The Program Manager is responsible for integrated development and Chemistry, Bioconjugation Development and manufacturing programs, ensuring alignment with Abzena’s functions, goals and values. The Program Manager manages the planning, scheduling and budgeting of CMC-related product/process development activities, including new product development, analytical methods development/validation, process improvements, and product characterization. Program Manager engages with clients on changes or addition to the scope of the project and generates change orders and helps with adjacent sells.
- Create project plans to meet client needs.
- Track, adjust and report milestone deliverables to the Director of Project Management.
- Communicate all changes, plans and goals to partnering functions.
- Assist with risk and mitigation planning .
- Create kick-off meetings and joint technical meeting content, agenda and minutes.
- Document agreements and any changes to the statement of work.
- Complete ERP system activities, invoicing, cost control, revenue recognition, material tracking and procurement and assist with forecasting and change management activities.
- Provide support with project budgets, including but not limited to: review cost/price analysis’, pressure test and align assumptions in the forecast, ensuring transparency and communication of the approved plan and funding status of activities.
- Provide support for the transfer of services between sites.
- Maintain positive personnel and client relationships and communication.
- Operate to the highest ethical and moral standards and participate effectively as a team player in all aspects of Abzena’s business and adhere to quality standards set by regulations and Abzena policies, procedures, and mission.
- Provide mentorship and guidance to more junior personnel.
- Providing mentoring to other Project Managers and project team
- Other related duties as assigned.
Qualifications/ Skills Required:
- MS in Life Science, Engineering or related field.
- 5+ years CMC experience in small molecules, biologics, or antibody drug conjugates and broad knowledge of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies.
- 5+ years project management experience, leading multiple complex projects/programs
- Minimum of 3 years’ experience in a client facing position.
- Knowledge of project management best practices and proficiency with supporting project management tools.
- Excellent written and oral communication skills in both individual and group settings.
- Excellent analytical, negotiation and problem-solving skills
- Demonstrated ability to organize, lead, and execute on a variety of assignments and action plans.
- Experience working with key stakeholders.
- A solid understanding of CMC development milestones from Phase 1 to commercialization.
- Knowledge of finance, accounting and managing budgets.
- Current industry knowledge of relevant regulations, guidelines, policies and CMC requirements.
- Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.
- Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.