Associate/Director of Manufacturing Science and Technology (MSAT) – Upstream Drug Substance
Location: Remote, Redwood City CA, or Bend OR
- Rezolute is a clinical-stage biopharmaceutical company developing novel therapies for diseases caused by chronic glucose imbalance.
- Rezolute has initiated a global Phase 2b trial in Europe for their lead clinical asset, RZ358, which is a potential treatment for Congenital hyperinsulinism (CHI), an ultra-rare pediatric genetic disorder characterized by excessive production of insulin by the pancreas.
- The company’s second clinical-stage asset, currently in Phase 1, RZ402, is a selective and potent plasma kallikrein inhibitor (PKI) being developed as a potential oral therapy for the chronic treatment of diabetic macular edema (DME)
- Rezolute has received orphan drug designation in the United States and European Union as well as a rare pediatric disease designation, for RZ358, enabling eligibility for a priority review voucher.
- More information can be found at rezolutebio.com.
The Associate/Director of Manufacturing Science and Technology (MSAT) will provide leadership in readiness for and conduct of product and process transfer, demonstration, scale up, facility fit, qualification, process characterization and validation for commercialization of biologics drug substance manufacture at Contract Development Manufacturing Organizations (CDMO’s). The individual will work amongst a team of CMC experts in a matrix organization, capitalizing on each other’s expertise in a highly collaborative and agile environment to advance a pipeline of metabolic disease and orphan drug therapeutics. This position will report into the Head of MSAT. Rezolute’s culture enables remote work through use of virtual communication tools integrated into its culture of innovation, agility transparency and execution. This role will be enabled to be a part of the CMC and Quality teams and will be expected to interact face to face with the internal teams and CDMO network as required.
Principle Duties and Responsibilities Include
- Provide leadership and oversight of upstream drug substance manufacturing sciences and technology (MSAT) operations as subject matter expert to the internal Rezolute team and functional interface to the external CRO and CDMO network utilized to advance the Rezolute pipeline.
- Responsible for Upstream Process Tech Transfer including but not limited to upstream (cell culture/CHO) process gap assessments, process establishment and demonstration activities. Once the process is transferred, continue to identify opportunities for process optimization, robustness and reliability
- Lead late-stage and pre-commercial upstream drug substance process qualification and validation operations, specifically PPQ and PV scope with responsibility for technical success
- Act as the upstream drug substance technical leader for all Process Characterization/DOE design, process development, Scale-down model qualification, Process demonstration, process comparability, process Qualification and Validation study design, documentation, investigations, reports and regulatory related submissions
- Integrate scientific rationale and appropriate data analysis techniques to aid in data-driven, objective decision making.
- Act as MSAT DS upstream support liaison with Rezolute matrix functions for a portfolio of externally manufactured products, ensuring readiness for regulatory filling and commercialization of the pipeline. This includes technical approval of scopes, change controls, change integration, cGMP qualification and validation documentation, review of pre/post execution documentation and data, and review of manufacturing and process investigations
- Drive development and cGMP of Scopes of Work, working collaboratively within Rezolute and the CDMO to achieve desired product / program outcomes
- Participation in CMO/vendor selection and strategy with Manufacturing, Quality, and other business functions
- Oversight and/or preparation of technical information packages, participation in due diligence and site assessments, technical evaluation of Supplier Proposal requests (RFP), supporting business agreements
- Enable (collaborate internally and externally) DS upstream process capability analysis and Continuous Process Verification of key quality attributes and parameters for biologic products, identifying and executing process robustness improvement projects where required. Drive timely, comprehensive, and accurate process data reviews and to support generation of Annual Product Quality Review documents.
- Provide advanced operational support and technical communication to Global Health Authorities in support of CMC preparation, CMC query resolution, and plant inspections. Author relevant sections of regulatory submissions (IND, IMPD, BLA, MAA); interface directly with Health Authorities to support submission approval
- Work collaboratively supporting processes (CI, OPEX etc.) to improve processing efficiency and to ensure optimized support for manufacturing, technical transfer and scale-up of processes to commercial scale.
Qualifications/Requirements - We are looking for a candidate with:
- Strong technical knowledge of upstream biologics (cell culture/CHO) drug substance manufacturing technology, operations, processing techniques, and cGMP controls with 7 – 10 years of experience in Pharmaceutical or Biotechnology industry is required.
- Direct experience designing and executing late-stage mammalian cell culture process characterization and process validation studies for monoclonal antibody products, including but not limited to DOE, scale-down model qualification, process comparability, process scale-up, establishment of process control strategy, determination of critical operating parameters, NOR/PAR range establishment and justification, process risk assessments (i.e. FMEA) and process gap assessments.
- Direct interaction, knowledge of complex biologics manufacturing and operations
- Demonstrated successes with upstream drug substance Technology Transfer and scale up of commercial monoclonal antibody manufacturing processes
- A bachelor’s or Master’s degree in relevant engineering or science discipline (biology, chemical/mechanical/bioprocess engineering, biotechnology, biochemistry, pharmacy, microbiology or a related pharmaceutical science) is required. Working knowledge of key statistical methods and tools is also highly preferred
- Candidate must demonstrate strong oral and written communication skills, as well as leadership experience. Collaboration and agility should be hallmarks of the candidate’s execution style and experience.
- The ability to travel domestically and internationally up to 20%
- Working knowledge of cGMPs, industry standards and associated regulations in manufacture of Biologics. Familiarity of regulatory environment and industry trends as appropriate
Preferred Experience, Special Skills and Knowledge - We are looking for a candidate that is:
- DS Upstream MSAT leadership and functional responsibilities within large pharma, CMO/CDMO and/or small virtual biotech companies
- Practical knowledge of IgG2 antibody product characteristics and production requirements
- Thorough knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, engineering design and process control fundamentals
- Strong understanding of project management systems and tools
- Working competency of Statistical Process Control and related tools
- Very strong technical writing and verbal communication
- Demonstrated ability to:
- influence areas not under direct control to achieve objectives
- work strategically, manage multiple programs or initiatives, and participate in a high performance work environment
- work in a matrix environment and effectively support the decentralized manufacturing function
- build alignment with business partners including Pharmaceutical Sciences, Quality Assurance, Quality Control, Regulatory and Management team
- budget, plan and manage resources efficiently
Interested and qualified candidates should send their resume to firstname.lastname@example.org to the attention of Melissa Quinn.