Project Manager, CMC

Job Description

Job Description

Salary : $110K / yr - $150K / yr

About SpyGlass Pharma :

At SpyGlass Pharma, we are actively engaged in projects addressing unmet needs in glaucoma and cataract surgery / intraocular lens replacement, striving for paradigm shifts in global eye care.

Our team comprises professionals with diverse expertise in ophthalmic devices and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology, IOL development, and commercial success.

Led by a proven team with expertise in science, R&D, communications, and operations, SpyGlass Pharma™ takes ideas from inception through commercialization.

Our commitment to actively improving patients’ quality of life drives the company to innovate and succeed.

Learn more at www.spyglasspharma.com

Summary

As the CMC Project Manager, you will be accountable for achieving program goals while directing a multi-disciplinary team to successfully complete projects.

You will be responsible for planning, executing, and managing projects. Serving as a key project leader, you will demonstrate a proactive problem-solving approach and foster strong relationships with key stakeholders and cross-functional team members.

Other responsibilities include :

Create and manage multiple Project Plans (scope, schedules, budgets, resources, and risks) securing input from all impacted functional areas of the company.

Evaluates tradeoffs within project.

• Set appropriate timelines, tracks key milestones, and reports project progress against key milestones. Understand timing, relationships between activities, and steps required for each task in the project timeline.
• Identify project risks and create mitigation strategies with the project team.
• Manage the scope of the project and act as a gatekeeper for project related items.
• Aggressively monitor critical path activities. Follow up with team members to ensure project stays on track. Work to resolve timing constraints if critical tasks are delayed.
• Manage project communication to all cross-functional project team members and stakeholders. Serve as project lead point of contact for all partners.
• Deliver the project successfully - on time and within budget.
• Elevate issues and escalate to upper management as needed to keep project on track and to remove barriers to success.
• Monitor project progress and can represent the project by regularly providing updates to upper management.
• Use detailed understanding of the process and examples from other projects to resolve complex issues and make improvements for future projects.
• Provide direction and guidance for project issues and drives issues to resolution.
• Build relationships with team members, functional teams, and partners to gain the trust to lead and influence a team.
• Schedule and conduct cross-functional team meetings. Publish meeting agendas and minutes with identified action items to hold team members accountable.

Review past due and upcoming activities to ensure team is aware of what is expected to keep the project on track. Elevate issues at the team level to determine next steps.

Manage the project documentation repository along with the design and / or stage gate reviews

Minimum Qualifications :

• Bachelor’s degree in engineering or technical discipline.
• 6+ years of project management experience including early stage pharmaceutical development
• Strong experience in project management, planning / execution, and risk management.
• Experience in effectively leading projects through all phases
• Familiarity with relevant regulations and standards.
• Strong understanding of pharmaceutical development and / or device design control
• Excellent problem-solving skills and ability to work in a fast-paced, multidisciplinary team environment.
• Strong communication skills, both written and verbal, with the ability to effectively present information to diverse audiences.
• Attention to detail, accuracy, and commitment to producing high-quality work.
• Demonstrated ability to write clear and concise documents.

Preferred Qualifications :

• Project Management Professional (PMP) certification or equivalent
• Proficiency in using project management software
• Experience with Chemistry, Manufacturing, and Controls (CMC)
• Exposure to various phases from early development through commercialization

SpyGlass Pharma is an Equal Opportunity Employer and participates in E-Verify. SpyGlass Pharma takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.

SpyGlass Pharma is also committed to working with and providing reasonable accommodation to individuals with disabilities.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to jobs@spyglasspharma.

com and let us know the nature of your request and your contact information.