Landmark Bio translates groundbreaking research into life-changing medicines. We provide development, manufacturing, and regulatory capabilities to help early-stage life science innovators rapidly progress advanced therapies from bench to clinic. Launched in 2021, and based in Watertown, Mass. Landmark Bio is an unprecedented venture bringing together the best of industry, academia and research hospitals to accelerate life sciences innovation. A public benefit company, our work advances emerging technologies, demonstrates therapeutic potential, and improves human health.
We are seeking a highly motivated and team-oriented professional with entrepreneurial spirit to join our company! This is an exciting opportunity for a well-qualified candidate to join a rapidly growing company focused on turning today's cutting-edge research into tomorrow's breakthrough therapies.
The Senior Specialist, Technical Operations at Landmark Bio will be responsible for overseeing critical operational activities within our Good Manufacturing Practice (GMP) facility. This role will focus on detailed management of compliance-related tasks, process optimization, and ensuring operational excellence in accordance with industry standards.
Key Responsibilities · Manage daily operations within the Tech Ops Group, focusing on areas like CAPA (Corrective and Preventive Actions), deviation management, change control, and adherence to SOPs.
· Lead the investigation and resolution of deviations and CAPAs, ensuring thorough root cause analysis and effective preventive measures.
· Manage change control processes, including impact assessments and documentation updates.
· Conduct system impact assessments to ensure new or modified systems meet GMP standards.
· Perform and oversee data integrity assessments to safeguard the integrity of manufacturing and quality data.
· Maintain up-to-date SOPs, work instructions, and production records.
· Ensure all technical drawings and documentation are current, accurate, and compliant with GMP.
· Implement process improvements to enhance operational efficiency, product quality, and compliance.
· Work closely with cross-functional teams to integrate new technologies or methods into production processes.
· Develop training modules for CAPA, deviation handling, change control, and data integrity.
· Mentor team members on compliance requirements and operational best practices.
· Lead or participate in projects involving facility upgrades, process improvements, or new product introductions, ensuring compliance and operational readiness.
· Interact with Project Teams and cross-functional groups as they impact operations.
· Writes clear and concise work procedures.
· Tracks and manages department compliance, and other assigned key performance indicators (KPI).
Qualification · At least 10 years of experience in a GMP environment, with a focus on quality assurance or technical operations, and related regulatory, engineering, and construction techniques.
· Extensive experience in managing CAPA, deviation, change control, and document control systems.
· Deep knowledge of FDA regulations, cGMP, and pharmaceutical quality systems.
· Proficiency in project management and process improvement methodologies.
· Strong analytical skills for root cause analysis and system impact assessments.
· Excellent communication, organizational and presentation skills.
· General knowledge of other related trades.
· Well-versed in CMMS environments.
· Proficiency with MS Office applications.
· Experience working with little supervision.
· Ability to gown and gain entry to manufacturing areas.
Preferred Experience Experience working for a maintenance organization in a CGMP Biotech/Pharmaceutical manufacturing environment.
· Bachelor's or Master's degree.
· Experience working in SAP as an ERP and Asset Management systems.
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\nLandmark Bio is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.