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Biotech Strategy Consulting Jobs in Ohio (NOW HIRING)

WuXi Biologics Group

$100 - $130/hr

Knowledge/Experience * 5-7+ years in strategy consulting, market intelligence, competitive analysis, or GTM strategy (biotech or B2B preferred). * Global experience or interest in working with ...

New

Mix Talent

Associate Recruiter

Columbus, OH · On-site

$42K - $51K/yr

A strong foundation in consultative recruiting and talent strategy * Exposure to high-level client interactions and decision-making * A network of professionals across the biotech and pharmaceutical ...

Mix Talent LLC

Associate Recruiter

Columbus, OH

$42K - $51K/yr

A strong foundation in consultative recruiting and talent strategy * Exposure to high-level client interactions and decision-making * A network of professionals across the biotech and pharmaceutical ...

Aptean

$74 - $135/hr

Prepare and deliver tailored software demonstrations, Executive Briefings and strategic ... Typically 3 to 5 years of experience in solutions consulting, pre-sales, consulting, supply chain ...

New

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Biotech Strategy Consulting information

What are the key skills and qualifications needed to thrive as a biotech strategy consultant, and why are they important?

To thrive as a Biotech Strategy Consultant, you need a strong background in life sciences or biotechnology, analytical acumen, and often an advanced degree such as a PhD, MBA, or related field. Familiarity with market analysis tools, data analytics software, and regulatory databases is typically required, along with experience using presentation and project management platforms. Outstanding communication, critical thinking, and client management skills help you build trust and deliver actionable insights in high-stakes environments. These competencies are crucial to drive evidence-based recommendations, support strategic decision-making, and ensure client success in a complex, rapidly evolving industry.

How do biotech strategy consultants typically collaborate with clients and internal teams during a project?

Biotech strategy consultants work closely with client stakeholders—often executives or R&D leaders—to deeply understand their business objectives and challenges. Collaboration involves frequent meetings, workshops, and data-sharing sessions to align on project goals and validate findings. Internally, consultants engage with multidisciplinary teams, including analysts, scientists, and industry experts, to synthesize research, develop strategic recommendations, and ensure deliverables are both actionable and tailored to client needs. This collaborative approach helps ensure that strategies are grounded in real-world data and are feasible for implementation.

What is biotech strategy consulting?

Biotech strategy consulting involves providing expert advice to biotechnology companies on business strategy, market entry, product development, regulatory pathways, and commercial operations. Consultants in this field help organizations navigate complex scientific, regulatory, and competitive landscapes to make informed decisions and maximize growth. They often conduct market analysis, develop strategic plans, and support mergers, acquisitions, or partnerships. The goal is to help biotech firms achieve their business objectives and bring innovative products to market efficiently.

What is the difference between Biotech Strategy Consulting vs Biotech Business Development?

AspectBiotech Strategy ConsultingBiotech Business Development
Required CredentialsAdvanced degree (MBA, PhD), consulting experienceBusiness or science degree, sales or marketing experience
Work EnvironmentConsulting firms, client offices, project-basedBiotech companies, startups, sales teams
Employer & Industry UsageConsulting firms, pharma, biotechBiotech firms, pharma companies, startups
Common Search & Comparison IntentUnderstanding consulting roles in biotechUnderstanding business development roles in biotech

Biotech Strategy Consulting focuses on advising biotech companies on market entry, product strategy, and competitive positioning, often working in consulting firms or as independent advisors. Biotech Business Development involves identifying partnership opportunities, licensing deals, and expanding market reach within biotech companies. While both roles require industry knowledge, strategy consulting emphasizes analysis and recommendations, whereas business development centers on deal-making and relationship building.

Does biotech strategy consulting pay well?

Biotech strategy consulting typically offers competitive salaries that are higher than average for management consulting roles, often ranging from $80,000 to over $150,000 annually depending on experience and location. Professionals in this field benefit from bonuses, profit sharing, and opportunities for advancement, with strong demand for expertise in biotech markets and strategic analysis tools like financial modeling and industry research.
What are popular job titles related to Biotech Strategy Consulting jobs in Ohio? For Biotech Strategy Consulting jobs in Ohio, the most frequently searched job titles are:
What job categories do people searching Biotech Strategy Consulting jobs in Ohio look for? The top searched job categories for Biotech Strategy Consulting jobs in Ohio are:
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Biotech Strategy Consulting jobs near you

Senior Validation SME - Aseptic Process Simulation

Tunnell Consulting

Columbus, OH

Contractor

Posted 17 days ago

Job description

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.

Tunnell Consulting, looks for top consultants on behalf of our Pharmaceutical/Biotech clients. Currently, one of our client's needs a Senior Validation SME - Aseptic Process Simulation. This is a 3-6 month contract role. Work to be performed Onsite. Client is based in the Greater Columbus, OH area.

Title: Senior Validation SME – Aseptic Process Simulation

The Senior Validation SME is responsible for improving the company's Aseptic Process Simulation (APS), or Media Fill, program. This role develops and manages strategies, validation plans, and testing methods to ensure sterile manufacturing processes consistently meet regulatory and quality requirements.

The position works closely with Manufacturing, Quality Assurance, Engineering, Microbiology, and other teams to plan, execute, analyze, and continuously improve media fill studies. The specialist also serves as the primary contact for regulatory agencies regarding aseptic process simulation activities.

Additionally, the role supports process validation programs to ensure manufacturing processes are reliable, compliant, and capable of consistently producing high-quality products.

Key Responsibilities

  • Develop and maintain the overall Media Fill (APS) strategy, including risk-based worst-case scenarios.
  • Define simulation requirements and interventions based on regulatory expectations and industry standards.
  • Plan, oversee, and document media fill studies from start to finish.
  • Investigate deviations, perform root cause analyses, and initiate corrective actions or revalidation when necessary.
  • Partner with Manufacturing, Quality Assurance, Engineering, MS&T, Microbiology, and Quality Control teams.
  • Incorporate Environmental Monitoring (EM) data into the APS program.
  • Ensure validation activities comply with GMP requirements and global regulations.
  • Support audits, inspections, regulatory submissions, and responses to health authorities.
  • Develop and manage Process Performance Qualification (PPQ) and Continued Process Validation (CPV) programs.
  • Create and maintain validation procedures, protocols, reports, templates, and work instructions.
  • Perform hands-on validation work, including protocol writing, execution, data analysis, and report preparation.

General Expectations

  • Demonstrate integrity, accountability, and sound judgment.
  • Maintain a positive, professional attitude.
  • Follow all regulatory requirements related to cell and gene therapy products.
  • Pay close attention to detail and quality.
  • Work independently with minimal supervision while meeting project objectives.
  • Manage multiple projects, investigations, and documentation assignments simultaneously.
  • Identify, solve, and prevent operational problems.
  • Support audits, customer interactions, and inspection readiness activities.

Qualifications

  • Bachelor's, Master's, or Ph.D. degree in Life Sciences, Biotechnology, Gene Therapy, or a related field.
  • 5–8 years of relevant experience, including at least 3 years supporting commercial drug product filling operations.
  • Strong expertise in:
    • Aseptic Process Simulation (Media Fills)
    • Process Validation
    • Contamination Control
    • Risk Assessment and Analysis
  • Knowledge of GMP regulations and industry standards, including FDA, EU GMP Annex 1, PIC/S, and ISO 13408-1.
  • Understanding of sterilization, aseptic processing, and first-air principles.
  • Experience in biologics or gene therapy manufacturing, preferably with isolator technology or other closed systems.
  • Strong communication, project management, and organizational skills.
  • Proficiency in Microsoft Office (Word, Excel, and PowerPoint).
  • Ability to work effectively both independently and within cross-functional teams.
  • Strong customer focus and ability to handle confidential information professionally.

Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.