Associate Manager Technical Project Management- Biologics Development

Ppt Consulting; San Francisco (CA); On-site; USD 125,000 - 155,000; Full time

Benefits offered by this job

Annual Performance Bonus

Medical, dental, and vision

401(k) with company match

HSA and FSA options

Paid parental leave

Generous PTO and holidays

Cell phone stipend

Job summary

Sia is seeking an Associate Manager in Technical Project Management for Biologics Development in San Francisco. You will own project plans, schedules, and updates, and serve as the central communication hub among design, discovery, CMC, regulatory, and manufacturing teams.

You will coordinate cross-functional activities, manage risks, and ensure on-time, on-budget delivery of biologics development programs, including CMC tasks and government-sponsored projects.

Qualifications

• 7+ years of relevant professional experience in biologics R&D including at least 3 years in project management.
• Advanced degree (PhD preferred) in biology, biochemistry, immunology, biophysics, or related discipline, or equivalent technical depth.
• Working knowledge of mAb and/or protein design, engineering, or optimization (e.g., affinity maturation).
• 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 development plans, Gantt charts, risk/communication/resource plans, and government sponsorship reporting.
• Experience managing projects and project management principles and tools.
• Project management experience with on-schedule and on-budget delivery.
• Fluency in project management tools (MS Project, Smartsheet, etc.), Excel, Word, and PowerPoint.
• Excellent written and oral communication, presentation, problem solving, and negotiation skills.
• Ability to work independently or in collaboration; adaptable to ambiguity.

Responsibilities

• Own project plans, integrated schedules, and Gantt charts across multiple concurrent product development efforts.
• Coordinate communications among technical subteams and all stakeholders.
• Work with cross-functional teams to drive program activities against timelines, scope, and budget.
• Coordinate CMC activities including developability assessment, process and analytical development, and scale-up with manufacturing partners.
• Interpret results, identify risks, and support go/no-go and prioritization discussions.

Skills

MS Project

Smartsheet

Excel

Word

PowerPoint

Education

PhD or related field

Job description

Associate Manager Technical Project Management- Biologics Development

550 California Street, 94104 San Francisco, United States

Company Description

Sia is a next-generation, global management consulting group. Founded in 1999, we were born digital. Today our strategy and management capabilities are augmented by data science, enhanced by creativity and driven by responsibility. We’re optimists for change and we help clients initiate, navigate and benefit from transformation. We believe optimism is a force multiplier, helping clients to mitigate downside and maximize opportunity. With expertise across a broad range of sectors and services, our 3,000 consultants serve clients worldwide from 48 locations in 19 countries. Our expertise delivers results. Our optimism transforms outcomes.

Sia’s Life Science and Healthcare Business Unit, Sia/LBG, focuses on supporting the life sciences and healthcare industries with strategic consulting, product development and non-dilutive funding expertise. This consulting division works with healthcare organizations, pharmaceutical & biotech companies, CROs, academia, medical device/diagnostic companies, and non-governmental organizations (NGOs) alike to solve complex business, scientific, regulatory, technological and product development challenges. Our subject matter experts help advance our clients products and programs; supporting these companies—both large and small—to achieve organizational objectives and create tangible value for their stakeholders.

Job Description

• 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.

Compensation & Benefits

Compensation

• Base Salary: $125,000-155,000. 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.

Our Commitment

At Sia, we believe in fostering a diverse, equitable, and inclusive culture where our employees and partners are valued and thrive in a sense of belonging.

Sia is an equal opportunity employer. All aspects of employment, including hiring, promotion, remuneration, or discipline, are based solely on performance, competence, conduct, or business needs.