Development Lab Manager Jobs in North Carolina (NOW HIRING)

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:

Position Summary

TheAnalytical Lab Operations Specialist II willbe responsibleforsupporting 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 withmaintainingGMP-compliant quality control, analytical development,and stability laboratoriesas it pertains to sample management, equipment maintenance, material inventory, and other general laboperationsneeds

• Perform sample management tasks(shipment, receipt, storage)in accordance withapplicable regulatory requirements and Standard Operating Procedures (SOPs)

• Schedule equipment maintenance and repair activitiesand capture documentation of services in the Computer Maintenance Management System (CMMS)inaccordance withapplicable 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 toQuality Control and Analytical Development lab operationswith Legal and IP departmentsin accordance withapplicable 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 Controlsrelated toall GMP operations and processes

• Authornew SOPsand reviseexistingSOPs as needed

• Support continuous improvement oflab operationsproceduresby independentlyidentifyingprocessgaps

• Participate in data review processes to ensure accuracy and completeness of information

• Interact with regulatory agencies as the subject matter expert forlab operationsrelatedinquiries, 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 jobrelated 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.