Arranta Bio is a rapidly growing and dynamic bio-pharmaceutical contract development and manufacturing organization (CDMO). Our vision is to be the best in class CDMO providing development and GMP manufacturing services to microbiome innovators within the pharmaceutical industry. Therapies focused on the human microbiome are exhibiting incredible potential towards revolutionizing disease etiology and associated medical treatments. Arranta Bio’s mission is to build a world class organization which provides microbiome bio-pharmaceutical innovators with a single source of supply from early process development through clinical and commercial GMP finished product.
WHO ARE WE
Arranta 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 Arranta Bio, we embrace ALIVE – our core values that we live and breathe daily! We are Agile, Leading, Innovating, Value Creating, and Engaging.
We embrace our challenges as opportunities.
We are empowered to think and act.
We never settle; we strive to improve through purposeful creativity.
We build aligned teams who learn, grow, and deliver.
We are committed to building strong relationships.
Are you ready to come ALIVE with a daring and intrepid team? Don’t wait another minute; Apply today!
The Scientist will identify and implement the Analytical Development methodologies employed for both 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 FUNCTIONS
• 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, etc. in order to characterize a diverse microbial product portfolio.
• 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 or
- Master’s degree in Bio-process Engineering or Bioscience with a minimum of 5 years of industry experience,
- or a PhD degree with a minimum of 3 years of industry 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.
- Ability to independently design experiments, analyze complex data and interpret and present experimental results is required.
- 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.
- Excellent verbal and written communications skills are required.
- Ability to multitask, strategically and tactically
- Strong organizational skills; able to prioritize and manage through complex processes/projects
- Will interpret and carry out an extensive variety of technical instructions in written, oral, schedule, mathematical or diagram form
- Ability to define problems, collect data, establish facts and draw valid conclusions
- 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 occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.
- The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
- Specific vision abilities required by this job include close vision, and ability to adjust focus.
- In the performance of the duties of this job the employee is not required to travel
- The employee will be required to communicate using telephone and e-mail.
- Phone reimbursement policy for qualified individuals
- Free parking
- Highly competitive healthcare with many plan options:
- Medical (HMO/PPO/EPO)
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Up to 10 weeks of 100% paid maternity leave
- 2 weeks of 100% paid paternity, domestic partner, & adoption leave
- Educational assistance program
- 401k (traditional and Roth offered) with 100% match on first 5% deferred.
- A suite of Arranta Bio paid insurance coverage, including life insurance, short-term and long-term disability
- Voluntary legal assistance plan
- Employee Referral program
- Competitive PTO plan, in addition to 10 company paid holidays (includes 2 floating holidays)