7+ years of relevant experience in biologics R&D, including 3 years in project management.
Advanced degree (PhD preferred) in biology, biochemistry, immunology, or related field.
Technical knowledge of mAb and protein design, engineering, or optimization.
Experience with CMC activities for biologics, including process development and technology transfer.
Proven ability to manage multiple concurrent R&D efforts and project management deliverables.
Fluency in project management tools and Microsoft Office Suite.
Excellent communication, problem-solving, and negotiation skills.
Responsibilities
Own project plans and Gantt charts for concurrent product development efforts.
Ensure quality and distribution of project management deliverables to stakeholders.
Serve as the central communication point among technical subteams and stakeholders.
Drive program activities with cross-functional teams against timelines and budgets.
Coordinate CMC activities with manufacturing partners.
Interpret technical results to identify risks and support decision-making.
Proactively manage strategic risks and implement mitigation activities.
Benefits
Medical, dental, and vision coverage; company-paid life and AD&D insurance.
401(k) with company match and immediate vesting; HSA and FSA options.
College savings and student loan repayment programs.
Paid parental leave; generous PTO and holidays.
Cell phone stipend; well-being and professional development programs.
Full Job Description
Job Description
Provide consulting services for Sia/LBG's clients including, but not limited to:
Own project plans, integrated schedules, and Gantt charts across multiple concurrent product development efforts, maintaining alignment of project milestones to day-to-day activities.
Responsible for content, quality, and distribution of project management deliverables and updates (programmatic reports, technical protocols and reports, process development plans and reports, schedules, risk register, and management plans) to the sponsor and internal leadership, usually serves as final reviewer.
Serve as the central point of communication among technical subteams (e.g., computational design, experimental, and CMC teams), and with all internal and external stakeholders (meetings, reports, etc.).
Work with cross-functional teams and partners (Design, Discovery, CMC, Nonclinical, Quality, Regulatory, etc.) to drive program activities against scheduled timelines, approved scope, and approved budget.
Coordinate CMC activities associated, such as developability assessment, process and analytical development, and scale-up with manufacturing partners.
Interpret technical results well enough to challenge timelines, identify emerging risks, and support go/no-go and prioritization discussions.
Proactively manage strategic risks and issues, providing expertise in the identification and implementation of risk mitigation activities.
Demonstrate and foster excellent teamwork, with the ability to navigate in different areas and work with multidisciplinary teams.
Balance project demands to align/ realign Budget, Quality, Timeline, and Scope as needed.
Facilitate team meetings and ensure that stakeholders have the information and support necessary to successfully execute projects.
Focus on customer service, with clear communication.
Adhere to Sia/LBG quality standards regarding client deliverables.
Qualifications
7+ years of relevant professional experience in biologics research and development efforts including at least 3 years in project management. Postdoctoral time does not count toward these years.
Advanced degree (PhD preferred) in biology, biochemistry, immunology, biophysics, or related discipline, or equivalent technical depth.
Working technical knowledge of mAb and/or protein design, engineering, or optimization (for example affinity maturation), with enough depth to manage the technical content of campaigns.
Experience with CMC activities for biologics, such as developability assessment, process and analytical development, technology transfer, and manufacturing.
Demonstrated experience managing multiple concurrent R&D efforts, including building and maintaining development plans, Gantt charts, project management plans (risk management plans, communication management plans, resource plans), and programmatic reports to a government sponsor.
Experience managing projects and in depth understanding of project management principles and tools.
Project management experience including successful delivery of projects on schedule and to budget.
Fluency in project management tools (MS Project, Smartsheet, etc.), Excel, Word, and PowerPoint.
Excellent written and oral communication, presentation, problem solving, and negotiation skills with an emphasis on building consensus.
Ability to work independently or in collaboration with others.
Flexibility and ability to deal with ambiguity, and sense of personal ownership of deliverables and results.
Works well with teams, often comprised of multiple disciplines, including computational scientists and experimentalists.
Desirable Qualifications
Experience with the management of US Government contracted programs.
Experience with project financial management including budget development, actuals tracking, forecasting, and reporting.
Working knowledge of computational and machine learning approaches to protein design.
Certified PMP and/or equivalent project management work experience.
Strong understanding of product development lifecycle and pharmaceutical manufacturing operations.
Strong understanding of cGXP guidelines and FDA regulatory requirements.
Additional Information
Compensation & Benefits
Sia invests in total rewards that support how our people work, live, and grow.
Compensation
Base Salary: $100,000-135,000. Actual compensation within this range will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by applicable law.
Annual Performance Bonus
Benefits
Medical, dental, and vision; company-paid life and AD&D; voluntary supplemental insurance and EAP
401(k) with company match and immediate vesting; HSA and FSA options
College savings and student loan repayment programs
Paid parental leave; generous PTO, nine company holidays, and one floating holiday
Cell phone stipend; well-being and professional development programs
Benefits are subject to applicable plan terms and eligibility requirements.
Work Authorization
Applicants must be legally authorized to work in the United States at the time of application and throughout their employment. This position is not eligible for employment visa sponsorship now or in the future.
