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POSITION SUMMARY:
The Director, Bioprocess Development will provide strategic leadership in establishing proper scientific rigor and methodologies for efficient and accurate process development. S/he will manage and lead biologic programs through development, including process characterization, scale-up, optimization, and tech transfer to external manufacturing sites. This will include providing technical support for external manufacturing for both clinical and commercial scales. The Director, Bioprocess Development will be a key leader and contributor within the CMC organization and work closely with cross functional teams (Analytical, Formulations, Drug Delivery, Operations Strategy, Manufacturing, Quality, and Regulatory) to define and execute against short, intermediate, and long-term strategic objectives, as well as drive continuous improvement.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:
Provide technical oversight and strategic guidance for bioprocess development including development, scale up, tech transfer, process characterization, and execution of robust upstream and downstream processes
Leverage prior knowledge, data, and scientific innovation to accelerate speed and efficiency of early and late stage development programs
Develop/test/qualify upstream and downstream scale-down models to accelerate bioprocess development research and effective use of the models to support product registration and/or life cycle management
Lead team members in implementation of best industry practices for the design and the development of new experimental methods and processes through quality by design (QbD engineering principles, and statistical process design/analysis to develop robust up-stream and downstream processes
Author technical reports, review manufacturing batch records, as well as author and review CMC documentation for regulatory submissions and the adjudication of FDA/health authorities’ questions
Provide on-going technical expertise in technical issue resolution with technical/experimental support for manufacturing processes that are currently being manufactured at contract manufacturing sites; includes support of deviations (CAPA), investigations, change control, process data review, as well as implementation of process improvements
Work proactively with cross-functional teams and/or external vendors to define project scope and ensure successful delivery regarding technical quality, timeline, and budget
Partner with Manufacturing team to develop and translate process knowledge and understanding into manufacturing controls strategy (product, process, materials, environment, etc.) to ensure successful process scale up and tech transfer, validation activities as well as resolve complex process/product issues
Responsible management of tech transfer activities between various manufacturing sites and work with internal lab to design and coordinate development studies
Motivate, and support the career development and technical expertise of staff; regularly meet with, set clear goals and expectations, and provide timely feedback to all staff in the group; hire, develop, and retain the best people
ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
Contribute to the identification and selection of external contract manufacturing sites and building/maintaining strong working relationships with their respective technical staff and management, as needed
Support the Director(s) of Manufacturing, Analytical Development, Supply Chain, Regulatory Affairs and Quality, as the principle process expert for CMC issues related to process development: assist in authoring sections of regulatory submissions; establish, justify and defend process development history and provide technical support for ongoing manufacturing investigatons.
Provide clear communication to functional line management and cross-functional team regarding progress against technical objectives/milestones
Other duties as assigned
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
Minimum of a MS degree in chemical/biochemical engineering, or biochemistry with at least 10 years’ experience in Process Development (an equivalent combination of education and experience may be considered)
Expert knowledge of upstream and downstream unit operations and process technologies as well as bioprocess related software/application and computer operationExtensive hands-on experience with upstream and downstream laboratory equipment (e.g. operation of high throughput mini bioreactors as well as pilot scale bioreactor systems, single use bioreactors, filtration, chromatography, TFF systems etc.)
Knowledge of bioreactor characterization and engineering principles (mass transfer, mixing, shear, etc.) as well as robust understanding of biochemistry and cell metabolic pathways is a must
Media development experience is a plus
Strong technical expertise and experience with applying Quality by Design (QbD) concepts and statistical process design and analysis (JMP® statistical software)
Experience and knowledge with viral clearance studies and process performance qualifications
Experience in Cell Line Development (e.g. following final construct/sequences, single cell clone creation, evaluation, and generation and maintenance of master and working cell banks) is a plus
Track record of demonstrable management skills of multiple projects and technical teams.
Experience with contract manufacturing partners while maintaining a positive working relationship as well as knowledge of cGMP’s, global regulatory guidelines, and other relevant regulatory requirements.
Experience in preparing and defending regulatory documents (IND/CTA/BLAs/NDSs/MAAs).
Expertise in ICH Guidance for Industry Q8 Pharmaceutical Development, Q9 Quality Risk Management and Q10 Pharmaceutical Quality Systems
Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results
Demonstrated ability to set clearly defined goals/objectives to ensure delivery of high-quality results
Proven ability to think outside of the box and challenge the status quo
Natural entrepreneurial spirit with unrelenting dedication to delivering results
Strong desire and ability to work in a fast-paced, innovative environment
Natural collaborator who enjoys working on/leading cross-functional teams
PhD is preferred
TECHNICAL KNOWLEDGE REQUIRED:
Equipment:PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other equipment required: N/A
Software Knowledge: Windows, MS Office (Outlook, Word, Excel, PowerPoint, Visio). Knowledge of other software required: JMP
INTERNAL AND EXTERNAL RELATIONSHIPS:
Develop and maintain productive relationship and open communication with key functional leaders and cross functional teams including Analytical, Formulations, Operations Strategy, Manufacturing, Quality, Alliance Management, Project Management and Regulatory
Work closely with contract manufacturing organizations and other third-party service providers
EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting to 20 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Laboratory Activities, if applicable:Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply.
TRAVEL:
Travel may be required up to 10% of your time
