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
Arranta Bio is seeking a talented individual to join our Continuous Manufacturing of mRNA Group (CMRG) in Watertown, MA. As a member of the elite CMRG team, this individual will be an integral member of the industry leading continuous manufacturing team supporting the Arranta’s mission of creating mRNA CM production lines capable of Real Time Release Testing (RTRT). Specifically, the role will focus on developing and implementing new technologies/methodologies to make mRNA continuous manufacturing a reality.
ESSENTIAL JOB FUNCTION
- You will have the opportunity to work in a dynamic and enthusiastic atmosphere, whilst leading the research and development activities of an mRNA continuous manufacturing process.
- You will work closely with a team of colleagues in a multi-skilled environment to design, develop and deliver continuous manufacturing skids for mRNA that is capable of RTRT.
- Apply deep knowledge in nucleic acid research to develop robust, scalable and well-characterized processes using QbD principles
- Develop scale-down process models and perform process characterization utilizing DOE principles
- Develop new innovative technologies and approaches to fit current and future manufacturing needs
- Support the procurement of materials and manufacturing equipment
- Examples of typical tasks: Serve as a senior expert/leader within CMRG, mentor colleagues and drive the scientific knowledge synergy.
- Provide strategic direction and advice on new science and technology with the scientific area of nucleic acid therapeutics, taking part in tech transfer of these advanced methods and technologies and giving consultation to internal and external parties, including regulatory authorities
- Continue to develop and drive scientific excellence in the area of nucleic acid manufacturing methodologies and technologies within the company as well as with world leading universities, scientific organizations and other institutional partners.
- Take responsibility or the quality, reputation, communication and delivery in a cross functional team.
Experience and Skills
- BS with a minimum of 8+ years, MS with a minimum of 6+ years, or PhD with minimum of 2+ years of industry experience in bioprocess development and/or manufacturing sciences
- Degree in Molecular Biology, Biotechnology, Bioengineering, Chemical Engineering or a related scientific field
- Experience in process development (late-phase preferred) and process technology transfer for large biomolecules using QbD principles
- Experience in nucleic acids (RNA/DNA) to support process development of RNA therapeutic candidates
- Experience in the large molecule regulatory environment, particularly FDA/ICH/ISPE guidelines on risk management, technology transfer and process validation
- Exceptional leadership, prioritization and project management skills
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.
- Bending, standing, walking, lifting, sitting, carrying, stooping, crouching, kneeling repetitive motions typing- filing - writing
- Ability to lift and carry 25 pounds
- Travel <10%
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 REQUIREMENTS
- 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.