ImmPACT Bio USA, Inc., is a clinical-stage company dedicated to the discovery of transformative chimeric antigen receptor (CAR) T-cell therapies that address key biological challenges in treating cancer and autoimmune diseases. The company's logic-gate-based CAR T-cell platforms, licensed from University of California, Los Angeles (UCLA) Technology Development Group, are specifically designed to deplete B cells, prevent antigen escape, and overcome the immunosuppressive tumor microenvironment. The company's technology is based on the work of pioneering scientists Yvonne Chen, Ph.D., and Antoni Ribas, M.D., Ph.D., both from UCLA. ImmPACT Bio is looking for an experienced GMP Documentation Specialist contractor that would be responsible for performing a wide variety of activities in support of final disposition for cell therapy products. The candidate would be responsible for the support of manufacturing documentation with a primary focus of owning manufacturing deviation investigations. 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. This position will be located at our clinical manufacturing facility in West Hills, CA and reports to the Supervisor, GMP Support.Primary Responsibilities:
- Author manufacturing deviations by applying technical, quality, and collaborative skills to conduct through investigations.
- Utilize different RCA methodologies to determine root causes and create effective CAPAs accordingly.
- Perform change control activities including strategizing changes and assessing impact with cross functional department input.
- Manage change control tasks for change control implementation and closure.
- Write, edit, and review of controlled documents to ensure documents comply with applicable process and regulatory requirements.
- Develop and monitor metrics for manufacturing documentation including SOPS, forms, deviations, CAPAs, and change control status.
- Support clinical production by receiving manufacturing batch records, reviewing logbooks for accuracy, completeness, good documentation practices, and compliance to cGMP and company procedures.
- Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to cell therapy, as well as technical understanding/problem solving capability.
- Participate in regular site and Quality/Manufacturing meetings.
- Participate in audits and regulatory inspections as assigned.
- Other duties as assigned.
Basic Qualifications:
- Bachelor's degree in Biological Science, Chemistry, or related scientific or technical field.
- 2-4 years of experience in the biopharmaceutical/pharmaceutical industry.
- Good knowledge of biologics cGMP manufacturing ideally including recombinant protein and cell therapy cGMP manufacturing.
- Strong verbal, written, and interpersonal communication skills.
- Proficiency in computer use, Microsoft Office applications, and Veeva.
- Proven ability to work independently and analyze and resolve issues that may 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.
- Exceptional organization and time-management skills. Ability to deliver under deadlines.
Worksite Location:
Travel Requirements:
- Up to 15% travel.
- Willingness to travel domestically and internationally for business meetings and scientific conferences.
At ImmPACT Bio we embrace transparency in our total rewards pay and benefits program and philosophy. We believe in offering and maintaining competitive compensation and benefits programs for our employees to attract and retain a talented, highly engaged workforce. Our compensation programs are focused on fair and equitable pay practices including market based and data supported base pay, an annual performance-based bonus plan, and equity grants (ISO) for new employees. Compensation for the role will depend on several factors, including a candidate's qualifications, skills, competencies, and experience. Salary Range$40-$50 USDImmPACT Bio provides a generous Total Rewards package, to include a competitive base salary, bonus, and equity package as well as generous benefits and paid time off programs. ImmPACT Bio is an Equal Opportunity Employer and will review all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. All information will be kept confidential according to EEO guidelines.