Senior Scientist, Viral Vector Downstream Process Development

About the Job

ReciBioPharm, the biologics business unit of Recipharm AB, is a visionary contract development and manufacturing organization (CDMO) that partners with companies seeking to develop and manufacture complex biological drugs and innovative therapies. Our dedicated team, state-of-the-art facilities, and unparalleled resources are crucial for advancing products from development to commercial launch.  Our vision is to be the trusted and innovative CDMO partner for advanced therapy pioneers, so that we can bring life-changing therapeutics to patients.  We partner with our clients to make treatments that can benefit vast patient populations, working across many indications.  ReciBioPharm’s mission is to change healthcare through our intrepid and daring team engaging with clients to develop, manufacture, and supply breakthrough therapies that transform lives.

Job Summary

RecibioPharm (Boxborough) is seeking a Senior Scientist for adeno-associated virus (AAV) / lentivirus (LV) downstream process development to join our growing AAV/LV process development group at Boxborough, MA.  The successful candidate is responsible for developing, optimizing, and leading the downstream AAV/LV process development, including design and implementation of chromatographic, filtration and centrifugation studies, performance qualification, process characterization and control strategies, scale-up, and tech transfer internally and externally. The candidate will be a crucial member of the AAV/LV group for developing AAV process development and manufacturing strategies. The successful candidate will be intellectually motivated to implement new technologies and novel strategies directly applied to human diseases.  Creativity, scientific rigor, and a thirst for excellence are essential.

Essential Job Functions

• Provide managerial and technical leadership on all aspects of AAV purification to understand, characterize, and optimize the downstream process.
• Develop and optimize filtration processes (depth filtration, UF/DF, tangential flow filtration, sterile filtration, etc.) and chromatography processes (including affinity, IEX, HIC, SEC, etc.) for high yield and quality of rAAV/LV viral vector.
• Plan, design, and execute purification development experimental studies using DOE to define process parameters, ranges, specifications, and control strategies for establishing a robust and reliable purification process.
• Pilot and optimize process scale-up, manufacturing operations, and deviations/investigations.
• Lead downstream tech-transfer activities internally and externally.
• Participate in ongoing downstream technology development initiatives and generate new ideas and proposals for future projects.
• Maintain lab notebooks, author and review technical development and regulatory documents.
• As part of a growing development team, the candidate will be required to perform activities across the team in addition to purification experiments (i.e. analytical characterization, bioreactor, and cell line).

Experience And Skills

• PhD in biochemistry, bioengineering or related field with 3-5 years of industry experience in downstream development. Excellent non-PhD candidates will also be considered.
• Demonstrated experience and working knowledge of cell lysis procedures and viral vector recovery strategy throughout downstream processes.
• Hands-on experience in downstream techniques, including but not limited to chromatography (Affinity, IEX, HIC, SEC, etc.) and filtration (depth filtration, UF/DF, tangential flow filtration, sterile filtration) is required.
• Expertise with AKTA chromatography systems and UNICORN software
• Experience with statistical analysis/software (e.g., JMP, Minitab, etc.) and Design of Experiments (DoE) is required.
• Demonstrated independent and self-driven ability to work in a dynamic environment with a strong work ethic.
• Ability to collaborate, work effectively on cross-functional teams, and rapidly adapt technologies and processes to meet project needs.
• Detail-oriented, organized, technically competent, and able to maintain written records, author reports, and appropriate regulatory filing sections.
• Excellent communication and decision-making skills and ability to lead the downstream team.
• Familiarity with analytical tools to evaluate process yield and quality is a plus.
• Experience with viruses, GMP manufacturing, process scale-up, and tech transfer is preferred.

Physical Demands

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.

• While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear.
• The employee is required to walk; climb or balance; and stoop, kneel, crouch, or crawl.
• The employee must frequently lift and/or move up to 20 pounds and occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include close vision, and ability to adjust focus.
• No travel required.
• Communicate using telephone and e-mail.

Work Environment

This will be a laboratory-based position that will require some non-standard working hours including early morning or later evening to support manufacturing activities.

Who We Are

ReciBioPharm hires people who are committed and passionate to the goal of bringing life-enhancing products to patients.  We want top talent who will render ideas and a relentless desire towards accomplishing our mission; when a job becomes a passion, it makes you feel ALIVE.  Here at ReciBioPharm, we embrace ALIVE – our core values that we live and breathe daily! We are Agile, Leading, Innovating, Value Creating, and Engaging.  Are you ready to come ALIVE with a daring and intrepid team?  Don’t wait another minute; Apply today!

Medical Requirement

• This position requires a criminal background check and drug screening
• COVID19 Vaccine required to come on site; Individuals seeking an exemption from this requirement for medical or religious reasons should reach out to Human Resources for an accommodation

Benefits

ReciBioPharm offers a very competitive benefits package including medical, dental, vision, prescription drug coverage, life and disability insurance, 401(k), and generous vacation and time off policies among other attractive benefits.  We operate in a world-class facility to attract the best and brightest talent to work collaboratively in our mission to bring novel therapies to the patients who need them most.

ReciBioPharm is an Equal Opportunity Employer.