and ensuring compliance with all regulatory requirements.

Accountabilities and Responsibilities:

• Perform the qualification and validation of analytical methods used for the characterization, potency, and purity testing of gene therapy products.
• Operate and maintain QC Lab instrumentation
• Author, review, and approve analytical method validation protocols, reports, and other validation documents. This includes interpretation of data to conclude acceptability of analytical methods.
• Support the transfer and qualification of analytical methods between different laboratories.
• Investigate and troubleshoot analytical method deviations and out-of-specification (OOS) results and ensure any resulting CAPAs are addressed appropriately.
• Interface with other departments (e.g., Manufacturing, Analytical Development, Regulatory Affairs) to ensure alignment and support for analytical method development and validation activities.
• Stay current with the latest advancements in analytical methods and regulatory guidance for gene therapy products.
• Perform other duties as assigned.

Essential Details:

Work Schedule

Full-time; day shift. May require weekend work to support validation activities.

Travel

N/A

Safety

Complies with all pertinent safety policies, rules and regulations.

Quality Responsibility

Maintenance of quality systems and GxP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.

Scope

Work on problems of moderate scope. Exercises judgement within defined procedures and policies in selecting methods and techniques in obtaining solutions and in determining appropriate action. Interprets results in comparison to established specifications.  

Minimum Requirements:

Education

Bachelor’s degree in life sciences (Chemistry, Biology, Microbiology, Biochemistry), pharmacy or related engineering field

Experience

2+ years of extensive experience in an analytical testing role within the pharmaceutical/biotechnology industry, preferred

Knowledge & Skills

• Working knowledge of CGMP requirements for biologics manufacturing.
• Understanding of typical analytical instrumentation.
• Experience with multiple assay types; HPLC, flow cytometer, PCR, ELISA, etc., preferred
• Proficiency in Microsoft Office Suite and laboratory informatics systems (LIMS) is a plus.
• Working knowledge of requirements for aseptic manufacturing.
• Good Aseptic technique
• Excellent communication, interpersonal, and organizational skills.
• Ability to work independently and as part of a team in a fast-paced environment.
• Continuous strong focus on meeting or exceeding expectations in executing deliverables, performance and results.
• Ability to track and measure performance against defined metrics.
• Self-starter with high degree of energy, independence, initiative, and self-motivation, as illustrated by the ability to instill a sense of pace and urgency into the team.
• Someone who moves fast and decisively in a balanced manner, with a passion for the growing company.
• Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families.

Work Environment

Majority of the work is performed in a laboratory environment; work may involve common hazards found in a lab environment. In some areas, gowning may be required. 

Relocation Assistance: Yes