Analytical Development Scientist I - Genezen

JOB SUMMARY

The role involves directing the establishment of analytical methods in the Analytical Development (AD) lab. This individual will be responsible for developing, qualifying, and validating analytical methods for Adeno-associated virus (AAV), Lentiviral vectors (LVV), and Retroviral vectors. They will oversee the transfer of these methods from the AD lab to the Quality Control (QC) lab, ensuring compliance with cGMP standards.

This is a client-facing position that demands constant interaction and adherence to strict timelines. The individual must collaborate with cross-functional teams to establish and implement best regulatory and laboratory practices and lead the execution of complex experiments.

ESSENTIAL JOB FUNCTIONS

• Develop, optimize, and standardize analytical methods for viral vector characterization, including Lentiviral (LVV), Retroviral (RVV), and Adeno-associated Virus (AAV) vectors.
• Ensure compliance with current Good Manufacturing Practices (cGMP) and regulatory standards.
• Implement best laboratory practices to maintain consistency, accuracy, and reliability of analytical results.
• Act as SME for the platform analytical process.
• Maintain familiarity with current analytical methods, including HPLC, Mass spectrometry (MS), DLS, ddPCR, cell-based assays and flow cytometry-based assays
• Maintain familiarity with current equipment used in Analytics lab
• Develop/establish a robust process transfer protocol to move analytical methods from the AD lab to the QC lab and or Client laboratories.
• Help train AD/QC associates and technicians and work closely with other departments, assisting in project planning
• Analyze regulatory authorities' programs, guidance documents, and activities in areas relevant to testing of biological products
• Execute development timelines to meet program and site objectives
• Deal with abstract and concrete variables in situations where only limited standardization exists
• Maintain high quality deliverables and open communication, creating a collaborative working environment
• Contribute to a collaborative, creative and rigorous culture of scientific discovery
• Provide weekly and monthly reports to department head

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Intent to work with the manager on meeting the company mission, vision and values to achieve department goals
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• Occasionally exposed to extremely loud noise levels
• Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required

Movement

•  Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Occasionally lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail