Scientist I, Analytical Development

JOB SUMMARY

We are looking for someone with high emotional intelligence and is comfortable working closely across the team to join us in facilitating the production of viral vectors. The Scientist role will be responsible for developing, implementing and qualifying analytical methods in addition to sample testing. The role will require close collaboration with Process Development and Quality Control as well as a flexible mindset to adjust to shifting dynamics within the organization.

ESSENTIAL JOB FUNCTIONS

• Develop, optimize and standardize analytical methods for viral vector characterization, including Lentiviral (LVV), Retroviral (RVV) and Adeno-associated Virus (AAV) vectors.
• Execute assays involved in viral vector characterization using modalities like flow cytometry, ddPCR, ELISA and cell culture.
• Assist with in-lab and out of lab (e.g., report writing) activities to qualify assays per ICH guidelines.
• Plan and execute analytical timelines to meet program and corporate objectives.
• Implement best laboratory practices to maintain efficiency, consistency and accuracy of work performed.
• Train new staff members and fellow employees in designated processes.
• Ensure compliance with current Good Manufacturing Practices (cGMP) and regulatory standards.
• Maintain appropriate documentation of processing activities, including written and electronic data.
• Assist with sample management for process development and clients.
• Handle and track laboratory materials and inventory.
• Help engage with new technology evaluations and incorporate new platforms.
• Perform routine lab maintenance and maintenance of laboratory equipment.
• Deal with abstract and concrete variables in situations where only limited standardization exists.
• Contribute to a collaborative, creative and rigorous culture of scientific excellence.
• Adaptability in schedules is highly required as work schedules 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.

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES	Essential/Desired
BS degree in scientific/technical discipline	Essential
PhD in a scientific discipline	Desired
ON-THE-JOB EXPERIENCE
BS with 5-7 years of CRO/CDMO or pertinent industry experience in bioanalytical methods (development, qualification and transfer)	Essential
PhD with 0 – 2 years of pertinent experience	Desired
Familiarity with aseptic technique and cell culture	Essential
Experience with PCR methods, flow cytometry, and ELISAs	Essenital
Proven assay qualification/validation experience	Preferred
3+ years of cGXP experience	Preferred
Experience with documentation and reporting of results using electronic lab notebooks	Preferred
SKILLS / ABILITIES
Strong people leadership skills	Essential
Ability to interpret and analyze data, define problems, establish facts, draw valid conclusions and make decisions	Essential
Ability to maintain multiple projects and timelines	Essential
Excellent verbal and written communication skills	Essential
Extremely high levels of initiative, adaptability, tenacity and troubleshooting skills	Essential

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