Bio-Pharma Manufacturing Lead
4 weeks ago
Tunnell Consulting is an employee-owned, life sciences management consulting firm. Known for solving complex problems in the life sciences, we support the mission and objectives of a variety organizations including biotech, pharma, the U.S. Government, foundations, public/private partnerships, investors, and emerging companies. The variety of clients and issues that we support give our team and our organization an ever-increasing breadth of experience to add to our deep industry and functional expertise. Headquartered in the Philadelphia area, we also have a presence in Washington DC, and Boston.
The staffing division of Tunnell Consulting, looks for top talent on behalf of our Pharmaceutical/Biotech clients. Currently, one of our client's need a Bio-Pharma Manufacturing Lead. This is a 3-6 month contract onsite with temp to perm opportunity in the Greater Indianapolis, IN area. Local candidates only.
Title: Bio-Pharma Manufacturing Lead – Downstream
Role: Lead routine performance of downstream manufacturing operations focused on viral vector production and analytics. Key responsibilities include using aseptic techniques, preparing solutions and media, performing molecular biology and cell culture techniques, and maintaining cleanroom standards. The role involves working independently, acting as the Downstream Subject Matter Expert (SME) for client processes, and working under the supervision of the Manufacturing Manager.
Responsibilities: Act as the lead Downstream operator, coordinating team responsibilities and handling manufacturing processes for viral vector production following established procedures and batch records. Key tasks include:
• Leading team activities in clarification, chromatography, TFF, and filling.
• Collaborating with Downstream Process Development experts to ensure processes are feasible for GMP manufacturing.
• Managing materials to keep manufacturing areas well-stocked and ready.
• Assisting with laboratory equipment maintenance and support operations.
• Creating, reviewing, and updating SOPs, batch records, and forms with management, Process Development, and Quality Assurance.
• Clarifying roles and responsibilities for operators and providing coaching/training as needed.
• Following detailed instructions with strong attention to detail and completing documentation on time.
• Keeping training up to date and maintaining lab spaces and equipment.
• Troubleshooting manufacturing issues with help from Manufacturing Management when necessary.
• Training new employees on downstream manufacturing processes.
• Complying with all policies and SOPs and performing safety inspections to maintain a safe work environment.
• Using industrial equipment like pallet jacks, performing area sanitization, and managing waste disposal according to procedures.
• Collecting process data for metrics and supporting GMP product optimization and improvements.
• Assisting with specification development and reviews via CAPA and change controls.
• Collaborating with Process Development, Quality Assurance, and other departments as required.
• Assist in tasks required to be performed in a BSL-1, -2 or -3 environment.
• Being adaptable to changing work schedules based on business needs.
• Criminal background check as required.
• Performing additional duties as assigned.
Education/Experience:
• BS degree in Biology, Biochemistry, Molecular Biology or similar field.
• Minimum 2 years of post-graduation experience in a GMP environment.
• 2 years experience operating in a GMP laboratory using aseptic, technique and risk mitigation strategies.
• 2 years experience with scale Clarification, Chromatography and TFF platforms.
• Experience in cell and gene therapy DS/DP manufacturing specifically viral vectors highly desired.
Work Environment:
• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning.
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities.
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock.
• Occasionally exposed to extremely loud noise levels.
Movement:
• Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms.
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.
• Frequently lift and/or move up to 25 pounds.
• Occasionally lift and/or move up to 50 pounds.
• Frequently utilize close vision and the ability to adjust focus.
Communication:
• Frequently required to communicate by talking, hearing, using telephone and e-mail.
Tunnell is proud to be an Equal Opportunity / Affirmative Action / Female / Minority / Disabled / Veteran Employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy, child-birth, or related medical conditions), national origin, ancestry, age, disability, family care status, veteran status, marital status, military status, sexual orientation, gender identity, or any other characteristic protected by law. Tunnell makes reasonable accommodation for persons with disabilities to apply for employment.
Please be advised that Tunnell resources are required to comply with all client COVID-19 requirements. This may include a requirement to be fully vaccinated against COVID-19, in accordance with the CDC guidelines and subject to legal requirements. Please contact Tunnell's Human Resources department if you would like to discuss any questions or concerns.
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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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Indianapolis, Indiana, United States Tunnell Consulting Full timeJob OverviewTunnell 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...
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