curiate.co
Director, Downstream Development
curiate.co, Hopkinton, Massachusetts, us, 01748
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
And more!
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
In depth knowledge of process that impact analytical results such as dsRNA impurity, aggregates, %fragments, residual DNA, free nucleosides.
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 resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.
All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. 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.
#LI-KS1
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
And more!
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
In depth knowledge of process that impact analytical results such as dsRNA impurity, aggregates, %fragments, residual DNA, free nucleosides.
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 resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.
All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. 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.
#LI-KS1