We are seeking an Associate Director – Drug Product Development and Manufacturing to lead/drive the development of drug formulations and drug product presentations for a class of novel therapeutics referred to as Navacims, to enable the advancement of the company’s therapeutic platform into human clinical trials. The scope also includes the development of a drug process manufacturing process (filling and lyophilization), technical responsibility for the manufacturing of drug product lots, and technical oversight of drug substance (DS) and drug product (DP) stability programs. All development, manufacturing and stability 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 to Vice President - Process Sciences and Manufacturing. Compensation and title will be commensurate with experience level.
Responsibilities and duties include:
- Technical leader of formulation development activities for drug substance and drug product, and for the development of a drug product manufacturing process
- Establish/maintain/lead relationships with relevant CRO/CMOs to drive the timely advancement of formulation and drug product process development
- Work closely with QC and Manufacturing functions within Parvus to give technical support and oversight to DP manufacturing, testing and stability activities.
- Responsibilities in establishing and managing the timeline and budget for drug product development and manufacturing within the Parvus development team
- Interface with Parvus collaboration partners to ensure understanding and alignment in areas of technical responsibility
- Finalize development, manufacturing, and testing documentation for quality records and regulatory filings specific to formulation development, stability, in-use, and drug product manufacturing
- Work with Parvus Development team in overall planning and coordination for the CMC function within Parvus
Required Skills/Experience:
- Doctorate (Ph.D.) degree in biochemistry, biology, chemistry, pharmaceutical sciences, chemical engineering, or a related field, is preferred.B.S./M.S. with equivalent professional experience also considered
- At least 5 years of experience in the development of drug formulations and drug product manufacturing processes to produce therapeutics for in vivo use
- Strong technical expertise in formulation science, related analytical methodologies and drug product manufacturing technologies
- Familiarity with ICH stability guidelines and the development of stability programs to enable clinical supply
- Experience optimizing and scaling-up drug product manufacturing processes, and transferring from development to manufacturing
- An understanding of GMP requirements and Quality documentation as related to drug product manufacturing and QC testing
- Experience interfacing and aligning with drug product 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 preparing regulatory filings
- Ability to travel ~20% of the time
If you are interested, please submit your CV to [email protected]
Organization Details
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.