Senior Manager, QC Technical Operations

ElevateBio; Pittsburgh (Allegheny County); On-site; USD 90,000 - 130,000; Full time

Job summary

ElevateBio is seeking an experienced Quality Control professional for our Pittsburgh facility to drive startup plans and establish QC operations. You will collaborate with MSAT and internal experts to implement procedural changes, digital systems, and business processes aligned to a defined project plan.

The role will help establish a microbiology function, support laboratory start-up, and eventually oversee QC docs, training, investigations, and outsourcing logistics in a GMP environment.

Qualifications

• 8+ years in GMP manufacturing with leadership experience.
• Experience with clean room qualification per ISO 14644.
• Experience with gene and cell therapy test methodologies (qPCR/ddPCR, Flow Cytometry, ELISA).

Responsibilities

• Own quality control procedure revisions to reflect desired business processes.
• Partner with MSAT on plans for initial tech transfer support and program onboarding.
• Assist in development, implementation, and maintenance of laboratory systems in compliance with applicable GMP practices and regulations.
• Support planning and implementation of site training program and implementation of EM and aseptic programs
• Review, trend and present data to senior management
• Oversee laboratory excursions, including; deviations, OOS, OOT and atypical investigations
• Participate in regulatory inspections and facility audits
• Hire, train and mentor staff

Skills

Team leadership

GMP knowledge

Quality systems

Regulatory inspections

Education

Bachelor's degree

Master's degree

PhD

Tools

LIMS

CMMS

QMS

ERP

Job description

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.

The Role

ElevateBio is looking for an outstanding candidate to represent Quality Control in our Pittsburgh facility. Initially, this role will be focused on execution of the Quality Control site startup plan and associated projects needed to prepare our new facility for clinical and commercial manufacturing for US and EU markets. You'll work collaboratively with the core team, internal subject matter experts, and external project team members to develop and implement procedural changes, digital systems, and business processes at the site according to a defined project plan. This role will also assist with establishing the microbiology function in Pittsburgh to support laboratory/clean room start-up and qualification. In operation, the position will transition to oversight of quality control functions including but not limited to documents, training, metrics, investigations, functional projects, and logistics/outsourcing and may support on-floor lab operations as needed to meet business goals. Candidates should have extensive experience in a GMP manufacturing facility. This role is based on site in Pittsburgh.

Here's What You'll Do

• Own quality control procedure revisions to reflect desired business processes. Support/review other functional documentation including protocols and reports.
• Partner with MSAT on plans for initial tech transfer support and program onboarding
• Assist in development, implementation, and maintenance of laboratory systems in compliance with applicable GMP practices and regulations.
• Support planning and implementation of site training program and implementation of EM and aseptic programs
• Review, trend and present data to senior management
• Oversee laboratory excursions, including; deviations, OOS, OOT and atypical investigations
• Participate in regulatory inspections and facility audits
• Hire, train and mentor staff

Requirements

• Bachelor's degree and at least 8 years of experience, OR Master's degree with 6 years of experience, OR PhD with at least 4 years of experience.
• Experience supervising teams of people.
• Experience with clean room qualification per ISO 14644
• Experience with compendial safety testing as well as rapid methodologies (BacT)
• Experience with gene and cell therapy test methodologies (qPCR/ddPCR, Flow Cytometry, ELISA, and cell-based assays).
• Experience working with electronic systems (LIMS, CMMS, QMS, ERP).
• Ability to communicate and work independently with scientific/technical personnel.
• Strong knowledge of GMP, SOPs, and quality system processes.
• Excellent organizational skills.
• Experience in cell and gene therapy manufacturing environment a plus
• Experience performing laboratory investigations

Physical and Environment Requirements

• Ability to stand, walk, bend and stretch for extended period of time
• Ability to lift 15-20 lbs
• Ability to push, pull, bend, kneel, twist and climb step ladders while wearing PPE.
• Ability to perform routine repetitive motions with use of arms, wrists and hands
• Ability to work nights, weekends, and holidays as needed to support business needs.

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.