Project Manager II

Bora Pharmaceuticals Inc; Maple Grove (MN); In loco; USD 108.000 - 150.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive salary and performance-based incentives

Comprehensive health coverage

Retirement savings plans

Paid time off

Flexible work arrangements

Professional development opportunities

Employee wellness programs

Employee Assistance Program

Descrizione del lavoro

Bora Pharmaceuticals Inc in Maple Grove, Minnesota, is looking for a Project Manager II to lead cross-functional project management. Responsibilities include managing timelines, budgets, and client relationships to ensure project milestones are achieved.

The ideal candidate will have at least 6 years of cGMP experience and a degree in Project Management or a related field. The position offers a competitive salary range and comprehensive benefits including health insurance and professional development opportunities.

Competenze

• 6+ years cGMP experience in solid oral dose pharmaceutical manufacturing.
• Comprehensive understanding of finance related to pharmaceutical manufacturing.
• Experience working with FDA and participating in regulatory inspections.

Mansioni

• Manage project budgets and ensure timelines are met.
• Execute client communications and manage internal/external meetings.
• Coordinate efforts for product handoff and maintain client relationships.

Conoscenze

Project Management

Client Relationship Management

Financial Forecasting

cGMP Experience

Effective Communication

Formazione

B.S./B.A. in Project Management or related field

PMP Certification

Descrizione del lavoro

About Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semisolid, biologics, and sterile injectable pharmaceutical products. From our world‑class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much‑needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain.

Job Summary

The Project Manager II provides dedicated, cross‑functional project management of development, technical transfer, operational activities that support the product lifecycle within the manufacturing site (e.g., purchase orders, forecasting schedules, change orders, invoicing, and shipping project management activities). The role executes a client engagement model and governance, assures effective and routine open communications and relationship management discussions with internal functional groups, as well as external client groups. The Project Manager is responsible for ensuring project milestones and budget are met, including ensuring pass through and change order costs are accounted for. The role is vital to business and development/tech transfer growth at the site. The person in this role integrates their understanding and knowledge of technical, financial and commercial needs to ensure projects run smoothly. The Project Manager is expected to be on‑site a minimum of three to four days per week, with additional consideration to prioritize client visits and other client‑engaging requests, and in accordance with business needs.

Essential Job Duties

• Support timelines during the quotation process and engage with BD early‑on to ensure successful handoff when contract is signed.
• Help organize client visits, both from a due diligence and plant perspective.
• Ensure financial forecasting and invoicing are as planned; if not, establish contingency plans.
• Manage and forecast project budgets and ensure change orders are passed on in a timely manner.
• Manage both internal and external team meetings for assigned clients and provide constant feedback and fast turnaround to partners.
• Execute client communications, including routine engagement, messaging, escalation, and notifications.
• Execute appropriate escalation for client matters within the PDS Management Team, appropriate functions, site leadership, and the CDMO BU.
• Serve as site operations business manager, working with site and Supply Chain leadership to assure client support prioritization alignment with product forecast and production priorities.
• Manage client inventory position, communicate client’s product necessity in market, and relevant business strategies and plans.
• Facilitate efforts of Ambassador team to deliver highest levels of service, attention to client inquiries, escalation, and needs for existing business.
• Assure connection and information sharing across site functions and with CDMO BU.
• Coordinate efforts to facilitate client product handoff from new product introduction and qualification activities to run‑the‑business portfolio management duties.
• Orchestrate and assure close management and execution of improvement‑the‑business activity (continuous improvement, deviation investigation and corrective/preventive action efforts) with assigned clients.
• Execute highly effective routines, tools, templates, and associated guidance for business meeting preparation, setting agendas, and associated standard work that aid client engagement experience.
• Ensure safe and compliant execution of activities, including collaboration with EH&S for client safety when on site.
• Execute goals and accountabilities based on agreed objectives and results.
• Collaborate and communicate with other functional areas to promote understanding and achieve strategic objectives.
• Promptly notify management, the team and Quality leadership of potential issues or problems.

Minimum Education/Experience Requirements

• B.S./B.A. degree in Project Management, Business or a related pharmaceutical sciences field.
• PMP certification preferred.
• 6+ years cGMP experience in solid oral dose pharmaceutical (preferred), biotech or biopharmaceutical manufacturing environment, ideally pre‑clinical phases to commercial, or equivalent amount of experience managing commercial operations or client portfolio management roles.
• Comprehensive understanding of finance – invoicing, financial forecasting, and impact of planning in pharmaceutical or biopharmaceutical manufacturing operations.
• 6+ years’ experience and strength in planning, orchestrating, and managing business critical relationships between providers/suppliers and clients.
• Experience working with FDA (Food and Drug Administration) and participating in regulatory agency inspections desirable.
• Strong interpersonal and collaborative/ facilitative skills across functions, across internal business enterprise, and externally with multiple clients within a portfolio.
• Proven, effective communication skills, oral and written, ability to drive and be assertive.
• Ability to work independently and in a team setting with minimal supervision.
• Ability to make sound decisions regarding compliance‑related issues with minimal supervision; proactive in identifying risks and creating mitigation plans.
• Demonstrated, proven record of personal accountability and responsibility with a delivery‑focused mindset.

Compensation

Range: $108,000 - $150,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies and experience.

Benefits

• Competitive salary and performance‑based incentives
• Comprehensive health coverage including medical, dental, and vision insurance
• Retirement savings plans with employer contributions
• Paid time off and flexible work arrangements
• Professional development opportunities
• Employee wellness programs and resources
• Employee Assistance Program and Mental Health Resources

Equal Employment Opportunity

Bora Pharmaceuticals Injectables, Inc. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals Injectables, Inc. will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.