Director, CMC Formulation Development and Manufacturing

IDEAYA Biosciences•South San Francisco, CA

2d•$215,000 - $266,000•Hybrid

About The Position

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer. When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see www.ideayabio.com. Location: South San Francisco, CA. Position Summary: We are seeking an experienced and highly motivated Director, CMC Formulation Development and Manufacturing to join our multidisciplinary team based in South San Francisco. This role requires the candidate to work collaboratively with the related cross-functional teams to support our drug discovery pipeline. The successful candidate will be responsible for but not limited to those listed below. This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy. Reporting to: Senior Director, Head of Formulation Development & Manufacturing

Requirements

Ph.D. in Pharmaceutics, Chemistry, Chemical Engineering or related discipline with a minimum of (12) years or M.S with a minimum of (15) years of development experience and demonstrated ability in leading cross-functional groups.
Late phase and commercial experience are a plus.
Demonstrated track record of success in delivering timely execution of DP and CMC activities ranging from preclinical, IND-enabling and NDA material supplies, through GMP clinical trial supplies and commercialization.
Demonstrated expertise in small molecule formulation development (traditional oral solid dosage and enabling formulations such as ASD and HME is a plus), scale-up and manufacturing, and phase appropriate control strategy and specification development.
Experience with analytical techniques for small molecules and oral solid dose products, with proficiency in UPLC/HPLC, dissolution, and solid-state characterization techniques such as DSC/TGA, PLM, XRPD and laser diffraction PSD method.
Track records to interpretate the analytical data and application to support formulation development.
Good understanding of physico-chemical properties of API, PK/PD correlation and develop the phase appropriate formulations
Strong understanding of Quality systems including SOPs, manufacturing record review, batch release and disposition, Good Documentation Practices, cGMP data traceability, Deviations, and Change Management.
Demonstrated knowledge and application of current industry and compendial standards and regulatory authority guidance and expectations, including ICH, FDA, MHRA, and EMA guidelines and USP-NF, Ph. Eur, BP, and JP compendia
Experience in managing global CDMOs and reviewing documentation and ensuring proper guidelines are followed.
Exceptional problem-solving skills and ability to quickly adapt and shift focus as needed
Excellent interpersonal and communication skills for internal and external collaborations
Ability to multi-task in a fast-paced dynamic environment while demonstrating a calm and positive attitude and a superior work ethic
Excellent interpersonal communication and decision-making skills
Able to travel domestic and internationally to oversee DP development and manufacturing at CDMOs
All employees are expected to act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies, including IDEAYA’s Code of Conduct. Employees must demonstrate good judgement and ethical behavior in all business activities, maintain patient and product safety as a top priority, and report any suspected violations of law or Company policy through appropriate channels

Nice To Haves

Late phase and commercial experience are a plus.
enabling formulations such as ASD and HME is a plus

Responsibilities

Lead the formulation efforts in facilitating drug development by managing multiple CDMOs across all stages of drug development (pre-clinical, Phase I – III, and commercial)
Author and review technical development reports, batch records, campaign reports, change controls, corrective and preventative actions, deviations, and investigation.
Author and review necessary technical sections in IND/IMPD/NDA supporting global CMC regulatory submission and remain current on Health Authority guidance and expectations.
Develop DP strategies to meet program and project development targets, ensure timely and efficient delivery of high-quality products, and facilitate regulatory approvals.
Represent DP/CMC and participate in cross functional project teams and manage multiple priorities in a fast-paced, dynamic environment and enact quick problem solving to ensure on-time supply of drug to support PK/PD, efficacy, DRF and pilot toxicology studies, IND-enabling activities, and clinical trials across a portfolio of programs.
Collaborate closely in cross-functional teams including but not limited to Medicinal Chemistry, DMPK, Analytical Chemistry, Process Chemistry, Toxicology, Quality, Project Management, CMC Regulatory, Development Sciences, and Clinical Pharmacology to achieve project goals.
Proactively communicate with and work closely with other functions to align DP and CMC strategies to achieve and maintain aggressive timelines to ensure goals are met
Lead dosage form selection, formulation development, process optimization, and scale-up activities, ensure robust, cost-effective, and scalable manufacturing processes.
Lead the evaluation, selection, and management of CDMOs to perform formulation and process development, and GMP manufacture.
Oversee technology transfer activities at CDMOs to ensure successful manufacturing and provide technical expertise in troubleshooting and resolving issues as necessary.