Senior Specialist, Manufacturing GMP Investigations

ImmunityBio, Inc.•El Segundo, CA

1d•$45 - $49•Onsite

About The Position

The Senior Specialist, Manufacturing GMP Investigations is responsible for writing and owning quality records for GMP Manufacturing Operation activities in support of the release of product. This position provides a unique opportunity to make an immediate impact and lay the foundation for processes and procedures in a fast-paced dynamic environment.

Requirements

Bachelor’s degree in biological science, chemistry, engineering, or related science field required.
4+ years of experience in the pharmaceutical/biopharmaceutical industry required.
Experience with biologics cGMP manufacturing ideally including cell therapy cGMP manufacturing required.
Strong knowledge of biologics cGMP manufacturing ideally including cell therapy cGMP manufacturing.
Strong verbal, written, and interpersonal communication skills.
Proficiency in computer use and Microsoft Office applications.
Proven ability to work independently and analyze and resolve issues that impact quality.
Attention to detail with strong analytical and problem-solving skills.
Ability to operate in a fast-paced, multi-disciplinary industrial environment while managing multiple priorities.
Strong decision-making skills with the ability to balance quality/compliance/risk.
High level of businesses acumen and ability to work with all levels in the organization.
Exceptional organization and time-management skills with the ability to deliver under deadlines.

Nice To Haves

Facility and Engineering experience/knowledge preferred.

Responsibilities

Independently manage closure of deviations, ensuring disposition cycle timelines are met and patient supply is maintained.
Plan, organize, and prioritize multiple concurrent investigative assignments to ensure deadlines are met and that results are aligned with current business strategy.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Perform analytical, statistical and trending analyses on deviation data to support timely management review and proactive response and implementation of corrective actions.
Serve as the primary point of contact for applicable procedures and work instructions related to investigation process; collaborate with subject matter experts (SME’s) and senior management in cross functional departments to adequately evaluate risk and impact.
Prepare and present deviation trend data to stakeholders to ensure potential underlying trends are addressed.
Lead training for root cause analysis and/or product impact for new investigators.
Identify and lead continuous improvement opportunities to reduce repeat and/or recurring deviations.
Participate in regular site and Quality/Manufacturing meetings.
Participate in audits and regulatory inspections as assigned.
Perform ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities.

Benefits

Medical, Dental and Vision Plan Options
Health and Financial Wellness Programs
Employer Assistance Program (EAP)
Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
Healthcare and Dependent Care Flexible Spending Accounts
401(k) Retirement Plan with Company Match
529 Education Savings Program
Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
Paid Time Off (PTO) includes: 11 Holidays
Exempt Employees are eligible for Unlimited PTO
Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day