Analytical Development Manager
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!
To continue our rapid growth, we are seeking a talented and highly motivated Analytical Development Manager to join our growing organization. This position is responsible for organizing and ensuring the successful implementation and validation of instruments and methods in the Analytical Development group. The ideal candidate will be an innovative leader with strong of experience in Analytical Development.
- Subject matter expert in CFU assays, Microscopy, qPCR, Sequencing, and general lab techniques related to the characterization of LBPs or biologics.
- Build and oversee team of AD Scientists through effective planning, mentoring, directing and coordination of Analytical Development activities.
- cGMP experience is required in order to effectively implement instrumentation and methodology for handoff to the Quality Control team.
- Oversee the scheduling of Analytical Development qualification and validation activities with client timelines in mind.
- Experience with Method Transfer is required. Technical writing skills are necessary.
- Anaerobic assay experience is a plus.
- Responsible for maintaining the integrity of work areas including maintenance and calibration of equipment, general work center safety and cleanliness in compliance with established Quality standards.
- Communicate and enforce laboratory quality requirements to all personnel working in the lab and ensure that they are completed per GMP requirements.
- Generate, revise, review specifications, SOPs, and other AD lab and testing documents
- Lead and facilitate initial and periodic training of AD Scientists to ensure adherence to laboratory practices, techniques, and GMP requirements
- Interact with auditors/clients during visits and tours
- Prepare and perform personnel evaluations and competency development and administer performance reviews.
Experience and Skills
EDUCATION AND/ OR EXPERIENCE
- B.S. or M.S. degree in a scientific field or related science discipline
- A minimum of 5-7 years related experience with biological products in a QC or Analytical Development lab
- A minimum of 1 year of supervisory experience.
- Experience with analytical methods
- Must have experience with cGMP and quality systems.
- Requires excellent written and oral communication skills.
- High attention to detail, excellent organizational skills and the ability to work on multiple projects with tight deadlines
- Demonstrated ability to work independently as well as a strong contributor in a cross functional team environment on complex projects.
- Skilled at analyzing data, summarizing results, and generating performance metrics to drive corrective actions
- Strong work ethic with ability to meet rapidly evolving and dynamic business priorities
- Possess the ability to proactively adapt to rapid changes in business priorities and foster teamwork among employees to maintain high quality standards
- Ability to drive functional, technical and operational excellence
- Ability to inspire and foster innovation, collaboration, transparency and team effectiveness
- Ability to manage timelines and coordinate work schedules of employees
- Direct supervisory experience strongly preferred
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.
- 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)