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 provide technical leadership on mRNA delivery using various technologies.
ESSENTIAL JOB FUNCTIONS
- formulation development team in support of building the world’s first continuous mRNA RTRT production line.
- Hands-on experience in early-stage pre-clinical formulations development of lipid nanoparticles (LNP), polymer micro/nano particles for delivering peptides, nucleic acids, and small molecules.
- Responsible for the scale up and process development of LNPs, polymer micro/nano particle, etc.
- Experience in formulation development of parenteral dosage forms.
- Author/review internal development reports
- Provide project progress updates/reports to manager to ensure management is engaged and aware of the project strategy, current activities, and future needs.
- Serve as subject matter expert and contribute to complex/multiple projects or functional areas through leading others.
- Key contributor to the implementation of drug product continuous processing by delivering critical experiments in the optimization and process understanding of individual, process unit operations and applying learnings to the continuous manufacturing skid.
- Analyze process data to identify normal process variation and identify areas for continual improvement
- Provide technical expertise in the operation of the continuous manufacturing skid and support delivery of drug product manufacturing campaigns.
- Provide technical leadership in conducting experimental troubleshooting.
- Collaborate with multiple Chemistry, Manufacturing, & Controls (CMC) project teams to define and execute a formulation design and process understanding strategy to ensure a successful launch of continuous processing drug products.
- Contribute to regulatory documentation in support of the global regulatory acceptance and approval of continuous processing drug products.
- Write technical reports and/or presentations relevant to drug product continuous processing activities and present to senior management levels.
Supervisory Responsibilities
- Yes. May oversee, manage, and provide guidance to the activities of lower-level team members.
Experience and Skills
- PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 3+ years relevant industry experience.
- Experience in CMC pharmaceutical development for drug products under cGMP's.
- Technical expertise in development of nucleic acids and peptides using non-viral delivery methods.
- Experience and demonstrated track record in several drug product development activities such as early formulation development, formulation characterization, manufacturing process development, tech transfer, scale up and validation.
- Demonstrated experience desirable in one or more formulation and process development including solubilization, polymer/lipid nanoparticles, encapsulation, liquid fill/finish and aseptic processing.
- Knowledge of common analytical techniques and nano/micro particle analysis.
- Experience with process analytical technologies, process modelling, or continuous manufacturing a plus.
- Well versed with statistical design and analysis.
- Communicate with senior management; technical writing skills to support authorship and approval of internal technical documents.
- Knowledge of common analytical techniques and nano/micro particle analysis.
- Strong background in physical chemistry and good understanding of material properties
- Proven experience managing the scale-up and manufacturing of parenteral oral dosage forms
- Proven ability to apply the principles of the basic sciences, such as physical and organic chemistry, thermodynamics, and materials science, to pre-formulation and formulation development, using a rational, scientific approach
- A history of success working in environments defined by innovation and initiative
- Ability to work effectively and comfortably in a multi-disciplinary team under defined timelines
- Excellent leadership, teamwork and organizational skills
- Broad perspective and a deep knowledge of related disciplines and possesses diverse project experience and a broad knowledge of relevant literature and regulatory compliance
- Understanding of QbD and experience with regulatory filings is a plus
- Experience with a range of dosage forms, including liquids, solids and oral. Experience with formulation development of poorly soluble compounds would be advantageous
- Experience with process analytical technologies, process modelling, or continuous manufacturing a plus.
- Well versed with statistical design and analysis.
- Communicate with senior management; technical writing skills to support authorship and approval of internal technical documents.
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.
