Role Description We are seeking a highly motivated and experienced downstream process development leader to support late-stage biologics programs through licensure and lifecycle management. This role will serve as the technical lead for downstream process development activities across clinical and commercial programs and will be accountable for process design, optimization, characterization, validation readiness, and regulatory authorship. This is a primarily hands-on role (approximately 70% technical execution / 30% strategic leadership) supporting monoclonal antibodies, antibody-related variants, and antibody-oligonucleotide conjugates. The successful candidate will operate as a key CMC contributor for BLA-stage programs and will play a central role in regulatory filings and health authority interactions. This position is structured as a flexible-level hire at either the Principal Scientist or Associate Director level, depending on experience. What You Will Contribute - Technical Leadership & Execution - Serve as the technical lead for downstream process development from late clinical stage through commercialization. - Design, optimize, and characterize purification processes including Protein A capture, polishing chromatography, viral clearance, filtration, and UF/DF. - Lead process characterization studies to identify and justify critical process parameters (CPPs), support control strategy development, and enable process performance qualification (PPQ). - Drive process robustness, scalability, and lifecycle management strategies consistent with commercial manufacturing requirements. - Troubleshoot purification performance issues across development, scale-up, and commercial manufacturing. - Provide technical oversight for scale-up and technology transfer activities to manufacturing sites. - Review and approve development protocols, reports, and technical documentation. - Interpret process development data to support regulatory filings and internal decision-making. - Regulatory & CMC - Author and own downstream process development sections of regulatory submissions (e.g., IND, BLA Module 3), including process description, control strategy, and process characterization summaries. - Support responses to regulatory questions and participate in health authority interactions as subject matter expert. - Ensure process development documentation supports comparability, validation, and commercial readiness. - Contribute to control strategy development and regulatory justification of CPPs and IPCs. - Cross-Functional Collaboration - Partner closely with Upstream Development, Analytical Development, Manufacturing, Quality, Regulatory, and Supply Chain. - Contribute to integrated CMC strategy and program risk assessments. - Support internal and external manufacturing campaigns through data review and real-time problem solving. - Provide mentorship and technical guidance to junior scientists. - Strategic Contribution (30%) - Contribute to downstream platform evolution and technical innovation. - Support long-term process optimization and lifecycle management planning. - Help build internal technical capabilities aligned with commercial strategy. - May assume people leadership responsibilities as the organization grows. Qualifications - Ph.D. in Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with 5+ years of relevant experience OR - M.S. with 8+ years of experience OR - B.S. with 12+ years of experience - Level will be commensurate with experience and demonstrated leadership. Requirements - Extensive experience in downstream process development for monoclonal antibodies or related biologics, including chromatography-based purification and filtration operations. - Experience with viral clearance strategies and regulatory expectations for viral safety. - Demonstrated experience supporting late-stage clinical programs and commercial readiness. - Direct authorship of CMC sections for IND and BLA submissions. - Experience defining CPPs and leading process characterization studies. - Strong understanding of scale-up, tech transfer, and process validation. - Experience supporting regulatory inspections or health authority interactions. - Proven troubleshooting skills in purification processes. Preferred Experience - Experience with antibody variants or antibody-oligonucleotide conjugates. - Experience supporting CDMO manufacturing and technology transfer. - Experience supporting commercial manufacturing. - Experience in comparability assessments and post-approval change management. - Prior experience in a matrixed biotech environment. - Demonstrated ability to lead without formal authority. Core Competencies - Deep technical expertise in downstream biologics processing. - Strong regulatory writing and CMC strategy skills. - Ability to operate independently in a fast-paced late-stage environment. - Excellent cross-functional communication skills. - Strategic thinking with hands-on execution capability. - Strong problem-solving and data-driven decision-making skills. - Ability to build alignment, foster collaboration, and drive shared ownership across functions to achieve results in a complex, matrixed environment. - Ability to travel to Avidity’s San Diego headquarters approximately twice per year for company development weeks and occasional in-person collaboration. - Demonstrated openness to adopting digital and AI-enabled tools that enhance data analysis, process understanding, and decision-making. Benefits - The base salary range for this role is $171,000 to $189,000. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity, and market factors. - Avidity offers competitive compensation and benefits, which includes the opportunity for annual bonus as well as a 401(k) with an employer match. - In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off. Additional Details - Title: Principal Scientist, Biologics Process Development - Location: Remote - Position Type: Full Time / Exempt - Department: Process Development - MAB - ID: 7625-Q224-7 - #LI-Remote

• Drive new business growth by achieving or exceeding sales targets and revenue goals • Build and manage your own pipeline through outbound prospecting, networking, and lead generation • Develop sales strategies to win new accounts or expand existing ones, lead sales cycle, tailor proposals and close contracts • Identify and engage new Life Sciences clients across pharmaceuticals, medical devices, and CROs • Collaborate with Marketing and Product teams to align go-to-market efforts and messaging • Represent RWS at events, trade shows, and client meetings to build brand visibility and credibility • Build and maintain relationships with prospective clients to understand their needs and position solutions effectively • Develop trusted relationships with key decision makers and stakeholders • Conduct market and competitor research to identify new opportunities and trends • Maintain accurate opportunity tracking and forecasting in CRM systems (e.g. Salesforce)

Description Ready to make a difference? We are seeking a Business Development Specialist who excels at uncovering and advancing new business opportunities. This role is central to driving growth by identifying the right prospects, understanding their needs, and developing pathways to engage them effectively. You will shape the front end of the sales process by researching markets, segmenting prospects, tailoring outreach, and ensuring sales managers receive well-developed leads. Success in this position requires a balance of strategic insight, research-driven execution, and meticulous follow-up to build a strong and actionable pipeline. Why you will love working here: - Quality of life: Flexible workplace arrangements, work-life balance - Investment of the community: Donation matching, volunteer opportunities - Investment in you: Tuition reimbursement, access to professional development resources, 401k matching, Employee Stock Purchase Plan - And many, many more: (Ask your recruiter for more Key Responsibilities - Source and identify new leads from direct and indirect marketing, regulatory research, referrals and other outbound/inbound channels. - Develop outreach plans for new business opportunities in alignment with company strategy, with a working understanding of core services and solutions. - Partner closely with corporate marketing and business development leaders to design campaigns and messaging that resonate with prospective clients. - Conduct research into target organizations, markets, and services to surface demand signals and fully develop opportunities. - Maintain disciplined organization of outreach, follow-ups, and engagement tracking to ensure progress is measurable and actionable. - Track lead status and engagement in CRM tools, maintaining clean and actionable records. - Monitor market and regulatory activity to surface new opportunities and inform outreach strategies. - Gather key information on budget, authority, need, and timing to prepare business development managers for lead qualification and pursuit. Required Qualifications - Bachelor’s degree in Business, Marketing, Public Policy, Environmental Science, Engineering, or related field. - 5+ years of experience in lead generation, sales development, or business development—ideally in the utilities, energy, or infrastructure sectors. Preferred Skills and Experience - Proven success in identifying and qualifying leads. - Familiarity with utility market dynamics, regulatory landscapes, energy efficiency and decarbonization programs and procurement cycles. - Proficiency with CRM platforms (e.g., Salesforce), plus familiarity with tools such as Outreach.io, Demandbase, or ZoomInfo. - Excellent verbal and written communication skills, with the ability to tailor messaging for various audiences. - Strong organizational skills and a detail-oriented approach to managing outreach pipelines. - A proactive, self-starter attitude with a natural curiosity to dig for leads and uncover opportunity signals. - A results-driven approach to building a healthy and measurable sales pipeline. - Ability to balance strategic thinking with day-to-day execution of lead generation and outreach activities. - Comfort working in a collaborative, fast-paced, and cross-functional environment. Working at ICF ICF is a global advisory and technology services provider, but we’re not your typical consultants. We combine unmatched expertise with cutting-edge technology to help clients solve their most complex challenges, navigate change, and shape the future. We can only solve the world's toughest challenges by building a workplace that allows everyone to thrive. We are an equal opportunity employer. Together, our employees are empowered to share their expertise and collaborate with others to achieve personal and professional goals. For more information, please read our EEO policy. We will consider for employment qualified applicants with arrest and conviction records. Reasonable Accommodations are available, including, but not limited to, for disabled veterans, individuals with disabilities, and individuals with sincerely held religious beliefs, in all phases of the application and employment process. To request an accommodation, please email Candidateaccommodation@icf.com and we will be happy to assist. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodations.  Read more about workplace discrimination rights or our benefit offerings which are included in the Transparency in (Benefits) Coverage Act. Candidate AI Usage Policy At ICF, we are committed to ensuring a fair interview process for all candidates based on their own skills and knowledge. As part of this commitment, the use of artificial intelligence (AI) tools to generate or assist with responses during interviews (whether in-person or virtual) is not permitted. This policy is in place to maintain the integrity and authenticity of the interview process.  However, we understand that some candidates may require accommodation that involves the use of AI. If such an accommodation is needed, candidates are instructed to contact us in advance at candidateaccommodation@icf.com. We are dedicated to providing the necessary support to ensure that all candidates have an equal opportunity to succeed.   Pay Range - There are multiple factors that are considered in determining final pay for a position, including, but not limited to, relevant work experience, skills, certifications and competencies that align to the specified role, geographic location, education and certifications as well as contract provisions regarding labor categories that are specific to the position. The pay range for this position based on full-time employment is: $81,499.00 - $138,549.00 Nationwide Remote Office (US99)

• Drive new business and sales across select target accounts in support of Medlive's Digital Solutions • Actively manage one or more strategic medical partner relationships