Senior Specialist, Lead Investigator

Resilience; Olde West Chester (OH); On-site; USD 80,000 - 117,500; Full time

Benefits offered by this job

Annual bonus

401(k) with company match

Healthcare (medical, dental, vision)

Paid vacation and holidays

Job summary

Resilience is seeking a Senior Specialist, Lead Investigator to drive investigations from scope to closure in a fast-paced biomanufacturing setting. You will document root-cause, CAPA actions, and cross-functional collaboration to prevent deviations and ensure quality outcomes.

The role requires deep understanding of pharmaceutical manufacturing processes, cGMP practices, and strong communication skills to present findings clearly to stakeholders.

Qualifications

• Experience in pharmaceutical manufacturing or similar regulated industry.
• Familiarity with cGMP documentation practices and regulatory requirements.
• Ability to present findings and complex information clearly.
• Ability to manage multiple investigations with timelines.
• Excellent written, verbal, and presentation skills.
• Ability to work in fast-paced, changing environments.
• Ability to prioritize to meet deadlines.
• Ability to own issues through full investigation cycle.

Responsibilities

• Manage and execute investigations with defined scope, strategy, and timeline.
• Author investigation reports covering scope, product impact, root cause, and CAPA actions.
• Utilize approved tools to drive root cause analyses.
• Prioritize work to enable timely decisions and closure.
• Escalate issues when appropriate.
• Collaborate cross-functionally to determine communication strategy and action plan.
• Define investigation strategy, tools, and timing, and ensure timely CAPA effectiveness checks.

Skills

Investigation management

Root cause analysis

cGMP knowledge

Regulatory documentation

Written & verbal communication

Presentation skills

Lean problem-solving tools

Time management

Education

Bachelor’s degree in Science/Engineering

Tools

Lean problem-solving tools

Job description

Brief Job Description

A career at Resilience is more than just a job - it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com

The Senior Specialist, Lead Investigator is responsible for performing investigations and driving each event to conclusion by working with others. The Lead Investigator ensures the investigation outcome and root cause analysis are completed in a timely, effective, and compliant manner. The speed and rigor demonstrated by the Lead Investigator will drive a culture that prevents unplanned deviations through a robust and proactive investigation process.

Job Responsibilities

• Investigation Management & Execution Conducts organized investigations with a well-defined scope, strategy, and timeline, documenting status and progress of the investigation.
• Authors reports that document the investigation of issues, including definition, scope, product impact, root cause, and corrective actions to prevent the recurrence of the issue.
• Utilizes the appropriate and approved investigation tools necessary to drive the team to root cause.
• Prioritizes work to aid in timely decisions and completion of investigations.
• Escalates issues as appropriate.

Root Cause & Cross-Functional Collaboration

• Seeks and leverages the skills and technical expertise of internal and external resources to improve the speed and rigor of investigations.
• Collaborates with a cross-functional team to determine:
  • Communication strategy so all stakeholders have appropriate information.
  • Investigation strategy including a clear and actionable problem statement.
  • Investigation tools.
  • Investigation action plan and timing.
  • Root cause.
  • Solution selection.
  • CAPA action plan and effectiveness checks.

Minimum Qualifications

• Experience in Pharmaceutical Manufacturing and/or other similar regulated industry.
• Familiarity with cGMP documentation practices and applicable regulatory requirements.
• Ability to quickly assess and assimilate technical data and conduct a thorough investigation; ability to present findings, conclusions, and complex information in a clear, concise, and logical manner.
• Ability to manage multiple concurrent investigations, monitoring progress against objectives and timelines to drive timely closure.
• Excellent written, verbal, and presentation skills, including technical and investigation report writing.
• Ability to work in a fast-paced and rapidly changing environment.
• Ability to prioritize work activities to meet customer needs and deadlines.
• Ability to take accountability with excellent follow up and follow through; owns issues through the full cycle investigation process.
• Exercises independent judgment to advance investigations with minimal direction; coaches others and builds cross-functional alignment on root cause and corrective-action decisions.

Preferred Qualifications

• Bachelor’s degree, preferably in Science, Engineering, or other related technical discipline.
• Relevant work experience will be considered in lieu of a degree.
• 5+ years of experience in a pharmaceutical or other regulated manufacturing environment, including quality investigations and deviation management.
• Understanding of the internal core business processes.
• Adept at identifying and understanding the critical factors in order to generate appropriate solutions.
• Multiple site or function experience.
• Familiar with Lean problem-solving tools.

Physical & Work Environment

Work is performed in a combination of office, laboratory, and cGMP manufacturing environments.

Work Schedule: 8 hours - Monday- Friday

The work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments. This position may also include the following conditions: sitting, standing, walking, repetitive motion, and / or wearing personal protective equipment. The items described here are representative of those that must be met successfully to perform the essential functions of this job.

Sponsorship or support for work authorization, including visas, is not available for this position.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs.

Our target base pay hiring range for this position is $80,000.00 - $117,500.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience