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Full-Time

Operations Performance Specialist

Confirmed live in the last 24 hours

CAI

CAI

1,001-5,000 employees

Consulting for operational readiness in healthcare

Consulting
Biotechnology
Healthcare

Compensation Overview

$87.1k - $94.6kAnnually

Mid, Senior

Baltimore, MD, USA

Category
Public Health
Biology Lab & Research
Biology & Biotech
Requirements
  • BS in a science or engineering field or equivalent years’ experience
  • 4+ years of experience in GMP Operations as Manufacturing Operator, Group Lead, Supervisor, and/or Manager
  • Experience in drug substance and/or drug product manufacturing including such systems/processes as Aseptic Filling lines, Lyophilizes, Depyrogenation, Vial Washer, Isolators, Bioreactors, AKTA skids, Fill skids, BSCs
  • Demonstrated experience in developing and/or continuous improvement in GMP on-floor operations, SOPs, Batch Records, and related processes / documentation
  • Demonstrated understanding of Good Documentation Practices
  • Lean practice education and experience is a plus
  • Superior oral and written communication skills in English, including communication with site supervision and management
  • Excellent oral and written communication skills in English
  • Able to travel domestically and internationally if required
  • Able to work (paid) overtime
  • Able to work in the US without sponsorship now or any time or in the future
Responsibilities
  • Delivering solutions such as process maps and workflows, procedures, training programs and content, and staffing plans to support the operational readiness of new or expanding biotech and pharmaceutical manufacturing sites.
  • Support operational improvement / excellence in existing manufacturing sites through GMP floor observation and/or coaching, process and performance improvement development and execution, and performance-based deviation investigation and risk control.
  • Active in creating industry-changing approaches that help guide clients and the broader industry toward higher performance.
  • Participating in professional societies to support industry improvement and expand CAI’s store of knowledge.

CAI Technical Consulting Malaysia SDN, under the brand cagents.com, offers consulting services focused on operational readiness for clients in the pharmaceutical, biotechnology, and healthcare sectors. They conduct operational readiness assessments to evaluate a company's preparedness and tailor their services accordingly, which include project planning and asset management. CAI stands out from competitors by emphasizing professional development and industry collaboration, ensuring their team stays updated on industry trends. Their goal is to help clients achieve operational excellence and readiness for full-scale production.

Company Stage

Pre-seed

Total Funding

$3.4M

Headquarters

Indianapolis, Indiana

Founded

1996

Growth & Insights
Headcount

6 month growth

-12%

1 year growth

-12%

2 year growth

-12%
Simplify Jobs

Simplify's Take

What believers are saying

  • The partnership with Fedegari Group could lead to significant advancements in sterilization technology, benefiting both CAI and its clients.
  • CAI's focus on operational readiness and compliance can help clients achieve smoother transitions to full-scale production, potentially reducing costs and increasing efficiency.
  • Active involvement in professional societies and industry webinars positions CAI as a thought leader, enhancing its reputation and attracting top talent.

What critics are saying

  • The highly specialized nature of CAI's services may limit its market to specific sectors, potentially constraining growth opportunities.
  • Dependence on partnerships, such as with Fedegari Group, could pose risks if these collaborations face challenges or fail to deliver expected outcomes.

What makes CAI unique

  • CAI's specialization in operational readiness for the pharmaceutical, biotechnology, and healthcare sectors sets it apart from more generalized consulting firms.
  • Their strategic partnership with Fedegari Group to deliver turnkey sterilization solutions enhances their service offerings and provides a unique value proposition.
  • CAI's emphasis on professional development and industry collaboration ensures they remain at the forefront of industry trends and best practices.

Benefits

100% Employee Owned

24 Days PTO/5 Sick days per year + Additional Holidays depending on Country

Medical / Dental / Vision (In accordance with each countries’ applicable regulations)

Professional Development (Approximately $5,000 paid career-related, continuing education)

ESOP/401k – 15% Company Contribution

Company Paid Long-Term Disability

Company Paid Life Insurance

Company Paid Parental Leave (In accordance with each countries’ applicable regulations)

Other Benefits Depending on Country