Lead Specialist in Bio-Pharmaceutical Manufacturing
1 week ago
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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Indianapolis, Indiana, United States Tunnell Consulting Full timeJob OverviewTunnell Consulting is a distinguished, employee-owned firm specializing in life sciences management consulting. We are recognized for addressing intricate challenges within the life sciences sector, aiding various organizations such as biotech firms, pharmaceutical companies, government entities, foundations, public/private partnerships,...
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