Manager, Process Characterization

ABOUT US

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!

JOB SUMMARY

The individual will manage and oversee daily activities, goals and milestones of the process characterization of late-stage Microbiome or Live Biotherapeutics Product (LBP) manufacturing processes. He/she will design, perform, and interpret complex experiments in collaboration with other process development scientists. He/She will have an extensive understanding of bacterial and microbiology techniques with direct experience in the development and characterization of LBP therapies. The Manager will work collaboratively in a cross-functional manner and provide guidance for experimental design to further understanding of processes and impacts to drug product attributes.

ESSENTIAL JOB FUNCTIONS

• The individual will be a laboratory leader supervise for both the design and execution of complex small-scale experiments following a Quality by Design (QbD) approach

• Execute and document risk assessments to identify critical quality attributes (CQA)

• Support cross-functional efforts to develop a process control strategy including classification of critical process parameters that impact CQAs as well as the strategies for appropriate control of CQAs

• Generate Process Justification and Control Strategy documents

• Review and approve PVMP, PPQ protocols and reports

• Author process validation documents and technical reports detailing experimental work, and summarizing outcomes

• Author CMC regulatory submissions and contribute to scientific publications, as required

• Manage multiple junior scientists across multiple projects

• Define/maintain a safe work environment in accordance with policies/procedures/regulations

• Represent process development functions in cross-functional team forums

Experience and Skills

 • B.S. Degree in Biochemical Engineering, Biologics Sciences or other relevant major with 5+ years of progressive related industry experience. M.S. or Ph.D. preferred

• Hands-on experience designing and implementing multi-variate experiments to evaluate processes, analytical methods, or formulations related to late-phase biologics process characterization

• Late-phase tech transfer and process validation

• Analyzing, interpreting, compiling data, logical conclusions, recommendations & decision making

• Statistical design of experiments and data analysis

• Experience commercializing biologics 

• Fermentation experience

• Media screening experience

• Development of small scale model experience

• Harvest technology experience

• Anerobic microbial cultivation experience is plus

• Familiarity with Process Validation guidelines (ICH, PDA)

• Experience with quality risk assessment tools

• Possess advanced skills in experimental design (e.g. DOE), data analysis and presentation

• Familiarity with a Quality by Design (QbD) approach to process characterization activities as well as product lifecycle management

• Experience authoring scientific publications and CMC regulatory submissions

• Understanding of safe lab practices and BSL requirements

• Detail-oriented, organized, and technically competent Interpersonal and leadership skills to work with teams in different functions and organizations

• Strong engineering or scientific knowledge appropriate for cellular process development

PHYSICAL DEMANDS

· 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 25 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 required to travel occasionally, drive a motor vehicle.

· Communicate using telephone and e-mail.

BENEFITS

• Phone reimbursement policy for qualified individuals
• Free parking
• Highly competitive healthcare with many plan options:

• Medical (HMO/PPO/EPO)
• Dental
• vision

• 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)