Technical Operations
FSA's expertise in life science technical operations centers on biomanufacturing and its related disciplines—including project management, process and product development, and purchasing and supply chain.
We provide comprehensive advisory and support services covering the range, from start-up through commercialization, pre-clinical through commercial launch. Our team is composed of highly qualified consultants with experience in emerging biotech and large biopharma with an average tenure of more than 10 years.
FSA can provide solutions in particular areas of need such as cost-of-goods optimization or expression system selection. As needed, we can take on an expanded role guiding process development activities, establishing a project management framework, or setting up compliant purchasing systems.
Through our network of experienced associates, we tailor each engagement to best serve our clients—delivering capabilities that are practical, flexible, and cost-effective.
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AREAS OF EXPERTISE
Project/Program Management
FSA's project management approach is grounded in the 10 PMBOK® Knowledge Areas, tailored specifically to life science operations. Our role ranges from mentor/advisor to acting as an as-needed PM for the company. 1-off assignments may involve setting up PM systems or project-specific, frequently customer-facing interactions to achieve a particular milestone. Again, we're flexible and we're Agile!
Basic PM service activities:
Communications & Reporting
Stakeholder Management
Variance Analysis
Risk Management
Scheduling
Cost Management
Process & Product Development
Through our associates, FSA can provide Subject Matter Expertise on specific topics of need such as Design of Experiments (DOE), formulation development, cell line selection, improving bioreactor yields, and process scale-up strategies. Or we can act as an adjunct to the company's PD staff, filling in where needed. We'll discuss what you need and together devise the optimal plan for how we can assist you.
Biomanufacturing
FSA's consultants have worked in GMP manufacturing across the scale of biotech/biopharma companies, beginning at the bench and advancing to senior management. With this range of experience, we cover every stage of biologic production, from media preparation to final drug product release.
Services include manufacturing process reviews, process optimization (upstream and downstream), SOP development, regulatory guidance, stability study design, and facility planning—from capital budgeting to equipment selection and single-use system sourcing. Whether you're working with microbial or mammalian systems, we provide actionable solutions that align with your program goals and regulatory requirements.
Purchasing / Supply Chain
FSA advisory services in purchasing / supply chain include:
Documentation templates, Specification writing, supplier qualification, compliance reviews, 2nd sourcing, OPEX and CAPEX optimization.
We have extensive experience in strategic sourcing based on our time as sellers and buyers know how to incorporate the common regulatory considerations to life science materials, supplies, and services.
WHY USE FSA?
1. We've actually done it.
Our credential is our experience, past and current. FSA consultants have managed technical operations for biotech/biopharmaceutical companies, medical device companies, and major development programs. We're engaged in developing and manufacturing the next generation of biologics - we continue to do it.
2. We know first-hand the importance and urgency of the problems you need solving.
This isn't a paper exercise for us. Because we've been there, it's a commitment to make your priorities our priorities, and to be a real partner as a solution provider. (And we're just as skeptical as you are when someone uses the term 'partner' and they don't have a stake in the outcome. We mean it!)
3. We know how to connect the dots.
We know how to manage the coordination required, the efficient interaction between activities, groups, and objectives. That way, when you connect the dots you get a horse and not a giraffe with a trunk.
4. You're not paying for overhead.
When you engage FSA, you get our A-Team at reasonable rates. We don’t have many junior associates, we use the tools efficiently and we make our own copies.