Analytical Development Senior Scientist
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!
Reporting directly to Head of Analytical Development the Bioassay Development Scientist will help develop and optimize analytical assays at Arranta Bio. The Scientist position is integral to the advancement of Arranta’s growing pipeline of bio-pharmaceutical customers and will execute highly technical operations. The ideal candidate will have a strong foundation in analytical development, excellent problem-solving skills, and be able to work with a high attention to detail in a fast-paced environment.
- 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.
- Author regulatory filing documents such as IND, IMPD, BLA.
- Setup/Maintain internal development lab and records.
- 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.
- Balance high quality science with embedding a zero tolerance safety culture
The individual selected for this role must be:
- Organized, conscientious and deadline driven.
- Team player.
- Very strong work ethic.
- Able to follow clear instructions.
- Attention to detail.
- Robust communication skills (oral and written).
- Flexible work hours.
Experience and Skills
- Masters or Ph.D. degree (preferably in Analytical Chemistry or Life Science) or equivalent work experience
- 5-10 years of analytical development experience
- Analytical sciences, cGMP compliance training, method development, qualification and validation experiences.
- Experience executing microbiological assays (i.e. CFU, microscopy, microbiological identification), molecular assays and/or biochemical assays is valuable
- Experience operating analytical instrumentation (i.e. flow cytometry, microscopy, etc.)
- Microbial analytical development experience preferred.
- Track record of developing technical assays/methods and SOPs
- Ability to design, communicate, and execute project plans within an aggressive timeline
- Experience achieving innovation on aggressive timelines while working in a regulated environment
- Excellent problem-solving skills and verbal and written communication skills
- A systematic approach to tasks and an inquisitive and creative mind
- Wide base of theoretical knowledge, preferably cross-functionally
- Ability to quickly interpret, digest, and apply researched methodologies and concepts
- Needs to be able to independently move between activities, as dictated by the essential functions and responsibilities of the position.
- Required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, crouch, or kneel.
- Ability to aseptically gown and/or sterile gown as needed and work within environmental clean rooms.
- Is frequently required to lift objects up to 25 pounds and use hands to handle, manipulate, and reach.
- While performing the duties of this job, the employee is required to read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
- 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)