Technical Project Manager

JOB SUMMARY

The Technical Project Manager provides dedicated, cross-functional project management of operational activities that support product manufacturing and testing (e.g., purchase orders, forecasting schedules, change orders, invoicing, and shipping project management activities). The Technical Project Manager is also responsible for supporting New Product Introductions (NPI) and technical transfer processes with client products in our Baltimore portfolio. This role reports directly into the Director of Project Management and collaborates with CDMO Commercial Operations, Quality, Supply Chain, Finance and Business Development teams.

This is a hybrid role. The Technical Project Manager is expected to be on-site a minimum of three days per week, with additional consideration to prioritize client visits and other client-engaging requests, and in accordance with business needs.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Business/ Technical Project Management

• Act as primary liaison with the CDMO Commercial Operations team for ongoing client business, operational and contract management matters for the assigned client portfolio.
• 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 their relevant business strategies and plans
• Prepare and execute performance and business reviews.
• Prepare for and executes client visits, including in person plant (PIP) visits.

Key Project Management Functions:

• Establish clear charters, plans, milestones, and assignment of responsibilities.
• Define critical success factors and critical path activities.
• Conduct risk assessments, identification of project risk mitigation actions, and identification of required resourcing.
• Organize and lead required product evaluation and team introductions, implementation and management of proper governance, establish decision-making processes, and appropriate escalation paths.
• Align and assure proper resources are secured to execute projects.
• Track and report status on KPIs and ensure commitment to key stakeholders are met in a timely manner.
• Assurance of adequate business case development and justification for projects managed, including rationale for new product introduction proposals into recommended production areas.
• Cross-collaboration with necessary internal and external stakeholders, Business Unit, Functional and Product Team leadership, to assure inclusion of right people and information.
• Demonstrate understanding of business needs, challenges and risks, advocacy and alignment with project plans, and connectivity with ongoing business processes.
• Ensure appropriate connection and escalation within project management team to assure alignment, clarity, prioritization, and proper escalation when required.
• Assure evaluation process for new product opportunities is well orchestrated per the new product evaluation process
• Maintain good working relationships with internal and external partners/customers.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

• B.S / B.A. degree in Project Management, Business or a related pharmaceutical sciences field or equivalent experience in regulated industry. PMP certification preferred.
• 3-5 years cGMP technical experience in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment, ideally pre-clinical phases through commercial, and / or equivalent amount of experience managing commercial operations or client portfolio management roles.

Experience

• Technical experience or exposure across key areas including manufacturing process technologies, biopharmaceutical best practices, lyophilization, formulation development, validation, statistical analysis, and analytical methods.
• Experience in managing products/clients in a fast paced, challenging environment.
• Proven track record of management and leadership effectiveness.
• Comprehensive understanding of business and operational planning, forecasting, and impact of demand planning on biotech, pharmaceutical or bio-pharmaceutical manufacturing operations.
• 3-5 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.

Skills

• Strong interpersonal and collaborative skills across functions, including internal business enterprise, as well as externally with multiple clients within a portfolio.
• Ability to work independently and in a team setting with minimal supervision.
• Ability to make sound decisions regarding compliance-related issues.
• Proactive in identifying risks and creating mitigation plans.
• Demonstrated record of personal accountability and responsibility with a delivery-focused mindset.
• Proficiency in MS Office, Teams, and project management software (e.g., MS Project, Smartsheet).

Compensation Range:
$121,954.00 - $182,931.00
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