Associate Director / Director, Contract Manufacturing

Programmable Medicine, a clinical stage biopharmaceutical company located in Redwood City, is seeking an experienced individual to focus on leading our contract manufacturing efforts including Drug Substance and Drug Product. The successful candidate will be required to work on site 5 days per week. We are focused on developing novel nanomedicines, HD therapeutics (HDTs), to treat unmet medical needs in ophthalmology, neurology, inflammatory diseases, and neuro-oncology. Our HD platform builds therapeutics that are selectively taken up only by inflamed tissues, allowing us to treat diseases with unprecedented precision.Role SummaryWe are seeking an experienced individual to manage uninterrupted manufacturing of Clinical Supply and eventual commercial products through execution of manufacturing campaigns within our external contract manufacturing network while ensuring compliance with cGMP, regulatory requirements. This is an individual contributor, hands-on position. As the company continues to grow, Individuals with demonstrated leadership experience may assume responsibility for managing direct reports.The candidate will have demonstrated experience working with cross functional teams (chemistry, translational, manufacturing, analytical, Clinical Supply Chain) and CDMOs in a pharmaceutical or biotechnology companyKey Responsibilities Act as drug substance and drug product technical lead for small molecule programs and dendrimers manufacturing Oversee the execution of activities associated with injectable and solid oral drug product development and manufacturing, supporting clinical development and subsequent commercialization Manage drug substance and drug product Tech Transfer activities and ensure timely resolution of complex issues associated with manufacturing and/or compliance Provide tactical and technical support and oversight of CDMOs and strategic suppliers to ensure overall program and company deliverables are achieved Work closely with CDMOs and internal Quality and Technical teams to complete investigations and deviations In collaboration with QA, conduct audits of CDMOs facilities and follow up Work closely with CDMOs and internal Quality and Technical teams to complete investigations and deviations Support root cause analysis and product impact assessments for technical issues including investigations resulting from deviations and OOS events Collaborate with Quality to ensure GMP practices are followed by the CDMOs and implement appropriate controls and act as a liaison for Quality release Author and review technical documents such as protocols, reports, risk assessments, and CMC sections of regulatory filings Ability to review master batch records and approve executed batch records Provide Person-In-Plant (PIP) support at CDMOs as needed Represent Technical Operations function at team meetings and sub-team meetings with Clinical Operations, Clinical, Clinical Supply Chian, Quality Assurance, and Regulatory Affairs Responsible for drug substance and drug product and collaborating with Finance to prepare budget recommendations and management/tracking of associated expenses Support regulatory submissions (IND, IMPD, amendments, IB, etc.) Deep understanding of pre-filled syringe and autoinjector device development to develop options and mitigate risks in transitioning between product presentations Develop the COG models for DS and DP Participate in identifying and selecting CDMOs, preparing RFP, negotiating contracts Requirements PhD, MS, or Bachelor's degree in Pharmaceutical, Chemical Engineering, Biotechnology, or life sciences 9+ years of small molecules or Biologics development and manufacturing experience of injectables and oral dosage forms Expertise with cGMP manufacturing as well as regulatory requirements and requirements for biopharmaceutical products Demonstrated ability to manage multiple complex relationships with CDMO network Demonstrated skills in collaborating both strategically and tactically with clinical development/operations, analytical development, QA, RA, and Clinical Supply Chain. Substantial experience leading tech transfer to CDMOs and supporting DS/DP campaigns Excellent communication skills Ability to multi-task and keep pace with a fast-moving organization Availability to participate in calls across multiple international time zones Ability and willingness to travel What We Can Offer YouThis is a unique opportunity to join a team focused on a new class of precision medicines that selectively treat diseased cells in regions of inflammation. By making precision medicine even more precise, our nanomedicine technology has the potential to change the standard of care across ophthalmology, neurology, inflammatory diseases and neuro-oncology. You will have the opportunity to learn new skills and gain a better understanding of the cutting-edge technology. We have a comprehensive total compensation package including fully paid medical, dental, and vision benefits for you and your family. We want all of our employees to have the opportunity to become shareholders and offer new hire stock options. The Company also offers participation in the annual bonus program. At the Associate Director level, the salary range for this position is $160,000 - $185,000 annually. The range for a Director is $185,000 - $243,000. We consider various factors when determining the base compensation, including market survey data, experience, qualifications, and geographic location, which means that the actual compensation may vary