Associate Director – Biologics Process Development and Manufacturing
CMC: We are seeking an Associate Director – Biologics Process Development and Manufacturing to lead/drive the development of processes for a class of novel recombinant pMHC proteins to enable the advancement of the company’s therapeutic platform into human clinical trials. The process scope includes development and manufacturing from cell line through purification, to produce active proteins for subsequent conjugation reactions. All development and manufacturing activities will be executed through a CRO/CMO network, which requires significant influencing, negotiation, problem solving and decision making. This individual must have the ability to quickly understand business and technical issues, and to build effective plans to mitigate risk and ensure timely progress and successful completion of process development and manufacturing activities. This position reports toVice President – Process Sciences and Manufacturing. Compensation and title will be commensurate with experience level.
Location: South San Francisco, CA
Parvus Therapeutics is pioneering a breakthrough class of disease-specific, non-immunosuppressive biologics called NavacimsTM that are designed to halt and potentially cure autoimmune disease and other inflammatory disorders by restoring immune tolerance. The Navacim technology platform is generating a rich pipeline of therapeutic candidates to address a wide range of inflammatory diseases. Our most advanced programs target Type 1 Diabetes (T1D) (partnered with Novartis) and autoimmune liver diseases. POC and efficacy in animals has been established not only for these two programs but also for multiple sclerosis (MS) and inflammatory bowel disease (IBD).
Drug candidates have also been identified for celiac disease with others in earlier stages of research. Parvus recently announced that it had entered into a worldwide collaboration and license agreement with Genentech covering three of these programs: autoimmune liver, IBD, and celiac. In support of our new partnership, Parvus is expanding rapidly to on-board the additional resources necessary to advance these programs to the clinic.
The Parvus management team combines decades of experience in start-ups and biopharma, with demonstrated success in commercializing drugs from the lab to the market. We are seeking extraordinary and ambitious individuals who share our drive and desire to transform medicine.
- Technical oversight of biologics development from cell line development through purification
- Scope includes the development of processes, optimization and transfer to the manufacturing scale, and Parvus oversight in the manufacture of pre-GMP and GMP lots
- Establish/maintain/lead relationships with biologics CRO/CMOs to drive the timely advancement of biologics process development, and ultimately technical oversight in biologics manufacturing activities
- Responsibilities in establishing and managing the timeline and budget for biologics development and manufacturing within the Parvus development team
- Interface with Parvus collaboration partners to ensure understanding and alignment across programs in area of cell line and biologics processing
- Finalize documentation for quality records and regulatory filings associated with biologics development and manufacturing
- Authoring sections specific to biologics development and manufacturing in regulatory filings
- Work with Parvus Development team in overall planning and coordination for the CMC function within Parvus
- Doctorate (Ph.D.) degree in biochemistry, biology, bioengineering, chemical engineering, or a related field, is preferred. S./M.S. with equivalent professional experience also considered
- At least 5 years of experience in the development of biological manufacturing processes to produce therapeutics for in vivo use
- Strong technical expertise in biologics process development. Experience optimizing and scaling-up biological processes, and transferring from development to manufacturing
- An understanding of GMP requirements and Quality documentation as related to manufacturing biotherapeutics
- Experience interfacing and aligning with biologics manufacturing for clinical production
- Ability to manage development timelines and budget to support programs
- Capable of working effectively in a small, virtual company, and executing a development plan through a third party CRO network
- Experience authoring regulatory filings
- Ability to travel ~10% of the time
Parvus Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Parvus is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment.
(Req # 1200-25)
No relocation offered-local candidates only