We’re pleased to share an exciting secondment opportunity at AskBio.
This role is available for a time period to be determined by leadership at both Bayer and AskBio. While most assignments range from one to two years, the exact duration will be based on business needs and mutual agreement.
This secondment offers a unique chance to broaden your experience, expand your knowledge, and contribute meaningfully to AskBio’s mission: to advance gene therapy and change the lives of patients around the world.
If you’re interested in exploring this opportunity, we encourage you to:
Speak with your direct manager to discuss your interest and alignment with your development goals.
Apply directly using the link provided in the posting.
We look forward to seeing how our colleagues continue to grow and make an impact across the Bayer-AskBio partnership.
Our vision: Pioneering science to create transformative molecular medicines.
Our mission: Lead innovative science and drive clinical outcomes to transform people's lives.
Our principles:
Advance innovative science by pushing boundaries.
Bring transformative therapeutics to patients in need.
Provide an environment for employees to reach their fullest potential.
Our values:
Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.
Position Summary
The Analytical Lab Operations Specialist II will be responsible for supporting lab operations within the Quality Control and Analytical Development laboratories. This includes management of materials, equipment, third party vendors, budget, documents, and quality events.
This position is based on site in Durham, NC and will report to the Lab Operations Manager.
Job Responsibilities
Perform tasks associated with maintaining GMP-compliant quality control, analytical development, and stability laboratories as it pertains to sample management, equipment maintenance, material inventory, and other general lab operations needs
Perform sample management tasks (shipment, receipt, storage) in accordance with applicable regulatory requirements and Standard Operating Procedures (SOPs)
Schedule equipment maintenance and repair activities and capture documentation of services in the Computer Maintenance Management System (CMMS) in accordance with applicable regulatory requirements and Standard Operating Procedures (SOPs)
Support management and execution of Operational and Capital Expenditure budgets for Quality Control and Analytical Development Labs
Support initiation, review, and maintenance of contracts related to Quality Control and Analytical Development lab operations with Legal and IP departments in accordance with applicable regulatory requirements and Standard Operating Procedures (SOPs)
Act as Single Point of Contact with Third Party vendors, Project Managers, Material Depots and Producers, Material Shippers, and Analytical Development Project Leads to coordinate shipment and receipt of samples and other lab reagents and materials
Own, initiate, and author deviations, CAPAs, and Change Controls related to all GMP operations and processes
Author new SOPs and revise existing SOPs as needed
Support continuous improvement of lab operations procedures by independently identifying process gaps
Participate in data review processes to ensure accuracy and completeness of information
Interact with regulatory agencies as the subject matter expert for lab operations related inquiries, including sample management, equipment management and maintenance, and reagent and consumable inventory management
Strictly adhere to all applicable written SOPs, company policies, and technical guidance documents, both internal and external
Minimum Requirements
Bachelor’s degree and minimum 2 years of relevant industry experience
Experience in regulated GMP laboratory within the pharmaceutical or biotech industry
Experience independently owning and authoring GMP quality events (i.e. deviations, CAPAs, change controls, etc.)
Strong technical writing skills
Ability to handle multiple projects/teams simultaneously
Ability to work independently in a fast-paced, highly interactive environment with minimal supervision
Excellent verbal and written communication skills
Ability to build open and collaborative relationships and work effectively as a member of a multi-disciplinary team
Excellent self-organization skills with ability to envisage/design/implement organizational systems to improve efficiency and function of working teams
Preferred Education, Experience and Skills
Experience and familiarity with LabVantage LIMS
Experience with CMMS for equipment maintenance and management
AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at
talent@askbio.com
.