Analytical Lab Operations Specialist II

Asklepios BioPharmaceutical, Inc. (AskBio)•Durham, NC

2d•Onsite

About The Position

This role is a secondment opportunity at AskBio, available for a duration determined by leadership at both Bayer and AskBio, typically ranging from one to two years. This position offers a chance to broaden experience and contribute to AskBio’s mission of advancing gene therapy. The Analytical Lab Operations Specialist II will support lab operations within the Quality Control and Analytical Development laboratories, managing materials, equipment, third-party vendors, budget, documents, and quality events. The position is based on-site in Durham, NC, and reports to the Lab Operations Manager.

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.

Nice To Haves

Experience and familiarity with LabVantage LIMS.
Experience with CMMS for equipment maintenance and management.

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.