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 be responsible for the design, execution, and management of scientific studies in the development of both liquid and /or lyophilized drug product formulation to support product development.

ESSENTIAL JOB FUNCTIONS

  • Design, definition, and execution of scientific formulation activities of solid and liquid drug product presentations. Scientific Activities including, but not limited to:
  • Design and execute Quality by Design (QbD) and Design of Experiment (DOE) principles in drug product and process development experimentation.
  • Assay method development and validation including: AUC, CD, Fluorescence spectroscopy, DSC, ITC, UV/Vis spectroscopy, FTIR, SLS and HPLC.
  • Develop activities to evaluate formulations, processes, and equipment.
  • Design lyophilization cycle studies for drug product manufacturing.
  • Participate in all scientific development and scale-up activities of drug product processes from bench top to pilot scale and technology transfers. Activities including, but not limited to:
  • Review all formulation developed methods and protocols.
  • Discovery and selection of techniques to solve current formulation issues.
  • Participation in cross-functional product development team to provide scientific expertise.
  • Collaboration with other departments to identify equipment, conduct scale-up studies, and support existing products.
  • Participate in Process Development activities.
  • Support development of new technologies and enhanced technology capabilities applicable to formulation development and commercialization.
  • Lead scientific discussion and investigations for all drug substances and drug products being developed.
  • Provide expert guidance to formulate small and large scale lots of liquid, frozen or lyophilized drug candidates.
  • Review and evaluate developed lyophilization cycle processes to manufacture freeze-dried drug products.
  • Presentation of scientific findings internally and publicly.

Supervisory Responsibilities

  • Yes.  May oversee, manage, and provide guidance to the activities of lower-level team members.

Experience and Skills

  • Requires PhD in relevant field with 5 years relevant experience or a minimum of 10 years relevant experience with a Masters degree.
  • Direct experience in leading direct reports in scientific projects
  • Experience in formulation product development, Quality by Design (QbD), Design of Experiment (DOE) processes.
  • Direct experience and expertise in mRNA, characterization, evaluations and formulation development.
  • Direct experience and expertise in biologics, and/or vaccine drug product development
  • Direct experience and expertise in lyophilization cycle design, operations, and evaluation for freeze-drying drug products.
  • Direct experience in project leadership and grant management.
  • Significant experience in designing and initiating research projects.
  • Knowledge of aseptic manufacturing and fill/finish process related to liquid and solid formulation products.
  • Demonstrated expertise with bio/analytical and physicochemical characterizations of mRNA, including structure, stability, aggregation, and solubility is highly desirable.
  • Ability to work independently with strong problem-solving skills.
  • Ability to lead scientific group discussions and capture and execute action items concluded from said groups.
  • Strong technical writing skilled supported by scientific publication history.
  • Other duties as assigned
  •  

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.

 

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