Lead Specialist in Bio-Pharmaceutical Manufacturing

1 week ago


Indianapolis, Indiana, United States Tunnell Consulting Full time
Job Overview

Tunnell Consulting is a prominent, employee-owned management consulting firm specializing in life sciences. We are recognized for addressing intricate challenges within the life sciences sector, assisting a diverse array of organizations including biotechnology firms, pharmaceutical companies, governmental bodies, foundations, public-private partnerships, investors, and emerging enterprises. Our extensive client base and the variety of issues we tackle provide our team with a continually expanding depth of experience, complementing our profound industry and functional expertise. Our headquarters is located in the Philadelphia area, with additional offices in Washington DC and Boston.

Position: Bio-Pharmaceutical Manufacturing Lead – Downstream

This role is designed for a professional with expertise in downstream manufacturing operations, particularly in viral vector production and analytics. The successful candidate will be responsible for:

  • Leading routine downstream manufacturing processes while adhering to established protocols and batch records.
  • Utilizing aseptic techniques and maintaining cleanroom standards.
  • Acting as the Downstream Subject Matter Expert (SME) and collaborating with various teams to ensure manufacturing feasibility.
  • Managing materials and ensuring that manufacturing areas are adequately stocked.
  • Assisting in the maintenance of laboratory equipment and supporting operational activities.
  • Creating and updating Standard Operating Procedures (SOPs) and batch records in collaboration with management and Quality Assurance.
  • Providing training and coaching to team members as needed.
  • Documenting processes meticulously and ensuring compliance with all safety regulations.
  • Engaging in troubleshooting manufacturing challenges and supporting continuous improvement initiatives.

Qualifications:

  • Bachelor's degree in Biology, Biochemistry, Molecular Biology, or a related field.
  • A minimum of two years of experience in a Good Manufacturing Practice (GMP) environment.
  • Experience with aseptic techniques and risk mitigation strategies.
  • Proficiency in scale clarification, chromatography, and TFF platforms.
  • Prior experience in cell and gene therapy manufacturing, particularly with viral vectors, is highly desirable.

Work Environment:

The role requires working in a BSL 2 environment with necessary personal protective equipment. Candidates should be prepared to operate around large machinery and typical utilities found in pharmaceutical facilities.

Physical Requirements:

  • Frequent standing, walking, and lifting of up to 25 pounds.
  • Occasional lifting of up to 50 pounds and the ability to perform tasks requiring close vision.

Tunnell Consulting is an Equal Opportunity / Affirmative Action employer. We do not discriminate based on race, color, religion, sex, national origin, age, disability, veteran status, or any other characteristic protected by law.



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