Scientist I/Ii, Analytical Development

Scientist I/II - Analytical Development

Rejuvenate Bio is a spinout from George Church's lab at Harvard Medical School and the Wyss Institute with headquarters in San Diego, CA. We are using a convergent, multi-disciplinary approach, combining gene therapy, proprietary targets, and the animal health market to bring human age-related therapies to market. We are targeting the core drivers of chronic age-related diseases by unlocking the power of gene expression and epigenetic reprogramming to reverse pre-existing heart disease, metabolic disease, and kidney failure in humans.

Overview:

We are seeking a highly motivated Scientist I/II to join our growing Process Development team! The Scientist I/II, Analytical Development will work cross-functionally to support process development and manufacturing activities and be responsible for identifying, developing, and validating analytical methods to support the characterization and release of our AAV gene therapy products. Ideal candidates will have expertise in protein biochemistry and a deep understanding of biophysical methods including but not limited to mass spectrometry, DLS/SLS and HPLC. This role reports to the Senior Director of Process Development.

Responsibilities:

• Evaluate and analyze reports generated by Contract Research Organizations (CROs) and Contract Testing Laboratories (CTLs), specifically pertaining to mass spectrometry, LC-MS, and HPLC read-outs.
• Stay current the latest developments in biophysical characterization methods and apply relevant technologies to support program goals.
• Collaborate with cross-functional teams to support process development and manufacturing activities.
• Foster cross-functional collaborations with CTLs and CROs.
• Adhere to laboratory protocols and safety regulations.
• Deliver on-time, high-quality results and effectively communicate progress clearly in group meetings.
• Perform method qualification and validation activities in compliance with relevant industry guidelines and regulations (e.g., ICH, FDA).
• Accountable for on-time, high quality results and clearly communicating progress.
• Analyze and interpret data, prepare technical reports, and present results to project teams.
• Heavy majority of time dedicated to performing experiments in the lab.
• Meticulously document all experiments and laboratory practices.
• Perform any additional duties assigned by supervisor or manager.
• All daily troubleshooting and experimental planning and design are done independently or with very little input.
• Develop and optimize analytical methods for characterization and release testing of AAV gene therapy products, including mass spectrometry-based techniques.
• Support stability studies and execute analytical testing to assess product stability over time.

Basic Requirements:

• Ability to work independently and as part of a team in a fast-paced environment.
• Demonstrable experience keeping pristine records of experiments and DNA constructs produced using a digital laboratory notebook.
• Ph.D. in Biophysics, Analytical Chemistry, Biochemistry, or related discipline.
• Excellent communication and interpersonal skills, with a demonstrated ability to work cross-functionally.
• Experience with ELISA, SDS-PAGE, Western blotting, and qPCR.
• 0-2 years of experience in biophysical characterization methods including but not limited to mass spectrometry, DLS/SLS and HPLC in an industry or post-doc setting.
• Strong understanding of biophysical characterization methods, protein biochemistry, analytical techniques, and regulatory requirements for biologics.
• Strong problem-solving and critical thinking skills.
• Knowledge of relevant industry guidelines and regulations (e.g., ICH, FDA) for analytical methods development and validation for biologics.

Preferred Qualifications:

• Experience with high-throughput screening methods for biophysical characterization.
• Demonstrated ability to lead and mentor junior scientists.
• Track record of presenting at scientific conferences and publishing in peer-reviewed journals.
• Familiarity with regulatory requirements for analytical methods development and validation for AAV gene therapy products.

Additional Information:

Base Salary: $100k - $130k+; exact salary, job title, and responsibilities will depend on experience.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Must be able to process paperwork and utilize office equipment (including personal computer, phone, copiers, etc.).
• Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards
• Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.
• Position is primarily sedentary, and employee may be required to sit for extended periods of time.
• Standing, walking and meeting activities are required frequently throughout the workday.
• Must be able to talk, listen and speak clearly on telephone
• Normal sight or corrected vision is required to read documents and use standard computer terminals. Some light lifting may be occasionally required.
• Must be able to lift and carry up to 25 lbs

EEO Statement

Rejuvenate Bio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Rejuvenate Bio is an E-Verify Employer in the United States. All your information will be kept confidential according to EEO guidelines.

The health and safety of our employees and their families is a top priority. The company encourages employees to remain up-to-date on their COVID-19 vaccinations. Rejuvenate Bio, Inc. employees may be required, in the future, to be vaccinated or have an approved disability/medical or religious accommodation.