Summary: The Director, Downstream Process Development, functions independently and productively in the Downstream Process Development Group, actively engaged in process development within a team based PD laboratory to support a wide variety of vaccine development projects. The individual should display strong technical knowledge and scientific understanding of purification procedures, including, but not limited to, viruses, proteins and plasmid DNA, as well as having experience in process development with both small and large process scales for vaccine development. The successful candidate will possess extensive experience with both traditional and single-use process equipment. The Director will lead downstream technology transfer and process development to achieve Phase I & II production in a cGMP facility and provide technical support for associated regulatory filings. The individual will provide significant scientific and technical contributions within the Process Development Group and will work closely with the customer to develop strong working relationships.
Individual will have considerable knowledge/expertise relevant to Downstream processing of viruses, proteins and plasmid DNA, ability to develop scalable, robust purification procedures and to evaluate and interpret data. 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., in a matrix management structure.
- Carry-out downstream processing of viruses, proteins and plasmid DNA.
- Develop scalable, robust purification procedures.
- Purify viruses, proteins and plasmid DNA of sufficient potency, purity, and quality to supply toxicology and clinical materials.
- Establish state-of-the-art scale small-scale downstream models and capabilities.
- Perform hands-on lab work designing and executing complex experiments and projects using a wide application of complex principles, theories, and concepts.
- Manage the Downstream Process Development group to be effective and efficient in a fast-paced environment.
- Provide expert input into developing, optimizing, scaling-up, and validating all steps in processes within the downstream process development group.
- Serve as the technical project lead for the development of robust high performing downstream processes with emphasis on transferability to cGMP manufacturing.
- Fully engage in Client development projects, including working collaboratively with clients to identify technical solutions and escalate risks appropriately; communicates project status and effectively provides technical explanation and rationalization.
- Provide strategy, vision, and direction; make 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.
- Lead in the development and implementation of processes from bench through scale-up, and to pilot scale, including technology transfer through clinical manufacturing.
- Take responsibility for instrument care, maintenance, troubleshooting and data interpretation.
- Perform document writing, including SOPs, data interpretation, presentation, statistical analysis and trending.
- Establish and maintain familiarity with industrial standards, practices, and technology focused on purification process development
- Work collaboratively with Upstream PD, Virology & AD, Project Management, and Manufacturing groups to develop an increased depth of knowledge of the processes for a given client and identify improvement opportunities.
- Participation in decision-making processes within the project team by actively engaging in scientific and technical discussions.
- Work collaboratively with internal staff to generate project and cost proposals, timelines, and work plans by applying scientific knowledge and business expertise.
- Resolve technical problems through scientific understanding, options assessment, and application of innovative solutions.
- Take responsibility in a leadership role in the day-to-day operations of the project, handle multiple priorities quickly and efficiently, including conducting and evaluating training for new or current team members and delegating tasks appropriately.
- All other duties as may be assigned.
Required Skills & Abilities:
- Builds credibility within lab group by performing high quality work.
- Expands the technical capabilities of Process Development Group, such as technology development, use of the literature and systems development.
- Effectively communicates results of own work though scientific meetings, presentations, discussions and documentation with some input from supervisor.
- Applies theoretical and applications knowledge of protein purification and protein chemistry.
- Strives for results by setting ambitious tangible results for himself/herself and the team and takes personal responsibility for achieving goals.
- Displays the essential ability to work in team oriented environment, as this person will work closely with other members of Process Development Group and participate on multidisciplinary project teams.
- Demonstrated experience leading complex projects or programs.
- Good interpersonal, follow-up, and excellent verbal and written communication skills.
- Exercises superior judgment and works independently with minimal supervision and/or guidance.
- Experience in cGMP and pilot scale manufacturing equipment and practices and with the transfer of technology to cGMP operations.
- Proven experience in the scale-up and technology transfer from pilot plant to manufacturing with extensive protein purification and protein chemistry knowledge.
- Hands on experience with virus and protein purification techniques.
Preferred Skills & Abilities:
- Advanced knowledge of protein purification methods.
- Strong background in cell biology and/or virology.
- Fluency with cGMP operations, manufacturing and regulatory requirements for pharmaceutical products.
- Proficiency with Microsoft Office, including Word, Excel, PowerPoint, and other analytical applications.
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.
- D. degree preferably in Chemistry, Biology, Life Sciences (preferably virology), or related field, with at least 8 years’ GMP experience in pharmaceutical or biotechnology industry of which at least 5 years of management/supervisory experience OR;
- Master’s degree in Chemistry, Biology, Life Sciences (preferably virology), or related field with at least 12 years’ GMP 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 is preferred.