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.
The Scientist will identify and implement the Analytical Development methodologies employed for RNA, Plasmid and Microbiome based platforms. Staying up to date with best practices and advancements in technology is anticipated and should result in creative and inspiring suggestions for alternative methodology and processes.
The Scientist will lead in solving complex problems by applying current best technical practices and be able to connect cross-functionally to leverage methodologies used in other fields as well as own. The Scientist will demonstrate a sense of urgency in the work while maintaining respect for best practices and an understanding for the importance and applicability of quality and controls in development activities.
The problem solving, data analysis and interpretation will be focused, data driven and result in thorough documentation and pointed technical reports suitable for executive management.
The Scientist will be well versed in internal and external best practices, lead internal and external projects, and be the technical expert in interactions with company colleagues. It is expected the Scientist will continuously improve operational effectiveness and participate actively in the recruitment of technical staff to maintain an effective level of technical ability for all business requirements.
ESSENTIAL JOB FUNCTION
- Plan and coordinate analytical development and tech transfer activities in a cGMP environment.
- Experiments and technology platforms will be designed and executed in order to meet the cGMP requirements of a Quality Control laboratory.
- 21CFR part 211 software implementation is a must.
- Direct and assist in the qualification of analytical methods and stability programs. Assays and platforms employed include qPCR, sequencing, MALDI-TOF, ELISA, Electrophoresis, LC, LC-MS, GC etc. in order to characterize diverse microbial, plasmid and RNA product portfolios.
- Direct and assist in developing novel methodologies or optimizing existing techniques.
- Analyze and interpret data collected by other team members and create reports and presentations.
- Ensure Analytical Development deliverables are met in a timely manner.
- Perform other duties as assigned by Head of Department
- Perform process monitoring, data analysis and data presentation in team meetings.
- Perform hands-on analytical development activities related to sequencing, stability indicating assays, release assays and characterization.
Experience and Skills
- B.S. degree with 6 years of assay development and validation experience
- Establish and maintain an understanding of current trends and emerging analytical technologies
- Develop robust assays for early/late-stage clinical development and commercial supply
- Design key experiments and execute key analytical assays
- Support tech transfer to internal Quality Control operations
- Author technical development reports, tech transfer documents
- Collaborates with Manufacturing, Quality, and external parties to successfully resolve deviations, investigations, change controls, etc.
- Mentor junior team members and support expansion of Analytical Development team
- Strong sense of responsibility, strong work ethic, self-motivated attitude and teamwork orientation is an absolute must.
- Ability to multitask, strategically and tactically
- Strong organizational skills; able to prioritize and manage through complex processes/projects
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.
- Employee will be required to move around the work site using pathways/ramps provided
- Communicating with others to exchange information
- Use of office equipment such as computers, telephones and filing systems will be required to fulfil duties
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!
- 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.
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.