Life At Xentria
Any business will have its days of dealing with the unknown: factors change, people must pivot, schedules don’t always go as planned. The question of culture becomes how people working together respond and adapt in the face of change, unpredictability and even adversity.
Xentria is a group of professionals with diverse talents yet similar minds in overcoming challenges. Achievement calls for swimming with the tide of transition rather than against it. We complete projects and goals by maintaining equal parts structure and flexibility in pursuing the desired outcome for patients. We also know and embrace that progress remains closer when team members are friendly, responsive and accessible to one another.
At Xentria, we can’t promise that one day will be just like the next – but we can ensure that whatever tomorrow brings, we’ll share the challenges and triumphs alike as a team.
Diversity & Inclusion
Located in the new Lincoln Yards development in Chicago, Xentria, Inc. is a biotech company focused on solving unmet clinical needs through meaningful patient engagement and novel scientific strategy.
We promote a culture of innovation, collaboration, inclusion and compassion. At all levels of the company, we are working to advance our diversity, equity, inclusion and accessibility (DEIA) practices.
This starts with company-wide DEIA learning and education and continues with encouraging an inclusive environment. We value diverse perspectives, experience and ideas and continually review our policies and procedures to ensure fair treatment of our employees, our patients and our community.
We are committed to developing therapeutics that will solve unmet patient needs. We strive to do this in a sustainable way by establishing a value-based culture with a focus on our people and our community. We know that our people are our greatest assets, and we are proud to support their involvement in community initiatives and volunteering.
Xentria, Inc. is committed to equal employment for all. In line with that commitment, Xentria provides equal employment opportunities to all employees and applicants without regard to race, color, religion, national origin, sex, age, disability and all other protections.
We strictly prohibit the harassment or discrimination of any employee or job candidate on the basis of race, color, religion, national origin, sex, age, disability or any other protected classes. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits and training. We make hiring decisions based solely on qualifications, merit and current business requirements.
We strive to offer a robust benefits program that meets the needs of each of our team members.
flexible work arrangements
annual performance-bonus opportunity
short and long-term disability
extensive health offerings including medical, dental, vision
paid time off (PTO)
401(k) retirement savings with employer contribution
paid parental leave
employee wellness resources
(11) company-paid holidays
life and AD&D insurance
onsite gym membership
The culture here is one of support and empowerment with a focus on employee life balance. Xentria values each and every employee and that is evident in all aspects of the business, from extensive benefit offerings to opportunities for both personal and professional development. Xentria truly cares about its employees as individuals and supports us in our endeavors in the office and in the community.
At Xentria, I get to work with really smart people who are experts in clinical research. I learn from them every day. But beyond the collective knowledge and creativity, I love the collaborative spirit at Xentria. Every role on the team is respected and every person is valued and encouraged to do their best work.
Director of CMC, Clinical Supply
Xentria is a patient-centric biotech company focused on development of novel biologics and biosimilars. Our first program is XT MAB 16, a monoclonal antibody for sarcoidosis. XT MAB 16 has received Orphan Drug Designation.
The Director, CMC and Clinical Supply will report to the Chief Operating Officer and be responsible for the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for partnered investigational biologic products. The Director manages preparation of CMC sections of regulatory submissions and provides guidance to cross-functional teams on CMC regulatory strategy and regional regulatory requirements. Director is a key interface as CMC subject matter with Contract Manufacturing Organization (CMO) for partnered biologics and biosimilars.
Essential Duties and Responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Provides strategic direction, develops and maintains the company’s Quality Assurance Management System (QMS).
- Responsible for developing, leading, and implementing global regulatory CMC strategies for partnered biologic investigational products and biosimilars in line with business objectives, and in coordination with key internal stakeholders
- Manage deliverables for multiple CDMOs and ensure that CDMOs meet the technical requirements and deliverables they are contractually committed to meet (e.g., process development, process characterization, tech transfer, cGMP productions, etc.) and adhere to specified timelines
- Provide strategic direction for scale up and clinical supply management vendor to successfully support early and late-stage clinical trials.
- Work closely with QA, the EU QP, and other stakeholders to refine CMC strategy on a global basis
- •Conduct product and process risk assessments based on QbD principles
- Translate clinical study requirements into demand and supply of drug product to ensure a timely study start and uninterrupted global clinical supply.
- Manage clinical trial materials inventory at multiple study depots, and work closely with clinical operations team to ensure sufficient inventory at clinical sites.
- Develop budget and timing forecast for clinical packaging, labeling, and distribution.
- Manage procurement of comparator or commercial products to support clinical trials, as needed.
- Serve as the primary point of contact for all supply chain activities, internally and externally to clinical supply vendors.
No direct reports associated at this time.
- Organizational skills
- Problem Solving
Education and / or Experience Required
- Bachelor's degree in Chemistry or other Scientific discipline.
- Advance degree preferred.
- Minimum of 10 years of experience in the pharmaceutical R&D industry, of which a minimum 8 years should be oversight of CMO and investigational biologic product development and CMC life-cycle management; experience in orphan drugs desired.
Ability to travel up to 20% (domestic and international)
Microsoft Word, PowerPoint, Excel, TrackWise Digital preferred but not required
While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 20 pounds.
The noise level in the work environment is usually moderate.
AAP/ EEO Statement
Equal Opportunity Employer Minorities/Women/Veterans/Disabled.