Analytical Development Associate
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 Analytical Development associate will primarily be responsible for supporting analytical methodology evaluations and implementation (qualification) for use in routine QC testing. This highly motivated member of the Quality Unit will support the organization through the execution of activities such as CFU (potency testing), Microscopic characterization, and molecular method platform evaluations to support the assay transfer process to the QC lab for release testing. This AD team member will be responsible for initiating and assisting in qualification studies and technical writing activities while adhering to cGMP and GDP practices.
ESSENTIAL JOB FUNCTIONS
- Actively participates in fostering a positive, collaborative work culture
- Authoring and revision of standard operating procedures, test methods, protocols, and reports
- Participate in execution of method qualifications, technical transfers, release testing, and method validations
- Testing of material utilizing methods such as CFU, TCC, VCC, % Viability, growth kinetics, qPCR, Karl Fischer, bacterial enumeration, and bioburden
- Data analysis and review
- Perform equipment calibrations and analysis of cell viability
- Execute method and equipment troubleshooting and optimization, as needed
- Maintain documentation in accordance with GDP
- Other duties as assigned
Experience and Skills
EDUCATION AND/ OR EXPERIENCE
- B.S. degree in science or a life science-related field of study
- 3+ years of experience in Quality Control in GMP environment, preferably with experience in a microbiology laboratory
- Proficiency in cell culture of microbiological organisms, operation of microscopes, and equipment calibrations (e.g. pH meters and balances)
- Strong technical laboratory skills (e.g. pipetting, weighing, and measuring pH)
- Experience with writing standard operating procedures and qualification protocols and reports
- Familiarity with FDA, ICH, and EU Regulations and Guidelines
- Involvement in continuous improvement initiatives and laboratory investigations
- Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO) experience desirable
- Proficiency in Microsoft Office suite applications
- Strong organizational and analytical skills; able to prioritize and manage through multiple complex processes/projects
- Ability to define problems, collect data, establish facts, and draw valid conclusions
- Detail-oriented and highly motivated with excellent written and verbal communication skills required.
- Ability to work independently and stay on task in a fast-paced environment without direct supervision.
- Ability to function in a rapidly changing environment and balance multiple priorities simultaneously.
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%
- This is a laboratory-based position that may require some non-standard working hours including early mornings or later evenings on weekdays and weekends to support global prospective and current clients
- 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)