DIRECTOR; DOWNSTREAM PROCESS DEVELOPMENT in HOPKINTON, MA
Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
The Director, Downstream Process Development will provide technical leadership and lead a team of scientists in support of biologics clinical development programs. In addition, the individual will collaborate closely with upstream process development, analytical development, manufacturing, and quality groups as well as clients to help ensure successful delivery of programs. This position is based at Curia Biologics’ manufacturing facility in Hopkinton, MA and reports to the Senior Director of Technical Operations.
Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.
We proudly offer:
- Generous benefit options (eligible first day of employment)
- Paid training, vacation and holidays (vacation accrual begins on first day of employment)
- Career advancement opportunities
- Education reimbursement
- 401k program
- Pension (for union employees)
- Learning platform
Responsibilities:
- Lead a group of scientists and engineers responsible for the development of mammalian and RNA purification processes and technology transfer to internal and external manufacturing sites.
- Responsible for successful mammalian and RNA process development, process characterization and process scale-up and scale-down for nonclinical studies.
- Create platform processes to minimize cost of goods, timeline and yield losses.
- In depth knowledge of processes that impact analytical results such as titer, host cell DNA size, conformational structure, PTMs, charge variants/deaminidation, peptide mapping, glycosylation, intact mass, protein integrity, oligomeric form, epitope mapping, disulfide formation/free thiols, thermal melting points, PI.
- Oversee process development and scale-up operations, define scale down models, viral clearance study designs and author associated regulatory filing documents.
- Design and execute Design of Experiments (DOEs) and Quality by Design (QbD) studies.
- Drive innovation, technology development and platform improvement to enhance productivity, quality and consistency.
- Present findings and results to senior management, external stakeholders and industry leaders at internal meetings and external conferences.
- Make strong technical and strategic contributions to cross functional project teams.
- Build strong interfaces within biologics CMC community and drive adoption of best practices and ways of working.
- Ensure material specifications, process capabilities, yields, and manufacturing and scale-up strategies are sound for GMP products.
- Lead teams on troubleshooting and data analysis to solve technical problems in manufacturing to ensure manufacturing output and product quality.
- Support and lead risk assessments and manufacturing deviation investigations.
- Author, review, and/or approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed.
Qualifications:
Education, experience, certification and licensures:
- Ph.D. in biological sciences, biochemistry, chemical engineering, or related field with a minimum of 8 years of relevant experience. Alternatively, a Bachelor's degree with 15+ years of relevant experience or a Master's degree with 12+ years of relevant experience will be considered.
- Significant experience in leading and managing a team of bioprocess development scientists or engineers, demonstrating direct involvement in developing programs from early stages through IND.
- Expertise and strong technical knowledge in downstream process development, scale-up, technology transfer, and manufacturing, with a specific focus on chromatography and membrane filtration.
- Proven experience in process characterization using Design of Experiments (DOEs) and Quality by Design (QbD) concepts.
- Proven track record of scientific publications and conference presentations.
- Experience in antibody optimization, analytical characterization and manufacturing for IND.
- Recognized leader in antibody/protein engineering and molecular biology as evidenced by publications, participation in international conferences, membership on journal editorial boards, etc.
- Excellent communicator and highly effective in interacting with key internal and external stakeholders.
Knowledge, skills and abilities:
- Experience developing purification unit operations scalable up to 2000 L bioreactor scale.
- Experience with Fast Protein Liquid Chromatography (FPLC) systems (e.g. Akta Avant, Akta Pilot, Akta Ready, etc) for chromatography-based purification development.
- Experience developing scalable chromatography purification unit operations (Affinity, IEX, HIC, SEC, mixed mode, etc).
- Experience developing scalable viral inactivation, viral filtration and TFF unit operations.
- Working knowledge of CMC upstream process development, analytical development, formulation development, bioconjugation process development, technology transfer, and GMP quality requirements.
- A strong technical focus is critical to ensure the speed, cost effectiveness, and technical quality of our CMC activities.
We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All interested applicants must apply online. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.
#J-18808-Ljbffr
