Individual will have considerable knowledge/expertise relevant to Upstream processing of cell, virus, and recombinant protein based products expressed in mammalian, bacterial, insect and yeast cells. Knowledge/expertise should be practical and focused on lab-related activities:
- Supervise technical staff including setting objectives and development plans, performance management, career development, training, mentoring, guiding, etc. Matrix management structure.
- Leads the team and/or advises team members involved in product development.
- Perform and/or oversee Upstream process research and development of virus and cell cultures.
- Hands on lab work designing and executing complex experiments and projects using a wide application of complex principles, theories, and concepts.
- Provide support to the Director, Upstream Process Development in the management of the group and be effective and efficient in a fast-paced environment.
- Develops new experimental approaches and related work processes and procedures that align with company and regulatory requirements.
- Provide expert input into developing, optimizing, scaling-up, and validating all steps in the upstream process development group, including cell bank production and characterization.
- Serve as a Subject Matter Expert (SME) for the development of robust, high performing upstream processes with emphasis on transferability to cGMP manufacturing.
- Participate in the development of PDO strategy, vision, and direction; and assist in forming decisions that establish objectives for the overall direction or operation of a significant project or area.
- Collaborate with others on the direction of activities relevant to long-term objectives.
- Provide significant input in the development and implementation of processes from bench through scale-up, and to pilot scale, including technology transfer through clinical manufacturing.
- Actively manage the day-to-day activities in PDO upstream laboratories, including instrument care, maintenance, troubleshooting and data interpretation.
- Identifies, develops, and implements innovative and complex projects with significant potential value to the Company.
- Document writing, including SOPs, data interpretation, presentation, statistical analysis and trending.
- Participation in decision-making processes within the project team by actively engaging in scientific and technical discussions.
- Assist in the generation of project and cost proposals, timelines, and work plans by applying scientific knowledge and project management experience.
- Resolve technical problems through scientific understanding, options assessment, and application of innovative solutions.
- Function in matrix management-based system and handle multiple priorities quickly and efficiently.
- Monitors project plans and resources to ensure alignment with overall research goals and objectives.
- Training new or current team members and delegating tasks appropriately.
- Provide input on the acquisition of capital equipment.
- Participates in global cross-functional teams to solve problems or to develop products or strategies.
- Responsible for and/or assists in documentation for tech transfer to manufacturing or method qualification with Quality Control.
- All other duties as may be assigned.
Required Skills & Abilities:
- Builds credibility within PDO by performing high quality work.
- Expands the technical capabilities of PDO Group, such as technology development, use of the literature and systems development.
- Experience in both small and large process scale-up for mammalian, bacterial, and viral vaccine development.
- The ability to work in team oriented environment is essential, as this person will work closely with other members of PDO Group and participate on multidisciplinary project teams.
- Demonstrated experience participating in and conducting complex work for projects or programs.
- Proficient with Microsoft Office, including Word, Excel, and PowerPoint as well as other analytical applications/programs.
- Ability to work on broad and highly complex development problems on the frontiers of new knowledge.
- Cell culture, lab-scale and pilot scale bioreactor experience.
- Good interpersonal, follow-up, and excellent verbal and written communication skills.
- Demonstrated ability to prepare/present complex scientific information to internal & external groups.
- Exercises good judgment and works independently with minimal supervision and/or guidance.
- Working knowledge of cGMP and pilot scale manufacturing equipment and practices and with the transfer of technology to cGMP operations.
- Hands on experience with cell culture and viral vaccine development techniques.
- Strong problem-solving and troubleshooting skills.
- Ability to manage multiple priorities while being flexible and responsive to shifting priorities.
- Responsible for maintaining up-to-date knowledge of regulatory requirements and quality standards related to area of development.
Preferred Skills & Abilities:
- Working knowledge of protein purification methods.
- Strong background in cell biology and/or virology.
- Fluency with cGMP operations, manufacturing and regulatory requirements for pharmaceutical products.
Carries out supervisory responsibilities in accordance with company policies and applicable laws including interviewing, hiring, planning, assigning, directing work, training and development, disciplinary actions, performance reviews, addressing complaints and resolving problems.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged standing, along with some bending, stooping, and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
- Attendance is mandatory.
- Ability to occasionally travel to other sites, vendor locations, and/or conferences.
- D. degree in Chemistry, Biology, Life Sciences (preferably virology), or related field, with at least 7 years’ experience in pharmaceutical or biotechnology industry of which at least 3 years of management/supervisory experience OR;
- Master’s degree in Chemistry, Biology, Life Sciences (preferably virology), or related field with at least 13 years’ experience in pharmaceutical or biotechnology industry of which at least 5 years of management/supervisory experience.
- Matrix management experience.
- Previous experience managing tech transfers and production in a Contract Manufacturing Organization (CMO) environment.