Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Various outside weather conditions, Working at heights

Job Description

Project Manager

We are seeking an experienced and strategic Project Manager to lead cross-functional teams in the execution of pharmaceutical development and commercialization projects. The successful candidate will be responsible for managing complex programs across drug discovery, clinical development, regulatory submission, and manufacturing scale-up. This role requires a strong understanding of the pharmaceutical development lifecycle, regulatory requirements (FDA, EMA), and project management methodologies.

Key Responsibilities:

• Project Leadership: Lead the planning, execution, and delivery of drug development projects from preclinical through commercialization phases.

• Cross-functional Coordination: Manage multidisciplinary teams including Clinical, Regulatory, CMC, QA, and Commercial to ensure alignment on project goals and deliverables.

• Timeline and Budget Management: Develop and track detailed project plans, timelines, resource allocations, and budgets. Identify and mitigate risks proactively.

• Stakeholder Communication: Provide regular updates to senior leadership and project sponsors. Facilitate decision-making through status reports, dashboards, and governance presentations.

• Regulatory Support: Coordinate with Regulatory Affairs to ensure timely preparation and submission of INDs, NDAs, MAAs, and other key filings.

• Vendor Oversight: Manage third-party partners and CROs to ensure contract deliverables, milestones, and quality standards are met.

• Change Management: Lead change control processes and project re-alignment as business or scientific priorities evolve.

• Compliance and Quality: Ensure all activities are conducted in accordance with GxP standards and relevant regulations.

Qualifications:

• Education: Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field required. Advanced degree (MBA, MS, PhD, PharmD) preferred.

Experience:

• 8+ years of project management experience in the pharmaceutical or biotechnology industry.

• Proven track record of leading complex development projects, ideally including clinical stage or commercial programs.

• Experience with global regulatory submissions and working in a matrix environment.

• Certifications: PMP certification or equivalent preferred.

Skills:

• Strong knowledge of drug development processes and regulatory frameworks (FDA, EMA, ICH).

• Excellent communication, leadership, and stakeholder management skills.

• Proficiency in project management tools (e.g., MS Project, Smartsheet, Primavera).

• Ability to lead under pressure and handle multiple priorities with agility.

Key Competencies:

• Strategic thinking with a strong execution mindset

• Collaborative leadership style with influence across teams

• Analytical and problem-solving abilities

• Adaptability in a fast-paced, evolving environment

Preferred Experience (Nice to Have):

• Experience with biologics, biosimilars, or advanced therapies (e.g., cell/gene therapy)

• Familiarity with Agile or hybrid project methodologies

• Global project management experience