The Project Manager for development project(s) require extensive experience with biologic and organic synthetic medical biological drugs development, to be familiar with the conduction of clinical stage of the development, an excellent ability to network and “get things done” within the sanctioned processes and systems, excellent team building skills and an ability to see the big picture but also dive into details as necessary to execute effectively on a development plan, ensuring timelines and project deliverables are met.
If assigned direct management responsibility, must be able to coach and develop staff to become effective Team Leaders / Project Managers, as appropriate. Must provide guidance and oversight of project managed by staff and be accountable for these programs with staff. As appropriate, lead and / or actively participate in change / process improvement initiatives within Mileutis that require extensive product development experience and understanding of Mileutis procedures and policies.
Qualifications
Education Minimum Requirement:
• PhD degree in biochemistry, or equivalent
Required Experience and Skills:
• At least 10 years lab experience in the biotech or pharma industry with a minimum of 5-year experience in the biopharmaceutical-protein/peptides industry
• Must have extensive experience with the planning and execution of strategies for drug product registration and commercialization / life-cycle management
• Assisting in the R&D phase of biologic products by:
o Participating in internal hand-off, study start, and investigator meetings
o Be high skill in running analytical tests for proteins (purification, characterization, experience in developing chromatographic methods (HPLC, FPLC) for protein and peptide analysis), designing validation protocols and validating analytical methods
o Be skill or have the ability to cell culture management
o Obtaining a proper understanding of the R&D protocol and other related study materials
o Be skilled in drug development’s validation process, validation protocols and their implementation
o Collecting relevant information from participating CRCs, including FDA 1572 forms and waivers (if applicable), Acknowledgement of Obligations, etc.
o Assisting to the Clinical Team with the set-up of the clinical trial in the Management System
• Assisting the R&D with on-going activities ensuring all timelines are met
• Contribute and supporting the drafting and maintaining of required study documents
• Ability to read and write in English
Preferred Experience and Skills:
• Knowledge of cGMPs and GLPs
• Maintaining quality service and departmental standards by:
o Reading, understanding and adhering to organizational Standard Operating Procedures (“SOPs”)
o Assisting in establishing and enforcing departmental standards
o Participating in the modification of company SOPs related to the project management team
o Reviewing and providing recommendations to management on operational procedures, and by participating in process improvement initiatives
• Experience writing regulatory documentation
• Provides support during audits and inspections (regulatory, internal, safety)
• Author standard operating procedures for laboratory methods
• Contributes to laboratory investigations and CAPAs
