JOB SUMMARY

Lead the establishment of methods in the Analytical Development (AD) and Quality Control lab from the bench. This individual will be accountable for development and validation of analytical and QC assays, equipment specification and selection and the direction of analytical method transfer from the analytical development lab to the QC lab while operating under cGMP standards. The person is expected to work collaboratively with the team to establish and implement best regulatory, laboratory practices and to lead the execution of complex experiments. The position requires expertise in potency and other cell based assays, ddPCR/qPCR, and ELISA. Considerable expertise with experimental design toward method qualification and validation per ICH guidelines in a phase appropriate manner. Considerable expertise with technical writing of protocols, SOPs, and technical reports. Experience with biophysical characterization methods including HPLC, LC-MS, CE-SDS etc. Direct line management experience is required.

JOB RESPONSIBILITIES

• Experience with AAV assay development is critical
• Expert in method qualification/validation experimental design per ICH guidelines
• Experience with specification setting for complex biologics
• Expert in potency method development
• Expert in ddPCR/qPCR from primer design and optimization to implementation
• Expert with ELISA assay development
• Experience in HPLC based methodology development and establishment including with the use of CAD and MALS detectors for use in the characterization of AAV vectors
• Maintain familiarity with other current analytical and bioassay methods, including Flow cytometry
• Maintain familiarity with current equipment used in Analytics lab
• Help management evaluate new technology and bring new platforms in-house
• Qualify/validate analytical methods to support cGMP testing
• Help facilitate tech transfer of analytical and bioassays from clients to AD lab and from AD lab to QC lab
• Supervise and train AD Associates and AD Technicians and work closely with other departments, assisting in project planning
• Support the establishment of electronic record keeping systems for site; e.g. LIMS or ELN
• Analyze regulatory authorities' programs, guidance documents, and activities in areas relevant to testing of biological products
• Work as a team with process development, manufacturing, quality assurance and quality control departments as needed
• Advise site and quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued
• Execute research timelines to meet program and corporate 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 collaborative, creative and rigorous culture of scientific discovery
• Provide weekly reports to department head in 1:1 environment

SPECIAL JOB REQUIREMENTS

• People training and leadership skills
• Ability to maintain multiple projects and timelines
• Excellent verbal and written communication skills
• Extremely high levels of initiative, adaptability, tenacity and troubleshooting skills

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

BS in scientific/technical discipline

Essential

ON-THE-JOB EXPERIENCE

5-6 years experience post graduation (with PhD), 6-8 years experience post graduation (with Masters), 8-12 years experience post graduation (with Bachelors)

Essential

2-4 years of CRO/CDMO experience in design, development and execution of bioanalytical methods (i.e. method development, qualification, validation and transfer). Methods include, but are not limited to: Potency for AAV vectors, cell based assays, ELISA, ddPCR, qPCR, HPLC using UV-Vis, CAD, and MALS detectors, and flow cytometry-based assays.

Essential

Expertise in molecular biology in the characterization of AAV particles and associated impurities.

Essential

Experience with documentation and reporting of results using electronic lab notebooks

Essential
SKILLS / ABILITIES

People training and leadership skills

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

Pay Range:

• The annual salary range for the Senior Scientist is $120,000-$150,000.

Work Environment

• Frequently required to work in BSL2 environment with personal protective equipment/aseptic gowning
• Occasionally exposed to moving mechanical parts, toxic or caustic chemicals, hazardous waste, and similar hazards associated with pharmaceutical lab facilities

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

Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.

Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum--to name just a few reasons why this area is a great place to live.

Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.